Welcome to the latest edition of the BioLines Weekender...

We look forward to seeing our Members on Thursday, February 4 for the first-ever BioNJ Board and Member ConnectionThis interactive Members-Only program is focused on providing our Members the opportunity to ENGAGE and discuss topics affecting the industry now. We'll start by welcoming BioNJ's next Chair of the Board and newest Board Members before hearing presentations by State representatives on New Jersey's Vaccine Rollout Plan and the newly announced New Jersey Economic Recovery Act
We'll end with a networking discussion allowing Members and Board Members to chat and make valuable connections! While this does not replace our traditional Annual Meeting and Innovation Celebration, we are hoping that it will kick off a much needed New Year in a meaningful way. Free to all current BioNJ Members, click here to register. 
Not yet a Member? Not a problem! Contact Kim Minton at KMinton@BioNJ.org to discuss how your organization can benefit from BioNJ Membership and how your Team can participate in this Members-Only event!

Because Patients Can't Wait®,
The BioNJ Team

P.S. As we continue to navigate COVID-19, we invite you to stay up to date on the latest information on vaccine approvals and distribution by visiting BioNJ's Online COVID-19 Vaccine Toolbox.
BioNJ Calendar

BioNJ Virtual IT/Cybersecurity Briefing
January 28, 2021
BioNJ Board & Member Virtual Meet Up

February 4, 2021
BioNJ BioPartnering Virtual Conference 
May 18 & 19, 2021
Click here for BioNJ's COVID-19 Vaccine Toolkit.

As the nation struggles to scale up its COVID-19 immunization rollout, another vaccine in the works could soon help bridge the gap. The two vaccines available now -- one by Pfizer/BioNTech and another by Moderna -- require two doses: a priming shot and then a booster three or four weeks later, depending on which company's injection you get. But another vaccine on the horizon -- developed by Johnson & Johnson -- would require only a single dose. It could be a game-changer for distribution.

Putting Patients First: The Value of Medical Innovation

In 2019, retail prescription medicine prices declined by 0.4%, on average, according to National Health Expenditures (NHE) data from the Centers for Medicare & Medicaid Services (CMS) published recently in Health Affairs. While retail prescription medicine spending grew 5.7% that same yearthis increase was due to more patients getting the medicines they need, not higher prices. 

While much of the talk about health care costs in the United States focus on prescription medicine spending, this overlooks the bigger picture of what's driving  health care spending growth. To address health care spending and affordability, we should focus on policies that lower patient out-of-pocket costs for medicines, address the true drivers of health care spending and ensure health coverage works when patients need it.

BioNJ in the News

With Joe Biden's victory in the U.S. presidential election -- and despite the fact that people across the globe have already received COVID-19 vaccines from Pfizer and Moderna -- the true impact on the biopharmaceutical industry will focus on a few highlights. They include collaboration with the U.S. Food & Drug Administration (FDA), providing affordable drugs to patients, innovation and venture capital investment. Obviously, the first priority will be to eliminate the current pandemic.

Debbie Hart, the president and CEO of BioNJ, a life sciences trade association in New Jersey, shared "We look forward to working with our Congressional delegation and the new Biden Administration to enact common sense reforms that both protect patient access and biopharmaceutical innovation and address the pandemic and other health challenges head on."

NJ Company News

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that it has treated the first patient in its Phase 2b FREEDOM trial of CLBS16 as a therapy for coronary microvascular dysfunction ("CMD") at The Christ Hospital Health Network in Cincinnati, Ohio. The 105-patient double-blind and placebo-controlled clinical trial is designed to further evaluate the efficacy and safety of intracoronary delivery of autologous CD34+ cells (CLBS16) in subjects with CMD and without obstructive coronary artery disease.

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise $25.0 million through the issuance of an aggregate 12,500,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 6,250,000 shares of common stock, at a purchase price of $2.00 per share of common stock (or common stock equivalent in lieu thereof) and associated warrant in a private placement priced at-the-market under Nasdaq rules.

