Financing from new and existing investors will support continued development of a novel treatment for food allergy
Jim Momtazee and George Montgomery to join Alladapt's Board of Directors
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Financing from new and existing investors will support continued development of a novel treatment for food allergy
Jim Momtazee and George Montgomery to join Alladapt's Board of Directors
Alladapt Immunotherapeutics Inc., a private, clinical-stage biopharmaceutical company developing prescription therapeutics to address IgE-mediated food allergy, announced today the closing of a $119 million financing round led by Enavate Sciences, a portfolio company created by Patient Square Capital. Additional investors participating in the financing include Alladapt's founding investor, Gurnet Point Capital, along with new investors Allerfund, Novartis (NYSE: NVS), Red Tree Venture Capital, and WestRiver Group.
Proceeds from this funding round will support the ongoing clinical development of ADP101, the Company's lead product candidate, as well as preparation for a potential pivotal trial, the continued buildout of Alladapt's manufacturing facility, and investment in further pipeline expansion. Leveraging an immense body of evidence in oral immunotherapy developed by many leading allergists, including Dr. Kari Nadeau, the Director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University and co-founder of Alladapt, ADP101 is currently being studied in Harmony, a Phase 1/2 trial, and Encore, the associated open-label extension (OLE) study, in food allergy patients.
"We are pleased to further accelerate the development of our investigative clinical program targeting the treatment of allergy to one or to multiple foods through a singular oral immunotherapy," commented Ashley Dombkowski, Ph.D., Alladapt's Chief Executive Officer and co-founder. "Food allergy is a serious, chronic disease in which accidental exposure to an allergen can cause a rapid onset, severe, potentially life-threatening reaction. The challenges of food allergy can be particularly difficult for patients who have allergies to many foods. Treatment options are urgently needed, and we believe ADP101 holds immense promise as a therapeutic modality targeting clinically meaningful allergen desensitization. With this financing, we are delighted to have the continued support of Gurnet Point Capital and to welcome George and Jim to our Board of Directors, who both bring a deep understanding of the food allergy space and can offer meaningful perspective as we advance our clinical programs."
Glenn Reicin, Alladapt's Chief Financial Officer, commented: "The substantial investment on behalf of this expert syndicate of investors enables us to allocate resources to expand the development of ADP101, which has the potential to be the first FDA-approved therapy to treat the majority of U.S. food allergy patients."
"Our firm remains committed to Alladapt's vision for a best-in-class approach that truly aligns with the needs of patients, their families, and clinicians," added Sophie Kornowski, Partner at Gurnet Point Capital, Alladapt's founding investor.
"We are excited to partner with Alladapt given our enthusiasm around oral immunotherapy, or OIT, as an important treatment option in the food allergy therapeutic landscape. I am equally pleased to join Alladapt's Board and support the Company's leadership in its endeavor to treat highly reactive pediatric and adult patients with food allergy," said Jim Momtazee, Managing Partner of Patient Square Capital.
"Having closely followed the food allergy space, and the commercial market at large, Alladapt stands out because of its potentially best-in-class prescription therapeutic targeted to treat multi-allergies simultaneously," said George Montgomery, consultant to WestRiver Group and Senior Advisor to Alvarium Investments LLC. "I look forward to working with Alladapt's co-founders, with whom I have collaborated in the past and who are acclaimed experts in the food allergy space, in addition to Alladapt's seasoned senior executives who hold diversified experiences across the food allergic disease landscape."
In conjunction with the financing, Heath Lukatch, Ph.D., Founder and Managing Partner of Red Tree Venture Capital, will become an Alladapt board observer.
Jefferies, LLC acted as placement agent for the financing.
About Alladapt Immunotherapeutics
Alladapt Immunotherapeutics Inc. is a private, clinical-stage biopharmaceutical company developing prescription therapeutics targeting food allergy. The company is currently conducting the Harmony Study, a Phase 1/2, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ADP101 for the treatment of food allergy in children and adults, and the Encore Study, an open-label extension study for its Harmony study. ADP101 is an investigational oral immunotherapy product candidate representing the nine food groups responsible for the vast majority of significant food allergic reactions globally.
