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CAMBRIDGE, Mass., March 11, 2019 (GLOBE NEWSWIRE) -- Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today reported financial results for the fourth quarter and full-year ended December 31, 2018 and provided a business update.
“2018 was a transformative year for Neon, highlighted by significant advances in applying our insights into neoantigen biology not only to our vaccine product candidates but also to our emerging cellular therapies. Our initial public offering in June provided us with capital to advance these important programs, which have the potential to truly change the paradigm for immunotherapy by enabling more targeted treatment,” said Hugh O’Dowd, Neon’s Chief Executive Officer. “As we move into 2019, we are excited about the opportunities ahead to share data from our ongoing clinical trials of our personal neoantigen vaccine NEO-PV-01. We are also making progress to advance our personal T cell therapy program, NEO-PTC-01, into the clinic. We have adjusted timelines to enable the release of more mature data from our NT-002 study and to complete the scale-up process for our NEO-PTC-01 program.”
“With regard to NEO-PV-01, we have been closely tracking multiple metrics of patients’ immune response following dosing with the vaccine, and we are looking forward to presenting a correlative analysis from our NT-001 trial with data from more than a dozen patients at the American Association for Cancer Research (AACR) Annual Meeting. Later this year, we will present the more mature 52-week data set, which will include additional patients followed for a full year, a time frame that allows us to further evaluate not only their immune responses but also clinical outcomes, including progression free-survival,” said Richard Gaynor, M.D., Neon’s President of Research and Development.
“We have also made important developments in our NEO-PTC-01 program, including the evaluation of additional patient sample materials, which builds upon data presented at the Society for Immunotherapy of Cancer’s 33rd Annual Meeting last year. The additional evaluation of both melanoma and non-small cell lung cancer patient materials confirm that NEO-STIM™, our proprietary ex vivo co-culture process using peripheral blood mononuclear cells, can reliably and reproducibly generate multiple enriched neoantigen-specific T cell populations. These findings, now replicated across multiple patient samples, support the feasibility of advancing this program into the clinic.
“Finally, we have meaningfully advanced the science behind our precision medicine approaches, which target mutations shared across patient populations known as shared neoantigens. We are leveraging our NEO-STIM induction protocol to rapidly generate T cells specific to these targets where multiple T cell receptors, or TCRs, can be sequenced and characterized. Importantly, since we can derive these TCRs from the natural repertoire of healthy donors, our TCRs show cytotoxic functionality and strong specificity for mutant targets without engineering or modification. Due to our focused efforts in this area, we now have libraries of these high-quality TCRs,” concluded Dr. Gaynor.
Fourth Quarter Business Highlights
Pipeline Overview and Upcoming Milestones
Fourth Quarter and Full Year 2018 Financial Results:
Based on its current operating plan, Neon expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its anticipated operating expenses and capital expenditure requirements into at least the second quarter of 2020.
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 estrogen-receptor-positive 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 and related regulatory submissions; the potential timing 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 Quarterly 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)
|Cash, cash equivalents and marketable securities||$||103,311||$||79,725|
|Working capital (1)||$||92,737||$||72,539|
|Redeemable convertible preferred stock & contingently redeemable restricted common stock||$||—||$||175,250|
|Total stockholders’ equity (deficit)||$||101,249||$||(93,572||)|
(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
Twelve Months Ended
|Research and development||$||18,022||$||10,921||$||60,425||$||37,195|
|General and administrative||5,752||3,712||18,276||10,892|
|Total operating expenses||23,774||14,633||78,701||48,087|
|Loss from operations||(23,774||)||(14,633||)||(78,701||)||(48,087||)|
|Other income (expense), net|
|Total other income, net||651||157||1,767||551|
|Accretion of redeemable convertible preferred stock to redemption value||—||(2,887||)||(6,371||)||(10,396||)|
|Net loss attributable to common stockholders||$||(23,123||)||$||(17,363||)||$||(83,305||)||$||(57,932||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.84||)||$||(8.93||)||$||(5.54||)||$||(34.32||)|
|Weighted average common shares outstanding, basic and diluted||27,507||1,944||15,036||1,688|
Stephanie Simon, Ten Bridge Communications
Will O’Connor, Stern Investor Relations