On April 27, 2020 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes (Press release, AbbVie, APR 27, 2020, View Source [SID1234556614]). AbbVie hereby extends such expiration date from 5:00 p.m., New York City time, on May 1, 2020 to 5:00 p.m., New York City time, on May 8, 2020 (as the same may be further extended, the "Expiration Date").

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020, February 24, 2020, March 9, 2020, March 23, 2020, April 6, 2020 and April 20, 2020 and as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and the Expiration Date of each of the Exchange Offers is expected to be extended to occur on or about the closing date of the Acquisition. As a result, the Expiration Date may be further extended one or more times. AbbVie currently anticipates providing notice of any such extension in advance of the Expiration Date.

On April 27, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE), a preclinical-stage biotechnology company focused on developing next generation therapies to treat rare genetic diseases caused by mutant genes, reported that it has commenced an underwritten public offering of shares of common stock (Press release, NeuBase Therapeutics, APR 27, 2020, View Source [SID1234556632]). The offering is subject to market and other 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. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock sold in the public offering on the same terms and conditions. All of the shares of common stock in the offering will be sold by NeuBase.

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Oppenheimer & Co. and BTIG are acting as the joint book-running managers for the offering, and National Securities Corporation, a wholly-owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD) is acting as co-manager.

NeuBase intends to use the net proceeds from this offering for working capital and general corporate purposes and to advance the development of its product candidates and expand its pipeline.

The securities described above will be offered by NeuBase pursuant to an effective "shelf" registration statement on Form S-3 (File No. 333-220487) previously filed with the Securities and Exchange Commission (the "SEC") on September 15, 2017 and declared effective by the SEC on September 27, 2017. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by e-mail at [email protected], or BTIG, LLC, Attention: Equity Capital Markets, 65 East 55th Street, New York, NY 10022, by telephone at (212) 593-7555 or by e-mail at [email protected].

This press release does 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On Aprii 27, 2020 RGENIX, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported it is presenting an abstract on RGX-104, RGENIX’s lead therapy in development. RGENIX’s abstract, "RGX-104, a first-in-class immunotherapy targeting the liver-X receptor (LXR); Initial results from the phase 1b RGX-104 plus Docetaxel combination dose escalation cohorts" was accepted for the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which this year was scheduled as two virtual meetings (Press release, Rgenix, APR 27, 2020, View Source [SID1234556651]). The abstract results will be presented as a virtual poster presentation (CT-146) during the VPO.CT01 – Phase I Clinical Trials session on April 27, by clinical investigator Dr. Emerson Lim from Columbia University Herbert Irving Comprehensive Cancer Center, who is lead author on the study.

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For the dose escalation stage of this Phase 1b study, RGX-104 was tested in combination with docetaxel across three different dose escalation cohorts. The presentation will outline the safety profile, pharmacodynamic effects, and clinical activity of the combination in unselected heavily pre-treated patients with refractory or relapsed solid tumors. The results support further development of this regimen.

RGX-104 is a small-molecule LXR agonist that modulates innate immunity via transcriptional activation of the ApoE gene. RGX-104 inhibits tumor angiogenesis and depletes myeloid derived suppressor cells (MDSC), thereby activating cytotoxic T-lymphocytes. MDSCs are associated with resistance to both checkpoint inhibitors (CPI) and chemotherapy, including docetaxel, providing a rationale for combination therapy with RGX-104. Consistent with this, RGX-104 plus docetaxel combination therapy is highly efficacious in pre-clinical models that demonstrate MDSC-associated docetaxel resistance.

