San Diego, November 14, 2024 – Shoreline Biosciences, Inc., a biopharmaceutical company developing disease modifying iNK cell therapies for autoimmune disorders, today announced its participation in the 2024 Stifel Healthcare Conference taking place November 18-19, 2024, in New York, NY.
Company management will present on Monday, November 18, 2024, at 4:45 pm ET and will also participate in one-on-one meetings with investors during the conference.
About Shoreline Biosciences
Shoreline Biosciences is a biopharmaceutical company developing disease modifying iNK cell therapies for autoimmune disorders. Shoreline is advancing a pipeline of induced pluripotent stem cells (iPSC) derived natural killer cells (iNK) and macrophage (iMACs) therapies to deliver safe, affordable and accessible medicines. The Company’s cellular design and gene editing technologies are built on a unique understanding of immune cell biology and premier gene editing tools such as SLEEK knock-in technology and access to AsCas12a, a high fidelity and high efficiency engineered CRISPR/CAS endonuclease. Shoreline has also developed an industry-leading SMART™ manufacturing platform to enable truly off the shelf and scalable cell therapies.
SAN DIEGO, Aug. 3, 2023 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing effective and differentiated cellular immunotherapies based on induced pluripotent stem cells (iPSCs) derived natural killer cells (iNK) and macrophages (iMACs), today announced that it will participate in the 2023 Wedbush Pacgrow Healthcare Conference taking place August 8-9, 2023 in New York, NY.
Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Chairman and CEO, will participate on a cell therapy panel on Tuesday, August 8, 2023 at 8am ET with 2Seventy Bio, Artiva and TScan Therapeutics. Shoreline management will also participate in one-on-one meetings with investors during the conference.
About Shoreline Biosciences
Shoreline Biosciences is a biopharmaceutical company developing effective and differentiated cellular immunotherapies based on induced pluripotent stem cells (iPSCs) derived natural killer cells (iNK) and macrophages (iMACs). The company’s cellular design and gene editing technologies are built on a unique understanding of iPSC differentiation, immune cell biology and premier gene editing tools such as SLEEK knock-in technology and access to AsCas12a, a high fidelity and high efficiency engineered CRISPR/CAS endonuclease. Our allogeneic effector cells are designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company.
SAN DIEGO, March 16, 2023 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced the presentation of preclinical data at the American Association for Cancer Research (AACR) annual meeting taking place in Orlando, FL, from April 14-19, 2023.
Details of the Shoreline poster are below:
Title: “A novel method for clinical scale production of natural killer cells from clonal master induced pluripotent stem cells with CISH knockout for next generation, off-the-shelf cancer immunotherapy” Session Category: Immunology Session Title: Natural Killer and Natural Killer T Cell-based Cellular Therapies Session Date and Time: Monday April 17, 2023, 1:30 PM – 5:00 PM Location: Poster Section 22 Abstract Number: 2919
Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.
SAN DIEGO, March 16, 2023 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced the presentation of preclinical data at the American Association for Cancer Research (AACR) annual meeting taking place in Orlando, FL, from April 14-19, 2023.
Details of the Shoreline poster are below:
Title: “A novel method for clinical scale production of natural killer cells from clonal master induced pluripotent stem cells with CISH knockout for next generation, off-the-shelf cancer immunotherapy” Session Category: Immunology Session Title: Natural Killer and Natural Killer T Cell-based Cellular Therapies Session Date and Time: Monday April 17, 2023, 1:30 PM – 5:00 PM Location: Poster Section 22 Abstract Number: 2919
Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.
SAN DIEGO, Feb. 21, 2023 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced the appointment of Mauro P. Avanzi, M.D., Ph.D. as Chief Medical Officer.
Dr. Avanzi is an experienced physician-scientist and hematologist/oncologist with over fifteen years of clinical experience, including over ten years of experience advancing cellular therapies through early and late-stage of development. In his new role, Dr. Avanzi will be responsible for leading and expanding Shoreline’s clinical portfolio and will serve as a key member of its Executive team.
