Jazz Pharmaceuticals Announces Private Offering of $850 Million of Exchangeable Senior Notes due 2030 and Concurrent Ordinary Share Repurchases

On September 3, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz Pharmaceuticals") reported that Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), intends to offer, subject to market conditions and other factors, $850 million aggregate principal amount of exchangeable senior notes due 2030 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Jazz Pharmaceuticals, SEP 3, 2024, View Source [SID1234646323]). The Issuer also expects to grant the initial purchasers of the notes an option, exercisable within a period of 13 days from and including the date the notes are first issued, to purchase up to an additional $150 million aggregate principal amount of notes.

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The notes will be exchangeable under certain conditions. The Issuer will settle exchanges by paying cash up to the aggregate principal amount of the notes to be exchanged. The remainder, if any, of the Issuer’s exchange obligation in excess of the aggregate principal amount of the notes, will be settled in cash, ordinary shares of Jazz Pharmaceuticals ("ordinary shares") or a combination of cash and ordinary shares, at the Issuer’s election. The interest rate, initial exchange rate and other terms of the notes will be determined at the time of pricing of the offering.

The notes will be general unsecured obligations of the Issuer and will accrue interest payable semiannually in arrears. The Issuer’s obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals; will rank pari passu in right of payment with the Issuer’s existing 2.000% exchangeable senior notes due 2026; will be effectively subordinated to the Issuer’s guarantees of the indebtedness under Jazz Pharmaceuticals’ credit agreement (the "credit agreement") and Jazz Pharmaceuticals’ 4.375% senior secured notes due 2029 (the "senior secured notes") to the extent of the value of the assets securing such guarantees; and will be structurally subordinated to the indebtedness and guarantees under the credit agreement and the senior secured notes of Jazz Pharmaceuticals’ other subsidiaries that are borrowers or have provided guarantees of such indebtedness.

Jazz Pharmaceuticals, together with its consolidated subsidiaries ("Jazz"), expects to use a portion of the net proceeds to prepay up to approximately $350 million of the term loans outstanding under the credit agreement and the remainder for general corporate purposes. If the initial purchasers exercise their option to purchase additional notes, Jazz expects to use the net proceeds from the sale of the additional notes for further prepayments of the term loans.

Jazz Pharmaceuticals also expects to repurchase up to $150 million of its ordinary shares from purchasers of the notes in privately negotiated transactions with or through one of the initial purchasers or its affiliate concurrently with the pricing of the offering (the "concurrent ordinary share repurchases"). Jazz Pharmaceuticals expects the purchase price per ordinary share repurchased in such concurrent ordinary share repurchases to equal the closing price per ordinary share on the date of the offering. To the extent Jazz Pharmaceuticals effects any such concurrent ordinary share repurchases, it will pay for such repurchases with existing cash on hand and such repurchases will be effected as part of Jazz Pharmaceuticals’ share repurchase program announced in July 2024. Accordingly, any such concurrent ordinary share repurchases will reduce the remaining amount authorized under the share repurchase program. No assurance can be given as to how much, if any, of Jazz Pharmaceuticals’ ordinary shares will be repurchased or the terms on which they will be repurchased. The concurrent ordinary share repurchases could increase, or reduce the size of any decrease in, the market price of the ordinary shares, including concurrently with the pricing of the notes, resulting in a higher effective exchange price for the notes. This press release is not an offer to repurchase the ordinary shares, and the offering of the notes is not contingent upon the repurchase of any ordinary shares.

None of the notes, the guarantee or the ordinary shares issuable upon exchange of the notes, if any, have been registered under the Securities Act or the securities laws of any other jurisdiction, and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

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

Primrose Bio and ExPLoRNA Therapeutics Announce Strategic Partnership to Advance mRNA Medicines

On September 3, 2024 Primrose Bio, a leading biotechnology company specializing in technologies that improve the manufacturing of next-generation therapeutics, and ExPLoRNA Therapeutics, a pioneering biotechnology company advancing mRNA technologies, vaccines, and therapeutics, reported a strategic partnership aimed at jointly developing and marketing products for mRNA medicines (Press release, ExploRNA Therapeutics, SEP 3, 2024, View Source [SID1234646291]).

