Precigen, Inc.

ROCKVILLE, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, today announced the appointment of Cynthia Collins to the Company’s Board of Directors as a non-executive director, effective October 14, 2024. Collins will serve on the board’s compensation committee. Following her appointment, MaxCyte’s total Board of Directors will increase to 10 members. “I am pleased to welcome Cynthia to MaxCyte’s Board of Directors,” said Maher Masoud, President and CEO of MaxCyte. “Cynthia has extensive and impressive leadership experience in the fields of cell therapy and genetic medicine that will be invaluable to MaxCyte in the coming years. I look forward to working alongside her to enable a growing set of next-generation cell therapies as the premier cell engineering platform in our industry.” Ms. Collins brings over 40 years of experience in the biotechnology industry and cell and gene medicines to MaxCyte, including her most recent role as Chief Executive Officer of Editas Medicine, where she was involved in dosing the first patient ever with an in-vivo gene modified therapy. Previously, Ms. Collins served as Chief Executive Officer of Human Longevity Inc., Chief Executive Officer/General Manager of General Electric Healthcare’s Cell Therapy and Lab Businesses, and Chief Executive Officer of GenVec, Inc., a vaccine and gene therapy company. Currently, Ms. Collins serves as a member of the Board of Directors of several healthcare companies, including Alanis Therapeutics, Nutcracker Therapeutics, Poseida Therapeutics (Nasdaq: PSTX), Certara (Nasdaq: CERT), DermTech (OTC: DMTKQ), Draper Laboratory, and Panavance Therapeutics. She is also a board member of the Foundation for mRNA Medicines. Cynthia Collins holds a Bachelor of Science degree in Microbiology from the University of Illinois, Urbana and an MBA from The University of Chicago Booth School of Business. “I am honored to join MaxCyte’s Board of Directors, where I believe there is exceptional work being done to propel the cell and genetic medicine industry forward,” said Cynthia Collins. “I am excited to support the Company’s growth and innovation as they continue to help developers bring a new class of therapies to market.” Regulatory Disclosures In accordance with Rule 17, Schedule Two paragraph (g) of the AIM Rules for Companies, Cynthia Lynne Collins (66) holds, or has held, the following directorship or partnerships in the last five years: CurrentPast 5 yearsAlanis Therapeutics, Inc.Triumvira Immunologics, Inc.Nutracker Therapeutics, Inc.Biocare Medical LLCPanavance Therapeutics, Inc.Human Longevity, Inc.The Charles Stark Draper Laboratory, Inc.Editas Medicine, Inc.Poseida Therapeutics, Inc.ARM Foundation for Cell and Gene MedicineCertara, Inc. DermTech Inc. The Foundation for MRNA Medicines, Inc. Cynthia Collins, was previously appointed as an independent director to the Board of DermTech, Inc. on May 24, 2018. On June 18, 2024, the Company filed for Chapter 11 bankruptcy. On August 21, 2024 the US Bankruptcy Court for the District of Delaware approved the sale of a substantial amount of DermTech Inc.’s assets through a court-supervised auction. Save as disclosed above, there is no further information to be disclosed pursuant to Rule 17 Schedule Two paragraph (g) of the AIM Rules for Companies in respect of the appointment of Cynthia Collins. About MaxCyte At MaxCyte, we pursue cell engineering excellence to maximize the potential of cells to improve patients’ lives. We have spent more than 20 years honing our expertise by building best-in-class platforms, perfecting the art of the transfection workflow, and venturing beyond today’s processes to innovate tomorrow’s solutions. Our ExPERT™ platform, which is based on our Flow Electroporation® technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: four instruments, the ATx™, STx™, GTx™ and VLx™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio. By providing our partners with the right technology platform, as well as scientific, technical and regulatory support, we aim to guide them on their journey to transform human health. Learn more at maxcyte.com and follow us on X and LinkedIn. MaxCyte Contacts: US IR AdviserGilmartin GroupDavid Deuchler, CFA+1 415-937-5400ir@maxcyte.com US Media RelationsSpectrum ScienceJordan Vinesjvines@spectrumscience.com+1 540-629-3137 Nominated Adviser and Joint Corporate BrokerPanmure LiberumEmma Earl / Freddy CrossleyCorporate BrokingRupert Dearden+44 (0)20 7886 2500 UK IR AdviserICR ConsiliumMary-Jane ElliottChris Welsh+44 (0)203 709 5700maxcyte@consilium-comms.com

