Financing & Funds Penn cell and gene therapy spinout Interius Biotherapeutics raises another $21.5M. The 4-year-old company has now raised nearly $100 million since its inception, including the $76 million it raised last year in a Series A round co-led by Boston-based Cormorant Asset Management and Fairmount Funds in Philadelphia. Interius Bio is initially focused on treating hematologic malignancies using its proprietary gene delivery platform to generate chimeric antigen receptor (CAR) T cells directly in vivo — meaning inside the body. The therapeutic approach bypasses the need for cell manipulations outside the body, and for the potentially toxic pre-conditioning chemotherapy required for standard CAR T-cell treatments. Bizjournal BioPhy Secures $4.5 Million in Funding to Propel Advancements in its Revolutionary AI Platform, Designed to Expedite the Trillion-Dollar Drug Development Market. With the newly acquired funding, the company has successfully developed an AI operating system finely tuned to support pharmaceutical companies in streamlining their drug development processes. Over the past 27 months, this validated technology, rigorously tested in real-world scenarios, has showcased an impressive 80 percent accuracy in predicting outcomes for more than 1,500 clinical trials. Noteworthy contributors to the $4.5 million funding include Metrodora Ventures, led by Chelsea Clinton and Caroline Kassie, Audere Capital, TRCM, and influential figures in the life sciences sector, such as Jeff Marrazzo, co-founder, and former CEO of Spark Therapeutics. The substantial funding injection positions BioPhy at the forefront of innovation in the dynamic landscape of AI-driven drug development. - PR Vittoria Biotherapeutics Successfully Raises Over $15 Million in Private Financing Round to Propel the Advancement of Cutting-Edge CAR-T Cell Therapies for cancer and autoimmune. The substantial funding will bolster the progress of their leading candidate, VIPER-101, as it moves towards clinical development. This funding round, spearheaded by Valley Forge Investment Corporation, has garnered support from prominent institutions, including Agent Capital, Tellus BioVentures, the University of Pennsylvania, BioAdvance, NYBC Ventures, and The Leukemia & Lymphoma Society Therapy Acceleration Program (LLS TAP), among others. Nicholas Siciliano, Ph.D., the company's CEO, boasts a proven track record in value creation, highlighted by his recent success with Invisible Sentinel. Notably, Invisible Sentinel was acquired by bioMérieux for approximately $75 million in cash in 2019. Vittoria Biotherapeutics is now well-positioned to leverage this financial support for groundbreaking advancements in the field of cell therapies. - PR SwanBio Therapeutics Raises $10 Million from Syncona Partners in Venture round to push forward its’  AAV-based therapies for the treatment of devastating, inherited neurological conditions, today announced it has begun the second dose-escalation cohort of its first interventional clinical study, PROPEL. PROPEL is a Phase 1/2 first-in-human clinical trial assessing the safety and efficacy of SBT101. Crunchbase biospace Funds 1315 Capital concludes two successful fundraising rounds, raising over $500 million for investments in commercial-stage healthcare companies. Both 1315 Capital III ("Fund III") and 1315 Capital Emerging Growth and Buyout ("EGB") exceeded their respective targets of $350 million and $150 million. The funds, supported by a diverse investor base, aim to invest in commercial-stage healthcare businesses with revenue potential between $50 million and $150 million, having a minimum of $5 million in revenue at the time of investment. This financial backing allows 1315 Capital flexibility in participating in transactions, with investments ranging from $5 million to $40 million. PR The new $28M GO PA Fund means collaboration between all 4 Ben Franklin Tech Partners, led by Philly. Ben Franklin Technology Partners of Southeastern Pennsylvania is leaning into statewide collaboration with the other Bens and state government with the new Global Opportunity Pennsylvania (GO PA) Fund II. The Philadelphia-area arm of the state-backed investment network announced the fund’s initial close this week after raising $28 million. Ben Franklin Technology Partners of Southeastern PA, headquartered in Philly’s Navy Yard, and Lancaster-based Fulton Bank are anchor investors. Ben Franklin Technology Development Authority, WSFS Bank, Robin Hood Ventures and Investors Circle also contributed.  