“We are extremely pleased that Mauro is joining Shoreline at such a pivotal time in the growth of our company. Mauro is a recognized immuno-oncology expert with a wealth of expertise in leading cross-functional clinical teams that have advanced important cellular therapies through all stages of development, including commercial approval in global markets,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Chairman and CEO. “Mauro’s unique background and proven track record in cell therapy will strengthen our capabilities as we bring next-generation immunotherapies to patients with cancer.”
Prior to joining Shoreline, Dr. Avanzi served as Vice President, Clinical Development at Neogene Therapeutics (acquired by AstraZeneca), where he was responsible for leading clinical studies with TCR T cells targeting neoantigens. Prior to Neogene, Dr. Avanzi held a number of positions of increasing responsibility at Kite Pharma (acquired by Gilead), where he supported multiple clinical programs through all stages of development. Dr. Avanzi has extensive clinical development experience in both the US and EU, and has played an integral role in multipe IND/CTA and sBLA filings, including the commercial approval of Yescarta for indolent NHL. Dr. Avanzi earned his M.D. at Campinas Medical School (Puc) in Brazil and completed an internal medicine residency and hematology/oncology fellowship at the São Paulo University (USP). He completed his Ph.D. research at the New York Blood Center/Santa Casa Medical School and a post-doctoral fellowship focusing on CAR-T cells at Memorial Sloan Kettering Cancer Center. Dr. Avanzi is an author of multiple peer-reviewed publications on adoptive cellular therapies.
Dr. Avanzi commented, “I have long admired Shoreline’s focus and leadership position in cell therapy and I am very excited about the clinical potential of the Shoreline pipeline. I believe that Shoreline has the strongest set of tools to win the war on cancer, including its industry-leading iPSC derived iNK and iMAC platforms and the recent addition of key gene-editing and manufacturing technologies. The company’s deep expertise in iPSC differentiation, immune cell biology, and gene-editing make this an opportunity that I find very compelling, and I look forward to building a meaningful clinical portfolio that will deliver therapeutic benefit to patients.”
About Shoreline Biosciences
Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.
Shoreline to obtain an exclusive license to SLEEK knock-in technology for iPSC-derived NK cells, an exclusive license to SLEEK for iPSC-derived macrophages in oncology and a non-exclusive license for AsCas12a
Shoreline to acquire Editas Medicine’s iNK cell franchise, including EDIT-202 and certain related manufacturing technologies
Economics to Editas Medicine to include upfront payment, and development and commercial milestone and royalty payments
CAMBRIDGE, Mass. And SAN DIEGO, Jan. 19, 2023 – Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today announced that it has entered into a definitive agreement with Shoreline Biosciences (Shoreline) for Shoreline to license Editas Medicine’s proprietary SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies and acquire Editas Medicine’s preclinical gene edited induced pluripotent stem cell (iPSC) derived natural killer cell (iNK) programs and related manufacturing technologies.
Shoreline Biosciences is a private biopharmaceutical company developing next-generation cellular immunotherapies based on iPSCs utilizing proprietary iNK and macrophage (iMACs) platforms.
Under the terms of the agreement, Shoreline will obtain an exclusive license to Editas Medicine’s interest in SLEEK gene editing knock-in technology for use in Shoreline’s iNK platform and for oncology in its iMACs platform, and on a non-exclusive basis for iMACs in other indications. Shoreline will also receive a non-exclusive license for the use of Editas Medicine’s engineered AsCas12a enzyme.
As part of the transaction, Shoreline will acquire EDIT-202, Editas Medicine’s preclinical multiplexed edited iNK cell medicine for the potential treatment of solid tumors, as well as an additional iNK program under development and certain related manufacturing technologies. The acquisition of the Company’s wholly owned oncology assets by Shoreline is part of Editas Medicine’s strategic portfolio reprioritization, including its focus on the development of in vivo gene edited medicines.
