On February 28, 2023 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported to advise the successful conclusion of its recent equity financing round (Press release, Kazia Therapeutics, FEB 28, 2023, View Source [SID1234627924]).

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Key Points

AU$ 4.5 million raised from existing sophisticated and institutional investors, as announced to ASX on 16 January 2023

AU$ 2.606 million raised from existing shareholders via Share Purchase Plan (SPP), which closed on 24 February 2023

Total gross proceeds of AU$ 7,106,000 will be applied (after application of expenses) to Kazia’s R&D pipeline, which comprises two assets in nine clinical trials

Multiple inflection points expected in CY2023, with potential to substantially revalue both paxalisib and EVT801 development candidates

Cash inflows provide runway to 4Q CY2023, on current cashflow forecast.

"We are grateful for the emphatic support of our shareholders," commented Iain Ross, Chairman of the Board at Kazia Therapeutics. "The proceeds of this financing will help the company to deliver a number of key read-outs during CY2023, which we expect to materially advance the development of our two assets, and in particular to position paxalisib for its further development and ultimate commercialization."

Shares subscribed for under the institutional placement have been issued, as per the company’s announcement of 28 February 2023. Shares subscribed for under the SPP will be issued on 3 March, as previously announced to ASX.

On February 28, 2023 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with liver diseases characterized by high unmet medical needs, reported its cash position as of December 31, 2022 and revenues for 2022 (Press release, Genfit, FEB 28, 2023, View Source [SID1234627923]).

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Financials

As of December 31, 2022, the Company’s cash, cash equivalents and current financial instruments amounted to €140.2 million compared with €258.8 million as of December 31, 2021. As of September 30, 2022, cash, cash equivalents and current financial instruments totaled €163.6 million.

The decrease in cash, cash equivalents and current financial instruments between September 30, 2022 and December 31, 2022 notably includes the payment of CHF2.4 million (€2.4 million) representing a net cash adjustment made at year end in accordance with the Versantis AG share purchase agreement, and related acquisition costs totaling €1.7 million.

The decrease in cash, cash equivalents and current financial instruments between December 31, 2021 and September 30, 2022 includes the payment of €24.0 million in January 2022 representing the VAT collected on the initial upfront payment received from Ipsen in December 2021, the disbursement of employee participation in the profits of GENFIT SA in May 2022 for a total of €0.6 million for the financial year 2021, and the initial consideration of CHF40.0 million (€41.9 million) for the acquisition of Versantis AG on September 29, 2022.

Revenues

Revenues for 2022 amounted to €20.2 million compared to €80.1 million for the same period in 2021.3

Of the €20.2 million in revenues for 2022, €15.9 million is attributable to the partial recognition of the €40.0 million deferred income described below. €1.0 million in revenue was generated from the services rendered by GENFIT to Ipsen in accordance with the Transition Services Agreement signed in 2022, which essentially outlines

1 Of the cash, cash equivalents and current financial instruments amount noted above as of December 31, 2022, there is a €4.5 million current financial instrument whose term is 180 days

2 Unaudited financial information under IFRS

3 Revenues as recognized under IFRS 15

the scope of services to facilitate the transition of some activities related to the Phase 3 clinical trial evaluating elafibranor in Primary Biliary Cholangitis. €3.3 million was recognized as revenue in 2022 in accordance with the Inventory Purchase Agreement signed with Ipsen, pursuant to which Ipsen purchased inventory of elafibranor active pharmaceutical ingredient and drug product during the second half of 2022 with the prospect of transferring the conduct of the ELATIVE study to Ipsen

Revenues for 2021 mainly resulted from the receipt of the €120 million upfront payment from Ipsen, out of which €80 million was recognized as 2021 revenue, and €40 million deducted as deferred revenue. The remainder will be gradually recognized as revenue following the completion of the ELATIVE double-blind study, in accordance with IFRS 15 and the terms of the strategic licensing and collaboration agreement with Ipsen on December 17, 2021

Upcoming topline data readout for the Phase 3 ELATIVETM study

Topline data for our Phase 3 global trial ELATIVE evaluating elafibranor in patients with Primary Biliary Cholangitis is expected to be announced in the second quarter 2023

Upcoming financial communications

The Company will release its full-year 2022 financial results on April 13, 2023. The 2022 Universal Registration Document, the 2022 Annual Financial Report (included in the 2022 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2023.