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The landscape of mRNA medicines is evolving, marked by an expanding pipeline of drug candidates, a diverse range of targeted therapeutic indications, and advancements in drug design and delivery. Consequently, the pharmaceutical industry is confronted with pressing challenges in manufacturing. To effectively address these challenges, innovative solutions are necessary.

Primrose Bio’s expertise in engineering high-performance RNA polymerases (Prima RNApols) enhances both the yield and fidelity of mRNA synthesis, effectively reducing double-stranded RNA (dsRNA) and lowering costs. This advancement meets the rigorous manufacturing demands for a wide range of mRNA-based applications in therapeutics and vaccines.

ExPLoRNA Therapeutics specializes in innovations of mRNA as a therapeutic platform, focusing on novel cap analogs vital for successful protein production. Their technology significantly increases protein production compared to standard cap analogs, limits double-stranded RNA formation, and brings down IVT cost, offering promising advancements in therapeutic effectiveness.

Together, Primrose Bio and ExPLoRNA will co-develop and offer RNA polymerases and capping compounds, co-optimized to enhance mRNA quality, manufacturing performance, and therapeutic safety and efficacy. This partnership provides mRNA drug developers with superior manufacturing solutions and innovative design options through advanced capping chemistry.

"We are excited to work with ExPLoRNA to bring industry-leading mRNA cap analogs to the market and pairing them with Primrose Bio’s RNA polymerases," said Helge Zieler, CEO of Primrose Bio. "This partnership will result in broader manufacturing and design options for companies developing mRNA therapeutics and vaccines, facilitating access to the most efficient capping chemistry available."

"Through joining forces, we’ll advance the mRNA as a modality from the first applications to the next generation," said Jacek Jemielity, CEO of ExPLoRNA Therapeutics. "We aim at creating the best synergies between our cap analogs and novel polymerases to surpass current manufacturing process and what is achievable with mRNA today."

Precision BioSciences Receives $13 Million in Proceeds from Imugene Convertible Note Maturity as Part of the August 2023 Azer-cel Deal

On September 3, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, gene insertion, and gene excision, reported maturity of a $13 million convertible note from its previously announced strategic transaction with Imugene Limited (ASX: IMU) for azercabtagene zapreleucel (azer-cel) in oncology (Press release, Precision Biosciences, SEP 3, 2024, View Source [SID1234646306]). The proceeds to Precision BioSciences include $9.75 million in cash and $3.25 million in Imugene ordinary shares.

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"We are pleased that Imugene continues to advance azer-cel toward a pivotal trial in LBCL for patients with significant unmet need," said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. "This marks one year since our strategic decision to focus our in-house programs exclusively on in vivo gene editing and further bolsters our balance sheet, enabling us to generate Phase 1 clinical data across multiple in vivo gene editing programs starting in the first half of 2025. In the near term, we are focused on progressing our pipeline towards the clinic and remain on track to file applications with multiple global regulatory bodies for PBGENE-HBV for chronic hepatitis B later this year."

In August 2023, Precision announced a strategic transaction with Imugene. Under the agreement, Imugene assumed global rights to azer-cel for cancer, the ongoing clinical execution for azer-cel in large B-cell lymphoma (LBCL) patients who have relapsed following autologous CAR T treatment as well as Precision BioSciences’ CAR T capability, including manufacturing. In exchange, Precision received upfront economics valued at $21 million (all figures in USD) consisting of $8 million in cash and a $13 million convertible note. The convertible note matured on August 30, 2024 and resulted in payment to Precision of $9.75 million in cash and $3.25 million in Imugene stock. Precision is also eligible for additional payments based on azer-cel clinical milestones as well as milestones for other future nominated cancer research programs.

