Onconova Therapeutics, Inc. Announces $5.0 Million Registered Direct Offering Priced At-The-Market

On December 9, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it has entered into definitive agreements with healthcare focused institutional investors for the issuance and sale in a registered direct offering of 14,326,648 shares of its common stock and warrants to purchase up to 7,163,324 shares of its common stock, at a combined purchase price of $0.349 per share and associated warrant, for aggregate gross proceeds of approximately $5.0 million in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Onconova, DEC 9, 2019, View Source [SID1234552124]).

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $0.287 per share and exercise period commencing immediately upon issuance and a term of five (5) years.

The offering is expected to close on or about December 10, 2019, subject to the satisfaction of customary closing conditions. Upon the closing of the offering, the Company’s stockholders’ equity is expected to exceed the minimum $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(b)(1), and the Company intends to provide further information to Nasdaq demonstrating its ability to sustain long-term compliance. In addition, 10,443,000 common stock warrants have been exercised since November 25, 2019, resulting in additional proceeds to the Company of approximately $2.1 million.

The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including advancing preparations for a planned New Drug Application (NDA) filing to the FDA for intravenous rigosertib in second-line higher-risk MDS in 2020. The Company surpassed 90% of the required enrollment of the INSPIRE Trial in November 2019 and anticipates reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events. With the additional proceeds from the offering and the proceeds from the recent warrant exercise, the Company believes that it has the sufficient funds to extend operations and ongoing trials late into the third quarter of 2020.

The securities described above are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-221684), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on December 28, 2017. The offering of the securities will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Novartis Kymriah® demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting

On December 9, 2019 Novartis reported results from two analyses of real-world experience with Kymriah (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications (Press release, Novartis, DEC 9, 2019, View Source [SID1234552123]). These analyses are from a readout of a 15-year post-marketing study that add to and complement the rigor of the Kymriah pivotal trials with evidence of the Kymriah real-world experience in expanded groups of patients. When Kymriah was used in the real-world setting, efficacy and safety were consistent when compared to the pivotal trials, including the 24-month analysis of JULIET in adults with r/r diffuse large B cell lymphoma (DLBCL) and ELIANA in children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL)1-6. The real-world experience data were presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.

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"With increased experience supplemented by real world data, physicians like myself have a better understanding of Kymriah and its safety profile," said lead author of this real-world experience analysis, Samantha Jaglowski, MD, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). "This along with the current practice of supportive care for CAR-T therapy provides the ability to routinely use this therapy in the hospital outpatient setting, which can reduce financial burden on patients and hospitals alike1,7."

Real-world experience with Kymriah in adults with r/r DLBCL

Efficacy
Efficacy outcomes for patients who received Kymriah in the real-world setting were similar to those demonstrated in JULIET. In this analysis of 80 patients with r/r DLBCL for whom three or more months of post-infusion outcomes were available, the overall response rate (ORR) was 58% including 40% who achieved a complete response (CR). Median follow-up was 4.5 months1. In the 24-month analysis of the JULIET trial, ORR was 52% and CR was 38% (N=115) 3.

Safety
The anticipation and management of adverse events of CAR-T cell therapy have been crucial to successful administration of this innovative and relatively new type of therapy. In this analysis of real-world experience with Kymriah (safety set, N=83), the rate of grade 3 or higher cytokine release syndrome (CRS) and neurologic events were approximately 4% and 5%, respectively, as compared to 23% and 11% in the JULIET clinical trial (safety set, N=115), suggesting safety outcomes appear more favorable. The real-world analysis used the grading scales ASTCT for CRS and ICANs for neurologic events, whereas the JULIET trial used the Penn Grading Scale for CRS and MedDRA SMQ for neurologic events1,3.

Further, for patients who had CRS, tocilizumab and corticosteroids were administered in 20% and 4% of patients, respectively, in the real-world setting, and in 27% and 19% of patients, respectively, in the JULIET trial8. Some patients in the real-world setting received tocilizumab earlier than in the clinical trial experience, indicating earlier use of supportive care may mitigate rates of high-grade CRS9. A total of 14 DLBCL patients died after treatment, all due to disease progression, however no deaths were attributed to toxicities from Kymriah1.

Patient and product characteristics
More patients in the real-word analysis had a worse performance status, and on average, these patients were older and had received more lines of therapy than those treated in the JULIET trial1-3.

Cell viability is one of many product release specifications for Kymriah. The commercial specification for the viability specification of Kymriah in the United States is set at greater than or equal to 80%. For all other markets where KYMRIAH is approved, the cell viability specification is greater than or equal to 70%. In this US real-world analysis, 29 of the 102 patients with evaluable data received product that was below 80% cell viability. Efficacy and safety for patients receiving product with cell viability below the commercial specification was the same as those receiving commercial Kymriah1.

