Allist announces that its partner ArriVent Biopharma has completed an oversubscribed Series B financing totaling up to US$155 million

On March 27, 2023 Allist Pharmaceuticals reported that its partner ArriVent Biopharma, Inc. (hereinafter referred to as "ArriVent" ) completed an oversubscription of US $ 155 million Series B financing (Press release, Allist Pharmaceuticals, MAR 27, 2023, https://www.allist.com.cn/newsd/101/2069.html [SID1234642122]). The proceeds will be used to support registration clinical trials and exploratory research for ArriVent ’s main product candidate, fumetinib mesylate (hereinafter referred to as " vometinib " ), as well as to expand its subsequent product pipeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fumetinib is a national Class I new drug independently developed by Ellis and has independent intellectual property rights. Currently, both first-line and second-line indications for lung cancer in China have been approved and included in the national medical insurance directory. On June 30 , 2021 , ArriVent and ArriVent announced an exclusive overseas licensing cooperation agreement. ArriVent has obtained the exclusive development and commercialization license rights for fumetinib in the world (except mainland China, Hong Kong, Macao and Taiwan), providing ArriVent with a global Scope-wide promotion of fumetinib and other treatments presents huge development opportunities. With the joint efforts of both parties, the overseas cooperation of fumetinib is progressing smoothly.

Deputy General Manager of Ellis

Hu Jie

ArriVent ‘s team has rich clinical development experience, and together with ArriVent, we have promoted the wider clinical application of fumetinib around the world, helping patients around the world obtain safe and effective treatment and improve their quality of life.

This financing has been recognized by many senior investors, laying a solid financial guarantee for ArriVent’s subsequent clinical development and pipeline expansion, which is of great significance. The excess fundraising fully demonstrates the investors ‘ high recognition of the ArriVent team, the efficacy, clinical advancement and market potential of the fumetinib product, and the high recognition of the cooperation between ArriVent and ArriVent . Ellis will continue to work closely with ArriVent to jointly commit to the global clinical development of fumetinib and jointly build new product pipelines. Here, on behalf of ArriVent, I would like to congratulate ArriVent on its successful Series B excess financing and the company’s smooth development.

Leadingtac’s IND application for IRAK4 degrader accepted by US FDA

On March 27, 2023 Shanghai Leadingtac Pharmaceutical Co., Ltd. (hereinafter referred to as "Leadingtac Biotech") reported that it has officially submitted an IND clinical trial application to the U.S. FDA for its first IRAK4 novel protein degrader, and plan to file an IND simultaneously in China and Australia in Q2 2023 for the following indications Hidradenitis Suppurativa (HS) and Atopic Dermatitis (AD) (Press release, Leadingtac Pharmaceutical, MAR 27, 2023, View Source [SID1234640718]). In February 2023, Leadingtac already established the communication with US FDA in a Pre-IND meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on publicly available information, in 2020 Sanofi acquires an autoimmune field interest in the Kymera IRAK4 program for an upfront payment of $150 million and $2 billion in potential development, regulatory and sales milestones, as well as significant royalty payments. On March 20, 2023, Gilead announced its exclusive rights to Nurix’s IRAK4 degrader, NX-0479, in exchange for $20 million in upfront cash and with $425 million in milestone payment. It’s the first target that Gilead has signed onto stemming from a June 2019 agreement with Nurix, with Gilead offering up to $2.35 billion in exchange for five protein degrader targets. (This information comes from "Smurf One" and "Pharma Notes" respectively)

About IRAK4 degraders:

IRAK4 (interleukin-1 receptor-associated kinase 4) is one of the human IRAK kinase family isozymes that plays a pivotal role in protein phosphorylation as well as in cellular signaling. It receives signals from the upstream toll-like receptors (TLRs) and the interleukin-1 receptor family (IL-1R) and activates the downstream NF-κB and JNK signaling pathways, which are important for human inflammatory responses and tumors. In December 2022, Kymera announced the phase 1 clinical data of its IRAK4 degrader KT-474, which demonstrated good efficacy in HS and AD patients.

Leadingtac’s LT-002-158 is the first IRAK4 protein degrader in China and the second in the world to submit an IND application to the FDA following Kymera’s KT-474. The molecule is developed on Nano-SPUD, a target protein degradation drug development platform of Leadingtac. In preclinical animal models, the compound showed superior efficacy in improving skin inflammation symptoms and a favorable safety profile.

Annual Results Announcement For the Year Ended 31 December 2022

On March 27, 2023 Shanghai Fudan-Zhangjiang reported its annual results for the year ended 31 December, 2022 (Press release, Shanghai Fudan-Zhangjiang, MAR 27, 2023, View Source [SID1234633147]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Securing a new pipeline and accelerating the development of new microbiome drugs

On March 27, 2023 CJ Bioscience reported it has signed a contract to acquire a promising new drug candidate and platform technology owned by 4D Pharma, a microbiome company based in the UK and Ireland (Press release, CJ Bioscience, MAR 27, 2023, View Source [SID1234632171]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A total of nine new drug candidates are introduced, targeting solid cancers, digestive diseases, brain diseases, and immune diseases. In addition, it plans to acquire all related intellectual property rights such as patents, including two cases of 4D Pharma’s diagnostic and new drug candidate discovery technology platforms, and the contract amount has not been disclosed in accordance with the agreement between the two companies.

