Neon Therapeutics, Inc. (Nasdaq: NTGN) today reported financial
results for the fourth quarter and full-year ended December
31, 2019 and provided a business update.
“Earlier this year, we were delighted to announce our entry into
a definitive merger agreement with BioNTech. Once closed, the
transaction will combine two organizations with a common culture of
pioneering translational science and a shared vision for the future
of cancer immunotherapy,” said Hugh O’Dowd, Chief Executive Officer
of Neon. “We continue to be encouraged by the potential of our
novel neoantigen-targeted T cell therapies and are confident that
this merger with BioNTech will provide the foundation from which to
ensure that potential will be realized.”
BioNTech Transaction Details
Under the terms of the definitive merger agreement, Neon will,
following consummation of the acquisition, merge with Endor Lights,
Inc., a Delaware corporation and a direct, wholly-owned subsidiary
of BioNTech SE (Nasdaq: BNTX) and become a wholly-owned subsidiary
of BioNTech. At closing, BioNTech will issue, and Neon shareholders
will receive, 0.063 American Depositary Shares (ADS) (each ADS
representing one ordinary share of BioNTech) in exchange for each
of their shares of Neon. The exchange ratio implies a deal value of
approximately $67 million, or $2.18 per share of Neon, based on the
closing price of BioNTech’s ADSs of $34.55 on Wednesday, January
15, 2020, the date of the definitive merger agreement.
The transaction was unanimously approved by both BioNTech’s and
Neon’s boards of directors. The transaction, which is expected to
close during the second quarter of 2020, is subject to approval by
Neon’s shareholders and the satisfaction of customary closing
conditions. Certain stockholders of Neon owning approximately 36%
of the outstanding Neon shares have entered into voting agreements,
pursuant to which they have agreed, among other things, and subject
to the terms and conditions of the agreements, to vote in favor of
the Neon acquisition.
Fourth Quarter and Full Year 2019 Financial
Results:
- Cash Position: As
of December 31, 2019, cash and cash equivalents were $29.4 million,
as compared to cash, cash equivalents and marketable securities of
$103.3 million as of December 31, 2018.
- R&D Expenses: R&D expenses were $12.7
million for the fourth quarter of 2019 and $59.7 million for the
year ended December 31, 2019, as compared to $18.0 million for the
fourth quarter of 2018 and $60.4 million for the year ended
December 31, 2018. The decrease for both fourth quarter and full
year 2019 was primarily driven by decreased costs supporting
NEO-PV-01, including clinical development and manufacturing costs,
as Neon shifted its strategic focus towards personal and precision
neoantigen-targeted T cell therapy candidates. The decreases were
partially offset by an increase in costs related to Neon's
investment in NEO-PTC-01 and other pre-clinical candidates that are
aligned with Neon's refined strategic focus, as well as an increase
in personnel-related costs, including one-time restructuring
charges in connection with our November 2019 workforce
reduction.
- G&A Expenses: G&A expenses were $5.3
million for the fourth quarter of 2019 and $21.4 million for the
year ended December 31, 2019, as compared to $5.8 million for the
fourth quarter of 2018 and $18.3 million for the year ended
December 31, 2018. The decrease for the fourth quarter was
primarily due to the timing of expenditures associated with
protecting Neon's owned and in-licensed intellectual property. The
increase for the full year was primarily due to increased
personnel-related costs and costs associated with being a public
company.
- Net Loss Attributable to
Common Stockholders: Net loss was $17.8 million for the
fourth quarter of 2019 and $79.8 million for the year ended
December 31, 2019, or a net loss per basic and diluted share of
$(0.63) and $(2.86), respectively, as compared to a net loss of
$23.1 million for the fourth quarter of 2018 and $83.3 million for
the year ended December 31, 2018, or a net loss per basic and
diluted share of $(0.84) and $(5.54), respectively.
About Neon Therapeutics
Neon is a biotechnology company developing novel
neoantigen-targeted T cell therapies, dedicated to transforming the
treatment of cancer by directing the immune system towards
neoantigens. Neon is using its neoantigen platform to develop both
personal and precision neoantigen-targeted T cell therapy
candidates. Neon’s most advanced program is NEO-PTC-01, its
personalized neoantigen-targeted T cell therapy candidate
consisting of multiple T cell populations targeting the most
therapeutically relevant neoantigens from each patient’s tumor.
For more information, please
visit www.neontherapeutics.com.
Important Additional Information and Where to Find
It
In connection with the proposed merger, BioNTech will file with
the Securities and Exchange Commission (the “SEC”) a Registration
Statement on Form F-4 containing a proxy statement of Neon and a
prospectus of BioNTech, and each of Neon and BioNTech may file with
the SEC other documents regarding the proposed merger. The
definitive proxy statement will be mailed to stockholders of Neon.
INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION
STATEMENT ON FORM F-4 AND THE PROXY STATEMENT/PROSPECTUS, AS WELL
AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS AND ANY OTHER
RELEVANT DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE
PROPOSED MERGER, WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT BIONTECH, NEON AND THE PROPOSED
MERGER.