As of February 7, 2020, 11 patients with refractory solid tumors were treated with the combination across 3 different dosing cohorts. The safety profile was consistent with the individual profiles of RGX-104 and docetaxel, with neutropenia the most common drug-related adverse event observed, but dose-limiting in only one patient in cohort one, where RGX-104 was administered at 80mg BID every day with docetaxel administered at 35mg/m2 weekly x 3. In cohorts two and three, in which patients received RGX-104 dosing five consecutive days out of seven (at either 80mg or 100mg BID) and a reduced dose of docetaxel (28mg/m2), no dose-limiting toxicity was observed, and sustained pharmacodynamic activity (ApoE activation and MDSC depletion) was achieved. The overall response rate (ORR) in all evaluable patients was 22%, with a disease control rate (DCR) of 56%. Across cohorts 2 and 3, where target RGX-104 pharmacodynamic effects were achieved, the ORR was 33% with a 67% DCR. Clinical responses included partial responses (PRs) in CPI refractory/resistant patients, including an ongoing confirmed PR in a CPI resistant melanoma patient treated in cohort 2 that remains on study at 10 months. Clinical activity was associated with increases in T cell activation markers exceeding that generally observed with RGX-104 alone.

As a result, the RGX-104/docetaxel regimen is being evaluated in a phase 1b/2 expansion study that has begun enrolling patients with relapsed/refractory extensive stage small-cell lung cancer (ES-SCLC) or high grade-neuroendocrine tumors (HG-NET).

Emerson Lim, M.D., principal investigator from Columbia University Herbert Irving Comprehensive Cancer Center and lead author and presenter of the poster, said, "The clinical activity seen in the dose escalation of RGX-104 combined with Docetaxel is quite encouraging; especially notable is the ongoing PR of greater than 10 months duration in a patient with metastatic melanoma who had previously progressed with combination Nivolumab and Ipilimumab as his second line therapy. I am hopeful this combination will provide a therapeutic option for patients with ES-SCLC/HG-NET as currently being tested in the expansion phase."

RGX-104 is also being evaluated in combination with the front-line standard-of-care regimen of pembrolizumab plus carboplatin/pemetrexed in a phase 1b/2 study currently enrolling patients with advanced non-squamous non-small cell lung cancer (NSCLC).

Masoud Tavazoie, M.D., Ph.D., and Chief Executive Officer of RGENIX, said, "The data from the RGX-104/docetaxel combination dose escalation cohorts are encouraging, providing early safety and efficacy data that support further development of the combination. Though we are still in the early stages of the RGX-104 Phase 1b/2 studies, the results show the potential of RGX-104 to provide durable clinical activity in refractory patients through a novel mechanism-of-action. We look forward to sharing additional findings from these ongoing studies."

On April 27, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported it has commenced an underwritten public offering of $350,000,000 of shares of its common stock (Press release, Immunomedics, APR 27, 2020, View Source [SID1234556912]). In addition, Immunomedics expects to grant the underwriters a 30-day option to purchase up to an aggregate of an additional $52,500,000 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 support the commercial launch of Trodelvy in the United States in metastatic triple-negative breast cancer, continue to expand the clinical development programs for Trodelvy, 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.

Cowen, BofA Securities, Jefferies LLC and Piper Sandler & Co. 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 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; 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]; 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]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN, 55402, Attention: Prospectus Department, or by telephone at (800) 747-3924 or by email 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On April 27, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that results from its ongoing Phase 1 dose escalation study of COM701, a first-in-class anti-PVRIG antibody, in patients with advanced solid tumors who have exhausted all available standard therapies, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, today at 11:45 am EDT (Press release, Compugen, APR 27, 2020, View Source [SID1234556615]).

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COM701 was well-tolerated with no dose-limiting toxicities observed as a monotherapy and in combination with Opdivo (nivolumab). Furthermore, COM701 demonstrated encouraging signals of anti-tumor activity with high disease control rate in both the monotherapy and combination therapy arms (69% and 75%, respectively), including two confirmed partial responses and durable responses of over six months across cohorts, in the heavily pretreated patients enrolled in the study.