The rising demand for vaccine adjuvants is mainly due to the increasing rates of infectious and cancerous diseases. Other significant factors include the heightened need for vaccines for specific illnesses, a greater emphasis on immunization, and the expansion of vaccination programs globally. This trend is projected to persist through the forecast period from 2024 to 2030. LAS VEGAS, Aug. 29, 2024 /PRNewswire/ -- DelveInsight's Vaccine Adjuvants Market Insights report provides the current and forecast market analysis, individual leading vaccine adjuvants companies' market shares, challenges, vaccine adjuvants market drivers, barriers, trends, and key market vaccine adjuvants companies in the market. Key Takeaways from the Vaccine Adjuvants Market Report As per DelveInsight estimates, North America is anticipated to dominate the global vaccine adjuvants market during the forecast period. In the product segment of the vaccine adjuvants market, the oil-in-water emulsion category had a significant revenue share in the vaccine adjuvants Market in 2023. Notable vaccine adjuvants companies such as Dynavax Technologies, GSK plc, Croda International plc, SEPPIC, Novavax, SPI Pharma, Agenus Inc., Aurorium, Merck KGaA, Vaxine Pty Ltd., Hawaii Biotech Inc., CSL, OZ Biosciences, InvivoGen, Allergy Therapeutics, EUBIOLOGICS CO., LTD., Pacific GeneTech Limited, Riboxx GmbH, CaPtivate Pharmaceuticals LLC, Mukta Industries, and several others, are currently operating in the vaccine adjuvants market. In May 2023 Croda International Plc entered into a partnership with Amyris and Botanical Solutions Inc. firstly for biotechnology-derived squalene and secondly with BSI to develop a sustainable QS-21 vaccine adjuvant moving towards plant tissue culture-derived approach rather than the traditional method of extracting QS-21 from soap bark trees. In August 2022, GSK Plc entered into an acquisition with Affinivax, Inc. to develop pneumococcal vaccines. To read more about the latest highlights related to the vaccine adjuvants market, get a snapshot of the key highlights entailed in the Global Vaccine Adjuvants Market Report Vaccine Adjuvants Overview Vaccine adjuvants are substances added to vaccines to enhance the body's immune response to the primary antigen. By stimulating the immune system more effectively, adjuvants can reduce the amount of antigen required and increase the duration of immunity. They play a crucial role in improving the efficacy of vaccines, particularly in cases where the antigen alone might not provoke a strong enough immune reaction. Adjuvants can work through various mechanisms, such as promoting a stronger local immune response at the injection site or facilitating a more robust activation of immune cells. Common types of adjuvants include aluminum salts, which have been used for decades and are known for their safety and effectiveness in boosting antibody responses. More recently, newer adjuvants like oil-in-water emulsions and toll-like receptor agonists have been developed to target specific aspects of the immune system. Research continues to explore and refine adjuvants to enhance vaccine performance, aiming to provide better protection against a range of infectious diseases and improve vaccine responses in different populations, including the elderly and immunocompromised individuals. Vaccine Adjuvants Market Insights In 2023, North America is anticipated to represent the largest share of the vaccine adjuvants market among all regions. This growth is driven by several factors. The region benefits from a well-established healthcare infrastructure and strong research and development capabilities, which stimulate advancements in vaccine adjuvant technologies. Additionally, increasing cases of infectious diseases and the threat of potential pandemics, like influenza or new pathogens, have led to greater investment in vaccine and adjuvant research. Government efforts to expand vaccination programs and enhance public health preparedness are also contributing to market growth. For example, the US Department of Health and Human Services (HHS) launched the HPV VAX NOW campaign in January 2021 to boost HPV vaccination rates among young adults. Similarly, the Government of Canada released updated guidelines on seasonal influenza vaccines for 2022-2023 in August 2022, which is expected to further stimulate market growth. Moreover, market expansion is supported by strategies such as product approvals, launches, and agreements. In November 2022, GSK plc's RSV vaccine candidate for older adults received a priority review from the FDA, indicating significant