IMMUNOGEN INC (IMGN) SPO
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|Company Name||IMMUNOGEN INC|
|Company Address||830 WINTER ST
WALTHAM, MA 02451
|CEO||Mark J. Enyedy|
|Employees (as of 12/31/2016)||308|
|State of Inc||MA|
|Fiscal Year End||6/30|
|Exchange||NASDAQ Global Select|
|Shares Over Alloted||0|
|Shareholder Shares Offered||--|
|Lockup Period (days)||180|
|Quiet Period Expiration||11/13/2017|
We estimate that the net proceeds we will receive from this offering, based on the assumed public offering price of $7.65 per share, the last reported sale price of our common stock on The NASDAQ Global Select Market on October 3, 2017, will be approximately $93.2 million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, or approximately $107.2 million if the underwriters exercise their option to purchase additional shares in full. A $1.00 increase (decrease) in the assumed public offering price would increase (decrease) the net proceeds to us by approximately $12.2 million, assuming that the number of shares offered by us (based on the assumed public offering price of $7.65 per share) remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. An increase (decrease) of 100,000 shares in the number of shares offered by us would increase (decrease) the net proceeds to us from this offering by approximately $0.7 million, assuming that the assumed public offering price of $7.65 per share remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering to fund our operations, including, but not limited to, research and development activities, clinical trial activities, manufacturing and supply of drug substance and drug products, commercialization preparation, acquisitions of new technologies, capital expenditures and working capital. We have not determined the amounts we plan to spend on any of the areas listed above or the timing of these expenditures. The amounts and timing of these expenditures will depend on a number of factors, such as whether and when we receive any regulatory approvals for our product candidates, our ability to enter into additional collaboration, licensing or similar transactions, the timing and progress of our research and development efforts, technological advances and the competitive environment for our product candidates. As a result, our management will have broad discretion to allocate the net proceeds from this offering. We have no current plans, commitments or agreements with respect to any acquisitions and may not make any acquisitions. Pending application of the net proceeds as described above, we intend to invest the net proceeds of the offering in short-term, investment-grade, interest-bearing securities.
We focus on highly competitive areas of product development. Our competitors include major pharmaceutical companies and other biotechnology firms. For example, Pfizer, Seattle Genetics, Roche, Takeda, AbbVie, and BristolMyers Squibb have programs to attach a cellkilling small molecule to an antibody for targeted delivery to cancer cells. Pharmaceutical and biotechnology companies, as well as other institutions, also compete with us for promising targets for antibodybased therapeutics and in recruiting highly qualified scientific personnel. Additionally, there are nonADC therapies available and/or in development for the cancer types we and our partners are targeting. Many competitors and potential competitors have substantially greater scientific, research and product development capabilities, as well as greater financial, marketing and human resources than we do. In addition, many specialized biotechnology firms have formed collaborations with large, established companies to support the research, development and commercialization of products that may be competitive with ours. In particular, competitive factors within the antibody and cancer therapeutic market include: . the safety and efficacy of products; . the timing of regulatory approval and commercial introduction; . special regulatory designation of products, such as Orphan Drug designation; and . the effectiveness of marketing, sales, and reimbursement efforts. Our competitive position depends on our ability to develop effective proprietary products, implement clinical development programs, production plans and marketing plans, including collaborations with other companies with greater marketing resources than ours, and to obtain patent protection and secure sufficient capital resources. Continuing development of conventional and targeted chemotherapeutics by large pharmaceutical companies and biotechnology companies may result in new compounds that may compete with our product candidates. Antibodies developed by certain of these companies have been approved for use as cancer therapeutics. In the future, new antibodies or other targeted therapies may compete with our product candidates. Other companies have created or have programs to create potent cellkilling agents for attachment to antibodies. These companies may compete with us for technology outlicense arrangements.
