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Planning to present more detailed data from NT-001 clinical trial evaluating NEO-PV-01 in advanced or metastatic melanoma, non-small cell lung and bladder cancers at an upcoming medical society meeting
Announces U.S. Food & Drug Administration (FDA) clearance of Neon’s Investigational New Drug (IND) application for off-the-shelf candidate, NEO-SV-01, for a genetically-defined subset of hormone receptor-positive breast cancer
Planning to file a Clinical Trial Application (CTA) in Europe in the second half of 2019 to evaluate personal neoantigen T cell therapy candidate, NEO-PTC-01, in refractory solid tumor settings
CAMBRIDGE, Mass., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today reported financial results for the second quarter ended June 30, 2019 and provided a business update.
“We continue to make important progress across Neon’s programs as we continue to advance our leadership in the field of neoantigen-bases therapies. In recent months, we made important steps forward, including the release of the top-line data from our NT-001 trial of NEO-PV-01 that demonstrated consistent prolongation of progression-free survival across all three tumor types compared with historical checkpoint inhibitor monotherapy studies. We are also proud that the FDA recently cleared the IND for our off-the-shelf neoantigen vaccine candidate, NEO-SV-01,” said Hugh O’Dowd, Neon’s Chief Executive Officer. “In the months ahead, we look forward to presenting detailed data from our NT-001 trial at a fall medical society meeting, including potential immune correlates and biomarker-selection strategies that could guide Phase 2 development, and also to completing process development work that will enable our planned CTA filing in Europe for our personal neoantigen T cell therapy candidate, NEO-PTC-01.”
Neon is developing neoantigen-targeting therapies across multiple treatment modalities, including both personal and precision vaccine and T cell therapy candidates.
Second 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-Q, 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)
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||60,999||$||103,311|
|Working capital (1)||$||52,722||$||92,737|
|Total stockholders’ equity||$||62,206||$||101,249|
(1) Working capital is defined as current assets less current liabilities.
Consolidated Statements of Operations (Unaudited)
(amounts in thousands, except share and per share data)
Three Months Ended
Six Months Ended
|Research and development||$||16,735||$||14,804||$||32,907||$||27,962|
|General and administrative||5,580||4,313||10,988||7,912|
|Total operating expenses||22,315||19,117||43,895||35,874|
|Loss from operations||(22,315||)||(19,117||)||(43,895||)||(35,874||)|
|Other income (expense), net|
|Total other income, net||383||218||939||454|
|Accretion of redeemable convertible preferred stock to redemption value||—||(3,185||)||—||(6,371||)|
|Net loss attributable to common stockholders||$||(21,932||)||$||(22,084||)||$||(42,956||)||$||(41,791||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.79||)||$||(7.84||)||$||(1.55||)||$||(17.05||)|
|Weighted average common shares outstanding, basic and diluted||27,787||2,816||27,720||2,450|
Paul Cox, Corporate Affairs and Strategy
Stephanie Simon, Ten Bridge Communications