“The acquisition of our allogeneic iNK franchise by Shoreline is highly aligned with our strategic portfolio reprioritization, as it allows us to sharpen our efforts on advancing current clinical stage trials and focus our resources on in vivo fit-for-purpose therapeutic construction and development.” said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine. “Shoreline is a leader in developing next generation iNK and macrophage cell therapies, and we believe they are the right company to move these assets toward clinical applications.”
“Our goal is to win the war on cancer, and through this agreement with Editas, we have strategically enhanced our ability to execute upon our mission. The addition of Editas Medicine’s novel gene editing SLEEK technology, combined with the use of a high efficiency and high fidelity proprietary CRISPR enzyme, and the other assets from Editas Medicine’s iNK franchise, strengthens our portfolio and ability to create next generation immunotherapies for patients with cancer,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Chairman and CEO, Shoreline Biosciences. “We look forward to advancing our pipeline towards the clinic, including these new assets and technologies from Editas.”
Shoreline will pay Editas Medicine an upfront payment at the close of the transaction. Additionally, Editas Medicine is eligible to receive future development and commercial milestone and royalty payments for each of the iNK programs and for future programs engineered with the gene editing technologies. Evercore Group LLC served as financial advisor to Editas Medicine on the transaction.
About Editas Medicine
As a clinical-stage genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute and Harvard University’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.
About Shoreline Biosciences
Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.
Editas Medicine Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the expected benefits of Editas Medicine’s transaction with Shoreline, including any future payments it may receive under the agreement and the impact on its strategic portfolio reprioritization. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials, and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.
SAN DIEGO, Dec. 5, 2022 /PRNewswire/ — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced that it will present new data on its iNK platform during an oral presentation and in a poster at the annual meeting of the American Society of Hematology 2022 (ASH 2022). ASH 2022 will be held from Saturday, December 10, to Tuesday, December 13, 2022, in New Orleans, Louisiana.
During the oral presentation, Shoreline scientists will showcase the Company’s novel manufacturing process to support the clinical scale cGmP production of CISH knock-out iNK cells.
“We are thrilled to showcase Shoreline’s CISH knock-out engine and our scalable manufacturing approach during our presentations at ASH 2022,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Co-Founder, Chairman and CEO. “We believe our approach holds tremendous potential to create next-generation products using iNKs that reduce the cost and complexity of conventional cell therapy approaches.”
Robert Hollingsworth, Ph.D., Shoreline’s Chief Scientifc Officer, added, “Our goal is to win the war on cancer with our iPSC-derived iNK and iMACs and presenting our scientific progress to our peers and collaborators is crucial to Shoreline’s growth. We want to thank the organizers at ASH for recognizing Shoreline and providing us with the opportunity to highlight our science and we look forward to advancing our pipeline towards the clinic.”
Details of the Shoreline presentations are below:
Oral Presentation:
Title: “A Novel Method for Efficient cGMP Production of Natural Killer Cells from Clonal Master Induced Pluripotent Stem Cells for Next Generation, Off-the-Shelf Cancer Immunotherapy” Session Name: 711. Cell Collection and Processing I Session Date: Sunday, December 11, 2022 Session Time: 4:30 PM – 6:00 PM Presentation Time: 5:45 PM Room: Ernest N. Morial Convention Center, 220-222
Authors: Davide Bernareggi, Caryn Gonsalves, Max Schabla, Alejandra Gárate-Carrillo, Mohammad El-Kalay, Dan S. Kaufman, Robert Hollingsworth, Huang Zhu
Poster Presentation:
Title:“Development of Next-Generation NK Cell Optimized Chimeric Antigen Receptors (CARs) for iPSC-Derived NK Cell Therapies Targeting Both Solid and Liquid Tumors”
Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster I Session Date: Saturday, December 10, 2022 Presentation Time: 5:30 PM – 7:30 PM Location: Ernest N. Morial Convention Center, Hall D
Authors: Lee Swanson, PhD, Kenyon Lyon, Wael Tadros, PhD, Mafalda Loreti,PhD, Tammy Babin, Benjamin Blair, Max Schabla, PhD, Paschalis Sideras, PhD, Dan S Kaufman, MD, PhD, Robert Hollingsworth, PhD and Huang Zhu
The abstracts are available on ASH’s official website.