PR M&A Philadelphia’s Resolian, the CRO formerly known as Alliance, makes move into China with Denali acquisition. Denali, which has 70 employees, is known for its work in the bioanalysis of oligonucleotide drugs and mRNA vaccines as well as liposomal drugs, ultra-sensitive assays for inhalation drugs and biomarker assays. Fiercebiotech Immunome and Morphimmune Announce Successful Completion of Merger with $125 Million PIPE to Develop Novel Targeted Cancer Therapies. Clay B. Siegall, Ph.D., former co-founder & CEO of Seagen, Inc., appointed as Chairman and CEO. $125 million private placement investment completed with leading institutional investors will support cash runway expected to extend into Q1 2026. Expected to submit three investigational new drug applications (INDs) within 18 months. PR Noramco Announces the Acquisition of the Cambrex Drug Product Business Unit, previously known as Halo Pharmaceuticals. The acquisition will provide API customers of Noramco, and its subsidiary Purisys, additional service options such as drug product formulation development, clinical and commercial drug product manufacturing, and packaging from facilities in Mirabel, Québec and Whippany, New Jersey. Noramco is returning to the Halo Pharmaceutical brand as part of this acquisition. PR Harmony Biosciences completed its acquisition of Zynerba Pharmaceuticals. Zynerba is a leader in pharmaceutically produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders. Zygel is the first-and-only pharmaceutically manufactured synthetic cannabidiol. It is a non-euphoric cannabinoid formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The product is manufactured through a synthetic process in a cGMP facility and is not extracted from the cannabis plant. PR

Facility and Expansions • MilliporeSigma Invests $25M to Expand Cell Culture Media Production in Kansas by 98,000sf. Cell culture media is an essential raw material used in the manufacture of therapies and in processes for vaccines, gene therapy, and mAb manufacturing. (genengnews) • Lonza and Vertex Pharmaceuticals Celebrate the Groundbreaking of Cell Tx Manufacturing Facility on Lonza’s campus in Portsmouth, NH. The large-scale facility is a co-investment of both companies and it will support the development and commercialization of the Vertex type 1 diabetes cell therapy portfolio. Operated by Lonza, the 130,000sf facility will employ 300 employees at peak capacity, in areas including manufacturing operations, quality assurance, and quality control. (PR) • Senti Biosciences extends cash runway through a $38m sublease deal with GeneFab – a newly formed CDMO backed by private equity firm Celadon Partners. The company’s former chief technology officer and co-founder Philip Lee has assumed the role of GeneFab’s CEO. (bioprocessintl) • AGC Biologics expanded its cell therapy facilities at its Longmont campus in Colorado. The capacity update includes three new Grade B cell therapy suites, with over 30,000 sf of additional space (RegMedNet) Investments & Acquisitions • Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, has secured $255 million in Series C funding. The company plans to use the money to launch the world’s first commercial-scale IDMO Smart Factory, which seamlessly integrates advanced robotics, purpose-built technology, and interconnected software. The 118,000sfIDMO Smart Factory, located in Bridgewater, NJ will be capable of producing 40,000 cell therapy batches per year. The funding was Led by new investor Koch Disruptive Technologies and participated by Bristol Myers Squibb DFJ Growth , Willett Advisors LLC , Eclipse , Decheng Capital , and 8VC .  • SK pharmteco to Expand Capabilities with Acquisition of Controlling Interest in Center for Breakthrough Medicines, the announcement is less than two years after an initial $350 million capital investment in 2022 and comes on the heels of SK pharmteco’s acquisition of Yposkesi, a French viral vector CDMO, in March 2021. Once the new deal is finalized, SK pharmteco will have a controlling stake in CBM, and the operations of CBM will be integrated with Yposkesi to establish a global CGT business unit with unprecedented capabilities and capacity (PR) • BlueWhale Bio Founded with $18M to Accelerate Cell Therapy Manufacturing. BlueWhale Bio Science Team led by world-renowned immunotherapy pioneers Carl June and James Riley of University of Pennsylvania. BlueWhale Bio technology platform aims to bring cell and gene therapy benefits to patients faster and at a lower cost. Investors include Danaher Life Sciences Ventures, Novalis LifeSciences LLC , Marshall Wace , Hillhouse Capital (bioscpace) Collaborations & Updated Offerings • PackGene Biotech and Kudo Biotechnology have partnered to provide high-quality, customized mRNA manufacturing services for drug and vaccine development. The global collaboration provides end-to-end coverage of mRNA development, from gene to mRNA, lipid nanoparticle (LNP) formulation development and encapsulation, through to fill-finished drug product, under GMP guidelines (PR) • Integrated DNA Technologies will sell Aldevron cGMP manufactured CRISPR nucleases (contractpharma) • AGC