Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage
biotechnology company committed to discovering and delivering the
next generation of precision cancer medicines, reported its
financial results for the third quarter ended September 30,
2023, and provided business highlights.
“We continue to make excellent progress across our precision
oncology pipeline, led by our two MTA-cooperative PRMT5 inhibitors
for MTAP-deleted cancers. For TNG462, we dosed the first patient in
the phase 1/2 trial in July 2023. TNG908 is also actively enrolling
patients and remains on track for a clinical update in 2024. Both
molecules have the potential to become important treatments for the
broad range of patients with MTAP-deleted cancers,” said Barbara
Weber, M.D., President and Chief Executive Officer of Tango
Therapeutics. “In addition, in June 2023, we initiated the phase
1/2 trial of TNG260, a first-in-class inhibitor of the CoREST
complex for the treatment of STK11-mutant cancers. In September
2023, we received FDA clearance of our IND application for TNG348,
a USP1 inhibitor for BRCA1/2 mutant and other HRD+ cancers, and we
plan to initiate the clinical trial in the first half of next year.
With additional capital resources following our August private
placement financing and our dedicated team, we believe we are
well-positioned to deliver proof-of-concept data on our four
clinical programs."
Recent Business Highlights
Pipeline Update
TNG908 phase 1 dose escalation ongoing
- Dose escalation and patient enrollment is ongoing in the phase
1/2 clinical trial evaluating TNG908 in patients with MTAP-deleted
solid tumors, including glioblastoma. Safety, tolerability and
pharmacokinetics are favorable.
- MTAP deletions occur in approximately 10%-15% of all human
cancers, including 40% of glioblastoma (GBM).
TNG462, a potentially best-in-class MTA-cooperative
PRMT5 inhibitor
- Dose escalation is ongoing in the TNG462 phase 1/2 clinical
trial in patients with MTAP-deleted solid tumors.
- TNG462 has the same mechanism of action as TNG908, but with
enhanced potency and selectivity in MTAP-deleted cell lines and
patient-derived xenografts. In preclinical studies, TNG462 is 45X
selective for MTAP-deleted cancer cells versus normal cells and
~30X more potent than TNG908.
TNG260, a first-in-class, highly selective CoREST
complex inhibitor
- Dose escalation is ongoing in the TNG260 phase 1/2 clinical
trial evaluating the safety, pharmacokinetics, pharmacodynamics and
efficacy of TNG260 in combination with pembrolizumab in patients
with locally advanced or metastatic solid tumors with an STK11
loss-of-function mutation.
- STK11 mutations occur in approximately 15% of NSCLC, 15% of
cervical, 10% of carcinoma of unknown primary, 5% of breast and 3%
of pancreatic cancers.
TNG348, a novel USP1 inhibitor
- The FDA granted Fast Track designation (FTD) for TNG348 in
September 2023 for the treatment of BRCA1/2-mutant breast and
ovarian cancer. FTD is designed to facilitate the development and
expedite the review of drugs to treat serious conditions and
fulfill an unmet need, with the potential to allow drugs to reach
more patients faster.
- In September 2023, the Company announced FDA clearance of the
TNG348 Investigational New Drug (IND) application.
- Initiation of the TNG348 phase 1/2 clinical trial is planned
for the first half of 2024. The trial will evaluate the safety,
pharmacokinetics, pharmacodynamics and efficacy of TNG348 as a
single agent and in combination with olaparib, a PARP inhibitor, in
patients with BRCA1/2-mutant and other HRD+ (homologous
recombination deficient) cancers.
- HRD+ cancers, including BRCA1/2 mutations, represent up to 50%
of ovarian cancers, 25% of breast cancers, 10% of prostate cancers
and 5% of pancreatic cancers.
Upcoming Milestones
- TNG348 phase 1/2 clinical trial initiation expected 1H
2024.
- Additional data from the ongoing TNG908 clinical trial expected
2024.
Corporate Updates
- In November 2023, Kanishka Pothula, a partner at Nextech
Ventures, was appointed to the Company's Board of Directors.
Previously, Mr. Pothula spent over 10 years with BVF Partners, a
biotechnology-focused hedge fund. He holds a B.S. in bioengineering
from the University of California San Diego and an M.S. in
biotechnology from Georgetown University.
- In November 2023, Reid Huber, Ph.D., a partner at Third Rock
Ventures, stepped down from his role on the Board of
Directors.
