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GENFIT Announces Final Terms For Proposed Renegotiation of 2022 OCEANE Convertible Bonds

On November 23, 2020 GENFIT (Nasdaq and Euronext: GNFT) a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, reported the final terms of the partial buyback of its convertible bonds maturing in October 2022 ("2022 OCEANEs" or "OCEANEs") and the proposed amendment of the existing terms of the 2022 OCEANEs (Press release, Genfit, NOV 23, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-announces-final-terms-proposed-renegotiation-2022-oceane [SID1234571540]).

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Objectives for the Proposed Renegotiation of 2022 OCEANE Terms

On November 16, 2020, GENFIT announced its intention to propose a partial buyback of the 2022 OCEANEs, as well as an amendment of the existing terms, with the objective of:

Capital preservation for the Company’s operational functionality;
Reduction of the nominal amount of financial debt to be redeemed;
Deferment of the OCEANEs maturity date in line with the next milestones in the Company’s two main programs: the ELATIVE Phase 3 clinical trial evaluating elafibranor in PBC and the NIS4 technology for NASH diagnosis;
Maximization of potential value-creation for shareholders and the 2022 OCEANEs holders.
Under these new terms, the final maturity of the 2022 OCEANEs would be deferred until October 16, 2025. The initiation of the early redemption period1 would be deferred until November 3, 2023.

Finally, in line with previous guidance, the Company has appointed Natixis and Kepler Cheuvreux (the "Counsels") to assist GENFIT with this transaction.

Partial buyback price, adjustment of the conversion ratio, and additional amendments to the existing terms of the 2022 OCEANEs

The Company and its Counsels have collected feedback from the 2022 OCEANEs holders in order to set the definitive terms of the partial buyback and the amendments of terms and conditions of the residual portion (following the partial buyback) of the 2022 OCEANEs.

The Company undertakes to repurchase, at a price of €16.40 per 2022 OCEANE, a maximum of 3,048,780 2022 OCEANEs, representing an amount equivalent to 50.1% of the outstanding 2022 OCEANEs.

The Company proposes to amend the terms of the 2022 OCEANEs that will not be repurchased and cancelled, as described below:

Maturity extension until October 16, 2025;
Increase of the conversion ratio from 1:1 to 1:5.5;
Deferral of the initiation of the early redemption period provided for in the 2022 OCEANEs terms and conditions (until November 3, 2023); and
Amendment of the ratchet clause adjusting the conversion ratio in the event of a tender offer targeting GENFIT shares, in order to take into account the extension of the 2022 OCEANEs maturity date from 2022 until 2025. The adjustment would be calculated from the date of approval by the 2022 OCEANEs holders of the amended terms (i.e. the date on which the 2022 OCEANEs holders meeting would be held) until the new maturity date (i.e. October 16, 2025).
The nominal value as well as the redemption price of the OCEANEs will remain unchanged at €29.60 per OCEANE. The other terms and conditions of the OCEANEs not mentioned above will remain unchanged.

The buyback price of €16.40 takes into account accrued interest until the buyback effective date that is anticipated to occur in January 2021, subject to the conditions set out below. The exact buyback date will be communicated at a later date.

Considering the new conversion ratio, the new shares that could be issued upon conversion of the OCEANEs would represent 42.9% of the current share capital of the Company (against 15.6% with the current conversion ratio). In the event of a full conversion of the OCEANEs, the OCEANEs holders would hold 30.0% of the share capital of the Company (29.7% in the case of exercise of the outstanding stock options, share warrants (BSA), and final allocation of the outstanding free shares as of the date hereof).

Implementation

The Company will collect through its Counsels, or through the 2022 OCEANEs Bondholder Representative (Representant de la Masse, at [email protected]) for the retail holders, the buyback requests through a fixed price reverse book building process.

Should the buyback requests from the 2022 OCEANEs holders exceed the €50 million maximum repurchase amount contemplated by the Company, buyback requests will be reduced proportionally to ensure equal treatment among all the 2022 OCEANEs holders.

Upon collection of requests and potential reduction as described above, the 2022 OCEANEs holders and the Company will be invited to enter into a Bond Repurchase Agreement, a draft of which is available upon request to the Counsels and, for retail holders, from the 2022 OCEANEs Bondholder Representative.

