Back Bay Life Science Report

In this DNB//Back Bay Healthcare Capital Markets podcast episode, Jim Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director and Head of Equity Capital Markets at DNB, and Vasilios Kofitsas, Partner and Managing Director of Investment Banking at Back Bay Life Science Advisors, review the performance of the healthcare markets in 2024, offering insights into what 2025 could bring. With a detailed analysis of market trends, IPO activities, and investor behaviors, they evaluate the past year's challenges and the cautious optimism prevailing in the sector as the new year unfolds. As well, there's an emphasis on the importance of European investor engagement for companies looking to list in the U.S. market.Learn more about the DNB//Back Bay Partnership and read our disclosures here.

The topic of bispecific antibodies has been an area of interest in the pharma space for a long time now. The recent news of the notable late-stage data from Akeso and Summit’s PD-1/VEGF bispecific antibody ivonescimab to treat non-small cell lung cancer that has captured the industry writ large encouraged us to revisit the topic. To date, there have been ten bispecific antibody approvals in oncology, seven of which are for hematological malignancies. Recently, there has been more traction in development pipelines for solid tumors. Most bispecific antibody approvals are currently or projected to be above the $1M annual revenue threshold. Podcast topics include:  • The biologics of a bispecific antibody • The benefits of a bispecific antibody compared to autologous therapies • The buzz around Akeso and Summit’s PD-1 VEGF bispecific antibody asset • The broad state of bispecifics in approved products and development pipelines • The potential of trispecifics, bispecific conjugates and beyond

In this DNB//Back Bay Healthcare Capital Markets Episode, Vasilios Kofitsas, Partner and Managing Director at Back Bay Life Science Advisors speaks with Jim Cirenza and Kristoffer Braaten of DNB Bank in New York. They focus on key drivers affecting markets this year and discuss the recent news of the Fed’s decision to cut interest rates by 50-basis points. Topics in the podcast include: After two difficult years, the appearance of a healthy market rotation since July The Fed’s decision mid-September to cut rates by 50 basis points Healthcare IPOs: historical and recent activity – is the window opening?An outlook including headwinds and tailwinds that may impact the healthcare sectorWe welcome listener questions and/or topics you’d like to learn more about.You can listen to previous episodes here or submit your inquiries here.Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership.

After a summer away from podcasting, Back Bay Life Science Advisors’ Dr. Pete Bak and Christian Thienel are back on the mic to discuss current market dynamics in liver disease with a focus on one of the most closely watched space in hepatology, MASH. The big news includes a rebrand from NASH (non-alcohol related steatohepatitis) to MASH (metabolic dysfunction-associated steatohepatitis), the FDA approval of Madrigal Pharmaceutical’s Rezdiffra and real-time court rulings in Europe that may affect the rate of play for Ocaliva, a drug used to treat adults with primary biliary cholangitis here in the US. As Christian mentions in this episode, “The path to success is not always a straight line.”Other topics in this podcast include: Hepatology market dynamics over the past five years, including activity from Gilead, Novo Nordisk, Intercept and CymaBay How treatment for primary biliary cholangitis, an autoimmune condition, went from a one to a three-product market Payer monographs and what’s required for hepatology drugsThe EMA recommendation earlier this month to revoke Ocaliva’s marketing authorization Which companies are active in the rare liver disease space and how they differentiate themselves Thank you for listening. You can find previous episodes of the podcast here. We’d love to hear from you. Ask questions and submit your feedback. 

In this DNB//Back Bay Healthcare Capital Markets podcast episode, learn about the key considerations, mechanics and timelines of going public on a US exchange.  Topics in this podcast include:  An overview of the decision-making process through execution for US-based and ex-US healthcare companies thinking about listing in the USCore considerations after deciding to pursue a US listing and how to prepare most effectivelyBuilding the “IPO advisory team”: types of advisors (legal, accounting, banking, IR firms, IP, etc.) and when to bring them inKey documents and associated timelines related to the SEC documentation as well as investor outreachWhat are the “don’ts” or mistakes companies make and how to avoid them You can listen to previous episodes here or submit your inquiries here. About our guests: DNB//Back Bay is a committed partner throughout the healthcare development journey, addressing positioning, partnering, financing, M&A strategies, and listing support and execution on US and Nordic exchanges. Our team of more than 100 healthcare strategy and financial specialists spans the globe. Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership. Cooley is among the top law firms for healthcare, tech and life science IPOs on both the issuer-side and underwriter-side. Their team of 1,300 lawyers is spread across 19 offices worldwide.