advancements in treatment or prevention. The combined effect of increased government and nonprofit investment in adjuvant development, alongside various product development activities, is set to drive the North American vaccine adjuvants market throughout the forecast period. To know more about why North America is leading the market growth in the vaccine adjuvants market, get a snapshot of the Vaccine Adjuvants Market Outlook Vaccine Adjuvants Market Dynamics The vaccine adjuvants market is experiencing significant growth driven by i ncreasing vaccine development and the demand for enhanced vaccine efficacy. Adjuvants are critical in improving the immune response to vaccines, which is particularly important as new and more complex pathogens emerge. The surge in research and development efforts, especially following the COVID-19 pandemic, has accelerated the need for innovative adjuvant technologies. Companies are focusing on developing adjuvants that can enhance the effectiveness of vaccines with lower doses, thereby addressing both efficacy and cost concerns. Technological advancements are playing a crucial role in shaping the dynamics of the adjuvants market. The development of novel adjuvants, such as nanoparticle-based and recombinant protein adjuvants, is gaining traction. These new technologies offer improved safety profiles and better control over immune responses. Additionally, the rise of personalized medicine and targeted therapies is driving interest in adjuvants that can be tailored to individual patient needs, further expanding the market potential. The r egulatory landscape and approval processes for vaccine adjuvants are also influencing market dynamics. Stringent regulatory requirements and the need for extensive clinical trials can pose challenges for market entry and innovation. However, successful navigation of these regulatory hurdles can lead to significant rewards, as demonstrated by the successful adjuvants used in COVID-19 vaccines. Companies that can efficiently meet regulatory standards while delivering effective solutions are likely to gain a competitive edge. Moreover, the vaccine adjuvants market is witnessing increased investment and collaboration between pharmaceutical companies, academic institutions, and government agencies. This collaborative approach is essential for advancing research, sharing knowledge, and accelerating the development of new adjuvant technologies. The convergence of resources and expertise from multiple stakeholders is expected to drive innovation and expand the market further. Overall, the vaccine adjuvants market is poised for substantial growth due to technological advancements, rising demand for effective vaccines, and increased investment in research and development. As the global focus on public health and disease prevention continues to intensify, the role of adjuvants in enhancing vaccine efficacy will remain a critical component of the healthcare landscape. Get a sneak peek at the vaccine adjuvants market dynamics @ Vaccine Adjuvants Market Dynamics Analysis Vaccine Adjuvants Market Assessment Vaccine Adjuvants Market Segmentation Vaccine Adjuvants Market Segmentation By Product Type: Oil-In-Water Emulsion, Aluminium Salts, Liposomes, Saponin-Based Adjuvants, and Others Vaccine Adjuvants Market Segmentation By Disease Type: Infectious Diseases, Cancer, and Others Vaccine Adjuvants Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the vaccine adjuvants market are set to emerge as the trendsetter explore @ Vaccine Adjuvants Companies Table of Contents Interested in knowing the vaccine adjuvants market by 2030? Click to get a snapshot of the Vaccine Adjuvants Market Trends Related Reports Vaccines Market Vaccines Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key vaccines companies, including GlaxoSmithKline, Bharat Biotech, AstraZeneca, Bavarian Nordic A/S, BioNTech, Sanofi, Merck & Co., Inc, Pfizer Inc, Moderna, Meiji Holdings Co., Ltd., EMERGENT, CSL Limited, Johnson & Johnson, VBI Vaccines Inc., Valneva SE., Novavax, CanSinoBIO, Biokangtai, Dynavax Technologies, Zhi Fei Biological, among others. 