Iselin-based BioNJ Member Helsinn announces the first patient has been dosed in a Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities. TAS0953/HM06 is an investigational oral treatment which inhibits several RET abnormalities identified as oncogenic driver alterations in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. This innovative drug candidate offers several differentiating features as compared to other RET inhibitors. The study will be initially conducted at sites in U.S. and Japan. 

Florham Park-based BioNJ Member Celularity Inc., announced it has signed a definitive merger agreement with GX Acquisition Corp. that will see it become a publicly traded entity. The deal will see GX, a special purpose acquisition company, be renamed Celularity Inc. and trade on the Nasdaq under the new symbols "CELU" and "CELUW." The transaction is expected to close in the second quarter, and the company will remain under the leadership of Celularity's current management team, led by Dr. Robert J. Hariri, founder, chairperson and CEO.

Pennington-based BioNJ Member OncoSec Medical Incorporated announced it entered into an agreement with Sirtex Medical, Inc. (Sirtex) granting Sirtex an option to non-exclusively co-promote the Company's lead product candidate, TAVO™ (tavokinogene telseplasmid) in anti-PD-1 checkpoint refractory metastatic melanoma in the U.S. By entering into this co-promotion, OncoSec intends to capitalize on both the extensive experience Sirtex has in marketing drug/device combination products, as well as their established oncology sales force in the U.S. Under the terms of the agreement, Sirtex will pay OncoSec $5 million for a non-exclusive option to co-promote TAVO in combination with KEYTRUDA® in patients with anti-PD-1 checkpoint refractory metastatic melanoma in the U.S.

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced the launch of the seventh annual STRIVE Awards program for Duchenne muscular dystrophy. The Awards provide a grant to patient advocacy organizations around the world who are committed to developing innovative and sustaining programs that help address the unmet needs of the rare disease community. This year, a new entry category dedicated to supporting programs that focus on the transition of those living with Duchenne from adolescence to adulthood has been introduced.

Princeton-based BioNJ Member Advaxis, Inc. announced that the company has received the first milestone payment related to its licensing agreement for ADXS31-164, now known as OST-HER2, to OS Therapies for evaluation in the treatment of osteosarcoma in humans. Under the terms of the amended and restated license agreement, OS Therapies, in collaboration with the Children's Oncology Group (COG)1, is responsible for the conduct and funding of a clinical study evaluating OST-HER2 in recurrent, completely resected osteosarcoma.

Plainsboro-based BioNJ Member Novo Nordisk announced the submission of a label expansion application to the US Food and Drug Administration (FDA) for the existing marketing authorisation for Ozempic®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg. Ozempic® is currently approved in the US in 0.5 mg and 1.0 mg doses for the treatment of type 2 diabetes in adults and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. The submission follows the application on 29 December 2020 for label extension to the European Medicines Agency (EMA).

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma America and and Aquestive Therapeutics, Inc. announced a licensing and supply deal for the U.S. rights to commercialize EXSERVAN (riluzole), an oral film formulation of riluzole for the treatment of amyotrophic lateral sclerosis (ALS).  As a result of the deal, MTPA will commercialize EXSERVAN in the U.S. Aquestive will serve as the exclusive sole manufacturer and supplier for the product. MTPA plans to make EXSERVAN available to patients in the middle of 2021.

Princeton-based BioNJ Member Genmab A/S announced that it has reached the first milestone in its collaboration with AbbVie. A USD 40 million milestone payment was triggered by the first patient dosed in the Phase 3 study of subcutaneous epcoritamab versus investigator's choice of chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). "We are very pleased that the first Phase 3 study of epcoritamab has been activated at multiple clinical sites and the first cancer patient has been dosed," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced Interim Phase 1/2a data were published in the New England Journal of Medicine demonstrating that the company's single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. The Phase 1/2a interim analysis showed that the company's COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.

