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, 2023, and
provided business highlights.
“The dose escalation update from the ongoing
clinical trial of TNG908 marks a significant accomplishment, as it
is the first time proof-of-mechanism has been demonstrated for an
MTA-cooperative PRMT5 inhibitor. While it remains early in the
study, initial pharmacokinetic and pharmacodynamic data are
consistent with what we observed preclinically. These data provide
us with conviction in the mechanism of action of TNG908 to enable
selective targeting of cancers with MTAP deletion without causing
dose-limiting bone marrow toxicity. We look forward to providing
additional data from the trial in 2024,” said Barbara Weber, M.D.,
President and Chief Executive Officer of Tango Therapeutics. “In
addition, we continue to advance our pipeline of synthetic lethal
precision oncology programs. We received IND clearance from the FDA
to enroll patients in a phase 1/2 study of TNG260, a first-in-class
CoREST inhibitor for the treatment of STK11-mutant cancers and were
granted Fast Track designation for TNG260 in patients previously
treated with advanced NSCLC with STK11-loss of function
mutations.”
Recent Business Highlights
Pipeline Update
TNG908 proof-of-mechanism demonstrated
with marked differential PRMT5 inhibition in MTAP-deleted cancers
versus normal tissue
- As of May 9, 16 patients with MTAP-deleted solid tumors
representing 12 different histologies across four cohorts have been
treated, and dose escalation is continuing.
- Favorable pharmacokinetics with dose-proportional increases in
exposure across cohorts.
- TNG908 proof-of-mechanism as an MTA-cooperative PRMT5 inhibitor
demonstrated by marked SDMA reduction in MTAP-deleted cancer cells
versus normal tissue. SDMA is a direct measure of TNG908 target
engagement and PRMT5 inhibition.
- Pre-treatment and on-treatment biopsies (cycle 2/day 1)
demonstrated dose-dependent decreases in tumor SDMA with minimal or
no decrease in normal tissue. Selective inhibition of PRMT5 in
MTAP-deleted cancer cells is essential to enable the therapeutic
index needed for efficacy.
- TNG908 exposure in cohorts 1 and 2, while sufficient to show
marked differential effects on SDMA, is not yet within the
efficacious range predicted by preclinical modeling.
- Dose levels 3 and 4 ongoing, cohorts not yet evaluable for
efficacy.
- To-date, no dose-limiting toxicities (DLTs) or greater than
grade 2 related adverse events have been observed. Notably, there
has been no evidence of bone marrow suppression as determined by
peripheral blood counts.
- MTAP deletions occur in approximately 10%-15% of all human
cancers, including 40% of glioblastoma (GBM).
TNG462, a next-generation MTA-cooperative
PRMT5 inhibitor
- The TNG462 Investigational New Drug (IND) application cleared
in January 2023, and the first patient is expected to be dosed in
mid-2023. The trial will evaluate TNG462 in patients with
MTAP-deleted solid tumors. Unlike TNG908, GBM will be excluded from
this clinical trial, as TNG462 does not cross the blood-brain
barrier in preclinical models.
- TNG462 has the same mechanism of action as TNG908, with
enhanced potency and selectivity in MTAP-deleted cell lines and
patient-derived xenografts. In preclinical studies, TNG462 is 45X
more selective for MTAP-deleted cancer cells versus normal cells
and ~30X more potent than TNG908.
TNG260, a first-in-class CoREST complex
inhibitor
- The FDA granted Fast Track designation (FTD) for TNG260, an
inhibitor of the CoREST complex (Co-repressor of Repressor
Element-1 Silencing Transcription), in combination with an
anti-PD-1 antibody for the treatment of patients with previously
treated advanced NSCLC with STK11-mutations.
- In April, the Company announced FDA clearance of the TNG260 IND
application.
- Initiation of the TNG260 phase 1/2 clinical trial is planned
for the second half of 2023. The trial will evaluate the safety,
pharmacokinetics, pharmacodynamics and efficacy of TNG260 in
combination with pembrolizumab, with a one cycle single agent
run-in to evaluate the safety and PK of TNG260, in patients with
locally advanced or metastatic cancer solid tumors with an STK11
loss-of-function mutation.