- In October 2023, Jannik Andersen, Ph.D., was promoted to Chief
Scientific Officer. Dr. Andersen, who joined the Company as Head of
Biology in January 2019, led the drug discovery efforts of TNG908,
TNG462, TNG260 and TNG348.
- In August 2023, the Company announced the appointment of John
Ketchum to its Board of Directors and the resignation of Aaron
Davis.
- In August 2023, the Company announced the closing of an $80
million private placement financing with participation from new and
existing healthcare investors.
Scientific Presentations
Society for NeuroOncology (SNO) 28th Annual Meeting,
November 15-19, 2023, Vancouver, Canada
- In November 2023, preclinical data will be presented in two
poster presentations supporting the development of PRMT5 inhibitors
in MTAP-deleted glioblastoma and malignant peripheral nerve sheath
tumors.
Society for Immunotherapy of Cancer (SITC) 38th Annual
Meeting, November 1-5, 2023, San Diego, CA
- In November 2023, Tango scientists presented preclinical data
highlighting the potential of TNG260 in STK11-mutant cancers.
- Preclinically, TNG260 combined with anti-PD1 therapy drives
tumor regression in STK11-deficient models that are resistant to
anti-PD1 monotherapy.
- These data further demonstrate the ability of TNG260 to alter
the expression of immunomodulatory genes in STK11-deficient cancer
cells, restoring sensitivity to anti-PD1 therapy, and support the
ongoing phase 1/2 clinical trial of TNG260 in combination with
pembrolizumab.
AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics, October 11-15, 2023, Boston,
MA
- In October 2023, Tango scientists presented five posters
highlighting preclinical data from the precision oncology pipeline
and synthetic lethality discovery platform.
Financial Results
As of September 30, 2023, the Company held $359.9 million
in cash, cash equivalents and marketable securities, which the
Company believes to be sufficient to fund operations into 2026.
Collaboration revenue was $10.7 million for the three months
ended September 30, 2023, compared to $6.9 million for the
same period in 2022, and $26.1 million for the nine months ended
September 30, 2023 compared to $18.4 million for the same
period in 2022. The increase was due to higher research costs
incurred under the collaboration resulting in higher collaboration
revenue recognized.
License revenue was $0 and $5.0 million for the three and nine
months ended September 30, 2023, respectively, compared to $0
for both the three and nine months ended September 30, 2022.
The year-to-date increase is the result of out-licensing a program
to Gilead for $5.0 million during the second quarter of 2023.
Research and development expenses were $27.1 million for the
three months ended September 30, 2023, compared to $28.7
million for the same period in 2022, and $83.9 million for the nine
months ended September 30, 2023 compared to $76.8 million for
the same period in 2022. The change is primarily due to increased
personnel-related costs to support our research and development
activities.
General and administrative expenses were $9.2 million for the
three months ended September 30, 2023, compared to $8.1
million for the same period in 2022, and $26.4 million for the nine
months ended September 30, 2023 compared to $22.1 million for
the same period in 2022. The change was primarily due to increases
in personnel-related costs.
Net loss for the three months ended September 30, 2023 was
$22.3 million, or $0.23 per share, compared to a net loss of $29.1
million, or $0.33 per share, in the same period in 2022. Net loss
for the nine months ended September 30, 2023 was $71.0
million, or $0.78 per share, compared to a net loss of $79.1
million, or $0.90 per share, in the same period in 2022.
About Tango Therapeutics
Tango Therapeutics is a clinical-stage biotechnology company
dedicated to discovering novel drug targets and delivering the next
generation of precision medicine for the treatment of cancer. Using
an approach that starts and ends with patients, Tango leverages the
genetic principle of synthetic lethality to discover and develop
therapies that take aim at critical targets in cancer. This
includes expanding the universe of precision oncology targets into
novel areas such as tumor suppressor gene loss and their
contribution to the ability of cancer cells to evade immune cell
killing. For more information, please visit www.tangotx.com.
