Horizon Therapeutics plc Announces Redemption of All $400 Million of Its Exchangeable Senior Notes

On June 3, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that it issued a notice of redemption for all $400 million of its 2.50% exchangeable senior notes due 2022 (Press release, Horizon Therapeutics, JUN 3, 2020, View Source [SID1234560800]). The redemption date is August 3, 2020. The exchangeable senior notes may be exchanged by holders at any time before 5 p.m. (Eastern time) on July 30, 2020. Each $1,000 principal amount of the notes is exchangeable into 34.8979 ordinary shares of the Company, plus cash in lieu of fractional shares.

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"The redemption of our $400 million in exchangeable senior notes is an additional step in successfully executing our strategy to improve our capital structure to be in line with that of our biopharma peers," said Paul Hoelscher, executive vice president, chief financial officer, Horizon. "We began to execute on this strategy about a year ago, and inclusive of this redemption, we will have reduced our gross debt by about $1 billion, while maintaining a strong cash balance. In addition, through our refinancing and debt reduction initiatives, we have lowered our annualized cash interest expense by more than 40 percent versus a year ago and extended the maturity of our senior secured term loans and senior notes out to 2026 and 2027, respectively."

As of March 31, 2020, the Company had cash and cash equivalents of $754.6 million. In addition, the total principal amount of debt outstanding was $1.418 billion, consisting of $418 million in senior secured term loans due 2026, $600 million of senior notes due 2027 and $400 million of exchangeable senior notes due 2022. Following the exchange or redemption of the exchangeable senior notes, the total principal amount of debt outstanding will be $1.018 billion. The Company has no maintenance covenants on its debt.

PORTAGE ANNOUNCES SHARE CONSOLIDATION (REVERSE SPLIT) EFFECTIVE DATE

On June 3, 2020 Portage Biotech Inc. (CSE:PBT.U, OTC Markets: PTGEF) ("Portage" or the "Corporation") reported that, further to its news release dated May 25, 2020, the Corporation’s common shares will commence trading on a one hundred (100) old for one (1) new share consolidated basis (the "Consolidation") (also known as a "reverse split") under a new CUSIP number G7185A128 and ISIN number VGG7185A1286. The corporate name and trading symbol for the Corporation will remain unchanged (Press release, Portage Biotech, JUN 3, 2020, View Source [SID1234560816]). The effective date that the post-consolidated common shares will begin trading on CSE is June 5, 2020.

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The Consolidation proposal was approved by shareholders at the Annual General and Special Meeting of Shareholders of the Corporation held on January 8, 2019, in which the Board of Directors was authorized, in its sole discretion and by means of a resolution, to proceed with the proposed consolidation of the common shares in the capital of the Corporation by a ratio of up to 120-for-1 basis, without further approval of shareholders. On May 19, 2020, the Board of Directors set the Consolidation ratio at 100-for-1.

There are currently 1,098,770,697 common shares issued and outstanding. Upon completion of the Consolidation, there will be approximately 10,987,707 common shares issued and outstanding. The exact number of post-consolidated shares will vary depending on the treatment of fractional shares, which will occur when each shareholder’s holdings in the Corporation are consolidated. The Corporation will not issue any fractional common shares as a result of the consolidation. Instead, all fractional shares will be rounded down to the nearest whole common share unless a shareholder will hold less than one share in which case the fractional share will be rounded up. Outstanding stock options will also be adjusted by the Consolidation ratio and their respective exercise prices adjusted accordingly.

On the effective date of Consolidation, registered shareholders may surrender their physical share certificates evidencing their common shares to the Corporation’s transfer agent, TSX Trust Company ("TSX Trust"), at 301-100 Adelaide Street West, Toronto, Ontario, M5H 4H1, for replacement certificates representing the number of post-consolidation shares to which they are entitled. All inquiries regarding the Consolidation or your shareholder account should be directed to TSX Trust at tel.: 1-866-600-5859 or by email to: [email protected]. No Letter of Transmittal needs to be executed in relation to the Consolidation. Until surrendered, each certificate representing the pre-Consolidation common shares will be deemed for all purposes to represent the number of shares to which the holder thereof is entitled as a result of the Consolidation. Shareholders who hold their shares in brokerage accounts or "street name" are not required to take any action to effect the exchange of their shares.

Aldeyra Therapeutics to Present at the Jefferies Virtual Healthcare Conference

On June 3, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference at 1:00 p.m. ET Thursday, June 4, 2020 (Press release, Aldeyra Therapeutics, JUN 3, 2020, View Source [SID1234560801]).

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A live webcast of the presentation will be available on the investor relations page of the company’s corporate website at View Source After the live webcast, the even will remain archived on the Aldeyra Therapeutics website for 90 days.

Ireland’s Shorla nabs $8.3M to bring improved cancer meds to the U.S.

