Neon Therapeutics Reports Second Quarter 2018 Financial Results and Recent Business Highlights
– Successfully completed initial public offering, raising $100 million in gross proceeds –
–Significant progress across platform and portfolio of vaccine and T-cell programs –
– Enrollment completed for NEO-PV-01 for NT-001 clinical trial;
updated data to be presented at
“The first half of 2018 was transformative for Neon, highlighted by the successful completion of our initial public offering. The capital raised will enable the continued execution of our strategy to develop neoantigen-targeted therapies that have the potential to transform patient lives,” said Hugh O’Dowd, President and Chief Executive Officer of Neon. “We are pleased by the continued progress across our entire product portfolio of vaccine and T-cell programs, including completion of enrollment of our first Phase 1b clinical trial for NEO-PV-01. In addition, updated data from this trial will be presented at the
Second Quarter Business Highlights
Neon achieved several key operational milestones during the second quarter of 2018, including the following:
June 2018, Neon completed its initial public offering of common stock, raising $100 millionin gross proceeds.
May 2018, Neon announced that the first patient was dosed in NT-002, its Phase 1b clinical trial evaluating the company’s personal neoantigen vaccine, NEO-PV-01, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), along with chemotherapy.
April 2018, Neon presented updated data from NT-001, its Phase 1b clinical trial of NEO-PV-01 in the metastatic setting, at the American Association for Cancer Research(AACR) Annual Meeting.
Pipeline Overview and Upcoming Milestones
- NT-001: Phase 1b Clinical Trial of NEO-PV-01 in the Metastatic Setting
- Updated data expected in
October 2018at ESMO
- 52-week data expected in the first half of 2019
- Updated data expected in
- NT-002: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Non-Small Cell Lung Cancer
- 52-week data expected in the second half of 2019
- NT-003: Phase 1b Clinical Trial of NEO-PV-01 in Metastatic Melanoma Combinations
- Trial initiation expected in the second half of 2018
- NT-004: Phase 1b Clinical Trial of NEO-PV-01 in Earlier Disease Setting
- Planning ongoing
- Phase 1 Clinical Trial in Solid Tumor Setting: Neon intends to submit a European Clinical Trial Application (CTA) for NEO-PTC-01, a personal neoantigen T-cell therapy, in the first half of 2019.
- Phase 1 Clinical Trial in Subset of ER+ Breast Cancer: Following the completion of target validation and preclinical product development work, Neon expects to submit an Investigational New Drug (IND) application to the
U.S. Food and Drug Administration( FDA) in the first half of 2019.
Second Quarter 2018 Financial Results
- Cash Position: As of June 30, 2018, cash, cash equivalents and marketable securities were $138.6 million, as compared to cash, cash equivalents and marketable securities of $79.7 million as of December 31, 2017.
- R&D Expenses: R&D expenses were $14.8 million for the quarter ended June 30, 2018, as compared to $7.3 million for the same quarter last year. The increase of $7.5 million was due primarily to increased costs related to the advancement of NEO-PV-01, including increased external manufacturing and other external costs to support our ongoing and planned clinical trials, as well as increased personnel-related costs due to additional headcount to support the growth of our research and development organization.
- G&A Expenses: G&A expenses were $4.3 million for the quarter ended June 30, 2018, compared to $2.4 million for the same quarter last year. The increase of $1.9 million was driven by increased personnel-related costs due to additional headcount, as well as increased consulting and professional fees.
- Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $22.1 million for the quarter ended June 30, 2018, or $7.84 per basic and diluted share, as compared to a net loss attributable to common stockholders of $12.1 million for the same quarter last year, or $7.55 per basic and diluted share.
Financial Guidance: Based on its current operating plan, Neon expects that its cash, cash equivalents and marketable securities as of June 30, 2018, including the proceeds from its initial public offering, will enable it to fund its operating expenses and capital expenditure requirements into at least the first quarter of 2020.
For more information, please visit www.neontherapeutics.com.
This press release contains “forward-looking statements” of
|SELECTED CONDENSED CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(amounts in thousands)|
| December 31,
|Cash, cash equivalents and marketable securities||$||138,633||$||79,725|
|Working capital (1)||$||131,062||$||72,539|
|Redeemable convertible preferred stock & contingently
redeemable restricted common stock
|Total stockholders' equity (deficit)||$||139,248||$||(93,572||)|
(1) Working capital is defined as current assets less current liabilities.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(amounts in thousands, except share and per share data)|
|Three Months Ended
|Six Months Ended
|Research and development||$ 14,804||$ 7,332||$ 27,962||$ 14,744|
|General and administrative||4,313||2,432||7,912||4,568|
|Total operating expenses||19,117||9,764||35,874||19,312|
|Loss from operations||(19,117)||(9,764)||(35,874)||(19,312)|
|Other income (expense), net|
|Total other income, net||218||162||454||241|
|Accretion of redeemable convertible preferred stock to|
|Net loss attributable to common stockholders||$ (22,084)||$ (12,105)||$ (41,791)||$ (24,050)|
|Net loss per share attributable to common stockholders,|
|basic and diluted||$ (7.84)||$ (7.55)||$ (17.05)||$ (15.62)|
|Weighted average common shares outstanding, basic|
KEYTRUDA® is a registered trademark of
Will O’Connor, Stern Investor Relations
Source: Neon Therapeutics, Inc.