The reverse book building period, at a fixed price, will begin on November 23, 2020, and end on November 27, 2020 (inclusive).

Should the buyback requests be significantly lower than the €50 million repurchase proposal, the Company would withdraw its partial buyback and the 2022 OCEANEs terms amendment offer.

The partial buyback will remain contingent on and will occur after the following two events:

Approval by the Extraordinary General Meeting of the Company’s shareholders of the new conversion ratio;
Approval by the 2022 OCEANEs holders of the aforementioned amendments.

Upon receipt of the selling commitments from the 2022 OCEANEs holders through the signing of the Bond Repurchase Agreements, the Company will convene a general meeting of the shareholders and a general meeting of the 2022 OCEANEs holders, which are expected to be held in the first quarter of 2021.

Entry into a Material Definitive Agreement

On November 22, 2020, Baudax Bio, Inc., (the "Company"), reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with an institutional investor named therein (the "Purchaser"), pursuant to which the Company agreed to issue and sell, in a registered direct offering (the "Offering"), 2,850,000 shares (the "Shares") of the Company’s common stock, par value $0.01 per share (the "Common Stock") and warrants exercisable for an aggregate of 10,126,583 shares of Common Stock (the "Series A Warrants") at a combined offering price of $1.185 per share (Filing, 8-K, Baudax Bio, NOV 22, 2020, View Source [SID1234572278]). The Series A Warrants have an exercise price of $1.20 per share. Each Series A Warrant is exercisable for one share of Common Stock and will be immediately exercisable and will expire five years from the issuance date.

The Company also offered and sold to the Purchaser pre-funded warrants to purchase an aggregate of 7,276,583 shares of Common Stock (the "Series B Warrants" and, together with the Shares and the Series A Warrants, the "Securities"), in lieu of shares of Common Stock at the Purchaser’s election. Each Series B Warrant is exercisable for one share of our Common Stock. The purchase price of each Series B Warrant is $1.175, and the exercise price of each pre-funded Series B Warrant is $0.01 per share. The Series B Warrants are immediately exercisable and may be exercised at any time until all of the Series B Warrants are exercised in full.

A holder (together with its affiliates) may not exercise any portion of such holder’s Series A Warrants or Series B Warrants to the extent that the holder would own more than 4.99% (or 9.99%, at the holder’s election) of the Company’s outstanding Common Stock immediately after exercise, except that upon notice from the holder to the Company, the holder may decrease or increase the limitation of ownership of outstanding stock after exercising the holder’s Series A Warrants or Series B Warrants up to 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Series A Warrants and Series B Warrants, provided that any increase in such limitation shall not be effective until 61 days following notice to the Company.

The Purchase Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties. The closing of the Offering is expected to occur on November 25, 2020. The Company is expected to receive gross proceeds of approximately $11.9 million in connection with the Offering, before deducting placement agent fees and related offering expenses.

As compensation to H.C. Wainwright & Co., LLC (the "Placement Agent") as placement agent in connection with the Offering, the Company agreed to pay to the Placement Agent a cash fee of 6.0% of the aggregate gross proceeds raised in the Offering, plus a management fee equal to 1.0% of the gross proceeds raised in the Offering and reimbursement of certain expenses and legal fees. The Company will also issue to designees of the Placement Agent warrants to purchase up to 6.0% of the aggregate number of shares of Common Stock sold in the transactions, or warrants to purchase up to 607,595 shares of Common Stock (the "Placement Agent Warrants"). The Placement Agent Warrants have substantially the same terms as the Series A Warrants, except that the Placement Agent Warrants have an exercise price equal to 125% of the offering price per share (or $1.48125 per share).

The foregoing summaries of the Purchase Agreement, the Series A Warrants, Series B Warrants and the Placement Agent Warrants do not purport to be complete and are subject to, and qualified in their entirety by, the forms of such documents attached as Exhibits 10.1, 4.1, 4.2 and 4.3, respectively, to this Current Report on Form 8-K (the "Report"), which are incorporated herein by reference.

