On March 9, 2020 Abbisko Therapeutics, a clinical-stage biopharmaceutical company, reported that it has received the regulatory approval by the National Medical Products Administration (NMPA) of China to initiate its phase 1 trial for ABSK-011, a novel FGFR4 inhibitor in advanced solid tumors (Press release, Abbisko Therapeutics, MAR 9, 2020, View Source;article_id=138&brd=1 [SID1234556285]).

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ABSK-011 is independently discovered and developed by Abbisko Therapeutics with full intellectual property rights worldwide. It is an orally administrated, highly potent, and selective small molecule inhibitor of FGFR4 with best-in-class drug-like properties. Through disruption of FGF19-FGFR4 pathway activities, ABSK-011 offers a potential novel therapeutic approach to treat cancers such liver cancers harboring aberrant FGFR4 pathway alterations. Liver cancer in China accounts for ~50% of the global incidence with poor survival rate and limited treatment options, representing a major unmet clinical needs in the territory and around the world. To date, no FGFR4-targeted therapies have been approved worldwide.

ABSK-011 is the first program of Abbisko Therapeutics to be approved for clinical studies in China. In December 2019, Abbisko has also received the IND approval in Taiwan to conduct first-in-human studies of ABSK-011.

Founded in April 2016, Abbisko Therapeutics Co., Ltd. is a biopharmaceutical company dedicated to discovering and developing innovative therapeutics to treat cancer and other diseases with unmet medical needs. The founders and core team of Abbisko are industrial veterans with strong leadership and managerial experiences from top international pharmaceutical companies. Over three years, Abbisko has established a strong oncology pipeline with multiple programs entering the clinic.

On March 9, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported the approval of its Investigational New Drug ("IND") application by the United States Food and Drug Administration ("FDA") for eftilagimod alpha ("efti" or "IMP321") (Press release, Immutep, MAR 9, 2020, View Source [SID1234555341]).

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The FDA approval of the IND allows Immutep to initiate its planned AIPAC-002 Phase I clinical study in metastatic breast cancer (MBC) patients. Immutep will commence the study, subject to the completion of other preparatory steps and pending positive results from its larger AIPAC Phase IIb study, which are expected to be reported by the end of March 2020.

Immutep CEO, Marc Voigt stated: "Receiving our second IND approval for efti from the FDA is a crucial step forward for Immutep. The IND allows us to initiate, effectively, a small bridging study called AIPAC-002 that enables us to further interact with the FDA in terms of efti in metastatic breast cancer. The results of our larger AIPAC trial will be reported this month. If they are positive, we will proceed with the final preparations and more importantly, will advance our discussions with regulators in order to make key strategic decisions about efti."

Overview of AIPAC-002

AIPAC-002 is a Phase I trial evaluating efti in combination with a taxane-based standard of care chemotherapy, called paclitaxel, in 24 patients with MBC in the US and the EU to boost the T-cell immune responses against tumours. This is the same combination therapy being investigated in Immutep’s Phase IIb AIPAC study. The trial forms part of Immutep’s strategy to expedite the possible use of efti for MBC patients in the US.

The IND application allows Immutep to ship efti across US state borders to US clinical investigators participating in the AIPAC-002 clinical study.

On March 9, 2020, BridgeBio Pharma, Inc. ("BridgeBio") reported an aggregate of $550.0 million aggregate principal amount of its 2.50% Convertible Senior Notes due 2027 (the "Notes"), pursuant to an Indenture dated March 9, 2020 (the "Indenture"), between BridgeBio and U.S. Bank National Association, as trustee (the "Trustee"), in a private offering to qualified institutional buyers (the "Note Offering") pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Filing, 8-K, BridgeBio, MAR 9, 2020, View Source [SID1234555340]). The Notes issued in the Note Offering include $75.0 aggregate principal amount of Notes sold to the initial purchasers in (the "Initial Purchasers") pursuant to the exercise in full of the Initial Purchasers’ option to purchase additional Notes.

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The Notes are senior, unsecured obligations of BridgeBio and will accrue interest payable semiannually in arrears on March 15 and September 15 of each year, beginning on September 15, 2020, at a rate of 2.50 % per year. The Notes will mature on March 15, 2027, unless earlier converted or repurchased. The Notes are convertible into cash, shares of BridgeBio’s common stock or a combination of cash and shares of BridgeBio’s common stock, at BridgeBio’s election.