ImmunoGen, Inc. is a biotechnology company that is progressing toward becoming a fully-integrated company delivering innovative antibody-drug conjugate, or ADC, therapies that meaningfully improve the lives of people with cancer. An ADC with our proprietary technology comprises an antibody that
binds to a target found on tumor cells and is conjugated to one of our potent anti-cancer agents as a "payload" to kill the tumor cell once the ADC has bound to its target. ADCs are an important and expanding approach to the treatment of cancer, with four approved products and the number of agents in development growing significantly in recent years. We have established a leadership position in ADCs, with a robust portfolio and a productive platform that has generated differentiated candidates for cancer treatment. --- Mirvetuximab Soravtansine — Speed-to-Market Strategy as Potential Single Agent Treatment for Platinum-Resistant Ovarian Cancer, Comprehensive Development Plan to Expand the Opportunity Our proprietary portfolio is led by mirvetuximab soravtansine, a first-in-class ADC targeting folate-receptor alpha, or FR a, that is now in a Phase 3 trial for platinum-resistant ovarian cancer. Mirvetuximab soravtansine has a differentiated profile with a distinct mechanism of action and is the first ADC to enter pivotal development for the treatment of ovarian cancer. It comprises an FR a-binding antibody, which serves to target the ADC to FR a-expressing cancer cells, and our potent DM4 payload agent to kill the targeted cancer cells. It has demonstrated activity in platinum-resistant and platinum-sensitive ovarian cancer with a safety profile that supports expanded use as a combination agent. It has been granted orphan drug status for ovarian cancer in the United States and the European Union. We have a comprehensive strategy for developing mirvetuximab soravtansine and believe it has a role across multiple treatment settings, including the potential to replace single-agent chemotherapy in the treatment of ovarian cancer and to be the preferred agent for combination treatment of the disease. Beyond ovarian cancer, we believe the opportunity for mirvetuximab soravtansine is further expanded with other FR a-positive cancers, including non-small cell lung, endometrial, and triple negative breast cancers. Ovarian cancer is the fifth most common cause of cancer death in women in the United States. Initial treatment typically entails tumor-debulking surgery, followed by platinum-based chemotherapy. Once the cancer becomes platinum-resistant, patients may receive a wide array of treatments. There remains an urgent need to improve treatment of ovarian cancer, including through combination therapies, as response rates with single-agent therapies are limited, with 3.5 to 4 months median progression-free survival, or PFS, and challenging side effects. In June 2017 at the American Society of Clinical Oncology, or ASCO, annual meeting, we reported data on 113 ovarian cancer patients treated with mirvetuximab soravtansine from three Phase 1 expansion cohorts. From this pooled analysis, in the subset of 36 patients meeting the key eligibility criteria for FORWARD I, the confirmed overall response rate, or cORR, was 47 percent (95% CI 30, 65) and median PFS, or mPFS, was 6.7 months (95% CI 4.1, 8.3). The findings reported with this pooled population were consistent with data previously reported (ASCO 2016), including the safety profile consisting of low grade, manageable adverse events. The following table shows cORR and mPFS as reported at the ASCO annual meeting in 2016 and 2017: ASCO 2016 Analysis ASCO 2017 Pooled Analysis PROC 1 - 3 PROC 1 - 3 priors + priors + All med/high FR a med/high FR a Patients expression expression (n=46) (n=16) All Patients (n=113) (n=36) cORR (95% CI) 26% 44% 30% 47% (14, 41) (20, 70) (22, 39) (30, 65) mPFS months (95% CI) 4.8 6.7 4.3 6.7 (3.9, 5.7) (3.9, 11.0) (3.9, 5.4) (4.1 ,8.3) FORWARD I — Single-Agent Therapy for Platinum-Resistant Disease We are conducting a Phase 3 registration trial, FORWARD I, with mirvetuximab soravtansine for use as single-agent therapy to treat patients with platinum-resistant ovarian cancer whose tumors express high or medium levels of FR a and who have received up to three prior treatment regimens. We estimate 12,000-14,000 patients per year in the United States and Europe, respectively, meet these criteria. We expect FORWARD I will enroll 333 patients who will be randomized 2:1 to mirvetuximab soravtansine, or physician's choice, which includes pegylated liposomal doxorubicin, or PLD, or topotecan, or weekly paclitaxel. The primary endpoint of the trial is PFS for high FR a expressers only and for all patients, or high and medium FR a expressers. We expect the trial to fully enroll in 2018. We expect to have data from FORWARD I in 2019 and, if favorable, to submit a biologics