Tango Therapeutics, Inc. (NASDAQ: TNGX), a biotechnology company
committed to discovering and delivering the next generation of
precision cancer medicines, reported its financial results for the
second quarter ended June 30, 2022 and provided business
highlights.
“We are continuing to advance our lead
MTA-cooperative PRMT5 inhibitor program, TNG908, as we actively
enroll patients with MTAP-deleted solid tumors in an ongoing Phase
1/2 trial,” said Barbara Weber, M.D., President and Chief Executive
Officer of Tango Therapeutics. “Receiving Orphan Drug Designation
for TNG908 highlights the unmet need for novel therapies that may
improve outcomes for patients with MPNST. We continue to progress
IND-enabling studies of TNG462, our next-generation PRMT5
inhibitor, and TNG260, a small molecule inhibitor that reverses the
immune evasion effect of STK11 mutations, as we advance both
programs towards IND submission in the first half of 2023.”
Recent Business Highlights
• TNG908 Phase 1/2 clinical trial
ongoing in patients with MTAP-deleted solid tumors; TNG908 received
Orphan Drug Designation (ODD): Patients are actively being
enrolled in the ongoing Phase 1/2 trial of TNG908. The Company
expects to have initial safety and efficacy data in the 1H
2023.
The U.S. Food and Drug Administration (FDA)
granted ODD to TNG908 for the treatment of malignant peripheral
nerve sheath tumors (MPNST). The FDA's Orphan Drug Designation is
granted to investigational therapies addressing rare medical
diseases or conditions that affect fewer than 200,000 people in the
United States. This designation provides for a seven-year marketing
exclusivity period upon regulatory approval, as well as certain
incentives, including federal grants and tax credits.
TNG908 is an MTA-cooperative small molecule
inhibitor of protein arginine methyltransferase 5 (PRMT5) designed
to selectively kill cancer cells with methylthioadenosine
phosphorylase (MTAP) deletions. MTAP deletions occur in
approximately 10% - 15% of all human cancers, including non-small
cell lung cancer, mesothelioma, cholangiocarcinoma and
glioblastoma.
- TNG462, a next-generation MTA-cooperative PRMT5
inhibitor, declared as a development candidate in 2Q 2022:
In May 2022, the Company disclosed TNG462, a next-generation PRMT5
inhibitor, is 45-fold more potent in cells with MTAP deletions than
those without and induces deep tumor regressions in preclinical
models of multiple cancer types. The Company plans to file an IND
for TNG462 in the first half of 2023. The clinical development path
for TNG462 is expected to be similar to TNG908, evaluating safety
and efficacy in multiple tumor types in a Phase 1/2 clinical trial.
Unlike TNG908, glioblastoma will be excluded from the clinical
trial as TNG462 does not cross the blood-brain barrier in
preclinical non-human primate models.
- TNG260, a small molecule inhibitor that reverses the
immune evasion effect of STK11 mutations, declared as a development
candidate in 2Q 2022: Also previously disclosed by the
Company, TNG260 was declared a development candidate in the second
quarter of 2022. TNG260 inhibits Target 3, an undisclosed synthetic
lethal target that reverses the immune evasion effect of
serine-threonine kinase 11 (STK11) loss-of-function mutations in
cancer models. The Company expects to file an IND for this program
in the first half of 2023. STK11 mutations occur in approximately
15% of non-small cell lung cancers, 15% of cervical cancers, 10%
carcinoma of unknown primary, 5% of breast cancers and 3% of
pancreatic cancers.
- Preclinical data on the Tango discovery platform, a
USP1 inhibitor program and TNG908 presented at 2022 American
Association for Cancer Research (AACR) Annual Meeting. In
April, the Company presented three posters at the 2022 AACR Annual
Meeting. The posters highlight the potential applicability of
synthetic lethal drugs targeting across a range of cancer types,
including with TNG908 and the USP1 (ubiquitin-specific protease 1)
program.