The net proceeds BridgeBio received from the Note Offering are equal to approximately $537.0 million, after deducting the Initial Purchasers’ discount and estimated offering expenses payable by BridgeBio. BridgeBio used approximately $49.3 million of the net proceeds from the Note Offering to pay the cost of the Capped Call Transactions described below, and approximately $75.0 million to pay the cost of Repurchases of shares of its common stock described below. BridgeBio intends to use the remainder of the net proceeds from the Note Offering for working capital and other general corporate purposes, including for its commercial organization and launch preparations. BridgeBio may also use any remaining net proceeds to fund possible acquisitions of, or investments in, complementary businesses, products, services and technologies. BridgeBio has not entered into any agreements or commitments with respect to any material acquisitions or investments at this time.

A holder of Notes may convert all or any portion of its Notes at its option at any time prior to the close of business on the business day immediately preceding December 15, 2026 only under the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2020 (and only during such calendar quarter), if the last reported sale price of BridgeBio’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (2) during the five business day period after any five consecutive trading day period (the "measurement period") in which the "trading price" (as defined in the Indenture) per $1,000 principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of BridgeBio’s common stock and the conversion rate on each such trading day; or (3) upon the occurrence of specified corporate events. On or after December 15, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, a holder may convert all or any portion of its Notes at any time, regardless of the foregoing.

The conversion rate will initially be 23.4151 shares of BridgeBio’s common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $42.71 per share of BridgeBio’s common stock). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, BridgeBio will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such a corporate event.

BridgeBio may not redeem the Notes prior to the maturity date, and no sinking fund is provided for the Notes.

If BridgeBio undergoes a fundamental change (as defined in the Indenture), holders may require BridgeBio to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

The Indenture contains customary terms and covenants, including that upon certain events of default occurring and continuing, either the Trustee or the holders of not less than 25% in aggregate principal amount of the Notes then outstanding may declare the entire principal amount of all the Notes plus accrued special interest, if any, to be immediately due and payable.

The Notes are BridgeBio’s general unsecured obligations and rank senior in right of payment to all of BridgeBio’s indebtedness that is expressly subordinated in right of payment to the Notes; equal in right of payment with all of BridgeBio’s liabilities that are not so subordinated; effectively junior to any of BridgeBio’s secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of BridgeBio’s subsidiaries.

A copy of the Indenture and form of Note are filed as Exhibit 4.1 and Exhibit 4.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. The foregoing description of the Indenture and Notes does not purport to be complete and is qualified in its entirety by reference to such exhibits.

On March 9, 2020 Elevar Therapeutics, a late stage biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, reported the initiation of a pivotal trial for the treatment of adenoid cystic cancer (ACC) with the enrollment of the first patient at the University of California, San Francisco Division of Hematology and Oncology (Press release, LSK BioPharma, MAR 9, 2020, View Source [SID1234555331]). This study is designed to evaluate the efficacy and safety of rivoceranib in subjects with recurrent or metastatic ACC of all anatomic sites of origin. Chief Drug Development Officer, Dr. Steven Norton, said, "The opportunity to study the impact Rivoceranib has on ACC could lead to a shift in the way ACC patients are treated. We recognize the high unmet need for these patients and are committed to advancing care for these patients."

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Adenoid cystic carcinoma (ACC) is a relatively uncommon tumor with a reported 1,200 new cases diagnosed each year in the United States. Elevar is preparing to file for orphan drug designation (fewer than 200,000 patients) in the United States. ACC is considered a low-grade malignancy, and is characterized by slow growth and invasion of the tumor to the space surrounding nerves. ACC typically occurs in salivary glands, but can also occur in secretory glands located in other tissues such as the esophagus, breast and lungs. Although good local control is usually achieved by resection of the primary tumor and adjuvant radiation therapy, more than half of patients eventually have recurrent and/or metastatic disease. There is no standard of care treatment option for ACC, and there is an unmet need for patients with recurrent and/or metastatic ACC.

Dr. Hyunseok Kang, Associate Professor of Clinical Medicine at University California, San Francisco, said, "Adenoid cystic cancer has been a very challenging disease with no standard treatment options other than repeated surgeries and/or radiation. We are glad to dose our first patient with Rivoceranib, which seems to be a very promising approach for these patients. Based on data we have seen out of China, I am optimistic that Rivoceranib would be proved to be a valuable treatment option for patients suffering advanced ACC."