About Shoreline Biosciences
Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.
SAN DIEGO, Oct. 24, 2022 / — Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced the appointment of Charles Calderaro III as Chief Technical Officer. Mr. Calderaro brings three decades of manufacturing and engineering experience to Shoreline, with industry-leading expertise in building and optimizing technical and manufacturing infrastructures for cell therapy products.
“Chuck is a drug manufacturing expert, highlighted by the successful creation and implementation of end-to-end manufacturing and commercial operations for Kite, a Gilead company and a leading cell therapy company. I am thrilled to welcome him to Shoreline as Chief Technical Officer,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s Co-Founder, Chairman and CEO. “With Chuck’s expertise and our iPSC platforms, we are well positioned to implement our planned scalable manufacturing approach, designed to reduce the cost and complexity of manufacturing and enable the development of true ‘off-the-shelf’ products for use in outpatient settings. This could lead to a significant competitive advantage as we move our iNKs and iMACs towards the clinic.”
Prior to joining Shoreline, Mr. Calderaro served as Global Head of Technical Operations for Kite, a pioneer in cell therapy development, where he was responsible for leading all aspects of Kite’s technical operations, including process development, CMC regulatory, manufacturing, quality, supply chain, engineering, and end-to-end optimization of commercial and pipeline products. While at Kite, Mr. Calderaro oversaw the manufacturing of CAR-T cell therapy products at commercial scale. Prior to Kite, Mr. Calderaro was Senior Vice President, Global Manufacturing at BioMarin Pharmaceutical, where he was responsible for the strategic oversight and leadership of a diverse international manufacturing network, which utilizes small molecule, oligonucleotide, biotechnology, and gene therapy technologies to deliver an innovative portfolio of clinical and commercial products to patients. Before that, he spent fourteen years at Genentech in roles of increasing responsibility in product management, engineering, and manufacturing. Early in his career, Mr. Calderaro spent time at Alcon, a division of Novartis, and at Aventis Behring, spanning roles in manufacturing, validation, and biopharmaceutical operations. Mr. Calderaro received a Bachelor’s degree, Electrical Engineering from the University of Notre Dame, a Master’s Degree, Nuclear Engineering from the US Naval Nuclear Power School and a Master of Business Administration from Texan Christian University.
“It is clear that a major gating factor to increasing the number of cellular immunotherapies on the market is the lack of automation in the manufacturing process. Shoreline’s smart manufacturing system holds tremendous promise to create a novel, scalable, end-to-end process, that will optimize the product quality of iPSC-derived cell therapies,” added Mr. Calderaro. “The strength of the technology and the team created a compelling opportunity for me and I look forward to creating the manufacturing system of the future, with the goal of finally winning the war on cancer and delivering benefit to patients.”
About Shoreline Biosciences
Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company’s cellular design technologies are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic “off-the-shelf” cellular immunotherapies designed for durability, scalability, safety, and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered in San Diego, CA.
COVID-19 pandemic, the challenging capital-markets climate in biotech, and a more innovative and specialty treatment focus has increased reliance on the finance arm as a key strategic cog.
Over the past three years, the pharmaceutical industry has gone through several impactful changes. During the early months of the COVID-19 pandemic, investors flooded the industry with money, allowing new companies to emerge and conduct multiple rounds of clinical trials while still being confident that more funding would be available. Over the past year, however, things have changed and funding is harder to come by. This has put the role of chief financial officer in the spotlight.