- TNGX added to the Russell 2000®, 3000® and Microcap®
Indexes. In June 2022, as part of the Russell indexes
annual reconstitution, Tango was added to the Russell 2000®, 3000®
and Microcap® Indexes.
Financial Results
As of June 30, 2022, the Company held $416.4
million in cash, cash equivalents and marketable securities.
Collaboration revenue was $5.8 million for the
three months ended June 30, 2022, compared to $7.2 million for the
same period in 2021, and $11.5 million for the six months ending on
June 30, 2022 compared to $13.5 million for the same period in
2021. The decrease was due to lower research costs incurred under
the Gilead collaboration during the three and six months ended
June 30, 2022 resulting in lower collaboration revenue
recognized.
License revenue was $0 for both the three and six
months ended June 30, 2022, compared to $11.0 million for both
the three and six months ended June 30, 2021. The decrease of
$11.0 million is primarily due to Gilead licensing a program for
$11.0 million during the second quarter of 2021.
Research and development expenses were $23.7
million for the three months ended June 30, 2022, compared to $19.1
million for the same period in 2021, and $48.1 million for the six
months ending on June 30, 2022 compared to $34.1 million for the
same period in 2021. The change is primarily due to increased spend
relating to the advancement of the TNG462 and TNG260 programs and
personnel-related costs.
General and administrative expenses were $7.2
million for the three months ended June 30, 2022, compared to $3.6
million for the same period in 2021, and $14.0 million for the six
months ending on June 30, 2022 compared to $7.1 million for the
same period in 2021. The change was primarily due to increases in
personnel-related costs.
Net loss for the three months ended June 30, 2022
was $24.9 million, or $ 0.28 per share, compared to a net loss of
$4.5 million, or $0.09 per share, in the same period in 2021. Net
loss for the six months ended June 30, 2022 was $50.1 million, or
$0.57 per share, compared to a net loss of $16.6 million, or $0.37
per share, in the same period in 2021.
About Tango Therapeutics
Tango Therapeutics is a 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),
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”, “potential” or “continue”, or
the negatives of these terms or variations of them or similar
terminology. For example, statements concerning the following
include or constitute forward-looking statements: patients being
actively enrolled in the TNG908 Phase 1/2 clinical trial; the
Company remains confident in its ability to advance its programs
through the clinic; the Company is continuing to successfully
advance the lead PRMT5 inhibitor program; the Company expects to
have initial safety and efficacy data in connection with the TNG908
Phase 1/2 clinical trial in the 1H 2023; Tango expects to advance
TNG462 and TNG260 towards IND submission in the first half of 2023;
the Company plans to file an INDs for TNG462 and TNG260 in the
first half of 2023; the clinical development path for TNG462 is
expected to be similar to TNG908; the indications expected to be
included in Company clinical trials; the potential applicability of
synthetic lethal drugs targeting across a range of cancer types,
including TNG908 and the USP1 program; expectations regarding
progressing Company development candidates in 2022 and beyond; the
expected benefits of TNG908 and the Company's other development
candidates and other product candidates; 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 and final clinical
trial results. 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: Tango has limited
experience conducting clinical trials (and will rely on a third
party to operate the clinical trial for TNG908) and may not be able
to commence the clinical trial (including opening clinical trial
sites and enrolling and dosing an adequate number of clinical trial
participants) when expected and may not generate results (including