Guests: Pete Bak and Christian Thienel Length: 27 minutes In this episode of The Life Science Report, Dr. Pete Bak and Back Bay Director, Christian Thienel catch up on the area attracting the most industry interest over the past couple of years: the anti-obesity space. From big players looking to capitalize on the renewed interest in the obesity space to the staggering success of Novo Nordisk’s and Eli Lilly’s GLP-1 agonists (Ozempic, Wegovy, Mounjaro, and Zepbound) for glycemic control and weight loss, there’s a lot to cover. Topics in this podcast include:A brief introduction to glucagon-like peptide 1 (GLP-1) agonistsWhy GLP-1s’ popularity is skyrocketing as treatment for type 2 diabetes and obesityHow amylin and petrelintide (a long-acting amylin analogue) are being newly re-imagined for the obesity space, as well as muscle-targeted approaches like myostatin and activinsWhere BD and investor interest lies as these drugs are expected to have north of $150B in sales annually within the next decadeWhat’s happening in early to late-stage drug developmentWhat the future holds for this sector, possibly to include cannabinoid one receptor inverse agonists and mitochondrial targets for metabolic disease As always, thank you for joining us. Did you know we welcome listener questions? If there any areas you’d like us to explore further in metabolic disease and obesity, please let us know. Submit your questions here. Our Nordic-American Healthcare Conference 2025 will feature metabolic track. Learn more: https://nordicamericanhealthcareconference.com/ You can find previous episodes of the podcast here.

Welcome to another episode with the DNB//Back Bay Partnership for Healthcare.In this episode Jonathan Gertler, Back Bay CEO and Managing Partner, is once again joined by James Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director of US Equity Capital Markets at DNB, and Vasilios Kofitsas, Managing Director of Investment Banking at Back Bay Life Science Advisors, to talk about current market dynamics and the 2024 IPO outlook in the US and in Europe.Topics in this podcast include:Trends, cycles and the current state of capital markets in Europe and the USIPO performance for Q1 2024 vs. previous yearsTop characteristics of companies well-suited to go public and be successfulIPO market dynamics in Europe vs. the USExpectations and advice for companies contemplating going publicAs always we welcome listener questions and/or topics you’d like to learn more about.You can listen to previous episodes here or submit your inquiries to info@bblsa.com.Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership.

Guests: Pete Bak and Christian Thienel Length: 37 minutes With the advent of COVID-19 in 2020 and 2021, we saw a tremendous amount of interest in not only COVID vaccines, but other companies riding the tailwind and developing vaccine therapies that span across viral illness, maternal infections and bacterial infections. In this episode resident immunologist Dr. Pete Bak and Christian Thienel discuss vaccine technology, up-and-coming areas of interest, such as RSV, and the vaccines currently in late-stage clinical development. Topics in this podcast include: Vaccine technology, vaccine types and their varying levels of durabilityThe ongoing interest of vaccine development for RSV, including data from GSK’s Arexvy and Pfizer’s Abrysvo vaccinesHow recommendations from the Advisory Committee on Immunization Practices (ACIP) influence commercial dynamicsThe interesting chess game of scheduling vaccines as they relate to COVID, flu and RSV (seasonality versus strains and antigens) Vaccine development and data as it applies to Cytomegalovirus (CMV) and Epstein-Barr (EBV)News from the bacterial front: MinervaX leading the way with a maternal vaccine against Group B streptococcus infections with a very large series B round for $54M; Pfizer’s recent Prevnar 20 against pneumococcal pneumoniaPricing, reimbursement and the interplay with ACIP guidelines As always, we welcome listener questions and/or topics you’d like to learn more about. You can listen to previous episodes here or submit your inquiries here.

