CASI PHARMACEUTICALS ANNOUNCES EXIT OF JUVENTAS INVESTMENT TO STRENGTHEN BALANCE SHEET

On September 23, 2022 CASI Pharmaceuticals, Inc. (NASDAQ: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products ("CASI"), reported that CASI Biopharmaceuticals (Wuxi) Co., Ltd, a subsidiary of CASI Pharmaceuticals, Inc. ("CASI Wuxi"), entered into an Equity Transfer Agreement with Shenzhen Jiadao Gongcheng Equity Investment Fund, LLP ("Jiadao Gongcheng"), pursuant to which CASI Wuxi agreed to transfer its equity interest in Juventas Biotechnology (Tianjin) Co., Ltd. ("Juventas") amounting to 12.0098% total Juventas equity to Jiadao Gongcheng for RMB 240.87 million (equivalent to USD 34.03 million) (Press release, CASI Pharmaceuticals, SEP 23, 2022, View Source [SID1234621382]). The Equity Transfer Agreement states there will be two even payment installments from Jiadao Gongcheng: one payment to be made after the Equity Transfer Agreement is signed and the second payment to be made after the completion of the equity transaction.

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We are confident in CNCT-19, and we expect Juventas to submit for NDA to the NMPA in 2022 for the B-ALL indication. CASI and Juventas will continue to maintain a working partnership, focusing on product launch and co-marketing for CNCT-19."

Dr. He continued, "The completion of the equity transfer transaction will strengthen CASI’s balance sheet by providing CASI with sufficient cash to operate until, at least, the end of 2023. This transaction will allow CASI to advance the development of our other pipeline projects while augmenting the efforts of our sales and marketing team."

About CNCT-19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

Allogene Therapeutics Announces Participation in the Jefferies Cell and Genetic Medicine Summit

On September 23, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that management plans to present at the Jefferies Cell and Genetic Medicine Summit on Friday, September 30, 2022 at 6:30AM Pacific Time/9:30AM Eastern Time (Press release, Allogene, SEP 23, 2022, View Source [SID1234621381]).

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The webcast will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

Wugen to Present at the Upcoming Jefferies Cell & Genetic Medicine Summit

On September 23, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that management will participate in a fireside chat at 1:30 p.m. ET on Friday, September 30, 2022 at the upcoming Jefferies Cell & Genetic Medicine Summit set to take place in New York City (Press release, Wugen, SEP 23, 2022, View Source [SID1234621379]).

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Spectrum Pharmaceuticals Announces Debt Financing Agreement with SLR Capital Partners with $30 Million Funded at Closing

On September 23, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) ("Spectrum" or the "Company"), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that it has entered into a five-year debt financing agreement with investment affiliates managed by SLR Capital Partners, LLC (SLR) for a term loan facility of up to $65 million (Press release, Spectrum Pharmaceuticals, SEP 23, 2022, View Source [SID1234621378]). The Company believes this transaction, combined with Spectrum’s existing cash balance, provides sufficient capital to optimize the commercial launch of ROLVEDON (eflapegrastim-xnst) injection, which received U.S. Food and Drug Administration (FDA) approval on September 9, 2022, as well as fund Spectrum’s operations through 2024.

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"We are pleased to announce this financing agreement and to partner with SLR, an experienced healthcare and life sciences lender and investor. This capital commitment immediately strengthens our balance sheet and is anticipated to provide the additional resources necessary for a successful launch of ROLVEDON," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We expect this transaction will further extend our cash runway through 2024, offering operational flexibility during our transition to a commercial stage company."

Under the terms of the agreement, Spectrum will have access to up to $65 million in debt financing, divided into four tranches, the first of which was a $30 million loan drawn upon closing on September 21, 2022. The remaining $35 million will be made available in three additional tranches subject to the achievement of pre-specified regulatory and financial milestones. The tranches are available for drawdown at Spectrum’s discretion at various points until November 15, 2023.

The loan facility maturity date is September 1, 2027, and payments consist of 36 monthly interest-only payments, followed by 24 monthly payments of principal and accrued interest. The Company holds the option to extend the interest only period for an additional year if certain financial milestones are achieved. In connection with the financing, and with each advance of the loan, Spectrum will issue warrants to the lenders under the financing to purchase shares of the Company’s common stock in an amount equal to 1.00% of the applicable lender’s loan amount divided by an exercise price calculated as of the applicable funding date.

Armentum Partners served as financial advisor to the Company on the transaction. Additional information regarding the transaction can be found in the Company’s current and future periodic reports with the Securities and Exchange Commission (SEC).

PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in South Korea

On September 23, 2022 PharmaMar (MSE:PHM) reported that its licensing partner, Boryung Corporation, has received the conditional marketing approval for Zepzelca (lurbinectedin) by the Ministry of Food and Drug Safety (MFDS) of South Korea for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, SEP 23, 2022, View Source [SID1234621377]).

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This new approval of lurbinectedin is based on the monotherapy clinical data from the open-label, multi-center, single-arm clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive, resistant and refractory disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

In November 2017, PharmaMar and Boryung signed a licensing agreement for lurbinectedin in South Korea. This approval allows Boryung to market lurbinectedin in South Korea in the following months.

The conditional approval is subject to confirmation with the LAGOON Phase III clinical trial in 2nd line SCLC, initiated in December 2021.