final or initial safety and efficacy data) in the anticipated
timeframe (or at all); benefits of product candidates seen in
preclinical analyses may not be evident when tested in clinical
trials or when used in broader patient populations (if approved for
commercial sale); the benefits of Tango pipeline products,
development candidates and potential combination therapies that are
seen in pre-clinical experiments may not be present in clinical
trials or in use commercially or may not be safe and/or effective
in humans; Tango has a limited operating history and has not
generated any revenue to date from drug sales, and may never become
profitable; 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; we 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’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; 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; our products 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, 2021, 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 presentation, 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: Joshua R. Mansbach
Argot Partners tango@argotpartners.com
Consolidated Statements of
Operations (In thousands, except share and per
share data)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Collaboration revenue |
|
$ |
5,771 |
|
|
$ |
7,153 |
|
|
$ |
11,529 |
|
|
$ |
13,539 |
|
License revenue |
|
|
- |
|
|
|
11,000 |
|
|
|
- |
|
|
|
11,000 |
|
Total revenue |
|
$ |
5,771 |
|
|
$ |
18,153 |
|
|
$ |
11,529 |
|
|
$ |
24,539 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
23,741 |
|
|
|
19,079 |
|
|
|
48,071 |
|
|
|
34,079 |
|
General and administrative |
|
|
7,232 |
|
|
|
3,630 |
|
|
|
14,039 |
|
|
|
7,097 |
|
Total operating expenses |
|
|
30,973 |
|
|
|
22,709 |
|
|
|
62,110 |
|
|
|
41,176 |
|
Loss from operations |
|
|
(25,202 |
) |
|
|
(4,556 |
) |
|
|
(50,581 |
) |
|
|
(16,637 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
297 |
|
|
|
104 |
|
|
|
515 |
|
|
|
208 |
|
Other income (expense), net |
|
|
50 |
|
|
|
(62 |
) |
|
|
3 |
|
|
|
(117 |
) |
Total other income, net |
|
|
347 |
|
|
|
42 |
|
|
|
518 |
|
|
|
91 |
|
Loss before income taxes |
|
|
(24,855 |
) |
|
|
(4,514 |
) |
|
|
(50,063 |
) |
|
|
(16,546 |
) |
(Provision for) benefit from income taxes |
|
|
(3 |
) |
|
|
21 |
|
|
|
(3 |
) |
|
|
(53 |
) |
Net loss |
|
$ |
(24,858 |
) |
|
$ |
(4,493 |
) |
|
$ |
(50,066 |
) |
|
$ |
(16,599 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.37 |
) |
Weighted average number of common shares outstanding – basic and
diluted |
|
|
87,839,804 |
|
|
|
48,524,511 |
|
|
|
87,775,440 |
|
|
|
45,088,434 |
|
Consolidated Balance Sheets
(In thousands)
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
104,582 |
|
|
$ |
142,745 |
|
Marketable securities |
|
|
311,774 |
|
|
|
342,510 |
|
Accounts receivable |
|
|
2,000 |
|
|
|
2,000 |
|
Restricted cash |
|
|
567 |
|
|
|
567 |
|
Prepaid expenses and other current assets |
|
|
17,162 |
|
|
|
4,516 |
|
Total current assets |
|
|
436,085 |
|
|
|
492,338 |
|
Property and equipment, net |
|
|
8,359 |
|
|
|
4,832 |
|
Operating lease right-of-use assets |
|
|
520 |
|
|
|
1,254 |
|
Restricted cash, net of current portion |
|
|
3,423 |
|
|
|
1,712 |
|
Other assets |
|
|
12 |
|
|
|
19 |
|
Total assets |
|
$ |
448,399 |
|
|
$ |
500,155 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,693 |
|
|
$ |
3,226 |
|
Accrued expenses and other current liabilities |
|
|
14,161 |
|
|
|
9,887 |
|
Operating lease liabilities |
|
|
629 |
|
|
|
1,503 |
|
Deferred revenue |
|
|
28,200 |
|
|
|
26,022 |
|
Income tax payable |
|
|
1 |
|
|
|
52 |
|
Total current liabilities |
|
|
44,684 |
|
|
|
40,690 |
|
Deferred revenue, net of current portion |
|
|
105,011 |
|
|
|
114,718 |
|
Total liabilities |
|
|
149,695 |
|
|
|
155,408 |
|
Total stockholders’ equity |
|
|
298,704 |
|
|
|
344,747 |
|
Total liabilities and stockholders’ equity |
|
$ |
448,399 |
|
|
$ |
500,155 |
|
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