Alladapt was co-founded in 2018 by biotechnology entrepreneur, Ashley Dombkowski, Ph.D. and allergist, clinician and protein biochemist, Kari Nadeau, M.D., Ph.D. Dr. Nadeau is also the Naddisy Foundation Endowed Professor of Medicine and Pediatrics and Director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University. Food allergen specific OIT conducted by Dr. Nadeau and other food allergy experts is an approach that has shown consistently promising results through administration of increasing amounts of an allergen to individuals with food allergy to raise the reactive threshold and decrease the severity of allergic responses to the allergenic food. This work, combined with research on disease mechanisms, pathways, and protein structures, led the founders to envision biopharmaceutical interventions capable of addressing food allergy due to a wide-ranging set of foods. For more information, please visit the Company's website at www.alladapt.com .
About Enavate Sciences
Enavate Sciences is a platform created by Patient Square Capital dedicated to supporting therapeutic companies advancing medicines and enabling technologies with transformative potential to address patient need. Through the application of capital support and operational experience, Enavate strives to enable and empower a diverse portfolio of therapeutics companies to accelerate innovation. To learn more about Enavate, please visit www.enavatesciences.com .
About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, Gurnet is able to deliver differentiated results for its investors and partners. www.gurnetpointcapital.com .
Source: Alladapt Immunotherapeutics, Inc.
Investor Contact:
Investor@alladapt.com
Media Contact:
Hannah Gendel
Solebury Trout
646-378-2943
hgendel@soleburytrout.com
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License option agreement with Novartis for target-specific access to TRACERâ„¢ next-generation AAV capsids for potential use with three CNS targets plus options to access capsids for two additional targets
Novartis agreement marks second recent major transaction to leverage Voyager's TRACER technology following October 2021 Pfizer agreement
Strengthened leadership with appointment of Al Sandrock, Jr., M.D., Ph.D., to Board of Directors and Board Executive Committee, promotion of Robin Swartz to chief operating officer
Cash runway extended into 2024 with $84 million aggregate upfront payments from Novartis and Pfizer transactions
Conference call and webcast today at 8:30 a.m. ET
CAMBRIDGE, Mass., March 08, 2022 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a gene therapy company developing life-changing treatments and next-generation adeno-associated virus (AAV) capsids, today reported fourth quarter and full year 2021 financial and operating results.
"We're extremely pleased with the value created by our TRACER™ capsid discovery platform, evidenced by the two major license option agreements with Novartis and Pfizer for target-specific access to our highly differentiated capsids, which affords us the opportunity to expand the impact of our technology through external program development by our partners. The potential of our novel TRACER capsids to improve transduction in target tissues and to minimize off target toxicities associated with conventional AAV delivery may enable a new wave of gene therapies to treat serious diseases," said Michael Higgins, interim CEO of Voyager. "We've also made important additions to our leadership team with Al Sandrock joining our Board and its Executive Committee, and the promotion of Robin Swartz to chief operating officer. We continue to leverage our proprietary AAV capsids to progress our pipeline and look forward to sharing new preclinical data from select programs and our TRACER platform at a medical conference this spring."
Target-Specific License Option Agreement with Novartis Expands Applications of TRACER Capsids
Transgene-Specific License Option Agreement with Pfizer Supports CNS and Cardiac Applications for TRACER
Additional Data from Evolving TRACER AAV9 and AAV5 Capsid Portfolio Planned for Spring Medical Conference
Positive Preclinical Data from Vectorized Anti-HER2 Antibody Program Highlights Advancement of Rich Early-Stage Pipeline
Key Leadership Appointments Add to Deep R&D and Operational Experience
Fourth Quarter and Full Year 2021 Financial Results
Financial Guidance
Participation in Upcoming Investor Event
Conference Call
The Voyager Therapeutics leadership team will host a conference call and webcast today at 8:30 a.m. ET to provide and discuss the fourth quarter and full year 2021 financial and operating results and the Novartis license option agreement. To access the call, please dial (877) 851-3834 (domestic) or (631) 291-4595 (international) and ask for the Voyager Therapeutics earnings call. A live webcast of the call will also be available on the Investors section of the Voyager website at ir.voyagertherapeutics.com , and a replay will be available at the same link approximately two hours after its completion. The replay will be available for at least 30 days following the conclusion of the call.
About the TRACERâ„¢ AAV Capsid Discovery Platform
Voyager's TRACER™ capsid discovery platform is a broadly applicable, RNA-based functional screening platform that allows for rapid in vivo evolution of AAV9- and AAV5-derived capsids with enhanced tropisms and cell- and tissue-specific transduction properties in multiple species, including non-human primates (NHPs). Initial data from the first of many libraries screened in NHPs demonstrated the proprietary capsid variants effectively penetrated the blood-brain barrier and achieved widespread biodistribution and transduction of multiple regions of the brain. Separate results have demonstrated the ability of certain capsids to transduce cardiac muscle and to de-target the dorsal root ganglia. Voyager is proceeding with additional capsid campaigns derived from AAV9, AAV5, and other capsid serotypes to identify novel AAV vectors optimized for specific therapeutic applications.
About Voyager Therapeutics
Voyager Therapeutics (Nasdaq: VYGR) is leading the next generation of AAV gene therapy to unlock the potential of the modality to treat devastating diseases. Proprietary capsids born from the Company's TRACER discovery platform are powering a rich early-stage pipeline of new and second-generation programs and may elevate the field to overcome the narrow therapeutic window associated with conventional gene therapy vectors across neurologic disorders and other therapeutic areas. voyagertherapeutics.com LinkedIn Twitter
Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "undoubtedly," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward-looking statements.
For example, all statements Voyager makes regarding Voyager's ability to continue to identify and develop proprietary capsids from its TRACER capsid discovery platform with increased transgene expression, increased blood-brain barrier penetration and increased biodistribution compared to conventional AAV9 and AAV5 capsids; Voyager's ability to utilize its novel proprietary capsids in its own product development programs; Voyager's ability to attract parties to license its novel proprietary capsids or to participate with Voyager in research and development collaborations utilizing its novel proprietary capsid; Voyager's ability to advance its AAV-based gene therapy programs; Voyager's ability to perform its obligations under its respective license option agreements with Novartis and Pfizer; Voyager's entitlement to receive upfront, option exercise, milestone and royalty-based fees from Novartis and Pfizer under the respective license option agreements; Voyager's ability to maintain its current partnerships and collaborations and to enter into new partnerships or collaborations; Voyager's ability to continue to advance and to receive regulatory approvals for product candidates under development in Voyager's pipeline; Voyager's anticipated financial results, including the receipt by Voyager of revenues or reimbursement payments from collaboration partners; and Voyager's ability to generate sufficient cash resources to enable it to continue to identify and develop proprietary capsids from its TRACER capsid discovery platform are forward looking.
All forward-looking statements are based on estimates and assumptions by Voyager's management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the severity and length of the COVID-19 health crisis, the imposition of governmental controls and guidance addressing the COVID health crisis, and the financial and human resources available to Voyager to manage the COVID-19 health crisis; the continued development of various technology platforms, including Voyager's TRACER platform; the development by third parties of capsid identification platforms that may be competitive to Voyager's TRACER capsid discovery platform; Voyager's scientific approach and general development progress; Voyager's ability to attract and retain talented contractors and employees to continue the development of the TRACER capsid discovery platform and the identification of proprietary capsids; Voyager's ability to create and protect intellectual property rights associated with the TRACER capsid discovery platform and the capsids identified by the platform; the response of the FDA and other regulators to Voyager's regulatory submissions and communications; the ability to attract and retain talented contractors and employees, including key scientists and business leaders; the ability to create and protect intellectual property; Voyager's ability to perform its obligations under its license option agreements and its counterparties' respective abilities to perform their obligations under such agreements; the sufficiency of cash resources; the possibility or the timing of the exercise of development, commercialization, license and other options under the Pfizer and Novartis license option agreements and other collaborations; the ability of Voyager to negotiate and complete licensing or collaboration agreements on terms acceptable to Voyager and third parties; and the availability or commercial potential of Voyager's product candidates.
These statements are also subject to a number of material risks and uncertainties that are described in Voyager's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Selected Financial Information
($-amounts in thousands, except per share data)
(Unaudited)
Three Months Ended | Year Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
Statement of Operations Items: | 2021 | 2020 | 2021 | 2020 | |||||||||||||
Collaboration revenue | $ | 28,073 | $ | 6,537 | $ | 37,415 | 171,128 | ||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 14,020 | 21,996 | 73,787 | 108,753 | |||||||||||||
General and administrative | 8,351 | 8,270 | 37,246 | 34,991 | |||||||||||||
Total operating expenses | 22,371 | 30,266 | 111,033 | 143,744 | |||||||||||||
Operating income (loss) | 5,702 | (23,729 | ) | (73,618 | ) | 27,384 | |||||||||||
Total other income | 6 | 7,802 | 2,421 | 9,357 | |||||||||||||
Net income (loss) | $ | 5,708 | $ | (15,927 | ) | $ | (71,197 | ) | $ | 36,741 | |||||||
Net income (loss) per share, basic | $ | 0.15 | $ | (0.43 | ) | $ | (1.89 | ) | $ | 0.99 | |||||||
Net income (loss) per share, diluted | 0.15 | (0.43 | ) | (1.89 | ) | 0.98 | |||||||||||
Weighted-average common shares outstanding, basic | 37,804,372 | 37,290,259 | 37,668,947 | 37,132,447 | |||||||||||||
Weighted-average common shares outstanding, diluted | 37,804,372 | 37,290,259 | 37,668,947 | 37,348,514 |
December 31, | ||||||
Selected Balance Sheet Items | 2021 | 2020 | ||||
Cash, cash equivalents, and marketable securities | $ | 132,539 | $ | 174,782 | ||
Total assets | $ | 193,855 | $ | 261,584 | ||
Accounts payable and accrued expenses | $ | 11,524 | $ | 14,839 | ||
Deferred revenue | $ | 42,096 | $ | 43,817 | ||
Total stockholders' equity | $ | 95,055 | $ | 154,320 |
Contacts Investors Investors@voyagertherapeutics.com Andrew Funderburk afunderburk@kendallir.com Media Scott Santiamo ssantiamo@vygr.com Â
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Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announces the appointment of Cintia Piccina as Chief Commercial Officer effective January 31, 2022.
"I am delighted to welcome Cintia to our leadership team. She brings extensive commercial experience, including in cell and gene therapy, that will be key as we prepare to submit our first BLA for afami-cel this year, and build our commercial capabilities to support the launch of this initial product and future next-gen cell therapies within our MAGE-A4 franchise. Her fresh perspective and leadership abilities will support our continued growth in our mission to design and develop cell therapies for people with cancer," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer.
Most recently, Cintia served as the Head of Commercial at 2Seventy Bio (Nasdaq:TSVT) and as SVP Commercial Oncology and US General Manager, leading the launch of the first cell therapy product in multiple myeloma, Abecma (idecabtagene vicleucel), for bluebird bio (Nasdaq:BLUE). Before that she spent over 20 years at Novartis (SIX:NOVN; NYSE:NVS) from 1997 to April 2020, first in Brazil then in the United States, where she held a series of commercial, marketing and sales roles across multiple therapeutic areas including oncology. In her final role at Novartis, Cintia was VP, Global Oncology Cell and Gene Strategy & Program Management Office, for Kymriah and the CAR-T pipeline, leading the cross-functional leadership teams for business (marketing, medical affairs, market access), manufacturing, and pipeline. Cintia holds a Doctorate in Pharmacy and Biochemistry from the University of Sao Paulo, Brazil, and an MBA from the Escola Superior de Propaganda e Marketing, Sao Paulo.
About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 4, 2021, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
Adaptimmune Contacts:
Media Relations:
Sébastien Desprez — VP, Corporate Affairs and Communications
T: +44 1235 430 583
M: +44 7718 453 176
Sebastien.Desprez@adaptimmune.com
Investor Relations:
Juli P. Miller, Ph.D. — VP, Investor Relations
T: +1 215 825 9310
M: +1 215 460 8920
Juli.Miller@adaptimmune.com
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