These data on the use of Kymriah in r/r DLBCL in the real-world setting will be presented in an oral session at the ASH (Free ASH Whitepaper) annual meeting (Abstract # 766; Monday, December 9, 3:30 PM EST).

"As pioneers in bringing CAR-T cell therapy to patients, our dedication to reimagining how CAR-T cell therapy can impact patients in the future remains steadfast," said Susanne Schaffert, PhD, President, Novartis Oncology. "Our efforts include gathering and sharing real-world evidence, expanding and improving our manufacturing capacity and technology and going broader and deeper in our clinical research with Kymriah and other CAR-T cell therapies."

Real-world experience with Kymriah in children and young adults with r/r ALL

Efficacy outcomes were similar and safety outcomes appear to be more favorable in the real world setting compared to the ELIANA pivotal trial4-6. Among 146 children and young adult patients with r/r ALL treated in the real world setting for whom three or more months of post-infusion outcomes were available, CR was 85% as compared to 82% in the ELIANA trial (n=79). Median follow-up in the real-world analysis was 6 months. In this analysis (safety set, N=154), the rate of grade 3 or higher CRS and neurologic events were 14% and 8%, respectively, as compared to 48% and 13% in the ELIANA clinical trial. The real-world analysis used the grading scales ASTCT for CRS and ICANs for neurologic events, whereas the ELIANA trial used the Penn Grading Scale for CRS and MedDRA SMQ for neurologic events4-6.
"It is exciting to see how oncologists are using Kymriah and how patients are responding to it in routine clinical practice," said Stephan A. Grupp, MD, PhD, Director of the Cancer Immunotherapy Program and Section Chief of Cell Therapy and Transplant at Children’s Hospital of Philadelphia, and a Professor of Pediatrics in the Perelman School of Medicine at the University of Pennsylvania. "We are seeing broader efficacy data that replicate what we saw in the pivotal trial, and the collection of these data is ensuring that we are getting a clear view of adverse events when administering Kymriah."

These data on the use of Kymriah in r/r pediatric ALL in the real-world setting will be presented in a poster presentation at the ASH (Free ASH Whitepaper) annual meeting (Abstract #2619; Sunday, December 8, 6:00 – 8:00 PM EST).

The collection of this real-world experience data was made possible by a collaboration between the CIBMTR (Center for International Blood and Marrow Transplant Research – the research collaboration between the National Marrow Donor Program/Be The Match and the Medical College of Wisconsin) and Novartis, developed to capture long-term follow-up of recipients of Kymriah who agree to participate in the registry. For patients whose cell viability was below 80%, product is provided through an established EAP program and long-term follow-up is captured through the CIBMTR. Globally, 90% patients who have been prescribed Kymriah have received the final manufactured product, either commercially, or when out of commercial specification.

Kymriah (tisagenlecleucel, formerly CTL019) US Important Safety information
Kymriah may cause side effects that are severe or life-threatening, such as Cytokine Release Syndrome (CRS) or Neurological Toxicities. Patients with CRS may experience symptoms including difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, or dizziness/lightheadedness. Patients may be admitted to the hospital for CRS and treated with other medications.

Patients with neurological toxicities may experience symptoms such as altered or decreased consciousness, headaches, delirium, confusion, agitation, anxiety, seizures, difficulty speaking and understanding, or loss of balance. Patients should be advised to call their healthcare provider or get emergency help right away if they experience any of these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after Kymriah infusion. Kymriah can increase the risk of life-threatening infections that may lead to death. Patients should be advised to tell their healthcare provider right away if they develop fever, chills, or any signs or symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia), where one or more types of blood cells (red blood cells, white blood cells, or platelets) are decreased. The patient’s healthcare provider will do blood tests to check all of their blood cell counts after treatment with Kymriah. Patients should be advised to tell their healthcare provider right away if they get a fever, are feeling tired, or have bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is increased. It is expected that patients may develop hypogammaglobulinemia with Kymriah, and may need to receive immunoglobulin replacement for an indefinite amount of time following treatment with Kymriah. Patients should tell their healthcare provider about their treatment with Kymriah before receiving a live virus vaccine.

After treatment with Kymriah, patients will be monitored lifelong by their healthcare provider, as they may develop secondary cancers or recurrence of their cancer.

Patients should not drive, operate heavy machinery, or do other dangerous activities for eight weeks after receiving Kymriah because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, weakness, dizziness, and seizures.
Some of the most common side effects of Kymriah are difficulty breathing, fever (100.4°F/38°C or higher), chills/shaking chills, confusion, severe nausea, vomiting and diarrhea, severe muscle or joint pain, very low blood pressure, dizziness/lightheadedness, and headache. However, these are not all of the possible side effects of Kymriah. Patients should talk to their healthcare provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their healthcare provider may do a pregnancy test. There is no information available for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah is not recommended for women who are pregnant or breast feeding. Patients should talk to their healthcare provider about birth control and pregnancy.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
After receiving Kymriah, patients should be advised that some commercial HIV tests may cause a false-positive test result. Patients should also be advised not to donate blood, organs, or tissues and cells for transplantation after receiving Kymriah.