Morgan Brown is CFO at Clene, a clinical-stage biopharmaceutical company working on treatments for neurodegenerative diseases. According to Brown, life sciences organizations are searching for new qualities in CFOs.
“Companies are looking for more contribution from the finance team on the whole, and the CFO specifically to be more strategic in nature, to really partner with the other c-suite executives and help them effectively operate the business,” he says.
Brown also elaborates on how the changing industry is impacting the role of the CFO in ways not directly connected to finance. “Although not specifically related to CFOs, I think the distribution of drugs isn’t going to be the same old retail-pharmacy model that we’ve seen in the past,” he explains. “It’s going to be more innovative and specialty pharmacy-based and at-home delivery.”
Justin Thacker, CFO at Aristea Therapeutics, says that the role has changed quite a bit over the past three years, with the past 12 months impacting the job significantly. “With the pandemic, obviously, working remotely has changed significantly for me and the teams that I’ve been involved with,” he tells Pharm Exec. “[Though] we were always moving to more automation, the pandemic pushed that along quite rapidly.”
Shane Kovacs, CFO and chief operating officer at Olema Oncology, believes there’s been a “dramatic shift in the tone of the capital markets as it relates to the biotech sector.” This can have big implications for CFOs since access to capital plays a large role in the success of biotech companies, Kovacs notes, and the past decade saw one of the largest booms the biotech sector has ever seen. Unfortunately, things have changed over the past 12 months.
“[As] we have witnessed across many historical periods of enthusiastic expansion in other industries, the pendulum likely swung too far in the positive direction by early 2021,” he says. “There were many examples of new companies being formed by licensing technology and IP out of academia that then catalyzed on the relatively easy access to capital with successive private-round financings followed quickly by an IPO. Pre-money valuations for biotech IPOs that historically struggled to achieve the $200 million mark were now going public with valuations exceeding $500 million and, in some cases, greater-than-$1 billion unicorn valuations.”
Kovacs explains that these companies were able to grow very quickly due to having access to the capital.
Pharm Exec financial columnist and Editorial Advisory Board member Barbara Ryan recently described how the biotech industry peaked with investors in early 2021. The previous year, biotech and biotech IPOs provided consistently large returns for investors. Since that time, however, the biotech industry entered the longest bear market in its history, leaving many companies struggling to find further funding.
Investors are learning the difference between biotech and the tech industry, Kovacs points out. New technologies must undergo periods of trial and tribulation before being approved, and many new biotechnologies never make it to the approval stage. This creates a much longer business cycle than the tech industry and requires more capital before becoming cash-flow positive.
“Over the past 12 months, we have, unfortunately, seen a complete reversal of this investor enthusiasm for the biotech sector,” says Kovacs. “Valuations are now at all-time lows with many companies trading at or even below their cash balances. New equity offerings and IPOs have fallen off a cliff. The big question looming over the heads of biotech boards and management teams is, ‘How long will this last?’”
Shoreline Biosciences’ CFO, Vanessa Jacoby, notices similar trends as well.“With the volatility of the market, I think capital is becoming sparser and you have to, again, navigate the trade-offs,” she tells Pharm Exec. “What is important to your organization? How do you focus? What are the products that are more likely to make it to the clinic, and what are the unmet needs that we’re trying to solve here?”
According to Jacoby, due to the volatility of the markets, CFOs are focused on making sure that their companies are well-resourced and can deliver the goals of the wider organization. Even if the markets become less volatile, those goals will remain the same.
She adds that the pandemic likely caused a good amount of capital to flood the industry. Over the past months, however, interests have changed, and she believes that many generalist investors have moved on to different sectors.
“It’s a cyclical process,” says Jacoby. “You have a lot of resources, and then they decline, and you have to do the best that you can, always with the goal in mind to bring drugs to patients.”
