Evotec receives € 150 m loan from European Investment Bank

On February 9, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and the European Investment Bank ("EIB") reported that the EIB has granted Evotec an unsecured loan facility of € 150 m to support the Company’s R&D activities, equity investments and the building of the new J.POD biologics manufacturing facility on Evotec’s Campus Curie in Toulouse, France (Press release, Evotec, FEB 9, 2023, View Source [SID1234627071]).

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Through this new financing of € 150 m, the EIB reiterates its supports to Evotec, a company that it already supported in 2017 with a financing of € 75 m. This new agreement is to be signed in Toulouse during a visit of the site on which the new biologics manufacturing facility will be built.

As a life science company focused on research, development, and manufacturing of novel precision medicines, Evotec aims to create global access to first- and best-in-class therapeutics. The Company works in partnerships with all Top 20 Pharma and more than 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders to achieve a better disease understanding and deliver novel and more targeted therapeutic approaches regardless of therapeutic modality.

The EIB funding specifically supports Evotec’s business strategy through a unique, innovative and flexible financing structure including a low fixed interest rate plus a reward-sharing component for the EIB. The loan with a total volume of up to € 150 m will be invested over a period of three years and each tranche will mature seven years after draw down. Evotec will use the financing to fund its internal R&D activities, equity investments, as well as the new biologics manufacturing facility, J.POD Toulouse, France (EU).

By providing funds for proprietary research in a broad range of currently underserved therapeutic areas, the EIB financing will enable Evotec to initiate additional innovative R&D activities as well as create new partnering opportunities, leveraging its precision medicine platforms. Since 2016, Evotec has also been driving medical innovation as an operational investor in early-stage biotechnology companies – spin-offs, joint ventures as well as independent start-ups. The EIB financing will enable Evotec to further broaden its portfolio, which currently spans more than 90 active projects across more than 30 companies worldwide.

On the manufacturing side, the EIB financing will support the construction of a highly innovative facility for continuous biologics manufacturing at Evotec’s Campus Curie. J.POD Toulouse, France (EU) is the second facility of its kind and the first one on European ground. It will bring advanced biomanufacturing to the EU and will deliver much-needed clinical and commercial manufacturing capacity for biologics. The construction of J.POD Toulouse, France (EU) is also supported by the French government, the Occitanie Region, Bpifrance, the Haute-Garonne prefecture as well as Toulouse Métropole with up to € 50 m.

Enno Spillner, Chief Financial Officer of Evotec, commented: "We are excited to enter into this second financing agreement with the European Investment Bank. By funding transformational projects in key areas of public interest, EIB is an important driver of innovation in the EU. We are honoured and excited to be able to create new R&D partnering opportunities and establish Europe’s first J.POD biologics manufacturing plant through the innovative financing model from the EIB at highly attractive terms. This new agreement with EIB builds on the excellent relationship we have developed as part of the first financing agreement entered in 2017. The EIB’s support will help us deliver on our mission ‘Together for Medicines that Matter’."

EIB Vice President Ambroise Fayolle said: "We are very pleased to support Evotec’s investments in research, development and innovation with this second financing agreement signed with the European Investment Bank. It demonstrates our commitment to supporting European biotech companies at the cutting edge of innovation in a sector marked by very strong global competition. This EIB investment will also have a significant impact on activity in the Toulouse region, as it will help to finance a 12,000 square metre plant that will create more than 200 highly skilled jobs."

The transaction is going to be signed by Members of Evotec’s Management Board and the Vice President of the European Investment Bank, Ambroise Fayolle, during a ceremony on Evotec’s Campus Curie in Toulouse today. This financing agreement, as well as a previous loan of € 75 m by the EIB in 2017, has been developed in cooperation with kENUP Foundation, an NGO supporting innovation in Europe.

Ultragenyx to Host Conference Call for Fourth Quarter and Full-Year 2022 Financial Results and Corporate Update

On February 9, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Thursday, February 16, 2023, at 5:00 p.m. ET to discuss its financial results and corporate update for the fourth quarter and the year ending December 31, 2022 (Press release, Ultragenyx Pharmaceutical, FEB 9, 2023, https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-fourth-quarter-and-full-year-7 [SID1234627069]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call, please register by clicking on the following link (registration link) and you will be provided with dial-in details. The replay of the call will be available for one year.

Syros Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On February 9, 2023 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported the grant of restricted stock unit (RSU) awards for an aggregate of 12,400 shares of Syros common stock to two newly hired employees in connection with their commencement of employment with Syros (Press release, Syros Pharmaceuticals, FEB 9, 2023, View Source [SID1234627068]). These RSUs were granted as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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The awards were granted on February 6, 2023, and vest as to one-quarter of the shares on January 31, 2024 and as to an additional one-quarter of the shares at the end of each successive year thereafter, subject to the employee’s continued service with Syros. These awards are subject to the terms and conditions of a restricted stock unit agreement covering the award and Syros’ 2022 Inducement Stock Incentive Plan.

Supernus Pharmaceuticals to Announce Fourth Quarter and Full Year 2022 Financial Results and Host Conference Call on February 28, 2023

On February 9, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial and business results for the fourth quarter and full year of 2022 after the market closes on Tuesday, February 28, 2023 (Press release, Supernus, FEB 9, 2023, View Source;2023.htm [SID1234627067]).