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– In June 2024, the Company announced groundbreaking pivotal study data for PRGN-2012 gene therapy at the 2024 ASCO annual meeting in which more than half of RRP patients achieved Complete Response – – In July 2024, the Company appointed Phil Tennant as Chief Commercial Officer to spearhead potential PRGN-2012 commercial launch – – In August 2024, the Company announced a strategic reprioritization of its pipeline to focus on advancement of its lead program, PRGN-2012 in RRP – – PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; the Company has initiated enrollment in the confirmatory clinical trial of PRGN-2012 – – In August 2024, the Company strengthened its cash position by raising approximately $31.4 million via a public offering of common stock – GERMANTOWN, Md., Aug. 14, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced second quarter and first half 2024 financial results and business updates. "We are all in on PRGN-2012 given the immense unmet need for RRP patients and our groundbreaking pivotal data supporting the potential of what we hope to be the first-ever FDA approved therapy to treat RRP," said Helen Sabzevari, PhD, President and CEO of Precigen. "By strategically focusing our portfolio, streamlining resources and recent public offering, we have optimized the company to rapidly prepare for submission of a rolling biologics license application under an accelerated approval pathway. We are excited to have initiated enrollment in the confirmatory clinical trial and will continue to accelerate our commercial readiness campaign for a potential launch in 2025 under the leadership of our newly hired Chief Commercial Officer. Additionally, we plan to maximize portfolio value by focusing on strategic partnerships to further advance our highly promising UltraCAR-T programs." "Our recent reprioritization and public offering is expected to fund our operations into early 2025 allowing us to focus on advancement of PRGN-2012 while continuing to explore potential non-dilutive financing opportunities for future liquidity," said Harry Thomasian Jr., CFO of Precigen. Key Program Highlights PRGN-2012 AdenoVerse® Gene Therapy in RRP: PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of recurrent respiratory papillomatosis (RRP). PRGN-2012 received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). PRGN-2012 also received Orphan Drug Designation from the FDA and Orphan Drug Designation from the European Commission. Results from the pivotal clinical study of PRGN-2012 for the treatment of RRP were presented at the 2024 American Society of Clinical Oncology (ASCO) annual meeting in a late-breaking oral presentation titled, "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients." Pivotal study met primary safety and efficacy endpoints. 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; Complete Responses have been durable beyond 12 months with median duration of follow up of 20 months as of the May 20, 2024 data cutoff. 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 (range: 3-10) pre-treatment to 0 (range: 0-7) post-treatment. PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2. PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders. PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders. A rolling Biologics License Application (BLA) submission under an accelerated approval pathway is anticipated in the second half of 2024. The Company has initiated enrollment in the confirmatory clinical trial, in accordance with the guidance from the FDA, prior to submission of the BLA. The Company and the Recurrent Respiratory Papillomatosis Foundation held the inaugural RRP Awareness Day on June 11, 2024. The multi-stakeholder event raised awareness by bringing together individuals living with RRP, caregivers, clinicians, and government officials. Strategic Prioritization: In August 2024, the Company announced a strategic prioritization of its clinical portfolio and associated streamlining of resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of PRGN-2012. PRGN-2009 AdenoVerse® Gene Therapy Clinical Trials The Company plans to continue PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer. PRGN-2009 cervical cancer clinical trial enrollment at non-NCI clinical sites will be paused. UltraCAR-T® Clinical Programs The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the FDA, and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps. The Company will pause the PRGN-3005 and PRGN-3007 clinical trials. The Company will minimize UltraCAR-T spend and focus on strategic partnerships to further advance UltraCAR-T programs. Preclinical Programs The Company will pause all preclinical programs. ActoBio The Company has initiated shutdown of its Belgium-based ActoBio subsidiary operations, including planned elimination of all ActoBio personnel. In conjunction with this shutdown, ActoBio's portfolio of intellectual property will be made available for prospective transactions. Financial Highlights Strategic prioritization resulted in non-cash