Quarterly Report Q3 2024

On November 13, 2024 PhotoCure reported its quarterly results (Presentation, PhotoCure, NOV 13, 2024, View Source [SID1234649494]).

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Photocure ASA: Results for the third quarter of 2024

On 13 November 2024 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 120.1 million in the third quarter of 2024 (Q3 2023: NOK 107.3 million), and EBITDA of NOK 5.0 million (NOK 3.3 million) for the Company (Press release, PhotoCure, NOV 13, 2024, View Source [SID1234649493]). Photocure reiterates its 2024 financial guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses.

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"We delivered solid performance in the third quarter, generating 12% Hexvix/Cysview revenue growth and NOK 5.0 million in EBITDA. Year-to-date, we have reported 9% growth in product revenues. Our business segments in North American and Europe both generated positive contributions during the quarter, and we made progress on key initiatives that we are pursuing to accelerate our growth going forward," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 120.2 million in the third quarter of 2024 (NOK 107.5 million), and EBITDA* of NOK 5.0 million (NOK 3.3 million), driven by revenue growth in North America and Europe. Hexvix/Cysview revenues ended at NOK 120.1 million in the quarter (Q3 2023: NOK 107.3 million). The EBIT was NOK -2.2 million (NOK -3.9 million) and the cash balance at the end of the period was NOK 291.1 million.

At the end of the third quarter of 2024, the installed base of rigid BLC systems in the U.S. was 387, up 13% since Q3 2023. This includes 18 mobile towers owned by ForTec Medical. Photocure estimates that 25 flexible BLC towers remain in the U.S. market. Photocure also entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation flexible blue light cystoscope based on Richard Wolf’s system blue technology with the goal to reintroduce and grow the use of BLC with Cysview/Hexvix in the surveillance setting.

"We are also positioning for the future with our Richard Wolf partnership to develop and commercialize a state-of-the-art flexible high-definition blue light system. This partnership is focused on ensuring that physicians and patients have reliable access to high quality BLC equipment in the surveillance setting. The development project is well underway, with the goal to bring a new flexible BLC system to patients globally as soon as possible. Additionally, the Karl Storz’ Citizen’s Petition to have BLC equipment reclassified in the U.S. from Class 3 to Class 2 is another significant opportunity that we continue to monitor and pro-actively support," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Photocure reiterates its 2024 guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency, positive EBITDA excluding business development expenses, and new and upgraded Saphira installations in the U.S. in the range of 55 to 70 towers.

"With our business continuing to show steady growth, industry trends in our favor, and a number of initiatives underway that can enable Hexvix/Cysview to grow faster, I believe that Photocure is well-positioned to deliver value to patients and our shareholders in the coming quarters," Schneider concludes.

Termination of a Material Definitive Agreement

On November 13, 2024, Syros Pharmaceuticals, Inc. (the "Company") reported to have gave notice to QIAGEN Manchester Limited ("QIAGEN") of its election to terminate the Master Collaboration Agreement dated March 7, 2022 (the "Agreement") relating to the development and commercialization of an assay as a companion diagnostic test for use with tamibarotene as a result of the failure of the Company’s SELECT-MDS-1 Phase 3 trial evaluating tamibarotene to meet its primary endpoint of complete response rate, which was previously disclosed on the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (the "SEC") on November 13, 2024 (Filing, 8-K, Syros Pharmaceuticals, NOV 18, 2024, View Source [SID1234648478]). The termination will be effective 90 days following such notice.

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Under the terms of the Agreement, QIAGEN was responsible for developing, and obtaining and maintaining regulatory approvals for the companion diagnostic test in the United States and, at the request of the Company and subject to the negotiation of mutually agreed payments, in certain additional markets. In addition, QIAGEN had agreed to use commercially reasonable efforts to manufacture the companion diagnostic test and, upon negotiation of mutually agreed terms, to make the companion diagnostic test commercially available in the United States, the additional markets, and such other countries as the parties may mutually agree. In connection with the termination of the Agreement, the Company will be obligated to pay QIAGEN certain wind-down and other costs and other final payments.

The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the complete text of the Agreement, which the Company has filed, with confidential terms redacted, with the SEC as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022.