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Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to present the fourth quarter and full year 2022 financial and business results on Tuesday, February 28, 2023 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be accessible in the Events & Presentations section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

MEI Pharma Reports Second Quarter Fiscal Year 2023 Results and Operational Highlights

On February 9, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended December 31, 2022, and highlighted recent corporate events (Press release, MEI Pharma, FEB 9, 2023, View Source [SID1234627064]).

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"MEI anticipates reporting key clinical data readouts on two clinical-stage oncology candidates, voruciclib and ME-344, around the end of the calendar year for each program," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "These clinical data will inform future plans in two promising areas of oncology drug development: CDK9 inhibition and mitochondrial inhibition, respectively. With approximately $124 million at the end of the quarter, we remain well capitalized to pursue these objectives and estimate that we will be able to fund operations for two years based upon our current development plans."

Second Quarter Fiscal Year 2023 Recent Developments

In December 2022, MEI Pharma and Kyowa Kirin announced that after receiving the most recent guidance in a late November meeting with the U.S. Food and Drug Administration, the companies jointly decided to discontinue global development of zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta ("PI3Kd") inhibitor, outside of Japan for B-cell malignancies. Kyowa Kirin is continuing the Phase 2 MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas, and will explore the potential for a marketing authorization submission to Japanese health authorities based on data from the MIRAGE and TIDAL clinical trials.

In December 2022, MEI announced that it is realigning its clinical development efforts following the discontinuation of global development outside Japan of zandelisib. As part of the announced program realignment and workforce reduction, the company is resizing its organization to support continued development of voruciclib and ME-344, while concurrently supporting the winding down of the zandelisib program outside of Japan. The company additionally announced that it had engaged Torreya Partners as financial advisor to help explore additional strategic opportunities.

In December 2022, MEI received notice from the U.S. Food and Drug Administration that it may proceed to initiate the Phase 1 study evaluating ME-344 plus Avastin(bevacizumab) in relapsed colorectal cancer patients. The study is expected to dose the first patient in the first half of calendar year 2023.

In November 2022, MEI dosed the first patient in the Phase 1b study evaluating voruciclib in combination with Venclexta (venetoclax), a BCL2 inhibitor. Initially the study is evaluating patients with acute myeloid leukemia (AML) after failure of prior standard therapies to assess safety and possible synergies for the combination treatment. Pending results from this ongoing study, the company may also evaluate the combination in patients across multiple indications with relapsed and refractory B-cell malignancies.

In November 2022, MEI and Kyowa Kirin announced topline data from the Phase 2 MIRAGE study evaluating zandelisib in Japanese patients with indolent B-cell Non-Hodgkin’s Lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström’s macroglobulinemia in Japan. The data demonstrated a 75.4% objective response rate and 24.6% of patients achieved a complete response as determined by Independent Review Committee assessment. Additionally, 14.8% of patients discontinued therapy due to any treatment emergent adverse event.

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Report key clinical data from the ongoing Phase 1b trial evaluating voruciclib plus Venclexta (venetoclax) in patients with acute myeloid leukemia around calendar year-end 2023.

ME-344 – Tumor selective mitochondrial inhibitor

Initiate a Phase 1b clinical trial evaluating ME-344 plus Avastin in relapsed colorectal cancer patients in the first half of calendar year 2023.

Report key clinical data from the Phase 1b clinical trial evaluating ME-344 plus Avastin in patients with relapsed colorectal cancer around calendar year-end 2023.

Zandelisib – Oral PI3K delta inhibitor for the treatment of indolent B-cell Non-Hodgkin’s Lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström’s macroglobulinemia in Japan

Provide an update on Kyowa Kirin’s plans for continued zandelisib development in Japan for patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas.

Second Quarter Fiscal Year 2023 Financial Results

As of December 31, 2022, MEI had $124.2 million in cash, cash equivalents, and short-term investments with no outstanding debt.

For the quarter ended December 31, 2022, cash used in operations was $14.3 million, compared to $18.6 million used in operations (after adjusting for the receipt of a $10.0 million milestone payment from Kyowa Kirin during the quarter ended December 31, 2021). The decrease in cash used in operations is due to a reduction in zandelisib costs as we discontinued the program and initiated the close down of development activities and changes in working capital.

Research and development expenses were $15.3 million for the quarter ended December 31, 2022, compared to $21.5 million for the quarter ended December 31, 2021. The decrease was primarily related to a reduction in zandelisib costs as we discontinued the program and initiated the closing down of development activities during the quarter ended December 31, 2022.

General and administrative expenses were $8.5 million for the quarter ended December 31, 2022, compared to $7.9 million for the quarter ended December 31, 2021. The increase primarily relates to personnel costs, including costs related to severance from a workforce reduction, professional services and general corporate expenses.

MEI recognized revenue of $32.7 million for the quarter ended December 31, 2022, compared to $11.8 million for the quarter ended December 31, 2021. As a result of the discontinuation of the zandelisib program, we updated our estimated costs to complete each development performance obligation under the license agreement with Kyowa Kirin. This resulted in a higher progress towards completion and revenue for performance obligations that will not commence.

Net income was $10.3 million, or $0.08 per share, for the quarter ended December 31, 2022, compared to net loss of $12.2 million, or $0.10 per share for the quarter ended December 31, 2021. The Company had 133,260,865 shares of common stock outstanding as of December 31, 2022, compared with 132,904,545 shares as of December 31, 2021.

The adjusted net income (a non-GAAP measure) for the quarter ended December 31, 2022, excluding non-cash expenses related to changes in the fair value of the warrants, was $9.8 million, compared to an adjusted net loss of $17.6 million for the quarter ended December 31, 2021.