A Podcast Discussion on the Trends and Investment Activity in Radiopharmaceuticals and PsychedelicsGuests: Pete Bak and Christian ThienelLength: 25 minutesHere at Back Bay we’ve seen a number of notable trends in the radiopharmaceutical and psychedelic spaces playing out over the past couple of years. Increasingly, investors have been asking our opinions and perspectives on these topics.Our team has written these whitepapers to address industry interest:The Radiopharmaceutical Renaissance: Radiating Hope in MedicineVision of Commercial Success: Investment and Partnering Landscape for PsychedelicsIn this episode, Dr. Pete Bak and Christian Thienel talk through the uptick of activity in these focus areas and discuss where the future of radiopharmaceuticals and psychedelics might be heading.Topics in this podcast include:A brief introduction into the history of radiation and radiopharmaWhy the early promise of first-generation radiopharmaceuticals like Zevalin and Bexxar didn’t turn out to be as commercially successfulKey advancements in manufacturing and production for second-generation products like Xofigo, Lutathera and PluvictoThe “theranostic” (therapeutic and diagnostic) potential of radiopharmaceuticalsThe growing investment and R&D support for psychedelics from private companies and academics, especially with the Otsuka and Mindset acquisition for $80M in 2023Realities within the new paradigm of novel treatments and patient/provider protocols adhering to the FDA’s Risk Evaluation and Mitigation StrategyThe evolving nature of the antibacterial space and some notable financing deals, three within two months (Antabio, Clarimedix and Revagenix)Listen to the full episode here.

As we move into 2024, Back Bay’s strategic advisors summarize key product approvals from three classes and indications over this past year, including the December CRISPR and Vertex approval of Exa-cel, Biogen and Sage’s August approval of an oral treatment for women with postpartum depression and Genmab and Roche’s May approval in oncology.   In this episode:  CRISPR and Vertex’s approval of Exa-cel, the first CRISPR-based genetic medicine approved by the FDA in the US The major depressive disorder vs. postpartum depression for Biogen/Sage GenMab and Roche approvals AbbVie acquisition of Cerevel Therapeutics strengthen neuroscience pipeline In 2023, on The Life Science Report, Back Bay covered a wide range of topics featuring stories from the frontline of healthcare development to the rising trends in cardiology to the transactional landscape of antibody drug conjugates. We always welcome listener questions or topics you’d like to learn more about. You can listen to previous episodes or submit your inquiries here.  Back Bay provides a snapshot of the healthcare markets every Monday. For IPO, Follow-On and M&A updates, subscribe to our healthcare updates. 

In our latest podcast, Back Bay Life Science Advisors focused on the chronic and rare disease development of kidney disease. Recently, there have been some changes in treatment, some recent commercial launches and certainly some interest from pharma consolidators, as M&A activity picks up in this area. In this next installment of The Life Science Report, Dr. Pete Bak and Christian Thienel of Back Bay Life Science Advisors talk about kidney disease and the various aspects of the renal disease landscape. Topics in this podcast include:The links between cardio and metabolic diseases and the therapeutic approaches and label expansions taking place in the renal disease landscapeHistoric evolutions beyond Chronic Kidney Disease (CKD), from rare diseases to all types of indications of CKDUnderstanding potential treatment priorities when some therapies have benefits in multiple indicationsRecent deals, including Novartis’ acquisition of Chinook Therapeutics and Novo Nordisk’s acquisition of KBP Biosciences’ ocedurenone, etc. The impact of Sodium-glucose cotransporter-2s (SGLT2s) in kidney disease over the last ~5 years, and how that has precipitated broader interest in renal indications across the industry

With the DNB//Back Bay Partnership for HealthcareIn the current markets, Healthcare continues to rally as the second-largest industry behind technology in the stock market, and in the US markets there’s been roughly $2.5B raised from an IPO standpoint YTD. In Europe, the markets have been more challenging, with IPOs for five companies going public this year, including Schott Pharma, Germany’s largest IPO earlier this year.In the first podcast episode with the DNB//Back Bay Partnership for Healthcare, Jonathan Gertler, Back Bay CEO and Managing Partner is joined by Jim Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director and Head of Equity Capital Markets at DNB, and Vasilios Kofitsas, Partner and Managing Director of Investment Banking at Back Bay Life Science Advisors, to discuss the current landscape of IPO and capital markets, optimal preparation strategies for companies hoping to go public and why it ultimately matters who you spend your time with.Topics in this episode include:Dynamics leading to the current IPO market and capital markets landscapeThe state of private and partnering markets and the renewed power of partnershipsCrucial roles of private investments, VC and other “mezzanine investors” for public emergence licensingThe importance of optimal prep and aftermarket support, and why spending good time in the preparation phase with both research and individual investor meetings is a key success factor, regardless of where companies are planning to listThe ever-important lesson of starting early