New Brunswick-based BioNJ Member The Johnson & Johnson Medical Devices Companies announced that DePuy Synthes has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VELYS™ Robotic-Assisted Solution designed for use with the ATTUNE® Total Knee System and its cleared indications for use. It will become part of the broader VELYS Digital Surgery Platform of connected technologies. With a growing and aging patient population, demand for joint replacement surgery is increasing. But across the industry, data shows up to 20% of knee replacement patients aren't satisfied with the outcome of their surgery.

Bridgewater-based BioNJ Member Eli Lilly and Company announced the successful completion of its acquisition of Prevail Therapeutics Inc. The acquisition establishes a new modality for drug discovery and development at Lilly, extending Lilly's research efforts through the creation of a gene therapy program that will be anchored by Prevail's portfolio of clinical-stage and preclinical neuroscience assets. "We are pleased to complete the acquisition of Prevail and establish a gene therapy program at Lilly that has the potential to deliver transformative treatments for patients with neurodegenerative diseases such as Parkinson's, Gaucher and dementia," said Mark Mintun, M.D., Vice President of Pain and Neurodegeneration Research at Lilly.

Bridgewater-based BioNJ Member Eli Lilly and Company announced that Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. The Phase 3 BLAZE-2 COVID-19 prevention trial - conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) - enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the U.S.

Bridgewater-based BioNJ Member Eli Lilly and Company and Boehringer Ingelheim announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes.

Bridgewater-based BioNJ Member Eli Lilly and Company announced Donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo in results from Eli Lilly and company's Phase 2 TRAILBLAZER-ALZ study. Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant. 

Bridgewater-based BioNJ Member Eli Lilly and Company announced Loxo Oncology at Lilly and Merus N.V. announced a research collaboration and exclusive license agreement that will leverage Merus' proprietary Biclonics® platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies. Under the terms of the agreement, Merus will lead discovery and early stage research activities while Loxo Oncology at Lilly will be responsible for additional research, development and commercialization activities. 

BioNJ Member Pfizer, with offices in Peapack, and BioNTechSE announced results f rom an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage or VOC 202012/01. The results were published on the preprint server b ioRxiv and submitted to a peer-reviewed journal.

BioNJ Member Pfizer, with offices in Peapackannounced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people.

BioNJ Member Pfizer, with offices in Peapackand BioNTech SE announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published on the preprint server bioRxiv and are available hereRapidly spreading variants of SARS-CoV-2 have been reported, initially in the United Kingdom and South Africa. These variants have multiple mutations in their spike or S glycoproteins, which are key targets of virus neutralizing antibodies.

BioNJ Member Pfizer, with offices in Peapackannounced that, during the second half of 2020, it invested a total of $120 million in four clinical-stage biotech companies as part of the Pfizer Breakthrough Growth Initiative (PBGI). Through PBGI, Pfizer is investing up to $500 million in biotechnology companies, providing funding and access to Pfizer's scientific expertise to help ensure the continuity of promising clinical development programs of potential future strategic interest to Pfizer.

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved VERQUVO, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The approval of VERQUVO by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. 

Kenilworth-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck's investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

Bridgewater-based BioNJ Member Sanofi chooses EUROAPI as the name for the future leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API). EUROAPI will represent the "made in Europe" API state-of-the-art industrial capabilities and technologies, with approximately €1 billion in expected sales by 2022. It will rank number 1 in small molecules API, and number 2 on the global API market2. Addressing recent increasing medicine shortages that critically impact patient care, EUROAPI will ensure additional API supply capacities for Europe and beyond, and help balancing the industry's heavy reliance on API sourced from other regions.

Bridgewater-based BioNJ Member Sanofi and Kymab have entered into an agreement under which Sanofi will acquire Kymab for an upfront payment of approximately $1.1 billion and up to $350 million upon achievement of certain milestones. The transaction will result in Sanofi having full global rights to KY1005, a fully human monoclonal antibody that has a novel mechanism of action. KY1005 binds to OX40-Ligand and has the potential to treat a wide variety of immune-mediated diseases and inflammatory disorders.