Forward-Looking Statements
Certain statements in this press release may be considered
forward-looking statements. Forward-looking statements generally
relate to future events, Tango’s future operating performance and
goals, the anticipated benefits of therapies and combination
therapies (that include a Tango pipeline product), as well as the
expectations, beliefs and development objectives for Tango’s
product pipeline and clinical trials. In some cases, you can
identify forward-looking statements by terminology such as “may”,
“should”, “expect”, “intend”, “will”, “goal”, “estimate”,
“anticipate”, “believe”, “predict”, “designed,” “potential” or
“continue”, or the negatives of these terms or variations of them
or similar terminology. For example, implicit or explicit
statements concerning the following include or constitute
forward-looking statements: dose escalation is ongoing in certain
Tango clinical trials; additional data from the TNG908 clinical
trial is expected in 2024; phase 1/2 clinical trial
initiation for TNG348 expected in the first half of 2024 (and the
endpoints that the trial will evaluate); cash runway into 2026
expected to fund all clinical programs through proof-of-concept
(and cash, cash equivalents and marketable securities are believed
to be sufficient to fund operations into 2026); Tango is committed
to discovering and delivering the next generation of precision
cancer medicines; the Company continues to make excellent progress
across its precision oncology pipeline; TNG908 is actively
enrolling patients and remains on track for a clinical update in
2024; TNG908 and TNG462 have the potential to become important
treatments for the broad range of patients with MTAP-deleted
cancers; Tango is well-positioned to deliver proof-of-concept data
on its four clinical programs; TNG462 is a potentially
best-in-class MTA-cooperative PRMT5 inhibitor; certain pre-clinical
data support the ongoing phase 1/2 clinical trial of TNG260 in
combination with pembrolizumab; the Fast Track designation of
TNG348 and potential benefits resulting from such designation;
Tango’s growth as a company and expectations regarding its expected
cash runway, uses of capital, expenses, and financial results; and
the expected timing of: (i) development candidate declaration for
certain targets, (ii) initiating IND-enabling studies; (iii) filing
INDs; (iv) clinical trial initiation and (v) disclosing initial,
interim and final clinical trial results; and the expected benefits
of the Company's development candidates and other product
candidates. Such forward-looking statements are subject to
risks, uncertainties, and other factors which could cause actual
results to differ materially from those expressed or implied by
such forward-looking statements. These forward-looking statements
are based upon estimates and assumptions that, while considered
reasonable by Tango and its management, are inherently uncertain.
New risks and uncertainties may emerge from time to time, and it is
not possible to predict all risks and uncertainties. Factors
that may cause actual results to differ materially from current
expectations include, but are not limited to: benefits of product
candidates seen in preclinical analyses may not be evident when
tested in later preclinical studies or in clinical trials or when
used in broader patient populations (if approved for commercial
sale); Tango has limited experience conducting clinical trials (and
will rely on a third party to operate its clinical trials) and may
not be able to commence the clinical trial (including opening
clinical trial sites, dosing the first patient, and enrolling and
dosing of an adequate number of clinical trial participants) when
expected, may not be able to continue dosing (and dose escalation)
on anticipated timelines, and may not generate results (including
final or initial safety, efficacy data and proof-of-mechanism and
proof-of-concept) in the anticipated timeframe (or at all); Tango’s
pipeline products may not be safe and/or effective in humans; Tango
has a limited operating history and has not generated any revenue
to date from product sales, and may never become profitable; other
companies may be able to identify and develop product candidates
more quickly than the Company and commercially introduce the
product prior to the Company; the Company’s proprietary discovery
platform is novel and may not identify any synthetic lethal targets
for future development; the Company may not be able to identify
development candidates on the schedule it anticipates due to
technical, financial or other reasons; the Company may not be able
to file INDs for development candidates on time, or at all, due to
technical or financial reasons or otherwise; the Company may
utilize cash resources more quickly than anticipated; Tango will
need to raise capital in the future and if we are unable to raise
capital when needed or on attractive terms, we would be forced to
delay, scale back or discontinue some of our development programs
or future commercialization efforts (which may delay filing of
INDs, dosing patients, reporting clinical trial results and filing
new drug applications); Tango’s approach to the discovery and
development of product candidates is novel and unproven, which
makes it difficult to predict the time, cost of development, and
likelihood of successfully developing any products; the Company may
be unable to advance our preclinical development programs into and
through the clinic for safety or efficacy reasons or commercialize
our product candidates or we may experience significant delays in
doing so as a result of factors beyond Tango’s control; the Company
may not be able to realize the benefits of Fast Track designation
(and such designation may not advance any anticipated approval
timelines); Tango may not identify or discover additional product
candidates or may expend limited resources to pursue a particular
product candidate or indication and fail to capitalize on product
candidates or indications that may be more profitable or for which
there is a greater likelihood of success; the Company’s product
candidates may cause adverse or other undesirable side effects (or
may not show requisite efficacy) that could, among other things,
delay or prevent regulatory approval; our dependence on third
parties for conducting clinical trials and producing drug product;
our ability to obtain and maintain patent and other intellectual
property protection for our technology and product candidates or
the scope of intellectual property protection obtained is not
sufficiently broad; and delays and other impacts on product
development and clinical trials from the COVID-19 pandemic.