Molecular Templates Announces Presentations at the American Society of Hematology (ASH) 2019 Annual Meeting

On December 9, 2019 Molecular Templates, Inc., (Nasdaq: MTEM) a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics, reported the presentations of two posters on its pipeline programs at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting, taking place December 7-10, 2019 in Orlando, Florida (Press release, Molecular Templates, DEC 9, 2019, View Source [SID1234552122]). One of these posters includes final results from the Phase 1/1b study of MT-3724, in subjects with relapsed/refractory (R/R) diffuse large b-cell lymphoma (DLBCL).

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Poster Title: Monotherapy Activity with the First CD20-Targeted Immunotoxin, MT-3724, in Subjects with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Abstract Number: 4098
Presenter: Daniel Persky MD, University of Arizona Cancer Center
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials
Time: Monday, December 9, 2019: 6:00 PM-8:00 PM ET
This is a multi-center, open-label, dose-escalation and dose-expansion study of MT-3724, the first CD20 targeted immunotoxin to enter clinical trials. The Phase 1/1b portion of the study consists of two Parts in which a total of 27 subjects with NHL were enrolled; 21 in Part 1 (dose escalation) and 6 in Part 2 (expansion cohort), both closed to enrollment. In total, 25 subjects were evaluable for efficacy, including 19 subjects with DLBCL or mixed DLBCL/follicular lymphoma.

MT-3724 competes for binding with rituximab (RTX) and other commercially available CD20-targeting monoclonal antibodies. Consistent with this competition, initial efficacy data from the dose expansion study revealed only one of eight subjects with measurable serum rituximab (RTX) levels had any suggestion of benefit (a mixed response) to MT-3724.

The expansion cohort mandated negative serum RTX levels for enrolled subjects. Of the 13 serum rituximab negative (RTX-neg) DLBCL or mixed DLBCL/FL subjects, 5 responded (38% objective response rate) across the range of 5 to 100 μg/kg doses. Of the 5 responses, 2 were complete responses (CRs) and 3 were partial responses (PRs). Three patients had stable disease (including 2 patients with 49% and 47% tumor reductions) and 5 patients had progressive disease.

Of the 5 serum RTX-neg subjects with DLBCL who received MT-3724 at 50 μg/kg, the maximum tolerated dose (MTD), 3 responded (2 CR, 1 PRs). Of all 25 subjects evaluable for efficacy, 13 developed anti-drug antibodies (ADAs) or neutralizing antibodies (NAbs); the development of ADAs or NAbs did not preclude benefit of MT-3724, consistent with what has been seen with other immunotoxins. Safety events were mostly mild to moderate, and dose limiting toxicities (DLTs) were indicative of innate immune response, including grade 2 capillary leak syndrome and grades 1-3 arthralgias and myalgias. No life-threatening toxicities were attributed to MT-3724.

A Phase 2 dose-expansion portion of the study (Part 3) has been initiated to investigate MT-3724 in serum RTX-neg subjects with DLBCL. This is actively enrolling globally. A tolerable dose and schedule for the Phase 2 has been identified: 50 μg/kg/dose with a cap of 6000 μg/dose infused over 1 hour on Days 1, 3, 5, 8, 10 and 12 of a 21-day cycle. (ClinicalTrials.gov Identifier: NCT02361346).

Poster Title: A Phase 2a Open-Label Study to Investigate Safety and Tolerability (including the MTD), Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in Combination with Lenalidomide in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Presenter: Jason Tache, DO, BRCR Medical Center
Abstract #: 1597
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials
Time and Location: Saturday, December 7, 2019: 5:30 PM-7:30 PM ET
MT-3724. a novel Engineered Toxin Body (ETB), possesses specific and high affinity for CD20+ cells and causes apoptosis via a unique mechanism of action, forced internalization of the ETB bound to the receptor, retrograde transport through the cytosol, and enzymatic deactivation of ribosomal function. Therefore, combining MT‑3724 with standard cytotoxic chemotherapy and/or immune modulatory agents may provide enhanced benefit in NHL treatment algorithms. This is a multi-center, open-label, multiple-dose Phase 2a study designed to evaluate MT-3724 in combination with lenalidomide in adult subjects with histologically confirmed, relapsed or refractory NHL. The primary objective is to determine safety and tolerability, including the MTD, of MT-3724 + lenalidomide. Secondary objectives include pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and tumor response.

