Delaware | 001-38551 | 46-3915846 | ||
(State or other jurisdiction | (Commission | (I.R.S. Employer | ||
of incorporation) | File Number) | Identification No.) |
Title of each class | Trade Symbol(s) | Name of each exchange on which registered |
Common Stock, $0.001 par value per share | NTGN | The Nasdaq Global Select Market |
Exhibit No. | Description | |
99.1 |
Neon Therapeutics, Inc. | ||
Date: August 6, 2019 | By: | /s/ Yasir B. Al-Wakeel |
Yasir B. Al-Wakeel, B.M., B.Ch. | ||
Chief Financial Officer |
• | NEO-PV-01: Neon’s investigational personal neoantigen vaccine, NEO-PV-01, is custom-designed and manufactured based on the unique mutational fingerprint of each individual patient. NEO-PV-01 is being studied in multiple ongoing Phase 1b clinical trials. |
◦ | NT-001 Trial: Neon’s ongoing, multicenter Phase 1b clinical is evaluating a combination of NEO-PV-01 with OPDIVO® (nivolumab) in patients with metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC) or bladder cancer. |
▪ | In July, Neon announced top-line results from 82 patients in the NT-001 trial, with at least 12-month median follow-up in each of the three cohorts. |
▪ | Across all three distinct tumor types, the results demonstrated prolonged and consistent improvements in progression-free survival (PFS) that compare favorably to those observed with checkpoint inhibitor monotherapy, based on historical benchmark data. At 13.4-month median follow-up in 34 patients with metastatic melanoma, the median PFS had not yet been reached; in 27 patients with metastatic NSCLC, median PFS was 5.6 months; and in 21 patients with metastatic bladder cancer, median PFS was 5.6 months. |
▪ | No serious adverse events were observed that were related to the NEO-PV-01/OPDIVO combination. Low grade adverse events attributable to the NEO-PV-01/OPDIVO combination included injection site reactions, fatigue and influenza-like illness. |
▪ | These top-line data, which come from the 82 patients in the Intention-to-Treat population who received at least one dose of OPDIVO in the Phase 1b NT-001 trial, support further development of NEO-PV-01, including randomized Phase 2 trials of NEO-PV-01 in metastatic disease settings. |
▪ | Neon plans to present more detailed data from its NT-001 clinical trial at an upcoming medical society meeting. |
◦ | NT-002 Trial: In April, Neon completed enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 in combination with the current standard of care, KEYTRUDA® (pembrolizumab) and chemotherapy, in first-line patients with untreated advanced or metastatic NSCLC. This trial is evaluating the safety, tolerability and efficacy of NEO-PV-01 in the metastatic setting. Neon expects to report immune monitoring and clinical outcome data from this trial by the end of Q3 2020. |
◦ | NT-003 Trial: This Phase 1b clinical trial of NEO-PV-01 in metastatic melanoma combinations is currently enrolling. NT-003 will evaluate NEO-PV-01 and OPDIVO in combination with other agents, including Apexigen’s CD40 agonist (APX005M) or a CTLA-4 antagonist, to further enhance any NEO-PV-01-induced neoantigen immune response and improve clinical outcomes. This trial will also evaluate alternative NEO-PV-01 dosing schedules. Neon plans to announce immune monitoring data from this study in the second half of 2020. |
• | NEO-PTC-01: Neon’s personal adoptive T cell therapy candidate consists of multiple T cell populations targeting neoantigens that are predicted to be the most therapeutically relevant from each patient's tumor. NEO-PTC-01 uses T cells from the periphery of each patient that are then primed, activated and expanded to generate a therapy that specifically targets that patient's personal neoantigens, with the potential to drive a robust and persistent anti-tumor response. |
◦ | CTA Filing: Building on success to date in generating both memory and de novo immune responses, Neon is completing process development, which supports its plan to file a CTA in Europe in the second half of 2019 to evaluate NEO-PTC-01 in refractory solid tumor settings. This work is being performed in collaboration with the Netherlands Cancer Institute (NKI), a leading academic research and treatment center with expertise in T cell biology and treatments. |
• | NEO-SV-01: Neon is planning to develop its off-the-shelf neoantigen vaccine for the treatment of a genetically-defined subset of hormone receptor-positive (HR+) breast cancer, potentially across disease stages, in combination with hormonal, chemotherapy or targeted therapies. |
◦ | IND Clearance: Neon today announced that the U.S. Food & Drug Administration (FDA) has cleared Neon’s IND application for NEO-SV-01. |
• | NEO-PV-01: Clinical results and correlative immune data from NT-001 Phase 1b trial planned for presentation at a medical congress (2H 2019) |
• | NEO-PTC-01: Planned European CTA filing to evaluate NEO-PTC-01 in a refractory solid tumor setting (2H 2019) |
• | NEO-PV-01: Planned clinical results and correlative immune data, including 12-month follow-up, from NT-002 Phase 1b trial in first-line metastatic NSCLC (Q3 2020) |
• | NEO-PTC-01: Planned Phase 1 initiation in a refractory solid tumor setting (Q2 or Q3 2020) |
• | NEO-PV-01: Planned immune data from NT-003 Phase 1b trial in metastatic melanoma combinations (2H 2020) |
• | NEO-PV-01: Planned Phase 2 initiation of randomized clinical trial in first-line metastatic melanoma (2020) |
• | R&D Expenses: Research and development expenses were $16.7 million for the second quarter of 2019, compared to $14.8 million for the same period last year. The increase was primarily due to costs related to continued research and development of NEO-PV-01, NEO-PTC-01 and NEO-SV-01, as well as investments in R&D headcount to support the advancement of Neon’s pipeline. |
• | G&A Expenses: General and administrative expenses were $5.6 million for the second quarter of 2019, compared to $4.3 million for the same period last year. The increase was primarily due to personnel-related costs, expenses associated with intellectual property protection and costs associated with being a public company. |
• | Net Loss: Net loss was $21.9 million for the second quarter of 2019, compared to $18.9 million for the same period last year. |
• | Cash Position: As of June 30, 2019, cash, cash equivalents and marketable securities were $61.0 million, as compared to cash, cash equivalents and marketable securities of $103.3 million as of December 31, 2018. |
• | Financial Guidance: 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 June 2020. |
June 30, 2019 | December 31, 2018 | ||||||
Cash, cash equivalents and marketable securities | $ | 60,999 | $ | 103,311 | |||
Working capital (1) | $ | 52,722 | $ | 92,737 | |||
Total assets | $ | 79,682 | $ | 114,088 | |||
Total stockholders’ equity | $ | 62,206 | $ | 101,249 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Operating expenses: | |||||||||||||||
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 | |||||||||||||||
Interest income | 418 | 218 | 974 | 464 | |||||||||||
Other expense | (35 | ) | — | (35 | ) | (10 | ) | ||||||||
Total other income, net | 383 | 218 | 939 | 454 | |||||||||||
Net loss | (21,932 | ) | (18,899 | ) | (42,956 | ) | (35,420 | ) | |||||||
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 |
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