A conversation on the rising trends in the cardiology spaceCardiology has historically been a cornerstone of large pharmaceutical portfolios. The late 2000s and 2010s saw many pharmaceutical companies and investors abandon or severely deprioritize cardiology research and development in favor of oncology, immunology, and neurology.During this episode of The Life Science Report, Dr. Pete Bak and Christian Thienel of Back Bay Life Science Advisors discuss the major players in the industry and novel approaches to future cardiology applications.Episode topics include: Why pharma’s interest in specialty-like approaches has shifted towards cardiologyThe promise of “advanced modalities” and gene therapies, such as antisense oligonucleotides (ASOs) and small interfering RNA (siRNA)How these newer treatments stack up against traditional small molecule orals, like statinsClinical stage pipeline analysis across cardiology and visible trends on the horizonThis is the 20th episode of Back Bay’s podcast, covering all facets of healthcare development and transactions. For questions, be in touch: www.bblsa.com

In this episode, Dr. Peter Bak is joined by Trent Gordon and Dr. Mavra Nasir as they discuss their Bioprocess Online article published earlier this year, “The Transactional Landscape of ADCs: A Payday for Payloads.” This conversation explores the dynamics and data within the emerging ADC field, including:Background information on the class of therapeutics known as ADCs, which have been on the market since 2000The number of headlines around ADCs lately, especially the standing ovation the data from Enhertu received at ASCO in 2022, making waves in breast cancer treatmentDeal structures and the BD side of ADCs, and their extended revenue generation potentialWhere the field is headed, in terms of clinical, BD and commercial standpointsRead and connect with our authors:  The Transactional Landscape Of ADCs: A Payday for Payloads

The world of health tech has changed dramatically since decades ago when physicians had to endure 11 keystrokes to prescribe a single aspirin. These days, AI-based radiology and AI-based pathology are transforming patient lives through machine learning and data analytics, in some cases offering early disease warning systems and improving quality of care while reducing healthcare costs.   In this episode of Back Bay’s industry podcast, the Life Science Report, Jonathan Gertler speaks with Mikaela Odlander, Director of Digital Therapeutics at Orexo, and Edward Kliphuis, Partner at Sofinnova Partners, about the opportunities and challenges ahead in the realm of health tech and digital medicine.  Topics in this episode include:  - The misperceptions around digital therapeutics and digital medicine- The impact health tech has on care, fostering adoption, hurdles to reimbursement- The stark difference between the European and Nordic vs. US healthcare markets- Examples of AI machine learning and how digital medicine is providing personalized, efficient and effective healthcare- The major challenge of replication and scale for a company

For biopharma and medtech companies developing new treatments, capital for advancement and growth is invariably dependent on strategic preparation, differentiation, and persistence. Good preparation can mean funding or famine in a retracted market—and ultimately can impact the trajectory of a company and whether treatment reaches people in the clinical setting. In a down market, there are creative and thoughtful approaches companies can take to stand out as capital becomes more closely guarded and the competition becomes fierce.  In this episode of Back Bay’s industry podcast, the Life Science Report, Jonathan Gertler speaks with Goodwin Procter life science partner Kristopher Brown about the current market landscape and how life science companies can recalibrate and prepare for capital raises—no matter the market outlook. This episode focuses on discussion of deal management in the current market, including:  The current deal scape—difficult times ahead or par for the course in the life science sector?Approaches to deal preparation in a challenging environmentTentative M&A, licensing, partnering activity and public markets necessitate preparation and strategic focus ahead of capital raise, particularly:Thorough knowledge of asset differentiation - positioning, competitive intensity, pricing, milestone development/definition and valuation, among other activitiesCreative deal financing models – royalty monetization, tranced investments, debt financing, preferred stock, liquidation preferencesStructure and valuation disciplinePortfolio and selection management toward a deal, including the use of AI in population identification  Find the video podcast and contribute to the conversation on Back Bay’s website: www.bblsa.com/podcasts 

In our first podcast episode of 2023, Back Bay’s strategic advisors summarize some of the most compelling healthcare development stories from 2022. From CRISPR and gene editing advancement to cross-species organ transplantation and the latest in the evolving regulatory and reimbursement landscape,  these stories captivated us and continue to herald progress in health and human care. Podcast experts include Brendan Wang, Christian Thienel and Peter Bak, with special thanks to Micheka Fenelon.