In addition, greater synergy is expected when the new drug candidate secured through this contract is combined with the Ez-Mx Platform, which is based on CJ Bioscience’s bioinformatics technology. In addition, 4D Pharma’s new drug development technology and know-how accumulated over 10 years are added to accelerate the development of new microbiome drugs.

CJ Bioscience plans to reflect it in its R&D strategy after analyzing detailed data of each pipeline. The company plans to prioritize clinical trials focusing on candidates with high potential for success, including CJRB-101, an immune anti-cancer treatment that received clinical approval from the US Food and Drug Administration (FDA) in January. The microbiome drug market is expected to grow explosively to $1 billion by 2030, and CJ Bioscience plans to conduct clinical research with the goal of leading the market.

An official from CJ Bioscience said, "The introduction of the new pipeline has given us the world’s best microbiome-based new drug development competitiveness. I will do it," he said.

Evotec SE preliminary fiscal year 2022 results: "Ahead of the curve" – very strong performance in a challenging year

On March 27, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported preliminary financial results and corporate updates for the fiscal year ended 31 December 2022 (Press release, Evotec, MAR 27, 2023, View Source;very-strong-performance-in-a-challenging-year-6267 [SID1234629405]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FINANCIALS REFLECT GREAT PERFORMANCE
Group revenues significantly exceeded the revenue target, up 22% to € 751.4 m (+15% like for like, excluding portfolio and fx effects (2021: € 618.0 m))
Excellent base business up 30% to € 725.3 m in 2022
Adjusted Group EBITDA at € 101.7 m, adjusted for portfolio effects at € 104.1 m (2021: € 107.3 m) after a very strong fourth quarter
Unpartnered R&D expenses of € 70.2 m up 20% (2021: € 58.1 m)
GREAT PROGRESS AND STRONG DEMAND IN ALL LANES
Significant progress in and 8-year extension of targeted protein degradation alliance with Bristol Myers Squibb ("BMS")
Important milestones achieved in iPSC-based neuroscience collaboration with BMSMultiple new strategic partnerships e.g. in metabolic diseases, ophthalmology, dermatology, oncology, as well as an iPSC-based beta cell replacement therapy alliance with Sernova to advance a functional cure for diabetes
Just – Evotec Biologics: Multiple new collaborations initiated at first J.POD in Redmond (US) laying foundation for strong strategic growth (e.g. Alpine, Department of Defense, …); Construction of second J.POD at Evotec’s Campus Curie in Toulouse started and progressing according to plan
Excellent progress in data-driven precision medicine platforms; Commercial launch of unique multi-omics data analysis platform PanHunter; Launch of translational molecular patient database E.MPD
Collaboration with Janssen to develop first-in-class targeted immune-based therapies for oncology (after period-end)
European Investment Bank ("EIB") has granted an additional unsecured loan facility of € 150 m (after period-end)
CORPORATE HIGHLIGHTS
Expansion of footprint with the acquisition of cell therapy manufacturing facility (Evotec Modena) and clinical & commercial manufacturing facility for small molecules (Evotec DS)
Laetitia Rouxel joins Evotec as Chief Financial Officer effective 01 April 2023 (after period-end)
FINANCIAL GUIDANCE 2023 – CONTINUED STRONG GROWTH
Group revenues expected to be in a range of € 820 – 840 m; € 835 – 855 m at constant exchange rates (2022: € 751.4 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2022: € 70.2 m)
Adjusted Group EBITDA expected to be in the range of € 115 – 130 m;
€ 125 – 140 m at constant exchange rates (2022: € 101.7 m)
FINANCIAL PERFORMANCE
Another year with double-digit top line growth
In 2022, Evotec has once more increased its Group revenues at a double-digit rate of 22%: During the twelve months ended 31 December 2022 Group revenues increased significantly by € 133.4 m to € 751.4 m compared with the same period of the previous year (2021: € 618.0 m) (€ 748.4 m excluding acquisitions and M&A-related revenues). The substantial rise against the prior-year period is based on a strong performance of the base business, compensating a slower start of Just – Evotec Biologics, which is still in its ramp-up phase. In addition, the comparable basis for revenues from milestones, upfronts and licenses was exceptionally strong in 2021. Growth of the base business was 30% from € 556.7 m in 2021 to € 725.5 m in 2022.

Adjusted Group EBITDA for the twelve months ended 31 December 2022 amounted to € 101.7 m and € 104.1 m excluding acquisitions and M&A-related costs (2021: € 107.3 m) which is the result of a well-balanced development between the very favourable growth and profitability of Evotec’s base business, preparations for future growth of Just – Evotec Biologics, and a lower contribution from milestones, upfronts and licenses. Moreover, higher energy costs as well as overall inflation affect the year-over-year comparison.