On June 3, 2020 Shorla Pharma reported that picking up $8.3 million to push its programs through regulatory approval and build up its technical and commercial operations ahead of its first drug launch in 2021 (Press release, Shorla Pharma, JUN 3, 2020, View Source [SID1234560786]). The company will hire "key personnel" in Ireland, Cunningham told FierceBiotech. And with the U.S. as its first market, part of the funds will go toward setting up an outpost to take care of business development and regulatory and commercialization activities stateside.

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The Dublin-based company is working on three programs, all of which are improvements on established drugs, which may have a difficult-to-use formulation, not treat certain types of cancer very well or be in limited supply. Cunningham and Ryan didn’t disclose what the drugs are, beyond saying they are all "established active substances" that have been "proven from a safety and efficacy perspective."

Maverick Therapeutics Announces Pipeline Updates for its Conditionally Active T Cell Engaging COBRA™ Platform at the Jefferies Virtual Global Healthcare Conference

On June 3, 2020 Maverick Therapeutics, Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported pipeline updates for its robust set of Conditional Bispecific Redirected Activation (COBRATM) programs at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020 (Press release, Maverick Therapeutics, JUN 3, 2020, View Source [SID1234560802]).

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By nature of its elegant and innovative design, the COBRATM platform is the most mature bispecific T cell engaging platform in its class that can safely target solid tumors with highly specific and potent activity. COBRA molecules are prodrugs selected to bind to specific targets, which may be expressed in both tumor and healthy tissue. However, COBRAs are engineered to take advantage of the tumor’s unique microenvironment for T cell activation; triggering T cell mediated killing only at the site of the tumor while sparing damage to patients’ healthy tissues.

"As we continue to advance our pipeline, we look forward to initiating the clinical development of our lead first-in-class COBRA programs, MVC-101 and MVC-280, both of which have generated promising pre-clinical data designed to validate the COBRA mechanism of action and be predictive of translation to patients. Our pipeline reflects our single focus on developing potent and conditionally active T cell engaging therapies for solid tumor cancers. Beyond our two lead programs, we have also generated compelling in vivo data for two additional COBRA molecules," said Jim Scibetta, Chief Executive Officer, Maverick Therapeutics. "The first patient who is safely and effectively treated for a solid tumor cancer with any form of T cell therapy, whether CAR T cell therapy or redirected T cell engagers like our COBRAs, will serve as a major breakthrough in the field of cancer immunotherapy. For us at Maverick, this is an incredibly important and humbling mission."

"Although evidence of anti-tumor activity has been observed in patients with solid cancers, the full potential of T cell engaging therapies against solid tumor cancers continues to be hindered by unacceptable toxicity," said Jim Vasselli, M.D., Senior Vice President, Clinical Development, Maverick Therapeutics. "Underpinning the pre-clinical development of COBRA technology is Maverick’s commitment to using gold standard in vivo and in vitro models to maximize our understanding of the molecules. We are encouraged by the early results generated by these first two programs and are excited to continue development towards the clinic."

MVC-101 Is a Highly Potent COBRA Targeting Tumors that Express EGFR

Maverick Therapeutics’ lead program candidate, MVC-101, is a proprietary COBRA molecule designed to target Epidermal Growth Factor Receptor (EGFR), a protein expressed on both malignant and healthy tissues. MVC-101 regressed established human tumors in several preclinical models. Exposures of MVC-101 at efficacious relative to tolerated doses in safety studies demonstrates an increased therapeutic index compared to standard T cell engagers. MVC-101 is designed to be a universal solution for patients with EGFR expressing solid tumor cancers. EGFR is expressed on a wide range of solid tumor cancers, including but not limited to colorectal, head & neck, renal, pancreatic, cervical and non small cell lung cancers. Maverick expects to initiate a Phase 1 trial in Q1 2021.

MVC-280 Is a Highly Potent COBRA Targeting Tumors that Express B7H3

Maverick Therapeutics’ second program candidate, MVC-280, is a proprietary COBRA molecule designed to target B7H3 (CD276). B7H3 is expressed in a broad range of malignant and healthy tissues, similar to EGFR. MVC-280 regressed established tumors in several preclinical models. It is cross-reactive to its target protein expressed on mouse tissues, creating an opportunity to measure both efficacy and relative safety in the same preclinical model and use that data to calculate a therapeutic index. MVC-280 is designed to be a universal solution for patients with B7H3 expressing solid tumor cancers. B7H3 is expressed on a wide range of solid tumor cancers, including but not limited to prostate, renal, triple negative breast, head & neck, ovarian and urothelial cancers. Maverick expects to initiate a Phase 1 trial in H2 2021.

About the COBRATM Therapeutics Platform

Maverick Therapeutics’ COBRATM platform is the most mature conditionally active bispecific T cell engaging platform designed to safely target a broad range of solid tumors with highly specific and potent activity while limiting on-target toxicities in normal tissues. By nature of its highly innovative design, the COBRA platform reflects a novel approach to T cell engaging immunotherapies where T cell activation and resulting cell killing only take place where it is needed – in tumors. This unique design delivers the long sought after trifecta in cancer care; high specificity, high potency and reduced toxicity.