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment. CSU is an unpredictable and severe disease of the skin, affecting 0.5-1% of the global population at any time. It is characterized by the development of itchy, painful wheals (hives), swelling (angioedema), or both, lasting for at least 6 weeks and occurring with no known cause

East Hanover-based BioNJ Member Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field. Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Basking Ridge-based Daiichi Sankyo Company, Limited and AstraZeneca's ENHERTU®  has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. "This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting and it has the potential to become the new standard of care for this patient population," said Ronan Kelly, M.D., MBA, Director of the Charles A. Sammons Cancer Center and the W.W. Caruth, Jr. Chair of Immunology at Baylor University Medical Center.

Basking Ridge-based Daiichi Sankyo Company, Limited and AstraZeneca's ENHERTU® (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. Approval by the European Commission of ENHERTU on was based on positive results from the single arm, pivotal phase 2 DESTINY-Breast01 trial. 

Lipocine Inc., with offices in  Lawrence Township, announced positive topline results from its LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study (NCT04134091), investigating LPCN 1144 in biopsy-confirmed non-cirrhotic non-alcoholic steatohepatitis ("NASH") male subjects. Currently, there are no approved treatments for NASH, a silent killer that affects ~30 million Americans. LPCN 1144 is an oral prodrug of endogenous testosterone. In the ongoing randomized, double-blind, placebo-controlled 36-week treatment LiFT study, subjects with F1-F3 fibrosis were randomized 1:1:1 to one of three arms (Treatment A is a twice daily oral dose of 142 mg testosterone equivalent, Treatment B is a twice daily oral dose of 142 mg testosterone equivalent formulated with 217 mg of d-alpha tocopherol equivalent and the third arm is twice daily matching placebo). 

Florham Park-based Cellectar Biosciences, Inc. announced the initiation of a pivotal trial for CLR 131 in Waldenstrom's macroglobulinemia (WM). The pivotal trial is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131. This design is in alignment with the feedback received from the U.S. Food and Drug Administration (FDA) during the guidance meeting held in September 2020. The study will enroll 50 WM patients who have failed first-line therapy and have failed to respond to, or have progressed while on treatment with a BTK inhibitor (i.e. ibrutinib).

Florham Park-based Phathom Pharmaceuticals, Inc. announced that it has completed patient enrollment in PHALCON-HP, a pivotal Phase 3 clinical trial of vonoprazan in combination with amoxicillin (vonoprazan dual therapy) and vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) for the eradication of H. pylori infection. Phathom continues to expect topline results from the study in the second quarter of 2021. PHALCON-HP is a randomized, multicenter, Phase 3 trial that has enrolled over 1,000 patients with H. pylori infection.

Paramus-based BrainStorm Cell Therapeutics Inc. announced the peer-reviewed publication of a preclinical study in the journal Stem Cell and Research Therapy. The study, entitled "MSC-NTF (NurOwn®) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model," evaluated the use of NurOwn® (MSC-NTF cell) derived exosomes in a mouse model of acute respiratory distress syndrome (ARDS). ARDS is a type of respiratory failure that is frequently associated with COVID-19 and mediated by dysregulated cytokine production. 

Bridgewater-based Amneal Pharmaceuticals, Inc. announced that it has received approval of an additional strength of 500 mg to its Abbreviated New Drug Application (ANDA), from the U.S. Food and Drug Administration (FDA) for Abiraterone Acetate Tablets, USP, 250 mg and 500 mg. This ANDA is approved for its use in combination with Prednisone. Abiraterone Acetate Tablets, USP, 250 mg and 500 mg, are the generic version of Zytiga® for treatment of metastatic prostate cancer. Amneal immediately initiated commercialization activities upon the approval of the additional 500 mg strength.

