Livzon Pharmaceutical Group, Inc.

Closed merger with Sesen Bio and commenced trading on Nasdaq under ticker symbol "CARM" Cash position as of the closing of the merger with Sesen Bio provides anticipated operating runway through 2024 PHILADELPHIA, April 4, 2023 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today reported financial results for the year ended December 31, 2022 and highlighted recent business updates. "2022 was a transformational year for Carisma as we made meaningful progress across all areas of our business, including entering a development collaboration with Moderna, advancing our lead program CT-0508 in HER2+ solid tumors, and announcing our merger with Sesen Bio," said Steven Kelly, President and Chief Executive Officer of Carisma. "The successful close of the merger and concurrent financing has further strengthened our foundation, enabling us to continue to advance our pipeline of important therapies. We look forward to the multiple potential value inflection points over the next 18 months, including the completion of our Phase 1 study of CT-0508, as well as data from clinical trial sub-study of CT-0508 in combination with pembrolizumab." Recent Business Highlights Completed merger transaction with Sesen Bio in March 2023. Carisma Therapeutics and Sesen Bio closed the previously announced merger, pursuant to which the combined company changed its name to "Carisma Therapeutics Inc." and commenced trading on The Nasdaq Global Market under the symbol "CARM." The combined company will focus on the development of Carisma's chimeric antigen receptor macrophage (CAR-M) therapies, which are believed to be the only therapies of their kind with demonstrated proof of mechanism and safety data in clinical trials. At the closing of the merger, taking into account the reverse stock split of shares of common stock of Sesen Bio prior to the closing, the combined company had approximately 40.3 million outstanding shares of common stock. Received $105.3 million of proceeds as a result of completing the merger transaction, which includes $74.7 million from Sesen Bio and $30.6 million from a concurrent financing. The $30.6 million financing was from a syndicate of investors, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio. Expanded Scientific Advisory Board (SAB) with additional expertise in solid tumor immunotherapy development capabilities. The Company appointed leading solid tumor immunotherapy expert Padmanee Sharma, MD, PhD to Carisma's SAB in January 2023. Dr. Sharma is a nationally regarded cancer immunologist and professor in the departments of Genitourinary Medical Oncology and Immunology, Associate VP of Immunobiology and the T.C. and Jeanette D. Hsu Endowed Chair in Cell Biology at The University of Texas MD Anderson Cancer Center. Additionally, the Company appointed Moderna CSO of External Research Ventures, Lin Guey, PhD to Carisma's SAB in February 2023. Dr. Guey is a leading expert in mRNA therapeutics and oversees Moderna's partnership with Carisma to develop in vivo CAR-M therapies. Presented new data from Phase 1 clinical trial of CT-0508 at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2022. Additional findings from the CT-0508 CAR-M clinical trial for patients with advanced metastatic human epidermal growth factor receptor 2 (HER2) overexpressing solid tumors, supported a favorable safety pro demonstrate that CT-0508 has been successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and has shown high CAR expression, viability, and purity. Anticipated Upcoming Milestones Additional data from Group 2 of Carisma's Phase 1 CT-0508 study expected in the second half of 2023 Initial data from clinical trial sub-study of CT-0508 in combination with KEYTRUDA® (pembrolizumab) expected in the second half of 2023 Submission of IND application to the FDA for CT-0525, Carisma's first anti-HER2 CAR-Mono product candidate, expected in the second half of 2023 Nomination of additional targets(s) under the Moderna development collaboration expected in 2023 Fiscal 2022 Financial Results Cash, cash equivalents and marketable securities as of December 31, 2022 were $52.0 million, compared to $28.6 million as of December 31, 2021, and is not inclusive of proceeds from the merger transaction with Sesen Bio and concurrent financing, which were completed in March of 2023. Moderna collaboration revenues were $9.8 million for the year ended December 31, 2022. The Company began its collaboration with Moderna in January 2022 and deferred $47.5 million in revenue from the Moderna collaboration agreement, which will be recognized in future periods. Research & development expenses were $56.6 million for the year ended December 31, 2022, compared to $34.4 million in 2021. The increase was primarily due to costs associated with