Biologics Offers Guaranteed Delivery of at least 1e11 TU of LVV Material in Nine Months. The CDMO expands its AGCellerate Program to provide Lentiviral vector support for advanced therapies developers (PR) • Bristol Myers Squibb partners with Cellares for robotic production of pipeline CAR-T drug. Cellares will perform a proof-of-concept transfer process for the manufacture of a BMS pipeline cell therapy. BMS will evaluate the automated process with comparability data (fiercepharma) • Cellares and Lyell Immunopharma to Evaluate Automated Manufacturing of Lyell's CAR T-Cell Therapy on Cellares' Cell Shuttle Platform. Proof-of-concept manufacturing to be provided by Cellares for a key Lyell CAR T-cell therapy using Cellares' exclusive Cell Shuttle. Collaboration to evaluate potential utilization of the Cell Shuttle for future Lyell CAR T-cell clinical trials and commercialization (PR) Manufacturing Agreements • Curia Supports Replicate Bioscience, Inc. Bioscience’s Phase 1 Clinical Trial of Novel Next-Generation RNA Vaccine (PR) • Otsuka Pharmaceutical Companies (U.S.) collaborates with Shape Therapeutics Inc. to develop novel AAV gene therapies for ocular diseases (biospace) • Cabaletta Bio and WuXi Advanced Therapies Announce Expansion of GMP Manufacturing Agreement to Include CABA-201 (biospace) • Kyverna Therapeutics and Oxford Biomedica Sign License and Supply Agreement for LentiVector® Platform People Movement  • Lonza announced today that Pierre-Alain Ruffieux, CEO, will leave the company at the end of September by mutual agreement. The Board of Directors also announced that Albert M. Baehny, Chairman, will take on the additional responsibility of Chief Executive Officer on an ad interim basis until a permanent successor is appointed (PR) • Kindeva Drug Delivery Names Brian Schubmehl l Chief Human Resources Officer,  Before joining Kindeva, Brian was VP, global human resources at Curia, where he steered expansion from 1,500 to 3,700 employees (contractpharma) • PYRAMID Laboratories Inc. , a large molecule drug product CDMO, appointed Amy D. vice president of business development and Peter Buzy to the board of directors (contractpharma) • Repligen Corporation Appoints Jason Garland as CFO, Mr. Garland is joining Repligen from his most recent role with medical device outsource manufacturer Integer Holdings Corporation (PR) • Catalent Pharma Solutions Appoints Lisa Evoli SVP and Chief Human Resources Officer. Ms. Evoli joins Catalent from Integra Lifesciences, a global medical technology company based in Princeton, New Jersey (PR) • Catalent Pharma Solutions named Lonza’s David McErlane group president of its biologics segment. McErlane, who most recently served as Lonza’s SVP and head of the bioscience business (fiercepharma) • Matica Biotechnology, Inc. Appoints Laura Parks , to spearhead development and execution of Matica Bio’s commercial strategic initiatives as EVP of Commercial Operations and Heather Nielsen Sugrue as VP of Alliance Management (PR) • Rentschler Biopharma SE appoints Benedikt von Braunmuehl as Chief Executive Officer he previously served as CEO of HMNC Brain Health in Munich, Germany in Addition the company appointed Tom Roberts, as President of Rentschler Biopharma Inc. and General Manager U.S. He was previously at Vitanova Biomedical, where he provided executive leadership, facilitated funding, and oversaw business and product development, regulatory compliance, manufacturing, and technology acquisition of a groundbreaking nanoparticle-based combination cancer therapeutic (PR)

The inaugural issue of Project Evolution’s State of the U.S. AT CDMO Sector delved into the recent surge in layoffs within the Biomanufacturing CDMO markets which includes Advanced Therapies and biologic CDMOs. In that post, we discussed the factors we believe have contributed to this slowdown. Now, we'd like to step back and examine the broader industry landscape and understand how the industry  In this week's installment, we embark on Part I of our exploration into the rapid growth of the Advanced Therapies CDMO sector, with a particular focus on the significant roles played by Private Equity, Venture Capital, and Major International Conglomerates. Join us in the following week as we delve into the impact of mergers and acquisitions on the industry's expansion. By delving deeper into these Private Placements, we aim to provide you with a comprehensive understanding of how financial stakeholders are shaping the landscape of Advanced Therapies and Biologic Capabilities in the United States. We will also explore the strategic considerations, regulatory implications, and competitive dynamics at play in this ever-evolving arena. Setting the table. How is the Industry Segmented? Before we dive into the rapid amount of private investment in the sector, I thought it would be beneficial to attempt a segmentation of the therapeutic category and CDMO capabilities. To accomplish this I am using the breakdown that I found in EY’s "How CDMOs are Leading Innovation for Pharmaceutical Partners" report found below. If you haven't already perused this report, I highly recommend taking a closer look at it.  