Item 2.04.
Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.

As previously disclosed in the Company’s Current Report on Form 8-K filed with the SEC on November 13, 2024, an event of default occurred on November 12, 2024 under the Loan and Security Agreement dated February 12, 2020 (as subsequently amended, the "Loan Agreement") between the Company and Oxford Finance LLC ("Oxford"), as a result of the failure of the Company’s SELECT-MDS-1 Phase 3 trial evaluating tamibarotene to meet its primary endpoint of complete response rate (the "Trial Results Default").

The Loan Agreement provides Oxford, as collateral agent, with the right, upon such an event of default, to exercise remedies against the Company and the collateral securing the loans under the Loan Agreement, including the right to declare all obligations of the Company under the Loan Agreement immediately due and payable and the right to foreclose against the Company’s cash and other property securing the Loan Agreement obligations. Pursuant to the Loan Agreement, a $20.0 million term loan was funded to the Company on February 12, 2020 and another $20.0 million term loan was funded to the Company on December 23, 2020. The floating annual rate for each term loan is equal to the greater of (i) 7.75% and (ii) the sum of (a) the 1-month CME Term SOFR reference rate, (b) 0.10%, and (c) 5.98%. Pursuant to the terms of an amendment dated May 9, 2024 (the "Fourth Loan Amendment"), Oxford agreed to extend the interest-only period from September 1, 2024 to November 1, 2025, and to provide for the repayment of the aggregate outstanding principal balance of the term loan in monthly installments starting on November 1, 2025 through February 1, 2028 (the "Maturity Date"). In connection with a prior extension of the interest-only period, the Company agreed to pay fees of $300,000 upon the first to occur of the Maturity Date or the acceleration or prepayment of any term loan. In connection with the Fourth Loan Amendment, the Company agreed to pay an additional fee of $1,050,000 upon the first to occur of the Maturity Date or the acceleration or prepayment of any term loan. The Company is also required to make a final payment equal to 5.00% of the amount of the term loan drawn upon the first to occur of the Maturity Date or the acceleration or prepayment of any term loan. If the term loans are accelerated following the occurrence of an event of default, the Company must also pay a prepayment fee equal to 0.50% of the amount of the outstanding term loans. The foregoing description of the Loan Agreement is qualified in its entirety by reference to the full text of the Loan Agreement which is filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and incorporated herein by reference.

On November 14, 2024, the Company received written notice from Oxford of the Trial Results Default, which notice declared all of the Loan Agreement obligations immediately due and payable and demanded the immediate repayment of approximately $43.7 million in satisfaction of all obligations under the Loan Agreement (the "Default Notice").

On November 15, 2024, the Company paid $33.5 million to Oxford in partial satisfaction of its obligations under the Loan Agreement. The Company intends to negotiate and enter into a forbearance agreement with Oxford that will further address the Trial Results Default and the Default Notice.

TAE Life Sciences and Stella Pharma Announce Strategic Agreement for Development and Commercialization of BPA for BNCT Cancer Therapy in the USA and Europe

On November 13, 2024 TAE Life Sciences (TLS), a leader in developing boron neutron capture therapy (BNCT) technology and associated innovative boron target drugs, and Stella Pharma, the pioneering developer of boronophenylalanine (BPA) under the product name, Steboronine, for BNCT, are pleased to announce a strategic collaboration focused on the development, commercialization and expansion of BNCT using BPA in the United States and European markets (Press release, TAE Life Sciences, NOV 13, 2024, View Source [SID1234648415]).

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Stella Pharma’s BPA drug is the world’s first and only clinically approved boron drug for BNCT, marking a breakthrough in cancer treatment. Japan became the first country to approve BNCT for the treatment of head and neck cancers, using Stella Pharma’s pioneering BPA drug. Now, Stella Pharma, as the leading producer and supplier of BPA, has joined forces with TAE Life Sciences to expand the adoption of BNCT worldwide.

Supporting the Future of BNCT Therapy

The collaboration objectives include extensive international cooperation in the development and commercialization of BNCT and BPA across the USA and Europe with clinical trials anticipated to begin in 2026. TLS will serve as the exclusive commercial partner for Stella Pharma’s BPA in these regions, representing a significant expansion of BNCT accessibility outside of Asia.