Additional information concerning risks, uncertainties and
assumptions can be found in Tango’s filings with the SEC, including
the risk factors referenced in Tango’s Annual Report on Form 10-K
for the fiscal year ended December 31, 2022, as supplemented and/or
modified by its most recent Quarterly Report on Form 10-Q. You
should not place undue reliance on forward-looking statements in
this press release, which speak only as of the date they are made
and are qualified in their entirety by reference to the cautionary
statements herein. Tango specifically disclaims any duty to update
these forward-looking statements.
Investor Contact:Sam Martin/Andrew Vulis Argot
Partners tango@argotpartners.com
Media Contact:Amanda Galgay SVP, Corporate
Communications, Tango Therapeutics media@tangotx.com
Consolidated Statements of Operations |
(In thousands, except share and per share
data) |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
|
10,732 |
|
|
|
6,920 |
|
|
|
26,096 |
|
|
|
18,449 |
|
License revenue |
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
Total revenue |
|
|
10,732 |
|
|
|
6,920 |
|
|
|
31,096 |
|
|
|
18,449 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
27,149 |
|
|
|
28,744 |
|
|
|
83,859 |
|
|
|
76,815 |
|
General and administrative |
|
|
9,209 |
|
|
|
8,099 |
|
|
|
26,397 |
|
|
|
22,138 |
|
Total operating expenses |
|
|
36,358 |
|
|
|
36,843 |
|
|
|
110,256 |
|
|
|
98,953 |
|
Loss from operations |
|
|
(25,626 |
) |
|
|
(29,923 |
) |
|
|
(79,160 |
) |
|
|
(80,504 |
) |
Other income, net |
|
|
3,386 |
|
|
|
873 |
|
|
|
8,266 |
|
|
|
1,391 |
|
Provision for income taxes |
|
|
(23 |
) |
|
|
— |
|
|
|
(87 |
) |
|
|
(3 |
) |
Net loss |
|
$ |
(22,263 |
) |
|
$ |
(29,050 |
) |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.90 |
) |
Weighted average number of
common shares outstanding – basic and diluted |
|
|
97,033,273 |
|
|
|
87,892,195 |
|
|
|
91,268,133 |
|
|
|
87,868,081 |
|
Condensed Consolidated Balance Sheets |
(In thousands) |
|
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
58,533 |
|
|
$ |
59,968 |
|
Marketable securities |
|
|
301,347 |
|
|
|
306,165 |
|
Accounts receivable |
|
|
— |
|
|
|
2,000 |
|
Restricted cash |
|
|
856 |
|
|
|
567 |
|
Prepaid expenses and other current assets |
|
|
10,155 |
|
|
|
6,572 |
|
Total current assets |
|
|
370,891 |
|
|
|
375,272 |
|
Property and equipment,
net |
|
|
10,261 |
|
|
|
10,884 |
|
Operating lease right-of-use
assets |
|
|
44,422 |
|
|
|
46,886 |
|
Restricted cash, net of
current portion |
|
|
2,567 |
|
|
|
3,423 |
|
Other assets |
|
|
48 |
|
|
|
5 |
|
Total assets |
|
$ |
428,189 |
|
|
$ |
436,470 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,837 |
|
|
$ |
4,453 |
|
Accrued expenses and other current liabilities |
|
|
11,467 |
|
|
|
17,495 |
|
Operating lease liabilities |
|
|
2,040 |
|
|
|
1,770 |
|
Deferred revenue |
|
|
27,072 |
|
|
|
31,792 |
|
Income tax payable |
|
|
— |
|
|
|
35 |
|
Total current liabilities |
|
|
43,416 |
|
|
|
55,545 |
|
Operating lease liabilities,
net of current portion |
|
|
37,466 |
|
|
|
39,361 |
|
Deferred revenue, net of
current portion |
|
|
70,712 |
|
|
|
92,088 |
|
Total liabilities |
|
|
151,594 |
|
|
|
186,994 |
|
Total stockholders’ equity |
|
|
276,595 |
|
|
|
249,476 |
|
Total liabilities and stockholders’ equity |
|
$ |
428,189 |
|
|
$ |
436,470 |
|
Tango Therapeutics (NASDAQ:TNGX)
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Tango Therapeutics (NASDAQ:TNGX)
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