– One of the biggest non-public financings of a UK biotech firm, and the biggest from a single supply – continues Blackstone conviction within the nation
– Durability and favorable toxicity profile of obe-cel helps its potential as the primary stand-alone remedy in grownup ALL with healing potential in a final line setting
– Blackstone strategic financing to allow Autolus to finish scientific growth of obe-cel in its first indication of relapsed / refractory grownup ALL and to assist preliminary pre-approval industrial actions
LONDON and CAMBRIDGE, Mass., Nov. 08, 2021 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical firm growing next-generation programmed T cell therapies, and Blackstone Life Sciences right this moment introduced that the 2 corporations have entered right into a strategic collaboration and financing settlement underneath which funds managed by Blackstone (NYSE: BX) will present as much as $250 million in fairness and product financing to assist Autolus’ development of its CD19 CAR T cell investigational remedy product candidate, obecabtagene autoleucel (obe-cel), in addition to subsequent technology product therapies of obe-cel in B-cell malignancies.
As a part of this $250 million transaction, Blackstone is committing to take a position $150 million in product financing to assist obe-cel growth and commercialization, with $50 million payable upon closing of the transaction and the rest payable based mostly on sure growth and regulatory achievements. Blackstone has additionally agreed to buy $100 million of Autolus’ American Depositary Shares (ADS) in a non-public placement, which is topic to customary closing circumstances. In reference to the collaboration, Blackstone acquired the best to appoint a member to Autolus’ board of administrators.
The transaction continues Blackstone’s dedication to the UK economic system which has seen the agency make investments greater than $18 billion throughout 44 investments headquartered in UK. These investments assist greater than 27,000 direct jobs and assist make Blackstone the UK’s largest overseas investor over the previous 10 years.
“Autolus is a world-class firm with an revolutionary platform and the potential to ship best-in-class, lifesaving remedies to sufferers affected by most cancers,” mentioned Dr. Nicholas Galakatos, Global Head of Blackstone Life Sciences. “Our funding in these subsequent technology cell therapies exemplify our conviction within the high quality and promise of the life sciences sector within the UK. We stay up for constructing on this funding within the years to come back.”
“We welcome Blackstone Life Sciences to hitch our drive to vary the outlook for leukemia and lymphoma sufferers, notably these with acute lymphoblastic leukemia. Blackstone’s funding and experience will assist the event and preparation for commercialization of obe-cel and put this system and the Company on a robust monetary footing as we’re approaching the read-out from the possibly pivotal FELIX scientific trial in the course of the course of 2022,” mentioned Dr. Christian Itin, Chief Executive Officer of Autolus.
“We are excited to collaborate with Autolus in assist of their revolutionary platform pursuing safer, extra sturdy, therapies with the potential to be lifesaving choices for sufferers with ALL and past. We see a big alternative to enhance the outlook for most cancers sufferers who’re going through a devastating course of their illness,” mentioned Nicholas Simon, Senior Managing Director of Blackstone Life Sciences. “This funding continues to construct on our conviction in not simply revolutionary cell and gene therapies, but additionally supporting innovation within the United Kingdom and Europe broadly.”
UK Science Minister George Freeman mentioned: “This is one other vote of confidence within the high quality of life science within the UK, reinforcing our fame as a world chief in discovering new cures for presently untreatable illnesses like Autolus’ T cell remedy medication for leukemia. Big investments like these give actual hope to these affected by illnesses like leukemia – and create excessive talent jobs & alternatives within the growth and manufacturing of remedies to assist develop and enhance our life science clusters throughout the UK.”
Autolus not too long ago introduced plans to construct a devoted manufacturing facility in Stevenage, UK to assist safe world industrial launch capability for obe-cel with a 70,000 sq. foot constructing. The ground-breaking ceremony for this new facility is because of be held right this moment, with constructing works commencing imminently.
Moelis & Company LLC acted as monetary advisor. Cooley LLP and Cooley (UK) LLP acted as authorized advisor to Autolus, and Goodwin Procter LLP acted as authorized advisor to Blackstone.
About the Transaction
The strategic financing collaboration by Autolus and Blackstone Life Sciences is predicted to assist the event and preparation for commercialization of Autolus’ product candidate, obe-cel. As a part of this $250 million transaction, Blackstone is committing to take a position an combination of $150 million in product financing to assist Autolus’ growth and potential commercialization of obe-cel, with $50 million payable upon closing of the transaction and the rest (as much as $100 million) payable based mostly on sure growth and regulatory achievements. In return for this strategic funding, Autolus has agreed to pay Blackstone a capped single digit royalty plus milestone funds based mostly on internet gross sales of obe‐cel. In addition, Blackstone will obtain a warrant to buy as much as $24 million price of Autolus ADSs at an train value premium to market. Blackstone has additionally agreed to make a $100 million fairness funding in Autolus which is predicted to shut on or about November 12, 2021, topic to customary closing circumstances. In reference to the collaboration, Blackstone acquired the best to appoint a member to Autolus’ board of administrators.
About Autolus Therapeutics plc
Autolus is a clinical-stage biopharmaceutical firm growing next-generation, programmed T cell therapies for the therapy of most cancers. Using a broad suite of proprietary and modular T cell programming applied sciences, the Company is engineering exactly focused, managed and extremely lively T cell therapies which can be designed to higher acknowledge most cancers cells, break down their protection mechanisms and get rid of these cells. Autolus has a pipeline of product candidates in growth for the therapy of hematological malignancies and stable tumors. For extra info, please go to www.autolus.com.
About obe-cel (obecabtagene autoleucel)
Obe-cel is a CD19 CAR T cell investigational remedy designed to beat the constraints in scientific exercise and security in comparison with present CD19 CAR T cell therapies. Designed to have a quick goal binding off-rate to reduce extreme activation of the programmed T cells, obe-cel could cut back toxicity and be much less susceptible to T cell exhaustion, which may improve persistence and enhance the power of the programmed T cells to have interaction in serial killing of goal most cancers cells. Obe-cel is presently being evaluated in a probably pivotal Phase 1b/2 scientific trial for the therapy of grownup ALL, known as the FELIX scientific trial. Also, in collaboration with Autolus’ educational associate, UCL, obe-cel is presently being evaluated in a Phase 1 scientific trial in B-NHL.
About obe-cel FELIX scientific trial
Autolus’ Phase 1b/2 scientific trial of obe-cel, or the FELIX scientific trial, is enrolling grownup sufferers with relapsed / refractory ALL. The trial had a brief Phase 1b part previous to continuing to a single arm, Phase 2 scientific trial. The major endpoint is general response charge, and the important thing secondary endpoints embody length of response, MRD detrimental CR charge and security. The trial is designed to enroll roughly 100 sufferers throughout 30 of the main educational and non-academic facilities within the United States, United Kingdom and Europe. [NCT04404660]
About Blackstone Life Sciences Blackstone Life Sciences is an industry-leading non-public funding platform with capabilities to take a position throughout the life cycle of corporations and merchandise inside the important thing life science sectors. By combining scale investments and hands-on operational management, Blackstone Life Sciences helps carry to market promising new medicines and medical applied sciences that enhance sufferers’ lives. More info is offered at https://www.blackstone.com/our-businesses/life-sciences/.
This press launch accommodates forward-looking statements throughout the which means of the “secure harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that aren’t historic details, and in some instances might be recognized by phrases akin to “could,” “will,” “may,” “expects,” “plans,” “anticipates,” and “believes.” These statements embody, however usually are not restricted to, statements concerning the collaboration between Autolus and Blackstone; the long run scientific growth, efficacy, security and therapeutic potential of obe-cel, together with progress, expectations as to the reporting of information, conduct and timing and potential future scientific exercise; the power of the FELIX trial to be a registrational trial; the receipt of regulatory approval from the U.S. Food and Drug Administration for obe-cel; the invention, growth and potential commercialization of potential product candidates together with obe-cel utilizing Autolus’ know-how and underneath the collaboration settlement; the therapeutic potential for Autolus in subsequent technology product developments of obe-cel in B-cell malignancies; the potential and timing to obtain milestone funds and pay royalties underneath the strategic collaboration; expectations concerning the anticipated use of proceeds from the collaboration and financing association with Blackstone; and the completion of the providing of Autolus securities. Any forward-looking statements are based mostly on administration’s present views and assumptions and contain dangers and uncertainties that would trigger precise outcomes, efficiency, or occasions to vary materially from these expressed or implied in such statements. These dangers and uncertainties embody, however usually are not restricted to, the dangers that Autolus’ preclinical or scientific packages don’t advance or end in authorised merchandise on a well timed or price efficient foundation or in any respect; the outcomes of early scientific trials usually are not at all times being predictive of future outcomes; the fee, timing and outcomes of scientific trials; that many product candidates don’t grow to be authorised medication on a well timed or price efficient foundation or in any respect; the power to enroll sufferers in scientific trials; potential security and efficacy considerations; and the affect of the continued COVID-19 pandemic on Autolus’ enterprise. For a dialogue of different dangers and uncertainties, and different necessary components, any of which may trigger Autolus’ precise outcomes to vary from these contained within the forward-looking statements, see the part titled “Risk Factors” in Autolus’ Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 4, 2021, in addition to discussions of potential dangers, uncertainties, and different necessary components in Autolus’ subsequent filings with the Securities and Exchange Commission together with its Reports on Form 6-Okay. All info on this press launch is as of the date of the discharge, and Autolus undertakes no obligation to publicly replace any forward-looking assertion, whether or not on account of new info, future occasions, or in any other case, besides as required by regulation.
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