Neon Therapeutics Reports First Quarter 2019 Financial Results and Provides Clinical Update
May 13 2019 - 8:00AM
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.”
Pipeline Updates
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.
- NEO-PV-01: Personal Neoantigen Vaccine
- NEO-PV-01: Neon is evaluating its lead product candidate, a
personal neoantigen vaccine, in a variety of treatment settings in
Phase 1b development to determine the optimal late-stage clinical
trials.
- NT-001 Trial: Neon’s ongoing Phase 1b open-label clinical trial
is evaluating a combination of NEO-PV-01 with OPDIVO® (nivolumab)
in patients with metastatic melanoma, non-small cell lung cancer
(NSCLC) or bladder cancer.
- Neon recently presented updated data from NT-001 at
the American Association for Cancer Research (AACR)
Annual Meeting, describing the immune and pathologic markers
associated with study subjects remaining progression-free at nine
months. The analysis both confirmed the mechanism of action of
NEO-PV-01 and highlighted new data on the association between
histology and epitope spread in patients who had not progressed at
nine months in the melanoma cohort. In addition, multiple molecular
markers were determined to correlate with lack of clinical
progression, which may prove useful for patient selection in
late-stage clinical trials.
- Neon expects to report top-line clinical results, including
12-month follow-up, from NT-001 in July 2019. The results are
expected to include data from an intention-to-treat (ITT) analysis
from 82 enrolled patients, including median progression-free
survival (PFS) and objective response rates (ORR), safety and
baseline patient characteristics in each of the three tumor
cohorts.
- NT-002 Trial: Neon recently 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 2H 2020.
- NT-004 Trial: Neon is planning to explore NEO-PV-01 in a
monotherapy approach in an earlier disease setting in this Phase 1b
trial.
- NEO-PTC-01: Personal Neoantigen T cell Therapy
- NEO-PTC-01: Neon’s personal adoptive T cell therapy 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 Clinical Trial
Application (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.
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.
- NEO-SV-01: Breast Neoantigen Vaccine
- 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 Filing: 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 for a Phase 1b clinical trial of NEO-SV-01 in
Q2 2019.
- TCR-based T cell Therapies
- TCRs: Neon continues to advance its precision T cell approach
and has assembled libraries of high-quality T-cell receptors (TCRs)
against various shared neoantigens. Neon is leveraging its
proprietary NEO-STIM induction protocol to rapidly generate T cells
specific to these targets where multiple TCRs can be sequenced and
characterized.
Expected Milestones
Clinical Trial Results:
- NEO-PV-01: Top-line clinical results, including 12-month
follow-up, from NT-001 Phase 1b trial in metastatic melanoma, NSCLC
and bladder cancers (July 2019)
- 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-PV-01: 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-PV-01: Immune data from NT-003 Phase 1b trial in metastatic
melanoma combinations (2H 2020)
Clinical Trial Applications/Initiations:
- NEO-SV-01: U.S. IND filing to evaluate NEO-SV-01 in a
genetically defined subset of HR+ breast cancer (Q2 2019)
- NEO-PTC-01: European CTA filing to evaluate NEO-PTC-01 in a
refractory solid tumor setting (2H 2019)
First Quarter 2019 Financial Results and Financial
Guidance:
- R&D Expenses: Research and
development expenses were $16.2 million for the first quarter of
2019, compared to $13.2 million for the same period last year. The
increase was primarily due to costs related to 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 $5.4 million for the first
quarter of 2019, compared to $3.6 million for the same
period last year. The increase was primarily due to
personnel-related expenses, professional fees to support expanding
operations and costs associated with being a public company.
- Net Loss: Net loss attributable to common stockholders was
$21.0 million for the first quarter of 2019, compared to $19.7
million for the same period last year.
- Cash Position: As of March 31, 2019,
cash, cash equivalents and marketable securities were $81.3
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 at
least Q2 2020.
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.
Forward-Looking Statements
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 assets |
$ |
101,040 |
|
|
$ |
114,088 |
|
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 EndedMarch
31, |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
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 |
|
|
|
Interest income |
556 |
|
|
247 |
|
Other expense |
— |
|
|
(10 |
) |
Total other income, net |
556 |
|
|
237 |
|
Net loss |
(21,024 |
) |
|
(16,520 |
) |
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 |
|
Investor Contact: Paul Cox, Corporate Affairs
and Strategy pcox@neontherapeutics.com 617-337-4762
Media Contact: Stephanie Simon, Ten Bridge
Communications stephanie@tenbridgecommunications.com
617-581-9333
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