"I am highly encouraged by the safety profile and preliminary anti-tumor activity observed with COM701 both as a monotherapy and in combination with nivolumab," said Ryan J. Sullivan, M.D., Assistant Professor, Medicine, Harvard Medical School and Faculty Member of the Termeer Center for Targeted Therapy and Immunotherapy Programs at Massachusetts General Hospital Cancer Center, and presenting author. "With a highly refractory and all comer patient population, this trial enrolled patients that are difficult to treat including those who progressed on numerous prior therapies. Achieving durable disease control, including partial responses, is remarkable in this population and I am particularly enthusiastic about the proportion of patients in the combination arm, currently 50%, who remain on treatment. Taken together, these results support further investigation of targeting PVRIG with COM701 and suggest that targeting the PVRIG/TIGIT pathways may broaden the patient population that can benefit from immunotherapies."

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, said, "We are thrilled to see durable responses in patients with extremely challenging cancer types with poor prognosis. These findings from the completed monotherapy dose escalation and ongoing combination dose escalation study arms continue to support the potential of COM701 as a monotherapy and in combination with nivolumab in patients who have exhausted all available treatment options. Notably, the ongoing responses in microsatellite stable colorectal cancer and primary peritoneal cancer, a type of ovarian cancer, are supportive of our biomarker-informed selection of indications for the monotherapy expansion cohorts."

The reported data are from the monotherapy and combination arms of the ongoing, Phase 1, open label, dose escalation study and include all eight cohorts from the monotherapy arm (n=16), and the first three of four cohorts of the combination arm (n=12).

Key findings to be presented by Dr. Sullivan in an oral virtual presentation titled "COM701 Demonstrates Antitumor Activity as Monotherapy and in Combination with Nivolumab in Patients with Advanced Malignancies" include:

COM701 was well-tolerated through 20 mg/kg IV Q4 weeks as a monotherapy and 10 mg/kg IV Q4 weeks in combination with Opdivo (480 mg IV Q4 weeks) with no dose-limiting toxicities reported.

No increased toxicity was observed in the combination arm.

No patients discontinued treatment due to toxicity of any study drug.

Preliminary COM701 pharmacokinetic data supports IV Q4 weeks dosing, allowing dosing schedule with Opdivo.

Encouraging disease control rates of 69% (11/16) for monotherapy and 75% (9/12) for combination arm.

50% of patients (6/12) in the combination arm remain on study, some with continued responses observed beyond 200 days of treatment.

Across cohorts, durable responses of stable disease for over six months in six of 28 (21%) patients.

The two patients previously reported with confirmed partial responses, one from the monotherapy arm (microsatellite stable primary peritoneal cancer) and one from the combination arm (microsatellite stable colorectal cancer), remain on treatment.

Enrollment in the COM701 monotherapy dose escalation arm is completed and enrollment in the combination dose escalation arm at 20 mg/kg IV Q4 weeks is ongoing. The monotherapy expansion cohorts that will follow the monotherapy dose escalation arm is based on a biomarker-informed selection of indications, and will include non-small cell lung cancer, ovarian, breast, endometrial and colorectal cancer. During this monotherapy expansion study, biopsies will be collected before and on COM701 treatment to allow retrospective analyses of Compugen’s DNAM axis biomarker approach.

About the COM701 Phase 1 Study
The Phase 1 open-label clinical trial of COM701 is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as of combination administration with Bristol-Myers Squibb’s Opdivo (nivolumab) in patients with advanced solid tumors. Additionally, secondary endpoints include preliminary antitumor activity, pharmacokinetics and pharmacodynamics of COM701 monotherapy and in combination with Opdivo (nivolumab) in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer, endometrial cancer and colorectal cancer. Additional information is available at www.clinicaltrials.gov (NCT 03667716).

About COM701
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, and blocks the interaction with its ligand, PVRL2. TIGIT, discovered by Compugen’s computational discovery platform in 2009, and PVRIG constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. Preclinical data suggest that the blockade of PVRIG induces a robust anti-tumor immune response and demonstrates synergistic activity when used in combination with inhibitors of TIGIT and/or PD-1. Currently, COM701 is being evaluated in a Phase 1 clinical study. Data from the ongoing study have shown that COM701 is well-tolerated and demonstrated preliminary signals of anti-tumor activity in a heavily pretreated patient population.