Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, announced that it has executed a securities purchase agreement to raise gross proceeds of $150 million resulting from the sale of 24,115,755 shares through a private investment in public equity (PIPE) financing at a price of $6.22 per share. The financing attracted several existing and new investors with expertise in healthcare, including RA Capital Management, Avidity Partners, Casdin Capital, Farallon Capital, and Surveyor Capital (a Citadel company), among others.

The Company intends to use the net proceeds from the offering to support its growing commercial capabilities, including the launch of Libmeldy^TM in Europe, advance its regulatory and clinical development activities and expand its hematopoietic stem cell (HSC) gene therapy approach into larger indications, as well as for general corporate purposes.

“The updates we made to our strategy in 2020 have allowed us to focus on successfully achieving a number of important milestones over the past few quarters, including the approval of Libmeldy in Europe and clearing an IND and receiving RMAT designation for OTL-200 for MLD in the U.S.,” said Frank Thomas, president and chief operating officer. “We look forward to building on this strong execution with the support of a strategic group of investors who recognize the potential of HSC gene therapy to address genetic diseases with high unmet need, including conditions such as MPS-I and MPS-IIIA, with new data on our related clinical programs at the WORLDSymposium next week.”

The financing is anticipated to close on February 9, 2021, subject to customary closing conditions. Cowen acted as lead placement agent, and Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. acted as co-placement agents.

The securities are being sold in a private placement and have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission, for purposes of registering the resale of the ordinary shares issued or issuable in connection with the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Source: Orchard Therapeutics (Press release)

Invest-NL is verheugd met het financieren van de innovatieve, snelgroeiende scale-up Protix. Het is de eerste transactie van Invest-NL die een directe bijdrage levert aan de eiwittransitie in de AgriFood sector.

Protix kweekt insecten voor de winning van duurzame eiwitten en vetten uit larven van de “Black Soldier Fly”. Deze eiwitten en vetten worden door de afnemers van Protix gebruikt als grondstof in diervoeding en visvoer, en zijn een aantrekkelijk en duurzamer ingrediënt dan bijvoorbeeld soja, vismeel en palmolie.

Als onderdeel van een investeringsronde van € 15,5 miljoen investeert Invest-NL € 7,5 miljoen in de vorm van een converteerbare lening. Naast Invest-NL zijn ook de huidige aandeelhouders van Protix bij de transactie betrokken; geleid door Aqua-Spark, Rabo Corporate Investments en de Brabantse Ontwikkelings Maatschappij. Met deze financieringsronde kan Protix haar productiecapaciteit verder optimaliseren en zich voorbereiden op de verdere internationale expansie.

Het financieren van Protix sluit goed aan bij de focus op de CO2 neutrale transitie en innovatieve, snelgroeiende bedrijven die leidend is in de investeringsstrategie van Invest-NL. Wouter Bos (CEO Invest-NL) over de Protix transactie: “Ik ben verheugd dat we Protix kunnen ondersteunen in het versterken van haar internationale toppositie in de snelgroeiende markt voor ‘Insect based ingredients’. Ook vind ik het positief dat we deze transactie samen met het Europees Investeringsfonds (EIF) tot stand brengen. Met de ‘InnovFin SME guarantee’ die we recent met het EIF zijn overeengekomen kunnen innovatieve, snelgroeiende bedrijven met behulp van Europese investeringsgelden nog sneller opschalen”.

“Protix is geboren uit innovatie met een focus op positieve milieu-impact. Wij zijn de grondlegger van een geheel nieuwe categorie aan eiwitten en andere voedingsstoffen en de briljante collega’s bij Protix werken daar dag en nacht aan.” vertelt Kees Aarts, oprichter en CEO van Protix. “Dit is wederom een mooie stap in de uitbreiding van ons leiderschap en er zullen er nog vele volgen in de komende periode”.

Bron: Invest-NL (Persbericht)

 Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS), a clinical-stage oncology company developing multi-specific antibodies, today 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. Merus will receive an upfront cash payment of $40 million, as well as an equity investment by Lilly of $20 million in Merus common shares. Merus is also eligible to receive up to $540 million in potential development and commercialization milestones per product, for a total of up to approximately $1.6 billion for three products, as well as tiered royalties ranging from the mid-single to low-double digits on product sales should Lilly successfully commercialize a therapy from the collaboration.