For biopharma and medtech companies, the decision to go public is predicated on many business decisions—what kind of capital can be raised? Is our investor base strong and interested? Is now the right time? The Nordic Markets offer some distinct advantages at the earlier stage, and also offer new possibilities for US companies to list abroad. And although the specific logistical and mechanical aspects are exceedingly important, at the end of the day, the decision to do something like this is predicated on an amalgam of strategic decisions. In this episode Back Bay Life Science Advisors and Nasdaq outline best practices for companies considering a public listing, including:Steps in best practice strategy in an increasingly complex marketAdvantages of listing with a smaller listing threshold marketSimilarities and differences between Nasdaq US and Nasdaq Nordic marketsThe strategic change and new dual listing option for US companiesThe unique way retail participation makes up a large portion of the Nasdaq Nordic market (>25% of trades come in from retail)Differences in support for emerging companies, Nordic v. US marketsJonathan Gertler is CEO of Back Bay Life Science Advisors and Managing Partner at Bioventures Medtech Funds. Maria Groschopp Dellwik is Nasdaq’s Head of Strategy and Business Development for Global Listing Services in the Nordics, where she manages new offerings and key strategic change initiatives to improve listing offerings and the Swedish capital market.Download “Preparing for a Public Listing: Best Practices for Biopharma, Medtech andHealthtech Companies” from Back Bay Life Science Advisors and Nasdaqhttps://bblsa.com/investment-banking-1

with Back Bay Life Science Advisors’ Dr. Peter Bak and Dr. Mavra NasirDr. Mavra Nasir recently published a thought piece in Biopharma Dealmakers outlining the current state of play in the promising field of protein degradation. In this episode, Dr. Nasir sits down with Peter Bak to discuss the recent surge of venture funding and partnerships surrounding TPDs.Read Dr. Nasir's article "From drug target inhibition to degradation: a TACtical strategy" here. Topics in this podcast include:An intro into targeted protein degradation (TPDs) and proteolysis-targeting chimeras (PROTACs)Industry advantages of TPDs vs. traditional antibodiesBiopharma and VC's growing interest in molecular gluesCommercial hurdles ahead in this spaceHow TPD companies can differentiate, from a pipeline and breadth of opportunities to select an indication, communicate to investors and drive valueIf you have a question about life sciences development, submit it here. We may feature it on an upcoming episode.Thanks for joining us!*Mavra Nasir, PhD is a senior consultant at Back Bay Life Science Advisors where she supports strategic engagements across a range of therapeutic areas including rare diseases, hematology/oncology and metabolic diseases for biopharma and MedTech. Dr. Nasir joined Back Bay after receiving her PhD in Quantitative Biomedical Sciences from Dartmouth College.

This is the first episode in our podcast series of Q&As on biopharma and medtech development—directly from active developers. Our podcast listeners, including Back Bay clients, have submitted timely and relevant questions about life science development and the daily challenges they face.Christian Thieniel and Brendan Wang, two senior members of the Back Bay Life Science Advisors team with a tremendous amount of experience in the life sciences, especially as it relates to scientific, clinical and commercial issues, offer guidance on issues related to pricing and early market access.Topics include:For early-stage clients, when is the right time to think about pricing and access, and why it is important to identify market access hurdles earlyFor later stage clients, how to get more granular on pricing and market access insights (narrowing the price range, broadening the payer sample, etc.)Which real-life and project examples lend clarity here, including an example from Back Bay’s past work in the anti-infectives space. How can upfront P&MA research lead to more confidence and varied project positioning in partnering discussions?Would you like us to include your life sciences development question in an upcoming episode? Please submit it here.Make sure to subscribe to our podcast on your favorite podcast platforms and follow Back Bay Life Science Advisors on LinkedIn.Thank you for joining us.