The Securities in the Offering and the Placement Agent Warrants were offered by the Company pursuant to a registration statement on Form S-3 (File No. 333-243488), which was filed with the Securities and Exchange Commission on August 10, 2020 and was declared effective by the Commission on October 2, 2020 (the "Registration Statement"). A copy of the opinion of Troutman Pepper Hamilton Sanders LLP relating to the legality of the issuance and sale of the Securities in the Offering is attached as Exhibit 5.1 hereto. This Report shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Innovent Releases Phase 3 Results of TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Biosimilar Injection) as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma (HCC) at ESMO ASIA Virtual Congress 2020

On November 20, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the results of the Phase 3 ORIENT-32 study were released in a late-breaking proffered oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia ("ESMO Asia") Virtual Congress 2020 (Press release, Innovent Biologics, NOV 22, 2020, View Source [SID1234571528]).

ORIENT-32 is the first randomized Phase 3 study reporting the efficacy and safety of an anti-PD-1 antibody-based combination therapy versus sorafenib as the first-line treatment in patients with advanced unresectable hepatocellular carcinoma (HCC). A total of 571 patients were enrolled in the trial. Based on an interim analysis conducted by the study’s Independent Data Monitoring Committee (IDMC), TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) demonstrated significantly improved overall survival (OS) and Independent Radiographic Review Committee (IRRC) progression-free survival (PFS) versus sorafenib. Compared to sorafenib, TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) demonstrated a 43.1% decreased risk of all-cause mortality (HR 0.569, 95%CI: 0.431-0.751, P<0.0001); the median OS was not reached in the TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) arm versus 10.4 months in the sorafenib arm. TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) also demonstrated 43.5% decreased risk of progression as assessed by IRRC (HR 0.565 95%CI: 0.455-0.701, P<0.0001); median PFS was 4.6 months in the TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) arm versus 2.8 months in the sorafenib arm.

The significantly improved OS and PFS benefits brought by TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) over sorafenib were generally consistent across all subgroups. The combination regimen showed an acceptable safety profile with no new safety signals. With these results, TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) could potentially provide a new option for the first-line treatment of patients with advanced HCC.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "In China, HCC is the fourth most common malignancy with the second highest mortality rate. More than half of new and fatal cases of HCC in the world occur in China every year. Despite the challenges and impact from the COVID-19 pandemic, the ORIENT-32 study was carried out smoothly and successfully under the joint efforts of all investigators and patients with their families. We are very pleased to see that the ORIENT-32 study demonstrated significant prolongation of OS and PFS in advanced HCC patients in China. With these encouraging results，we will apply to the National Medical Products Administration for the new drug application of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection). We look forward to this potentially becoming a new treatment regimen that could help more patients with HCC to live longer without their disease worsening."

About ORIENT-32 Trial

ORIENT-32 is a Phase 3 randomized, open-label，multi-center study to evaluate the efficacy and safety of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma（ClinicalTrials.gov, NCT 03794440）. The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1.

Enrolled patients were randomly assigned 2:1 to receive TYVYT (sintilimab injection) combination with BYVASDA (bevacizumab biosimilar injection) or sorafenib, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons stated in the protocol, whichever occurs first.

About Hepatocellular Carcinoma (HCC)

Primary liver cancer（PLC）is a common malignancy of the digestive system worldwide, among which about half new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), accounting for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma（ICC） and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor included in the new Catalogue of the National Reimbursement Drug List (NRDL). In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with nonsquamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT (sintilimab injection) is a fully human immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. This includes global clinical research studies on TYVYT (sintilimab injection).

About BYVASDA (Bevacizumab Biosimilar Injection)

BYVASDA is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.

Contract with Ki-CONNECT for academic advisory support.

On November 20, 2020 Thyas reported that it has signed an advisory agreement with Kyoto Innovation Center for Next Generation Clinical Trials and iPS Cell Therapy, Kyoto University Hospital ("KiCONNECT"; Sakyo-ku, Kyoto, Director Dr. Manabu Muto) for strategic planning for a clinical trial of autologous iPS cell-derived cytotoxic T cell therapy (Press release, Thyas , NOV 20, 2020, View Source [SID1234629211]).

Seres Therapeutics, Inc. Corporate Slide Presentation as of November 20, 2020

On November 20, 2020 Seres Therapeutics Presented the Corporate Presentation (Press release, Seres Therapeutics, NOV 20, 2020, View Source [SID1234575087]).