In the financial year 2022, unpartnered R&D expenses increased by 20% (€ 70.2 m vs. 2021: € 58.1 m) reflecting continued strong investments in Evotec’s capabilities to improve its efficiency and precision medicine platforms.

GREAT PROGRESS AND STRONG DEMAND IN ALL LANES
Selected highlights
Evotec continued its successful development in 2022 with new and extended alliances. In 2022, Evotec was involved in > 800 alliances and recorded a repeat business of 92%. Evotec achieved notable progress within its strategic partnerships, important clinical trial initiations, the generation of the milestone income and signed multiple new partnerships e.g., with Eli Lilly in metabolic diseases, with Almirall in medical dermatology, and with Boehringer Ingelheim in ophthalmology.

Evotec also made significant progress towards building globally leading data-driven precision medicine platforms with the launch of its molecular patient database ("E.MPD"). E.MPD is Evotec’s central data repository of PanOmics data for precision drug understanding. Starting out from metabolic diseases, the database is continuously growing through proprietary screens and data partnerships to build up critical mass into other disease areas. Also in 2022, a first commercial version of PanHunter, Evotec’s A.I./M.L.-enabled multi-omics data analysis platform, was launched.

In May 2022, Evotec significantly expanded its alliance with BMS in targeted protein degradation for an additional 8 years with the goal of generating a promising pipeline of molecular glue degraders. The partnership has a deal potential of $ 5 bn and Evotec received an upfront payment of $ 200 m. In March 2023 (after period-end), Evotec announced that further performance- and programme-based achievements in the strategic partnership triggered payments of in total $ 75 m to Evotec.

Over the course of 2022, further important progress was achieved within the iPSC-based neuroscience collaboration with BMS leading to payments totalling $ 57 m from BMS.

In May 2022, Evotec and Sernova Corp., announced a partnership in the field of diabetes. Both Companies will leverage their respective strengths to develop an implantable iPSC-based beta cell replacement therapy for the treatment of insulin-dependent diabetes, including type 1 and 2. In conjunction with the agreement, Evotec made a strategic € 20 m equity investment in Sernova.

Just – Evotec Biologics laid the foundation for strong growth in 2023 and beyond by continuing the collaboration with the US Department of Defense. In September 2022, Evotec’s Seattle-based subsidiary was awarded a contract valued up to $ 49.9 m for the rapid development of monoclonal antibody-based drug product prototypes targeting plague, one of the designated targets of interest under the Accelerated Antibodies Program. In September 2022, Evotec launched the construction of its second J.POD biologics manufacturing facility at Evotec’s Campus Curie in Toulouse. J.POD Toulouse, France (EU) is expected to be operational in the second half of 2024.

In January 2023 (after period-end), Evotec entered into a strategic collaboration and licence agreement with Janssen to develop first-in-class targeted immune-based therapies for oncology. Besides research funding, Evotec is entitled to an undisclosed upfront payment, success-based research and commercial milestones exceeding $ 350 m as well as tiered royalties on products resulting from the collaboration.

In February 2023 (after period-end), Evotec announced that the European Investment Bank 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.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "2022 was a successful year for Evotec because of significantly increased revenues, our excellent base business, and a strong balance sheet as a solid base for future growth. Together with our partners, we focus on a comprehensive disease understanding at the molecular level, cutting-edge technologies and platforms to translate this understanding into effective precision therapeutics. Evotec’s technological leadership in all our focus areas is why we consider ourselves ‘ahead of the curve’ for medicines that matter."

OUTLOOK
In 2023, Evotec expects revenues of € 820 – 840 m based on current exchange rates of major currencies (esp. USD; GBP). Based on constant exchange rates compared to 2022, Group revenues are expected to increase to € 835 – 855 m. This assumption is based on the current orders on hand, foreseeable new contracts and the extension of contracts as well as prospective milestone payments. Furthermore, the forecast takes account – as far as possible – of the potential impact of current global uncertainties.

Adj. EBITDA is expected to be in a range of € 115 – 130 m. This projection takes into account the strong order book, an improving revenue mix, but also increasing expenses for wages, materials, energy, promising R&D projects, the adoption of organisation structures to ensure sustainable growth, and the continued ramp-up of the Just – Evotec Biologics business via the remaining investments in the further expansion of the J.POD capacity in the US and the construction of a second J.POD in Europe (Toulouse, France). At constant currencies, Evotec expects the adjusted Group EBITDA to grow to € 125 – 140 m.

Evotec’s activities are all related to R&D. Aside from the partnered and funded R&D, Evotec will continue to strongly invest in its own unpartnered R&D to further expand its long-term and sustainable pipeline of first-in-class projects and platforms. Evotec expects unpartnered R&D investments in this area between € 70 and 80 m in 2023.

Annual report
The full annual report 2022 as well as the sustainability report 2022 will be available for download on 25 April.

Webcast/Conference Call
The Company is going to hold a conference call to discuss the preliminary results as well as provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 28 March 2023

Time: 02.00 pm CEST (08.00 am EDT, 01.00 pm BST)

To join via phone, please pre-register via this link. You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available under this link.

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.

The on-demand version of the webcast will be available on our website: View Source