– Dose expansion initiated in TNG908 phase 1/2
clinical trial –
– Dose expansion expected to initiate in TNG462
phase 1/2 clinical trial in 2Q 2024 –
– Clinical data expected in 2H 2024 from PRMT5
program –
– Dose escalation ongoing in TNG260 and TNG348
clinical-stage precision oncology programs –
– Strong cash position of $344 million as of
March 31, 2024; cash runway into late 2026 expected to fund all
clinical programs through proof-of-concept –
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 first quarter ended March 31, 2024, and
provided business highlights.
“We are progressing both TNG908 and TNG462 into dose expansion
in order to accelerate our clinical development. We look forward to
sharing a comprehensive clinical data update on our PRMT5 program
in the second half of this year,” said Barbara Weber, M.D.,
President and Chief Executive Officer of Tango Therapeutics. “We
continue to make substantial progress across our other programs as
enrollment and dose escalation are continuing in the phase 1/2
clinical trials of TNG260 and TNG348. Finally, we welcomed the
newest member of our leadership team, Julie Carretero, as Chief
Human Resources Officer. She will play an instrumental role in
growing the company while maintaining our culture at a pivotal time
for the company.”
Recent Business Highlights
Pipeline Update
TNG908, a blood-brain barrier penetrant, MTA-cooperative
PRMT5 inhibitor
- Expansion cohorts have been opened in MTAP-deleted solid tumors
in glioblastoma (GBM), non-small cell lung and pancreatic cancers
at 600 mg BID in the TNG908 phase 1/2 clinical trial.
- MTAP deletions occur in approximately 10%-15% of all human
cancers, including 40% of GBM.
TNG462, a potentially best-in-class MTA-cooperative PRMT5
inhibitor
- Dose expansion is expected to initiate in the TNG462 phase 1/2
clinical trial in 2Q 2024.
- The safety, tolerability and pharmacokinetic profiles of TNG462
remain favorable with increasing doses.
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. To date, safety, tolerability and
pharmacokinetic profiles remain favorable.
- 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
- Single agent dose escalation is ongoing in the TNG348 phase 1/2
clinical trial evaluating 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.
- Early clinical data support switch to once-a-day dosing.
- Single agent dose escalation pharmacokinetic, pharmacodynamic,
safety and tolerability data are favorable and support the opening
of the combination cohort with olaparib in 2Q 2024.
- 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
- Dose expansion in the TNG462 phase 1/2 clinical trial is
expected to initiate in 2Q 2024.
- A comprehensive update of the PRMT5 program, including clinical
data from the ongoing phase 1/2 clinical trials of TNG908 and
TNG462, is expected in 2H 2024.
Scientific Publications
- “Discovery of TNG908: A Selective, Brain Penetrant,
MTA-Cooperative PRMT5 Inhibitor That Is Synthetically Lethal with
MTAP-Deleted Cancers,” was published in March in the Journal of
Medicinal Chemistry.
Leadership Update
- Julie Carretero joined as Chief Human Resources Officer in
March. Ms. Carretero brings over 25 years of biopharmaceutical and
human resources experience to this newly created role. Most
recently, Ms. Carretero served as Chief People Officer at Evelo
Biosciences where she oversaw growth from a clinical to a
commercial-stage company. Previously she held senior human
resources roles at multiple companies, including FXI, Matter
Communications and Novartis.
Financial Results
As of March 31, 2024, the Company held $343.6 million in cash,
cash equivalents and marketable securities, which the Company
expects to be sufficient to fund operations into late 2026.
Collaboration revenue was $6.5 million for the three months
ended March 31, 2024, compared to $5.8 million for the same period
in 2023. Research costs incurred under the collaboration were
similar during each of the three-month periods presented which
resulted in similar collaboration revenue amounts recognized.
Research and development expenses were $38.1 million for the
three months ended March 31, 2024, compared to $28.0 million for
the same period in 2023. The change is due to increased spend
relating to the advancement of our clinical programs and
personnel-related costs to support our research and development
activities.
General and administrative expenses were $10.7 million for the
three months ended March 31, 2024, compared to $8.0 million for the
same period in 2023. The change was primarily due to increases in
personnel-related costs.