“CD3-engaging bispecific antibodies are rapidly becoming one of the most transformative immune-modulating modalities used to treat cancer. We expect these therapies will become an important component of the Loxo Oncology at Lilly biologics strategy,” said Jacob Van Naarden, chief operating officer of Loxo Oncology at Lilly. “Merus has built a differentiated platform and one that we believe can enable us to create bispecific antibody therapies with wider therapeutic indexes than those available today. We look forward to working closely with Merus to develop new potential medicines for patients with cancer.”

“The collaboration with Loxo Oncology at Lilly and their world class research capabilities opens up exciting possibilities for Merus’ Biclonics^® platform,” said Bill Lundberg, MD., President and Chief Executive Officer at Merus. “Our CD3 T-cell engager platform includes over 175 novel and diverse anti-CD3 common light chain antibodies across a wide range of affinities and attributes and enables functional screening of large libraries for optimal performance. We look forward to working together with Loxo Oncology at Lilly to define a new generation of medicines to treat cancer.” 

This transaction is subject to customary closing conditions. This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.

Source: Merus (Press release)

NewAmsterdam Pharma (NAP), a clinical stage company focused on the research and development of transformative therapies for cardio-metabolic diseases, today announced completion of a $196M (€160M) Series A funding round.

The financing will support the full Phase 3 development of its ApoB and LDL-c lowering small molecule drug, obicetrapib. The drug, a cholesteryl ester transfer protein (CETP) inhibitor, is being developed for patients who are not well-controlled on statins.

Forbion, NAP’s founding investor, was joined by Morningside Ventures and Ascendant BioCapital as co-lead investors in the Series A financing. Also participating in this funding round were Kaiser Foundation Hospitals, BVF Partners L.P., Population Health Partners, LSP Dementia Fund, Peter Thiel, Janus Henderson Investors, Medpace, GL Capital, JVC Investment Partners, and Presight Capital.  

“This is an important milestone in the advancement of obicetrapib and the growth of NewAmsterdam Pharma,” said Michael Davidson, MD, chief executive officer of NewAmsterdam Pharma. “The tremendous support of our investors allows us to initiate a large, Phase 3 development program as we work to create a new option for the millions of high cardiovascular risks patients globally who, despite maximally tolerated statin therapy, require additional LDL-c lowering options.”

“Effectively inhibiting CETP to reduce atherosclerotic risk in patients is something Dr. Davidson and I have been endeavoring to achieve in our field of research for more than two decades,” said John Kastelein, MD, PhD, FESC, chief scientific officer of NewAmsterdam Pharma. “Long term follow up from the 2017 REVEAL study validated CETP as a target to lower LDL-c and reduce major adverse cardiac events (MACE).¹ We believe that in obicetrapib, based on clinical studies to date, we have a molecule which is well tolerated and has not shown any of the safety issues of previous CETP inhibitors. Furthermore, based on the surrogate endpoints of the REVEAL study, obicetrapib was shown to be more effective at lowering LDL-c at a 5 mg dose in comparison to a 100 mg dose of anacetrapib.”

“We are very pleased to support the development of obicetrapib and contribute to the success of NAP,” said Jason Dinges of Morningside. “We believe that obicetrapib has a unique efficacy and safety profile that will further demonstrate not only a potent LDL-c lowering ability but other key attributes which could potentially benefit the large and underserved number of patients at risk of cardiovascular disease. We have confidence in the deep expertise and proven track record of Dr. Davidson and Dr. Kastelein to deliver these results.”

“Cardiovascular disease remains the leading cause of disability-adjusted life years globally, and tens of millions of patients struggle to reach LDL-c goals on current therapies, demonstrating a clear need for novel agents,” said Gaurav Gupta, MD of Ascendant BioCapital. “CETP-silencing mutations correspond to lower cardiovascular risk, and given the potent pharmacology demonstrated in the TULIP study², we expect obicetrapib to become a significant part of the treatment paradigm for dyslipidemia globally.”

Two Phase 2b clinical trials for obicetrapib are underway with targeted completion in Q2 2021. NAP is looking to initiate Phase 3 clinical trials in Q4 2021.

Source: NewAmsterdam Pharma (Press release)

Read more: https://fd.nl/ondernemen/1385332/biotechbedrijf-dezima-maakt-doorstart-met-160-mln