The primary endpoint for this study is the frequency of patients with partial or complete responses to treatment (objective response rate). Secondary objectives include Overall Survival, Progression Free Survival, Duration of Response and Time to Progression. The study is being conducted at multiple centers across the United States and South Korea. Additional information can be found at ClinicalTrials.gov (Identifier: NCT04119453).

About Rivoceranib (Apatinib)

Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder, Jiangsu Hengrui Medicine Co., Ltd. Elevar Therapeutics holds the global rights (ex-China). The Company has completed a global (12 countries across Asia, US, and Europe) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric/gastroesophageal junction cancer patients ("ANGEL study"). Elevar Therapeutics is also developing rivoceranib for the treatment of patients with earlier lines of gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. Elevar Therapeutics has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea. The Company is in discussions with the FDA to receive advice on regulatory submissions for monotherapy gastric cancer treatment.

On March 9, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2019 (Press release, Innate Pharma, MAR 9, 2020, View Source [SID1234555330]). The consolidated financial statements are attached to this press release.

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"2019 was a defining moment for Innate Pharma, as we successfully executed our Nasdaq listing in the US and announced plans to advance the Company’s first molecule into Phase III, monalizumab. In addition, we started building out our commercial infrastructure in the US. Collectively, these achievements marked a significant step in raising the Company’s global profile and executing on our corporate, clinical and commercial strategy," commented Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We thank our employees and all of our external stakeholders who have contributed to Innate’s success. We look forward to another exciting year ahead where we’ll continue to deliver on our broad and balanced portfolio, and work to get innovative medicines to patients as quickly as possible."

Financial highlights for 2019:
The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2019 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €255.9 million (€m) as of December 31, 2019 (€202.7m as of December 31, 2018), including non-current financial instruments amounting to €37.0m (€35.2m as of December 31, 2018).
Net proceeds of €66.0m from the Company’s global offering in October 2019, including its initial public offering on the Nasdaq Global Select Market.
Net proceeds of €44.9m from the final payments under the October 2018 agreements with AstraZeneca, after payments received from AstraZeneca and payments made to AstraZeneca, Novo Nordisk A/S and Orega Biotech.
As of December 31, 2019, financial liabilities amounted to €18.7m (€4.5m as of December 31, 2018) as a result of the draw down in August 2019 of the remaining portion of €13.9m of the €15.2m loan granted in July 2017 by Société Générale.
Revenue and other income amounted to €85.8m in 2019 (2018: €94.0m) and mainly comprise:
Revenue from collaboration and licensing agreements mainly resulting from the spreading of the upfront and opt-in payments received from AstraZeneca. Revenue from collaboration and licensing agreements for monalizumab decreased by €19.0m to €42.5m in 2019 (2018: €61.5m), primarily due to its exercise of the option by AstraZeneca in October 2018 which resulted in a catch up additional revenue of €32.0m in 2018. Revenue from collaboration and licensing agreements for IPH5201 increased by €3.2m to €18.8m in 2019 (2018: €15.6m). Revenue from invoicing of R&D costs for IPH5401 and IPH5201 was €6.9m in 2019 (2018: €2.2m)..
Research tax credit increased by €3.2m to €16.7m (2018: €13.5m) mainly as a result of an increase in the amortization expense for the intangible assets related to acquired licenses (monalizumab, Lumoxiti, IPH5201).
Operating expenses of €104.6m in 2019 (2018: €87.7m), of which 75.3% are related to research and development (R&D).
R&D expenses increased by €9.3m to €78.8m in 2019 (2018: €69.6m), including amortization expenses of €15.5m in 2019 (2018: €6.7m). This increase in amortization expenses is primarily due to the full year impact of the amortization of Lumoxiti and IPH5201.
Selling, general and administrative (SG&A) expenses increased by €7.7m to €25.8m in 2019 (2018: €18.1m) in the context of the structuration of the US subsidiary and commercialization of Lumoxiti as well as general reinforcement of support functions in light of Innate’s corporate evolution.
The Lumoxiti distribution agreement generated a net loss of €8.2m in 2019 (2018: loss of €1.1m). In 2019, the Company had a cost sharing mechanism with AstraZeneca that will be reimbursed in 2020.
A net loss of €20.8m in 2019 (2018: net income of €3.0m).