Bridgewater-based Amneal Pharmaceuticals, Inc. and Kashiv BioSciences LLC announced they have entered into a definitive agreement under which Amneal Pharmaceuticals LLC will acquire a 98% interest in Kashiv Specialty Pharmaceuticals, LLC"The acquisition of Kashiv Specialty aligns strongly with our Amneal 2.0 growth strategy which we expect will deliver substantial value for our Specialty and Generics businesses," said Chirag Patel, Co-Chief Executive Officer. "With this acquisition, Amneal will gain an exciting pipeline of valuable 505(b)2 branded products primarily in neurology and endocrinology, where we have a well-established commercial infrastructure, as well as a valuable pipeline of complex generics."

Princeton-based UroGen Pharma Ltd. announced a strategic three-year collaboration agreement to advance combinatorial intravesical immunotherapy, which is delivered directly into the bladder, for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC). UroGen's approach involves the local delivery of potent immunomodulators (UGN-201, a TLR 7/8 agonist and UGN-301, an anti-CTLA-4 antibody). UGN-301, an immune checkpoint inhibitor, is delivered using UroGen's proprietary RTGel™ platform to increase dwell time, which has been shown to significantly improve the effectiveness of intravesical therapy.

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals. The government has said it will provide these doses at no cost to patients, though health care facilities may charge fees related to administration. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, up to 1.25 million doses.

Visikol, which moved from Whitehouse Station to Hampton last year, has now expanded its laboratory space. The health care imaging technology company said that it is adding 2,000 square feet to the 6,500 square feet of lab and office space it has in Hampton, giving it more room for growth. Visikol noted that it had a strong year in 2020, growing revenue by more than 50% and launching several new assays and capabilities. The new space will include cell culture and high content imaging to support the company's advanced in vitro assays. The company hopes to double its staff and operations in the next two years.

Eisai Inc. is relocating its U.S. headquarters from Woodcliff Lake to the ON3 complex in Nutley, choosing SJP Project Solutions to lead the buildout of its new location. Eisai, which focuses on oncology and neurology, will occupy the entirety of the 200 Metro Blvd. building at the former Hoffmann-La Roche campus in Clifton and Nutley, with occupancy expected in the fourth quarter. Eisai signed a lease in August for 300,000 square feet at the campus. "Continued and constant growth of the health care ecosystem is essential during these challenging times," said Joel Beetsch, Vice President of Corporate Affairs at Eisai.

Princeton-based Integra LifeSciences Holdings Corp. has completed its previously announced $300 million-plus acquisition of ACell Inc"Acquiring ACell and its proprietary MatriStem UBM technologies will enable Integra to provide more comprehensive complex wound management solutions to address our customers' most pressing clinical challenges," said CEO and President Peter Arduini.

Raritan-based Ortho Clinical Diagnostics Holdings PLC has announced the details of its initial public offering, which could be worth more than $1.6 billion. Ortho said in a news release that it is offering 70 million ordinary shares at a price between $20 and $23 per share, producing a range of $1.4 billion to $1.61 billion if all shares are sold in range. The stock would be listed on the Nasdaq Stock Market under the symbol "OCDX." Underwriters would have a 30-day option to purchase up to 10.5 million additional shares. It intends to use net proceeds from the IPO to pay down debt, for working capital and other purposes.

People in the News

Dr. Andrew Pecora, CEO of Outcomes Matter Innovations LLC, has added the role of executive chairman to his duties, the company announced this week. Dr. Pecora, who became CEO of Jersey City-based OMI in May 2019, has led the company through a period of rapid growth tied to its value-based care line of business, as well as overseeing the overall development of its point-of-care technology. "Dr. Pecora continues to be a transformative force in health care," Dr. Andrew Jennis, a board member, said in a prepared statement.

Bridgewater-based BioNJ Member Eli Lilly and Company announced the Board of Directors has elected Gabrielle Sulzberger as a new member, effective January 25, 2021. As a member of Lilly's board, she will serve on both the Audit Committee and the Ethics and Compliance Committee. Ms. Sulzberger is a strategic advisor to Two Sigma Impact, a private equity firm that combines active, principled ownership and data science, with the goal of achieving superior returns and positive social outcomes.