As of June 30, 2024, Precision had approximately $123.6 million in cash and cash equivalents, prior to receipt of the payment from Imugene. Existing cash and cash equivalents, upfront and potential near-term cash from CAR T transactions, along with expected operational receipts, continued fiscal and operating discipline, availability of Precision’s at-the-market (ATM) facility, and marketable securities are expected to extend Precision’s cash runway into the second half of 2026.

Immune Phenotyping Identified as Promising Predictive Biomarker by Lunit AI in Biliary Tract Cancer – New publication in CCR

On September 3, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported that Lunit SCOPE IO has demonstrated significant potential in predicting immunotherapy response for patients with advanced biliary tract cancer (BTC), via AI-powered analysis of immune phenotype and tumor-infiltrating lymphocytes (TILs) (Press release, Lunit, SEP 3, 2024, View Source;new-publication-in-ccr-302236317.html [SID1234646324]). The groundbreaking study, conducted in collaboration with researchers from Asan Medical Center and Severance Hospital in Seoul, Korea, was recently published in Clinical Cancer Research (CCR), an AACR (Free AACR Whitepaper) journal.

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BTC is known for its poor prognosis, with limited treatment options available. While recent studies have shown promise in combining immunotherapy, such as anti-PD-1 inhibitors with standard chemotherapy, there has been a lack of effective predictive tools to guide treatment decisions.

The study analyzed pre-treatment pathology samples (H&E slides) from 339 patients with advanced BTC who received anti-PD-1 monotherapy as second-line or later treatment. Using Lunit SCOPE IO, researchers performed a detailed analysis of the tumor microenvironment, classifying patients’ immune phenotypes into three categories: inflamed (high intratumoral TIL), immune-excluded (low intratumoral TIL and high stromal TIL), and immune desert (low TIL overall). Immune phenotypes are an emerging pan-cancer biomarker with support from leaders of the immuno-oncology community.[1]

Key findings include:

Patients classified as having an "inflamed" immune phenotype showed significantly better treatment outcomes compared to those with non-inflamed phenotypes, as consistent with previously published studies.[2]
The inflamed group demonstrated both longer overall survival (12.6 vs. 5.1 months) and progression-free survival (4.5 vs. 1.9 months), as well as higher overall response rates (27.5% vs. 7.7%).
Lunit SCOPE IO provided objective and efficient assessment of the tumor microenvironment, overcoming limitations of manual evaluation demonstrating high feasibility for AI-powered analysis of immune phenotype and TIL.
Notably, this study suggests immune phenotyping can serve as a predictive biomarker for possible response to immunotherapy in BTC, addressing a long-standing gap in personalized treatment approaches for this class of cancers with a high unmet need.

"Lunit SCOPE IO represents a significant advancement in the precision medicine landscape for cancer treatment," said Brandon Suh, CEO at Lunit. "By providing a deeper understanding of the tumor microenvironment, particularly immune phenotyping, our AI technology empowers clinicians to make informed treatment decisions, identifying patients most likely to benefit from immunotherapy and opening new avenues for personalized treatment strategies in challenging cancer types."

FibroGen to Present at the H.C. Wainwright 26th Annual Global Investment Conference

On September 3, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported that the Company will be attending and presenting at the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY (Press release, FibroGen, SEP 3, 2024, View Source [SID1234646292]).

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Thane Wettig, Chief Executive Officer of FibroGen, will deliver a company presentation on Tuesday, September 10 at 3:00 PM ET at the Lotte New York Palace Hotel. A live webcast of the presentation will be available here.

FibroGen’s management team will be available for one-on-one meetings during the conference. Interested investors should contact their representative at H.C. Wainwright. A replay of the presentation will be posted, when available, to the FibroGen website on the Events & Presentation page of the investors section for 90 days.