Net loss for the three months ended March 31, 2024 was $37.9
million, or $0.35 per share, compared to a net loss of $28.0
million, or $0.32 per share, in the same period in 2023.
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 expansion expected to initiate in
TNG462 phase 1/2 clinical trial in 2Q 2024; clinical data expected
in 2H 2024 from PRMT5 program; Company expects cash runway into
late 2026 and this cash runway is expected to fund all clinical
programs through proof-of-concept; the Company is progressing both
TNG908 and TNG462 into dose expansion in order to accelerate
clinical development; Company expects to share a comprehensive
clinical data update on our PRMT5 program in the second half of
this year; Company continues to make substantial progress across
other programs as enrollment and dose escalation are continuing in
the phase 1/2 clinical trials of TNG260 and TNG348; early clinical
data for TNG348 support switch to once-a-day dosing; single agent
dose escalation pharmacokinetic, pharmacodynamic, safety and
tolerability data for TNG348 support opening of combination with
olaparib in 2Q 2024; a comprehensive update of the PRMT5 program,
including clinical data from ongoing phase 1/2 clinical trials of
TNG908 and TNG462, is expected in 2H 2024; Tango is committed to
discovering and delivering the next generation of precision cancer
medicines; and the expected timing of: (i) development candidate
declaration for certain targets; (ii) initiating IND-enabling
studies; (iii) filing INDs; (iv) clinical trial initiation, dose
escalation and dose expansion and (v) disclosing initial, interim,
additional 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 tests and 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 continued enrollment and dosing of an adequate number of
clinical trial participants) when expected, may not be able to
continue dosing, initiate dose escalation and/or dose expansion on
anticipated timelines, and may not generate results (including
final, initial or additional 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, initiation of dose expansion, 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 ODD or Fast Track designation (and such designations
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 one or a limited
number third parties for conducting clinical trials and producing
drug substance and drug product (including drug substance, which is
currently sole sourced); government regulation may negatively
impact the Company’s business, including the potential approval of
the BIOSECURE Act; and 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. 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, 2023, 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.
Consolidated Statements of
Operations
(In thousands, except share
and per share data)
Three Months Ended March
31,
2024
2023
Collaboration revenue
$
6,471
$
5,766
Operating expenses:
Research and development
38,065
28,039
General and administrative
10,661
8,013
Total operating expenses
48,726
36,052
Loss from operations
(42,255
)
(30,286
)
Other income, net
4,381
2,278
Loss before income taxes
(37,874
)
(28,008
)
Provision for income taxes
(40
)
—
Net loss
$
(37,914
)
$
(28,008
)
Net loss per common share – basic and
diluted
$
(0.35
)
$
(0.32
)
Weighted average number of common shares
outstanding – basic and diluted
108,171,463
88,193,917
Consolidated Balance
Sheets
(In thousands)
March 31, 2024
December 31, 2023
Assets
Current assets:
Cash and cash equivalents
$
61,163
$
66,385
Marketable securities
282,436
270,500
Restricted cash
—
856
Prepaid expenses and other current
assets
8,437
8,797
Total current assets
352,036
346,538
Property and equipment, net
9,522
9,908
Operating lease right-of-use assets
42,086
43,508
Restricted cash, net of current
portion
2,567
2,567
Other assets
11
46
Total assets
$
406,222
$
402,567
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
3,898
$
2,785
Accrued expenses and other current
liabilities
13,755
15,401
Operating lease liabilities
2,066
2,082
Deferred revenue
23,070
25,670
Total current liabilities
42,789
45,938
Operating lease liabilities, net of
current portion
36,169
36,838
Deferred revenue, net of current
portion
62,812
66,683
Total liabilities
141,770
149,459
Total stockholders’ equity
264,452
253,108
Total liabilities and stockholders’
equity
$
406,222
$
402,567
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240508412703/en/
Investors: Sam Martin/Andrew Vulis Argot Partners
tango@argotpartners.com
Media: Amanda Brown Galgay SVP, Corporate Communications,
Tango Therapeutics media@tangotx.com
Tango Therapeutics (NASDAQ:TNGX)
Historical Stock Chart
From Jul 2024 to Aug 2024
Tango Therapeutics (NASDAQ:TNGX)
Historical Stock Chart
From Aug 2023 to Aug 2024