growth and expansion of Carisma's clinical and pre-clinical activities to support advancing CT-0508 in clinical development and expand research for the Company's Moderna in vivo research. General & administrative expenses were $9.4 million for the year ended December 31, 2022, compared to $6.4 million in 2021, primarily due to costs associated with the expanded patent portfolio and preparing to operate as a public company. Net loss was $61.2 million for the year ended December 31, 2022, compared to net loss of $40.8 million in 2021, primarily due to increased research and development expenses, which was partially offset by Moderna collaboration revenue. Outlook Carisma believes that its cash, cash equivalents and marketable securities of $52.0 million as of December 31, 2022, in combination with the net proceeds of $105.3 million from the completion of the merger with Sesen Bio and concurrent financing, are sufficient to sustain Carisma's planned operations through the end of 2024. About CT-0508 CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. We are selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center. About Carisma Therapeutics Carisma Therapeutics Inc. is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. Carisma is headquartered in Philadelphia, PA. For more information, please visit . Cautionary Note on Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma's business, strategy and future operations, the sufficiency of its cash resources, the advancement of Carisma's product candidates and product pipeline, and clinical development of Carisma's product candidates, including expectations regarding timing of initiation and results of clinical trials. The words ""anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "goals," "intend," "may," "might," "outlook," "plan," "project," "potential," "predict," "target," "possible," "will," "would," "could," "should," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) risks associated with the possible failure to realize certain anticipated benefits of the merger, including with respect to future financial and operating results; (ii) the effect of the completion of the merger on Carisma's business relationships, operating results and business generally; (iii) the outcome of any legal proceedings related to the merger agreement or the transactions contemplated thereby; (iv) Carisma's ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (v) Carisma's ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; (vi) Carisma's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (vii) Carisma's ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (viii) regulatory requirements or developments and Carisma's ability to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; (ix) changes to clinical trial designs and regulatory pathways; (x) risks associated with Carisma's ability to manage expenses; (xii) changes in capital resource requirements; (xii) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (xiii) legislative, regulatory, political and economic developments. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" set forth in Exhibit 99.3 to Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on March 8, 2023, as well as discussions of potential risks, uncertainties, and other important factors in the Company's most recent filings with the Securities and Exchange Commission. Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws. Investor Contact: investors@carismatx.com Company Codes: EuronextParis:CARM, NASDAQ-NMS:CARM

TAIPEI, March 22, 2023 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announces that they have signed an exclusive licensing agreement with Joincare Pharmaceutical Group Industry Co., Ltd., a top 10 China pharmaceutical company, to develop and commercialize TG-1000 in China. TG-1000 is a novel pan-influenza antiviral, which interrupts viral replication and transmission via a cap-snatching mechanism to demonstrate broad-spectrum activity against influenza-A, influenza-B, avian flu H7N9, and Tamiflu-resistant viruses. Upon the agreement takes effect, Joincare will be responsible for the subsequent development, registration, and commercialization of TG-1000 in the territory by undertaking all costs of clinical trials. The territory includes China, Hong Kong and Macao. Under the terms of the agreement, Joincare will make an upfront payment of RMB 20 million and milestone payments, followed by up to 11% of royalties. TG-1000 is a novel pan-influenza antiviral by interrupting viral replication and transmission via a cap-snatching mechanism, which reveals its efficacy against influenza-A, influenza-B, avian flu H7N9, and Tamiflu-resistant viruses. TG-1000 phase II clinical study has been completed, and the data indicate that TG-1000 effectively alleviate flu symptoms and clear flu viruses. Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "We are highly confident in the successful development of TG-1000. Joincare is one of the TOP 10 pharmaceutical companies in mainland China, and its revenue and R&D investment rank sixth and fifth among listed pharmaceuticals in mainland China, respectively. By partnering with Joincare, TaiGen will be able to tap into these potential marketplaces with TG-1000." Baoguo Zhu, Chairman of Joincare Pharmaceutical, said, "TaiGen is highly experienced in the development of innovative drugs against infectious diseases. Both pre-clinical and clinical trial data with TG-1000 treatment exhibit excellent performance by reducing virus load and pharmacokinetics in flu-infected animals and patients. The partnership between TaiGen and Joincare will fulfill the unmet medical need by delivering TG-1000 to the patients with improved quality of life." The license agreement is the first step of TG-1000 global licensing strategy, and it's also the first milestone of business partnership after the COVID-19 pandemic. Next step of TaiGen is to focus on the licensing in the territories of Europe, the U.S. and other marketplaces. Influenza is a critical infectious disease listed as one of the TOP 10 global health threats. With the loosening of the COVID-19 epidemic prevention measures, the flu has come back again. Australia has had its worst flu season in 5 years in 2022. The US CDC estimated 26~50 million people infected and 18,000~55,000 patients died in 2022~2023 flu season. The flu infection in mainland China has surpassed the peak of the past three years. About Joincare Pharmaceutical Group Joincare Pharmaceutical Group Industry Co., Ltd. ("Joincare") (Stock code: 600380), established in 1992, is a TOP 10 leading pharmaceutical group in China. The company has always adhered to technological innovation as its strategic basis, and its strategic goal is to build a high-barrier complex preparation technology platform. Currently, it has deployed four high-barrier complex preparation R&D platforms. It owns two large listed companies of Joincare and Livzon Pharmaceutical, more than 20 holding subsidiaries. About TaiGen Biotechnology TaiGen Biotechnology is a fully-integrated pharmaceutical company combining drug discovery & development, global regulatory approval & registration, and commercialization. This business strategy capitalizes on the extensive expertise by senior executives whom were recruited from major pharma in the West and from Asian-based multinational companies. TaiGen was listed in Taiwan OTC Stock Market on the 17th Jan. 2014. To date, there are approx. 716 million shares issued and outstanding, with a par value of US$0.001. SOURCE TaiGen

DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Global Biosimilars Partnering Terms and Agreements 2010 to 2022" report has been added to ResearchAndMarkets.com's offering. The Global Biosimilars Partnering Terms and Agreements 2010 to 2022 report provides an understanding and access to 190 biosimilars partnering deals and agreements entered into by the worlds leading healthcare companies. The report provides a detailed understanding and analysis of how and why companies enter biosimilars partnering deals. The majority of deals are early development stage whereby the licensee obtains a right or an option right to license the licensors biosimilars technology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains links to online copies of actual biosimilars deals and contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. The initial chapters of this report provide an orientation of biosimilars dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in biosimilars dealmaking since 2010, including details of average headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading biosimilars deals since 2010. Deals are listed by headline value, signed by big pharma, most active biosimilars dealmaking companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in biosimilars dealmaking with a brief summary followed by a comprehensive listing of biosimilars deals, as well as contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand. Chapter 5 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010, where a contract document is available in the public domain. The chapter is organized by company A-Z, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of biosimilars partnering deals signed and announced since Jan 2010. The chapter is organized by specific biosimilars technology type in focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. In addition, a comprehensive appendix is provided organized by biosimilars partnering company A-Z, deal type definitions and biosimilars partnering agreements example. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand. Analyzing actual company deals and agreements allows assessment of the following: What is actually granted by the agreement to the partner company? What exclusivity is granted? What are the precise rights granted or optioned? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Global Biosimilars Partnering Terms and Agreements 2010 to 2022 includes: Trends in biosimilars dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to over 190 biosimilars deal records and contract documents where available The leading biosimilar deals by value since 2010 Most active biosimilars dealmakers since 2010 The leading biosimilars partnering resources In Global Biosimilars Partnering Terms and Agreements 2010 to 2022, the available contracts are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy and technology target Key Topics Covered: Executive Summary Chapter 1 - Introduction Chapter 2 - Trends in biosimilars dealmaking 2.1. Introduction 2.2. Biosimilars partnering over the years 2.3. Most active biosimilars dealmakers 2.4. Biosimilars partnering by deal type 2.5. Biosimilars partnering by therapy area 2.6. Deal terms for biosimilars partnering 2.6.1 Biosimilars partnering headline values 2.6.2 Biosimilars deal upfront payments 2.6.3 Biosimilars deal milestone payments 2.6.4 Biosimilars royalty rates Chapter 3 - Leading biosimilars deals 3.1. Introduction 3.2. Top biosimilars deals by value Chapter 4 - Most active biosimilars dealmakers 4.1. Introduction 4.2. Most active biosimilars dealmakers 4.3. Most active biosimilars partnering company profiles Chapter 5 - Biosimilars contracts dealmaking directory 5.1. Introduction 5.2. Biosimilars contracts dealmaking directory Chapter 6 - Biosimilars dealmaking by technology type Appendices Appendix 1 - Biosimilars deals by company A-Z Appendix 2 - Biosimilars deals by stage of development Appendix 3 - Biosimilars deals by deal type Appendix 4 - Biosimilars deals by therapy area Appendix 5 - Appendix 6 - Recent report titles from Companies Mentioned 3SBio 180 Life Sciences Abbvie Abreos Biosciences Abzena Accord Healthcare Aceno Biotherapeutics AdAlta AET Biotech Aetos Biologics AffaMed Therapeutics Agila Specialties AIT Bioscience Algorithme Pharma Holdings Alteogen Altiora Alvogen Alvotech Amedica Amgen Amneal Pharmaceuticals Arecor Avid Bioservices Axantia Back-A-Line Bacterin International Baxalta Baxter International BeiGene Bio-Manguinhos/Fiocruz Bio-Thera Solutions Biocnd Biocon Bioeq IP Bio Farma Biogen Biooutsource BiosanaPharma BioSavita BioSciencesCorp Bioton BioXpress Boehringer Ingelheim Bolt Biotherapeutics Boston Oncology Bruker C-Bridge Capital Catalent CEA-Leti Celares Celerion Cellectis Celltrion Changchun High & New Technology Industries Chemo Sa Lugano Chungnam National University Cipla CJ Corp Clinigen Cobra Biologics Coherus Biosciences Compass Biotechnologies Concord Biosciences Cook Pharmica CR Pharma Daiichi Sankyo Diabeloop DM Corporation Dong-A ST Dr. Reddy's Laboratories Dyadic International EirGenix EMD Millipore Enzene Biosciences Epirus Biopharmaceuticals Epivax European Commission Evercyte Evotec Ewopharma Formosa Pharmaceuticals Formycon Fujifilm Fujifilm Kyowa Kirin Biologics Fuji Pharma GC Pharma Gedeon Richter GE Healthcare Genentech Genhelix Biopharmaceutical Genor Biopharma GenScript ProBio Gerresheimer Hadasit Medical Research Services and Development Hanwha Chemical Helvetic Biopharma Henlius Biotech Hikma Pharmaceuticals Hoffmann La Roche Horizon 2020 Hospira Innovent Biologics Intas Pharmaceuticals inVentiv Health Ipca Laboratories Ipsen Jacobson Pharma JAMP Pharma Group JHL Biotech Kamada Karolinska Institute Kemwell BioPharma Kymos Pharma Services Kyowa Hakko Kirin Laboratorios Liomont LABORATORIOS SAVAL Ligacept Livzon Mabpharm Lupin M+W Group Mab-Venture Biopharma Mabion mAbXience Medicago Medicure Medipolis Meiji Seika Merck and Co Merck BioVentures Merck KGaA Merck Serono MGC Diagnostics Ministry of Health (Brazil) Mithra Pharmaceuticals Mitsubishi Chemical Mochida Pharmaceutical Momenta Pharmaceuticals Mundipharma Mylan Laboratories Mylan Pharmaceuticals Nan Fung Group NanoLock Natco Pharmaceuticals National Cancer Institute National Comprehensive Cancer Network (NCCN) NCPC GeneTech Neoletix Biotechnology NeuClone Nora Pharma Novo Nordisk Ocumension Therapeutics Oncobiologics ORF Genetics Orox Pharmaceuticals Orygen Biotecnologia Pall Corporation Pangen Biotech Parexel PBS Biotech Perfinity Biosciences Pfenex Pfizer Pharmapark PharmaPraxis PlantForm PlantPraxis Biotecnologia Polpharma Portal Instruments PPD PRA Health Sciences Premier Inc Premier Research Prestige BioPharma ProBioGen PT Etana Biotechnologies Qilu Pharmaceutical Quanta BioDesign QuiaPEG Pharmaceuticals For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets