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Advancing a class-leading position in neoantigen-based therapies with ongoing progress across its multiple clinical-stage programs, pre-clinical pipeline and bioinformatics engine
Expect to report in July top-line clinical results, including 12-month follow-up, from NT-001 trial of personal neoantigen vaccine NEO-PV-01 in metastatic melanoma, non-small cell lung and bladder cancers
Completed enrollment in NT-002 trial of NEO-PV-01, in combination with standard of care, in first-line metastatic non-small cell lung cancer, with data expected in 2020
Continued pipeline progress with near-term expected submissions of clinical trial applications for personal T cell therapy program, NEO-PTC-01 and off-the-shelf neoantigen vaccine, NEO-SV-01
CAMBRIDGE, Mass., May 13, 2019 (GLOBE NEWSWIRE) -- Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today reported financial results for the first quarter ended March 31, 2019 and provided a business update.
“The field of cancer immunotherapy has advanced considerably in recent years, but there remains a significant need for new approaches that could extend the benefits of immunotherapy and lead to improved patient outcomes. Neoantigen-based therapies hold the promise to transform the treatment of cancer and we are proud of our leadership in pursuing these untapped targets,” said Hugh O’Dowd, Neon’s Chief Executive Officer. “We continue to make important progress across the Company, including our efforts to establish RECON® as the best-in-class neoantigen bioinformatic prediction engine with our machine learning and proteomics expertise. We intend to further strengthen our position as a class-leader in neoantigen selection by continuing to leverage proprietary immunogenicity data from our ongoing clinical studies. We remain excited about numerous upcoming clinical milestones, including the top-line results from our NT-001 study of NEO-PV-01, which we expect to be the first clinical dataset ever reported with 12-month follow-up for a personal neoantigen vaccine in metastatic melanoma, non-small cell lung and bladder cancers.”
Neon is developing neoantigen-targeting therapies across multiple treatment modalities, including vaccines, adoptive T cell therapies and TCR-based T cell therapies to bring benefit to a broad set of patients across tumor types and stages of disease. This approach requires effectively identifying and selecting the optimal neoantigen targets for the unique mutational fingerprint of each individual patient’s tumor. Neon is pioneering a proprietary neoantigen platform to identify and harness the most therapeutically relevant neoantigens, including through its RECON bioinformatic neoantigen prediction engine, deep capabilities in peptide chemistry and manufacturing, and NEO-STIM™ T cell biology and immune-monitoring expertise.
Neon is using two distinct neoantigen therapeutic approaches across this platform: personal therapies that target individualized mutations (NEON / ONE), and off-the-shelf precision therapies (NEON / SELECT) that target shared mutations present in sub-populations of cancer patients.
“Neon is pursuing novel therapeutic approaches at the frontiers of immuno-oncology. We designed our R&D strategy to enable us to determine how our neoantigen-targeted platform and product candidates could improve patient outcomes beyond the limitations of current standard of care treatment. Our near-term R&D strategy is focused on leveraging Phase 1b clinical trials to determine the optimal patient selection, rational combinations and trial designs to inform subsequent Phase 2 and later-stage clinical trials,” said Richard Gaynor, M.D., Neon’s President of Research and Development.
NEON / ONE is Neon’s personal medicine approach to neoantigen-targeted therapies that are tailored for the individual profile of each patient's tumor. Neon’s initial clinical strategy has focused on solid tumor indications where checkpoint inhibitors have been approved, either in combination or in refractory settings.
NEON / SELECT is Neon’s off-the-shelf precision approach to neoantigen-targeted therapies that seek to target prevalent neoantigens that are shared across subsets of patients or tumor types.
Clinical Trial Results:
Clinical Trial Applications/Initiations:
First Quarter 2019 Financial Results and Financial Guidance:
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About Neon Therapeutics
Neon Therapeutics is a clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical-stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of a subset of hormone receptor-positive (HR+) breast cancer.
For more information, please visit www.neontherapeutics.com.
This press release contains “forward-looking statements” of Neon Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to obtain and maintain regulatory approval of our product candidates; the potential timing and advancement of our preclinical studies and clinical trials; the potential timing and manner of data readouts from our ongoing and planned clinical trials; the design and potential efficacy of our therapeutic approaches; the ability and willingness of our third-party research institution collaborators to continue research and development activities relating to our product candidates; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; regulatory developments in the United States and foreign countries; our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; and our expectations regarding our uses of capital, expenses, future accumulated deficit and other financial results. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing and conduct of studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies and clinical trials will be predictive of future results in connection with future studies or trials; the risk that Neon’s collaborations will not continue or will not be successful; risks related to our ability to protect and maintain our intellectual property position; and risks related to the ability of our licensors to protect and maintain their intellectual property position. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Neon’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Neon’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Neon’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Neon undertakes no duty to update this information unless required by law.
Selected Consolidated Balance Sheet Data (Unaudited)
(amounts in thousands)
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||81,264||$||103,311|
|Working capital (1)||$||72,154||$||92,737|
|Total stockholders’ equity||$||82,071||$||101,249|
(1) Working capital is defined as current assets less current liabilities.
Consolidated Statements of Operations (Unaudited)
(amounts in thousands, except per share data)
Three Months Ended
|Research and development||$||16,172||$||13,158|
|General and administrative||5,408||3,599|
|Total operating expenses||21,580||16,757|
|Loss from operations||(21,580||)||(16,757||)|
|Other income (expense), net|
|Total other income, net||556||237|
|Accretion of redeemable convertible preferred stock to redemption value||—||(3,186||)|
|Net loss attributable to common stockholders||$||(21,024||)||$||(19,706||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.76||)||$||(9.47||)|
|Weighted average common shares outstanding, basic and diluted||27,651||2,081|
Paul Cox, Corporate Affairs and Strategy
Stephanie Simon, Ten Bridge Communications