On February 28, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed regulatory applications with the Ministry of Health, Labour and Welfare for the humanized anti-human IL-6 receptor monoclonal antibody, "Actemra Intravenous Infusion 80mg, 200mg, and 400mg" [generic name: tocilizumab (genetical recombination)] for the treatment of cytokine release syndrome induced by cancer treatment. This application is based on the clinical study results of an antineoplastic agent (Press release, Chugai, FEB 28, 2023, View Source [SID1234627922]).

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"We are very pleased to file for regulatory application of Actemra for the additional indication of cytokine release syndrome induced by cancer treatment in Japan," said Chugai’s President and CEO, Dr. Osamu Okuda. "Cytokine release syndrome, a common adverse reaction in CAR-T cell therapy and some antibody drugs, can be life-threatening in severe cases. We are closely working with the Japanese health authority to ensure that proper treatment is provided to patients on cancer therapies other than CAR-T cell therapy."

About Actemra
Actemra is the first therapeutic antibody created in Japan by Chugai. It is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June 2005, the intravenous injection is approved for seven indications in Japan: Castleman’s disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, adult Still’s disease, and SARS-CoV-2 pneumonia. In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, and giant cell arteritis. Actemra has obtained regulatory approval in more than 110 countries worldwide.

On February 28, 2023 Applied DNA Sciences, Inc. (the "Company") reported that it has entered into that certain Amended and Restated Lease Agreement with Long Island High Technology Incubator, Inc. (the "Landlord") with respect to the Company’s office space consisting of 30,000 gross rentable square feet in the building known as LIHTI 2 located at 50 Health Sciences Drive, Stony Brook, New York 11790 (the "Office Lease" ) (Filing, 8-K, Applied DNA Sciences, FEB 28, 2023, View Source [SID1234627920]). Also on February 24, 2023, the Company entered into that certain Amended and Restated Lease Agreement with the Landlord with respect to the Company’s laboratory space consisting of an aggregate of 2,500 gross rentable square feet located at 25 Health Sciences Drive, Stony Brook, New York 11790 (the "Laboratory Lease").

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The term of the Office Lease commenced on February 1, 2023 and expires on January 31, 2026, unless terminated prior to such expiration date as provided in the Office Lease. The term of the Laboratory Lease commenced on February 1, 2023 and expires on January 31, 2024, unless terminated prior to such expiration date as provided in the Laboratory Lease.

Under the Office Lease, beginning on February 1, 2023 and ending on January 31, 2024, the base rent will be $48,861.17 per month. Beginning on February 1, 2024, the base rent under the Office Lease shall be increased in February of each year by a percentage equal to the percentage change in the Consumer Price Index statistics published by the United States Bureau of Labor Statistics. Under the Laboratory Lease, beginning on February 1, 2023 and ending on January 31, 2024, the base rent will be $8,750 per month.

The foregoing descriptions of the Office Lease and the Laboratory Lease contained in this Current Report on Form 8-K do not purport to be complete and are qualified in their entirety by reference to the Office Lease and Laboratory Lease, copies of which are filed as Exhibit 10.1 and Exhibit 10.2, respectively.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The descriptions of the Office Lease and the Laboratory Lease in "Item 1.01 Entry into a Material Definitive Agreement" of this Current Report on Form 8-K are incorporated by reference in their entirety into this Item 2.03.

On February 28, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will attend Cowen’s 43rd Annual Health Care Conference, which will be held March 6 – 8, 2023 at the Boston Marriott Copley Place in Boston (Press release, Puma Biotechnology, FEB 28, 2023, View Source [SID1234627919]). Mr. Auerbach will participate in a Breast and Lung Cancer Panel Discussion on March 7 at 10:30 a.m. ET.

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A live webcast of the Breast and Lung Cancer Panel Discussion will be available at https://wsw.com/webcast/cowen132/panel8/2250192, and a replay will be available on Puma’s website for 30 days following the presentation at View Source