Investors and security holders may obtain copies of these
documents free of charge through the website maintained by the SEC
at www.sec.gov or from BioNTech at its website,
https://biontech.de, or from Neon at its website,
https://neontherapeutics.com. Documents filed with the SEC by
BioNTech will be available free of charge by accessing BioNTech’s
website under the heading Investors & Media, or,
alternatively, by directing a request by telephone or mail to
BioNTech at An der Goldgrube 12, 55131 Mainz, Germany, and
documents filed with the SEC by Neon will be available free of
charge by accessing Neon’s website at https://neontherapeutics.com
under the heading Investor Resources or, alternatively, by
directing a request by telephone or mail to Neon at 40 Erie Street,
Suite 110, Cambridge, MA 02139.
No Offer or Solicitation
This Press Release does not constitute an offer to sell or the
solicitation of an offer to buy any securities nor a solicitation
of any vote or approval with respect to the proposed transaction or
otherwise. No offering of securities shall be made except by means
of a prospectus meeting the requirements of Section 10 of the
U.S. Securities Act of 1933, as amended, and otherwise in
accordance with applicable law.
Participants in Solicitation
BioNTech and Neon and certain of their respective directors and
executive officers and other members of management and employees
may be deemed to be participants in the solicitation of proxies
from the stockholders of Neon in respect of the proposed merger
under the rules of the SEC. Information about Neon’s directors and
executive officers is available in Neon’s definitive proxy
statement dated April 26, 2019 for its 2019 Annual Meeting of
Stockholders and certain of its Current Reports on Form 8-K.
Information about BioNTech’s directors and executive officers is
available in BioNTech’s Registration Statement on Form F-1 filed
with the SEC on September 9, 2019, as amended. Other
information regarding the participants in the proxy solicitation
and a description of their direct and indirect interests, by
security holdings or otherwise, will be contained in the proxy
statement/prospectus and other relevant materials to be filed with
the SEC regarding the proposed merger when they become available.
Investors should read the proxy statement/prospectus carefully when
it becomes available before making any voting or investment
decisions. You may obtain free copies of these documents from Neon
or BioNTech using the sources indicated above.
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 the proposed acquisition of
Neon by BioNTech and the potential timing of the closing of that
proposed transaction; our ability to obtain and maintain regulatory
approval of our product candidates; the potential timing and
advancement of our 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;
financial plans and projections; and our ability to replicate
results achieved in our preclinical studies or clinical trials in
any future studies or trials. 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 timing and
occurrence of the closing of the proposed acquisition of Neon by
BioNTech; the reaction to the proposed acquisition of our business
partners, the reaction of competitors to the proposed acquisition,
the retention of our employees, BioNTech’s plans for us, the future
growth of our and BioNTech’s businesses and the possibility that
integration following the proposed acquisition may be more
difficult than expected; risks 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 may not be predictive of future results in connection with
future studies or trials; the risk that our collaborations will not
continue or will not be successful; risks related to our ability to
protect and maintain our intellectual property position; risks
related to our capital requirements and use of capital and
unexpected expenditures; 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)
|
December 31, 2019 |
|
December 31, 2018 |
Cash, cash equivalents and marketable securities |
$ |
29,395 |
|
|
$ |
103,311 |
|
Working capital (1) |
$ |
20,836 |
|
|
$ |
92,737 |
|
Total assets |
$ |
46,372 |
|
|
$ |
114,088 |
|
Total stockholders’
equity |
$ |
29,417 |
|
|
$ |
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 EndedDecember
31, |
|
Twelve Months EndedDecember
31, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
12,691 |
|
|
$ |
18,022 |
|
|
$ |
59,718 |
|
|
$ |
60,425 |
|
General and administrative |
5,298 |
|
|
5,752 |
|
|
21,420 |
|
|
18,276 |
|
Total operating expenses |
17,989 |
|
|
23,774 |
|
|
81,138 |
|
|
78,701 |
|
Loss from operations |
(17,989 |
) |
|
(23,774 |
) |
|
(81,138 |
) |
|
(78,701 |
) |
Other income (expense),
net |
|
|
|
|
|
|
|
Interest income |
149 |
|
|
656 |
|
|
1,401 |
|
|
1,792 |
|
Other expense |
— |
|
|
(5 |
) |
|
(39 |
) |
|
(25 |
) |
Total other income, net |
149 |
|
|
651 |
|
|
1,362 |
|
|
1,767 |
|
Net loss |
(17,840 |
) |
|
(23,123 |
) |
|
(79,776 |
) |
|
(76,934 |
) |
Accretion of redeemable
convertible preferred stock to redemption value |
— |
|
|
— |
|
|
— |
|
|
(6,371 |
) |
Net loss attributable to
common stockholders |
$ |
(17,840 |
) |
|
$ |
(23,123 |
) |
|
$ |
(79,776 |
) |
|
$ |
(83,305 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.63 |
) |
|
$ |
(0.84 |
) |
|
$ |
(2.86 |
) |
|
$ |
(5.54 |
) |
Weighted average common shares
outstanding, basic and diluted |
28,136 |
|
|
27,507 |
|
|
27,879 |
|
|
15,036 |
|
Investor Contact:Will O'Connor, Stern Investor
Relationswill@sternir.com212-362-1200
Media Contact:Stephanie Simon, Ten Bridge
Communicationsstephanie@tenbridgecommunications.com617-581-9333
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