license application to the U.S. Food and Drug Administration, or FDA, in 2019. FORWARD II — Combination Therapy for Expanded Patient Population Additionally, we are accruing patients in a companion study, FORWARD II, to evaluate mirvetuximab soravtansine in combination regimens to potentially expand the number of patients with ovarian cancer eligible for treatment with the ADC, including to those with platinum-sensitive disease. The FORWARD II trial consists of cohorts assessing mirvetuximab soravtansine in combination with, in separate doublets, Avastin® (bevacizumab), PLD, carboplatin, and Keytruda® (pembrolizumab) for evaluation in combination with mirvetuximab soravtansine. We reported the first clinical data from FORWARD II in June 2017, from which we concluded that mirvetuximab soravtansine may complement currently available therapies in a range of treatment settings, including earlier lines of therapy. The following table shows cohort data with respect to combination treatment with Avastin, Keytruda and carboplatin: Combination Agents Phase 1b/2 Study Avastin Keytruda Carboplatin Number enrolled 14 13 (platinum-resistant) 18 (platinum-resistant) (platinum-sensitive) Median number of 6 (2 - 8) 5 (2 - 7) 3 (1 - 5) prior therapies (range) Grade 3 or Hypertension, small None Neutropenia, anemia, greater adverse intestinal thrombocytopenia, events in >1 pt obstruction hypokalemia Dose limiting 1 pt with Grade 2 None 1 pt with Grade 3 toxicity neutropenia and vasculitis thrombocytopenia Objective 29% (95% CI 8, 58) NA 65% (95% CI 38, 86) response rate Median 9.5 (95% CI 3.5, NA 12.1 (95% CI 9.0, progression-free 15.2) 15.0) survival (months) Based on the data from these initial cohorts, including observation of clinical benefit beyond one year, we have advanced expansion cohorts for the Avastin and Keytruda combinations to Phase 2 testing and are planning an expansion cohort for a triplet combination evaluating mirvetuximab plus Avastin and carboplatin. We expect to report additional data from FORWARD II during 2018. Commercialization If we receive marketing approvals, we intend to market mirvetuximab soravtansine ourselves in the United States and Europe and to partner it in other geographies. Expanding into earlier lines of treatment through use in combination regimens could significantly expand the opportunity. IMGN779 and IMGN632 — Accelerating Pipeline of Earlier-Stage Antibody-Drug Conjugates We have also developed a new class of indolino-benzodiazepine DNA-acting payload agents that we refer to as IGNs. Our IGNs alkylate DNA without cross-linking it, which we have found to provide important tolerability benefits in preclinical models. Preclinically, IGN ADCs have demonstrated the ability to retain anti-tumor potency of crosslinking drugs with less toxicity to normal cells. This potentially allows for repeat administration with reduced cumulative toxicity compared to an ADC with a crosslinking payload. Our IMGN779 and IMGN632 product candidates use our IGN payloads. IMGN779 combines a high-affinity, humanized anti-CD33 antibody with one of our novel IGNs, resulting in potent anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells. We reported the first clinical data from a Phase 1 clinical trial in June 2017. To date, we have observed a favorable safety profile with repeat dosing, no dose-limiting toxicities and dose-dependent biological and anti-leukemia activity. IMGN779 is progressing through dose escalation in a Phase 1 trial in AML. We expect to report additional data from the Phase 1 trial in late 2017. We are also advancing IMGN632, a preclinical CD123-targeting ADC that uses an even more potent IGN with a new engineered linker and novel antibody, which we are developing for hematological malignancies. We expect to begin clinical testing of IMGN632 before the end of 2017. In August 2017, we announced a strategic collaboration and option agreement with Jazz Pharmaceuticals to develop and co-commercialize ADCs. Jazz has exclusive worldwide rights to opt into development and commercialization of IMGN779, IMGN632 and a third program to be named later from our early-stage pipeline. --- We were organized as a Massachusetts corporation in March 1981. Our principal offices are located at 830 Winter Street, Waltham, Massachusetts 02451, and our telephone number is (781) 895-0600. We maintain a web site at www.immunogen.com.
|Auditor||Ernst & Young LLP|
|Company Counsel||Mintz, Levin, Cohn, Ferris, Glovksy and Popeo, P.C|
|Company Counsel||Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.|
|Lead Underwriter||Jefferies LLC|
|Lead Underwriter||Leerink Partners LLC|
|Lead Underwriter||RBC Capital Markets, LLC|
|Transfer Agent||Broadridge Corporate Issuer Solutions, Inc|
|Underwriter||Canaccord Genuity Inc|
|Underwriter Counsel||Latham & Watkins LLP|
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