"Our partnership with Stella Pharma combines our shared commitment to advancing BNCT as a viable cancer treatment for patients worldwide," said Rob Hill, CEO of TAE Life Sciences. "We are excited to bring the proven benefits of BPA to U.S. and European healthcare institutions and to support BNCT globally with this powerful therapeutic solution."

Both companies have also committed to supporting BNCT equipment vendors across all markets in implementing BPA-based BNCT treatments. By fostering partnerships within the BNCT ecosystem, TLS and Stella Pharma aim to enhance the clinical reach of BNCT in treating recurrent head and neck cancers and advancing clinical studies for other cancers, including brain, skin, breast, esophagus, and lung cancers.

"Our alliance with TAE Life Sciences marks a significant step in expanding the reach of BPA-based BNCT treatments beyond Asia," said Koki Uehara, President and Chief Operating Officer of Stella Pharma. "We look forward to collaborating internationally to develop and commercialize BNCT and aim to deliver this advancing cancer treatments to patients and their families worldwide."

Exploring Future Opportunities Together

Stella Pharma and TAE Life Sciences share a vision of advancing BNCT treatment for hard-to-treat cancers and pledge to explore additional areas for collaboration. Through this alliance, they seek to accelerate innovation, expand treatment options, and ultimately improve outcomes for cancer patients worldwide.

For more information about TAE Life Sciences, Alphabeam, and the company’s proprietary boronated BNCT drugs, please visit taelifesciences.com.

Reverb Therapeutics to Collaborate With Royalmount Laboratories on Development of Advanced Bispecific Antibodies

On November 13, 2024 Reverb Therapeutics, a leader harnessing the body’s immune system and cytokine signaling to treat life-threatening diseases, reported it has launched a collaboration with Royalmount Laboratories, based in Montreal, as Reverb works towards lead selection and pre-IND enabling work on its first drug candidate (Press release, Royalmount Laboratories, NOV 13, 2024, View Source [SID1234648314]).

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Royalmount Laboratories is one of Canada’s premier CRO organizations, supporting biopharma and pharma companies with their bioanalytical needs to advance their discovery, preclinical and clinical programs. It is rapidly becoming the leading niche small and large molecule bioanalytical CRO in Canada.

"As we move towards the start of clinical trials in about 18 months’ time, we needed a scientific partner that could assist with toxicity studies, scale-up of manufacturing, and a variety of CMC tasks to ensure that our drug candidate moves swiftly from the lab to the clinic," said David de Graaf, Ph.D., CEO of Reverb Therapeutics. "We are impressed with Royalmount Laboratories’ capabilities and the quality of their staff."

Adrien Musuku, Senior Director of biopharmaceutics for Royalmount Laboratories, said, "At Royalmount Laboratories, we provide both small and large molecule bioanalytical support needed to bring life-changing therapies to those in need. Our proven track record of strong science, unmatched quality and consistent on-time delivery facilitates quick advancement in the development of new therapeutic entities. We are proud to support companies like Reverb Therapeutics, an early-stage firm with novel science and a unique approach to harnessing the power of cytokines to treat disease. Reverb Therapeutics is a perfect example of the kind of dynamic company we want to help advance to the clinic and beyond."

Terms of the collaboration were not disclosed. Development work for Reverb begins immediately.

Reverb’s novel Amplify•R platform combines bispecific antibody engineering with data-driven modelling of antibody-tissue interaction to amplify endogenous cytokines and redirect them to tissues of interest. This approach avoids the hurdles that have blocked other attempts to enlist cytokines to treat disease, which include systemic toxicity, immunogenicity, and manufacturing issues. Reverb Therapeutics is developing its precision medicine for the immune system with a focus on the treatment of cancer and auto-immune diseases.

The Amplify•R platform is designed to expand the therapeutic window of cytokines by harnessing the body’s own endogenous cytokines and amplifying their activity in a tissue-specific manner, leading to profound disease-modifying effects. The Amplify•R platform is a modular, plug-and-play, IgG-based platform, enabling rapid pre-clinical testing and ease of manufacturing for scale-up and clinical utility.