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).

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.

On September 23, 2022 ORPHELIA Pharma reported that it will attend 54th Annual SIOP Congress in Barcelona, Spain (Press release, ORPHELIA Pharma, SEP 23, 2022, View Source;utm_medium=rss&utm_campaign=siop-2022-barcelona-spain [SID1234621376]). M. Jeremy Bastid, Chief Development Officer at ORPHELIA Pharma, will have the pleasure to present a poster entitled: "Dispensing oral temozolomide in children: precision and stability of a novel and ready-to-use liquid formulation in comparison with capsule-derived mixtures" .

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The SIOP 2022 Annual Meetings will bring together more than 3,000 leading clinicians and scientists from over 100 countries to share recent momentous scientific advances in the field of paediatric oncology. The SIOP 2020 Annual Meeting will take place in Barcelona, Spain, from September 28-October 1, 2022 (View Source).

On 22 September 2022 Roca Therapeutics, a leading biotech startup specialized in the discovery and development of small molecules addressing severe life-threatening disorders caused by hypervascularization and macrophages M2 driven immunosuppression, reported the closing of a seed funding round led by 3B Future Health Fund II and SATT Sud-Est (Press release, , SEP 22, 2022, View Source [SID1234628559]).

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Roca Therapeutics will use these funds to i) to develop its Lead Clinical candidate RCT001 (Metastatic Uveal Melanoma) until IND/CTA readiness in 2023, ii) and to further expand the company’s portfolio of assets with the nomination of a second clinical candidate against Neovascular Glaucoma associated to Uveal melanoma.

Uveal melanoma is a rare deadly disease with a very poor prognosis and high unmet need. Roca Therapeutics has uniquely designed innovating small molecules addressing dedicated pathobiological mechanisms (M2 Macrophages driven immunosuppression and resistant angiogenesis) recently linked to indications such as Uveal Melanoma as well as Renal Cell Carcinoma and Head and Neck Squamous Cell Carcinoma.

Roca Therapeutics has received grants and non-dilutive funding from BPI (French Public Investment Bank), PACA Cancéropôle, UCA (Université Cote d’Azur), Eurobiomed Grand Sud (competitive cluster), the Incubator PACA-Est, Nice Metropole, and Southern Regional council.

"I am thrilled to welcome 3B Future Health Fund II and SATT Sud-Est as new shareholders in Roca Therapeutics, and I would like to thank them for their support as we move forward with developing our lead "First in Class" small molecule asset, as well as targeting the expansion of our pipeline. Today’s investment will be integral to us fulfilling our mission to offer patients with no current treatment options, a potentially extended life and restored vision.", said, Maeva Dufies, Co-founder, CEO and CSO of Roca Therapeutics."

"Roca Therapeutics is leveraging an exceptional combination of knowledge of the antitumor resistance mechanisms and a seasoned complementary team to develop new small molecules in aggressive tumors and hypervascularization", commented, Roberto de Ponti, Managing Director and General Partner of 3B Future Health Fund II. "We are excited to support ROCA Therapeutics’ talented team in converting their highly promising and valuable research into new treatments."

"We are proud and grateful to have to the opportunity to support the creation of Roca Therapeutics. The evolution of the company and progress of their projects to date is very encouraging and we are delighted to be shareholders in the company", said, Laurent BALY, President of SATT Sud-Est.

"This collaboration with 3B Future Health Fund and SATT Sud-Est will help Roca Therapeutics to put in place the foundations on which to execute on the company’s strategic goal to offer an holistic approach for the treatment of Uveal Melanoma and its complications for the patients", commented, Zaki SELLAM, Co-founder and Executive Chairman of Roca Therapeutics and Managing Partner of Landmark BioVentures AG, he added, "I am also highly excited to announce that the Board of Roca Therapeutics has decided to immediately initiate a Series A funding round in preparation for funding the clinical development of our lead small molecule asset against Uveal Melanoma and other indications fueled by hypervascularization and immunosuppressive inflammation."

The Roca Therapeutics Board of Directors now consists of: Dr Maeva Dufies (CEO and CSO, scientific co-founder), Zaki Sellam (Executive Chairman, co-founder, representative of Landmark BioVentures AG), Dr Gilles Pagès (Scientific co-founder), Dr Rachid Benhida (Scientific co-founder), Dr Cyril Ronco (Scientific co-founder) and Roberto De Ponti (Representative of 3B Future Health Fund II).

On September 22, 2022, NovAccess Global Inc. ("NovAccess" or the "company"), reported that entered into a securities purchase agreement (the "SPA") with 1800 Diagonal Lending LLC ("1800 Diagonal Lending") and issued a convertible promissory note in the original principal amount of $79,250 (the "note") to 1800 Diagonal Lending pursuant to the SPA (Filing, 8-K, NovAccess Global, SEP 22, 2022, View Source [SID1234622547]). The loan funded on September 28, 2022. NovAccess will use the proceeds of the loan for general working capital purposes.

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NovAccess provided typical representations and agreed to standard covenants pursuant to the SPA. The SPA does not include any financial covenants.

The note bears interest at 8% a year and is due on September 22, 2023. NovAccess may prepay the note upon payment of a prepayment penalty ranging from 15-25% of the amount outstanding on the note when prepaid. Under the terms of the note, NovAccess may not sell a significant portion of its assets without the approval of 1800 Diagonal Lending, must comply with the company’s reporting requirements under the Securities Exchange Act of 1934, and must maintain the listing of the company’s common stock on the OTCQB Market or other exchange. NovAccess’ failure to comply with any of these covenants, among other matters, would constitute an event of default. Upon an event of default, the note will bear interest at 22% and 1800 Diagonal Lending will be entitled to its costs of collection.

Beginning on March 21, 2023, 1800 Diagonal Lending may convert the amount outstanding under the note into shares of NovAccess common stock at a conversion price equal to 65% of the average of the three lowest trading prices of the stock during the fifteen trading days before the conversion date.

The SPA and note are filed as exhibits to this Current Report on Form 8-K. The descriptions above are qualified in their entirety by reference to the full text of these documents.