Institution and Education News

The Institute for Life Science Entrepreneurship (ILSE) at Kean University has created Biotech LaunchPad, a comprehensive suite of business and scientific services to support the commercial success of life sciences start-ups. This new resource for scientists, clinicians and entrepreneurs gives early stage life sciences companies flexibility in choosing services to support their growth and development. "Start-ups face many challenges, particularly for first-time founders who have to navigate a life sciences product through unknown waters," said Thomas Richardson, Ph.D., President of ILSE. "Biotech LaunchPad's custom-fit support and services are tailored to the level of expertise and know-how of the founding team. We have taken start-ups to the next level, including funding, product development and team building." 

A life sciences company born from Princeton laboratory research has received a National Science Foundation (NSF) small business technology transfer (STTR) grant for their technology, which can help create a more robust, versatile and potent COVID-19 vaccine. Optimeos Life Sciences was founded by Keller Center faculty member Shahram Hejazi and Chemical and Biological Engineering Professor Robert Prud'homme. The proposal entitled Formulation of a COVID-19 mRNA Vaccine by Inverse Flash NanoPrecipitation was based on research developed over a 20 year period in Prud'homme's laboratory.

Funding News

The New Jersey Commission on Science, Innovation and Technology (CSIT) announced that it will launch its Clean Tech Seed Grant Program next month. The program will help accelerate development and innovation of clean technologies by furthering research and development (R&D) within the Garden State's clean technology startup community. CSIT developed the program in coordination with the New Jersey Board of Public Utilities (NJBPU) and the New Jersey Economic Development Authority (NJEDA). The application will be available at http://www.njeda.com/csit

Venture Capital investment set records in 2020. Early stage investment hit a trough in Q2, but swift action by the angel community and tailwind opportunities created by COVID-19 fueled a rebound in Q3 and Q4. Locally, 2020 was a banner year for Keiretsu Forum's Mid-Atlantic (K4-MA) and South-East (K4-SE) Regions booking record growth. U.S. Venture Capital investing set records in 2020, surpassing surprising performance in 2018 (PitchBook Venture Monitor). Investors deployed just over $156B and liquidated over $290B in exit value, with massive exits happening in Q3 and Q4. 

Special Programs from Our Partners for BioNJ Members

January 27, 2021

Opportunities in Neuroscience will feature three panel sessions to discuss the opportunities and challenges in neuroscience. This event seeks to begin building a more robust regional neuroscience ecosystem to spur collaborations and speed technology commercialization.

February 2, 2021

With the news that the UK Government has authorized the emergency use of the Oxford-AstraZeneca COVID-19 vaccine, and the commencement of the roll-out program throughout the UK, OBN invites you to attend an "CEO Interview with Professor Adrian Hill, Director of Oxford's Jenner Institute on Tuesday, February 2.

February 16-19, 2021

This online virtual training course will provide a detailed understanding in upstream and downstream processing of viral vectors used in cell and gene therapy. The course will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics. The course is intended for scientists and engineers from the biopharma industry interested in learning about upstream and downstream processing of viral vectors. Click here for more information.

March 15-17, 2021

Take advantage of this unique opportunity for professionals to make connections, start collaborations and forge partnerships in North America's life sciences and health technology hub. The agenda co-created by the organizing committee is aimed at entrepreneurs, scientists, researchers, students, investors and life sciences and health technology professionals in Canada and abroad. 

BioNJ Member Services Provider Directory

BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:

The NJBAC is a state agency offering free and confidential assistance to help your business grow. As a "one-stop shop," NJBAC can help businesses of all sizes and types manage the state's regulatory processes, boost exports, gain access to financial resources where applicable and tackle other obstacles along the way. You can download the NJBAC guide by clicking here or contact their business advocates at 1-800 JERSEY 7.

Please contact BioNJ at BioNJ@BioNJ.org 
or call 609-890-3185 with any questions.