The study will be conducted in two parts: Part 1 will include MT-3724 dose escalation according to the modified 3+3 design to identify the MTD of MT-3724 in combination with standard doses of lenalidomide and will include up to 24 subjects with histologically confirmed NHL. Part 2 is designed to confirm the safety and tolerability of MT-3724 + lenalidomide in the MTD Expansion Cohort, where the dose declared as MTD of MT-3724 in Part 1 would be given in combination with lenalidomide in up to 40 subjects with CD20+ DLBCL. In addition, the PK, PD, immunogenicity and tumor response of MT-3724 + lenalidomide will be evaluated in Part 2.

The study is currently ongoing; eligible subjects will be identified and treated through competitive enrollment at multiple study centers (ClinicalTrials.gov Identifier: NCT03645395).

Copies of the posters presented at ASH (Free ASH Whitepaper) can be found in the Presentations section of Molecular Templates’ website at View Source

Merck to Acquire ArQule, Advancing Leadership in Oncology

On December 9, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and ArQule, Inc. (Nasdaq: ARQL) reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion (Press release, Merck & Co, DEC 9, 2019, View Source [SID1234552121]). ArQule is a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. ArQule’s lead investigational candidate, ARQ 531, is a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies.

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"ArQule’s focus on precision medicine has yielded multiple clinical-stage oral kinase inhibitors that have novel and important properties," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "This acquisition strengthens Merck’s pipeline with the addition of these strategic assets including, most notably, ARQ 531, a compelling candidate for the treatment of B-cell malignancies."

BTK inhibition has been shown to prevent B-cell receptor signaling that is critical for the survival and proliferation of leukemic cells in many B-cell malignancies. ARQ 531 is a highly selective, reversible inhibitor that blocks both wild-type BTK and the C481S mutant form of the enzyme that is commonly associated with resistance to other BTK inhibitors. In early clinical trials, ARQ 531 demonstrated a manageable safety profile and early signs of anti-tumor activity for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and Richter’s Transformation. Final data from the Phase 1 study of ARQ 531 will be presented on Dec. 9, 2019 at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida.

"We are proud that Merck has recognized the contributions that ArQule, together with its scientific collaborators, has made to the field of precision medicine in oncology with ARQ 531 for the treatment of B-cell malignancies and with the rest of our clinical-stage pipeline," said Paolo Pucci, CEO, ArQule. "With this agreement, ArQule’s pipeline will benefit from Merck’s vast capabilities and determined engagement to benefit the patients who we have always strived to serve."

Under the terms of the acquisition agreement announced today, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of ArQule. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of ArQule’s outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the successful completion of the tender offer, Merck’s acquisition subsidiary will be merged into ArQule, and any remaining shares of common stock of ArQule will be canceled and converted into the right to receive the same $20 per share price payable in the tender offer. The transaction is expected to close early in the first quarter of 2020.

BofA Securities acted as financial advisor to Merck in this transaction and Covington & Burling LLP as its legal advisor. Centerview Partners acted as exclusive financial advisor to ArQule and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor.

Important Information About the Tender Offer

The tender offer described in this press release (the "Offer") has not yet commenced. This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of ArQule, Inc. ("ArQule") or any other securities. At the time the planned tender offer is commenced, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed by Merck Sharp & Dohme Corp. ("Merck") and Argon Merger Sub, Inc., a wholly-owned subsidiary of Merck, with the Securities and Exchange Commission (the "SEC"), and a solicitation/recommendation statement on Schedule 14D-9 will be filed by ArQule with the SEC. The offer to purchase shares of ArQule common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO.

INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 423-1000. In addition, Merck and ArQule will file annual, quarterly and current reports and other information with the SEC. Merck’s and ArQule’s filings with the SEC also will be available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

IMMUNOMEDICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK

On December 9, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported it has commenced an underwritten public offering of $250,000,000 of shares of its common stock (Press release, Immunomedics, DEC 9, 2019, View Source [SID1234552120]). In addition, Immunomedics expects to grant the underwriters a 30-day option to purchase up to an aggregate of an additional $37,500,000 of shares of common stock sold in connection with the offering at the public offering price.

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Immunomedics intends to use the net proceeds from this offering primarily to accelerate commercial launch readiness, pending FDA approval, of sacituzumab govitecan in the United States in metastatic triple-negative breast cancer, continue to expand the clinical development programs for sacituzumab govitecan, invest in the broader clinical development of the platform (including IMMU-130 and IMMU-140), continued scale-up of manufacturing and manufacturing process improvements, as well as for working capital and general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, Cowen and Company, LLC and Jefferies LLC are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 that Immunomedics filed with the Securities and Exchange Commission on June 11, 2018 and that became effective upon filing. A preliminary prospectus supplement and the accompanying prospectus relating to this offering are being filed with the SEC and will be available at the SEC’s website located at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or by email at [email protected].