impairment charges of $32.9 million, net of tax, in the second quarter and severance charges of $3.0 million, of which $2.1 million was recorded in the second quarter and $0.9 million is expected to be recorded in the third quarter. The Company closed a public offering of its common stock in August 2024, resulting in net proceeds of approximately $31.4 million. Second Quarter 2024 Financial Results Compared to Prior Year Period Research and development expenses increased $3.8 million, or 32%, compared to the three months ended June 30, 2023. Salaries, benefits, and other personnel costs increased $2.1 million primarily due to severance charges related to the shutdown of the Company's ActoBio subsidiary. Additionally, fees paid to contract research organizations related to the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to our manufacturing facility readiness for anticipated BLA submission increased compared to the same period in 2023. SG&A expenses increased by $1.0 million, or 11%, compared to the three months ended June 30, 2023. This increase was primarily driven by severance costs incurred related to the suspension of ActoBio operations of $0.4 million, increased costs associated with PRGN-2012 commercial readiness as well as increased professional fees incurred related to general corporate matters compared to the same period in 2023. In conjunction with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill and other noncurrent assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million. Total revenues decreased $1.1 million, or 59%, compared to the three months ended June 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar. Net loss was $58.8 million, or $(0.23) per basic and diluted share, compared to net loss of $20.3 million, or $(0.08) per basic and diluted share, in period ended June 30, 2023. First Half 2024 Financial Results Compared to Prior Year Period Research and development expenses increased $5.9 million, or 25%, compared to the six months ended June 30, 2023. Salaries, benefits, and other personnel costs increased by $3.3 million primarily due to $2.1 million of severance charges related to the shutdown of the Company's ActoBio subsidiary and an increase in the hiring of employees related to the advancement of PRGN-2012 in 2023 at Precigen. Additionally, fees paid to contract research organizations related to the start of the PRGN-2012 confirmatory clinical trial and close out of the PRGN-2012 pivotal clinical trial activities and professional fees incurred related to our manufacturing facility readiness for anticipated BLA submission increased compared to the prior year period. These increases were offset by lower costs incurred at contract research organizations for other programs compared to the same period in 2023. SG&A expenses decreased by $0.5 million, or 2%, compared to the six months ended June 30, 2023. This decrease was primarily due to lower stock compensation and insurance expenses in 2024 compared to the same period in 2023. These decreases were offset by severance costs incurred in the second quarter of 2024 related to the suspension of ActoBio's operations, and increased costs related to PRGN-2012 commercial readiness compared to the same period in 2023. In conjunction with the suspension of ActoBio's operations, the Company recorded $34.5 million of impairment charges related to goodwill and other noncurrent assets in the second quarter of 2024, as well as a related tax benefit of $1.7 million. Total revenues decreased $1.9 million, or 51%, compared to the six months ended June 30, 2023. This decrease was related to reductions in product and service revenues at Exemplar. Net loss was $82.5 million, or $(0.33) per basic and diluted share, compared to net loss of $43.1 million, or $(0.18) per basic and diluted share, in period ended June 30, 2023. Precigen: Advancing Medicine with Precision™ Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit or follow us on X @Precigen, LinkedIn or YouTube. Trademarks Precigen, UltraCAR-T, UltraPorator, AdenoVerse, UltraVector and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners. Cautionary Statement Regarding Forward-Looking Statements Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential 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 section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission. Investor Contact: Steven M. Harasym Vice President, Investor Relations Tel: +1 (301) 556-9850 [email protected] Media Contacts: Donelle M. Gregory [email protected] Glenn Silver Lazar-FINN Partners [email protected] SOURCE Precigen, Inc.