While it may not be flawless, I believe it offers the most comprehensive framework for understanding the sector and the various types of products within it. For the purposes of this analysis, scrutiny will extend to CDMOs specializing in Advanced Therapies (Novel Therapies), and those boasting significant Biologic Capabilities from 2018 to 2023. In order to keep everything “bucketed” I have segmented CDMO providers into the following categories: • Advanced Therapies  • Advanced Therapies & Biologics  • Biologics Number of Deals: From 2018 to the present day, September 2023, our comprehensive analysis has diligently monitored fifty (50) investments and acquisitions made by prominent financial institutions in the realm of Biomanufacturing Contract Development and Manufacturing Organizations (CDMOs) in the United States. Among these investments, the category that has displayed the highest level of activity in private placements has been Advanced Therapies, accounting for a remarkable thirty-three (33) investments and/or acquisitions, which corresponds to an impressive 66% of all transactions within the period spanning 2018 to 2023. Furthermore, CDMOs with Advanced Therapies and Biologic capabilities combined, constituting 8% of the total, with a total of 4 deals, thereby emerging as significant contributors to the overall landscape, jointly representing nearly two-thirds of the entire deal flow.  Biologics, another noteworthy category, contributed to 26% of the overall deal flow, involving a total of 13 deals. It's noteworthy to mention that in 2018, Biologics dominated the scene, representing a staggering 75% of the deals, marking the only instance during our analysis when Biologics accounted for more than 30% of the annual deal flow. Total Investment (in $m) Our analysis was constrained to publicly accessible information, primarily focusing on the financial specifics of each deal. Nevertheless, throughout our investigation, we successfully ascertained the financial details for 35 out of the 50 transactions, accounting for 70% of the total deals. With this consideration, we find it valuable to explore the cumulative proceeds based on the available public data. Advanced Therapies CDMOs garnered an impressive total of over $7.2 billion in private placements and acquisitions from leading institutions between 2018 and 2023. Intriguingly, the highest aggregate transaction value was recorded in 2019, largely attributed to EQT's substantial investment of $3.4 billion for the acquisition of Aldeveron, a prominent manufacturer specializing in Plasmid DNA.  Turning our attention to Biologics CDMOs, their financial activity during the same timeframe amounted to approximately $1.6 billion, signifying a substantial presence in the market. Notably, the most substantial transaction within this category occurred in 2020, involving the acquisition of Ambio for approximately $1 billion. Unfortunately, the specific details surrounding this transaction remain relatively scarce in the public domain, adding an element of mystery to this significant deal. Leading Investment Firms  Throughout numerous industry discussions, I've nurtured a curiosity to discern the frontrunners in terms of investments within this sector. Unsurprisingly, Ampersand has exhibited remarkable dominance, having successfully executed seven (7) significant investments and acquisitions. It's crucial to highlight that this analysis encompasses data extending beyond 2018, notably incorporating Ampersand's pivotal investment in Brammer Bio back in 2016. This particular investment ultimately culminated in the acquisition of Brammer Bio by Thermo Fisher for a substantial $1.7 billion in 2019, further exemplifying Ampersand's impactful presence in the sector. Below, we provide a comprehensive breakdown of the six (6) most active investors in this dynamic sector, shedding light on their noteworthy contributions and influence: 2023 Investments to-date As of September 7th, 2023, there has been a conspicuous surge in deal activity within the current year. Our records indicate the completion of eight (8) significant transactions involving six (6) distinct companies, showcasing a diverse range of deals and investments. However, it's noteworthy that, at the current pace of investment, 2023 seems poised to be a year with a comparatively lower level of activity when juxtaposed against the robust deal flow experienced in 2022 and 2020. Below, we offer an insightful overview of the noteworthy deals that have unfolded thus far in the current year.