- The CoREST complex plays a major role in regulating the
expression of immunomodulatory proteins. In preclinical studies,
TNG260 reverses the immune evasion effect of STK11 loss-of-function
mutations in STK11-mutant cancers and restores sensitivity to an
anti-PD-1 antibody.
- 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.
Upcoming Milestones
- First patient dose in the TNG462 phase 1/2 clinical trial
expected mid-2023.
- TNG348 IND filing expected mid-2023.
- TNG260 phase 1/2 clinical trial initiation expected 2H
2023.
- Additional data from the ongoing TNG908 clinical trial expected
2024.
Leadership Update
- In February 2023, the Company strengthened its management team
with the appointment of Adam Crystal, M.D., Ph.D., as President of
Research and Development.
Scientific Presentations
American Association for Cancer Research
(AACR) 2023 Annual Meeting, April 14-19, 2023, Orlando,
FL
- Tango scientists presented two oral and two poster
presentations highlighting preclinical data from four programs
across its pipeline of precision cancer medicines.
Financial Results
As of March 31, 2023, the Company held $333.6
million in cash, cash equivalents and marketable securities, which
the Company believes to be sufficient to fund operations into
2026.
Collaboration revenue was $5.8 million for the
three months ended March 31, 2023, compared to $5.8 million
for the same period in 2022. 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 $28.0
million for the three months ended March 31, 2023, compared to
$24.3 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 $8.0
million for the three months ended March 31, 2023, compared to
$6.8 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 March 31,
2023 was $28.0 million, or $0.32 per share, compared to a net loss
of $25.2 million, or $0.29 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),
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: the Company believes its cash, cash
equivalents and marketable securities are sufficient to fund
operations into 2026 (and to support advancing the Company’s
precision oncology pipeline); TNG908 dose escalation data provide
the Company with conviction in the mechanism of action of TNG908 to
enable selective targeting of cancers with MTAP deletion without
causing dose-limiting bone marrow toxicity; the Company will
provide additional data from the TNG908 trial in 2024; the Company
continues to advance its pipeline of synthetic lethal precision
oncology programs; dose escalation in the TNG908 clinical trial is
continuing; the first patient in the TNG462 clinical trial is
expected to be dosed in mid-2023; Initiation of the TNG260 phase
1/2 clinical trial is planned for the second half of 2023; TNG348
IND filing expected mid-2023; the expected benefits of the
Company's 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,
interim 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 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 an adequate number of clinical trial participants) when
expected 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); 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 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); 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, 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 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: 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
March 31, |
|
|
|
2023 |
|
|
2022 |
|
Total revenue |
|
|
5,766 |
|
|
|
5,758 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
28,039 |
|
|
|
24,330 |
|
General and administrative |
|
|
8,013 |
|
|
|
6,807 |
|
Total operating expenses |
|
|
36,052 |
|
|
|
31,137 |
|
Loss from operations |
|
|
(30,286 |
) |
|
|
(25,379 |
) |
Other income, net |
|
|
2,278 |
|
|
|
171 |
|
Net loss |
|
$ |
(28,008 |
) |
|
$ |
(25,208 |
) |
|
|
|
|
|
|
|
Net loss per common share – basic and diluted |
|
$ |
(0.32 |
) |
|
$ |
(0.29 |
) |
Weighted average number of common shares outstanding – basic and
diluted |
|
|
88,193,917 |
|
|
|
87,670,653 |
|
Condensed Consolidated Balance
Sheets (In thousands)
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
57,252 |
|
|
$ |
59,968 |
|
Marketable securities |
|
|
276,387 |
|
|
|
306,165 |
|
Accounts receivable |
|
|
— |
|
|
|
2,000 |
|
Restricted cash |
|
|
— |
|
|
|
567 |
|
Prepaid expenses and other current assets |
|
|
9,361 |
|
|
|
6,572 |
|
Total current assets |
|
|
343,000 |
|
|
|
375,272 |
|
Property and equipment, net |
|
|
11,106 |
|
|
|
10,884 |
|
Operating lease right-of-use assets |
|
|
46,225 |
|
|
|
46,886 |
|
Restricted cash, net of current portion |
|
|
3,423 |
|
|
|
3,423 |
|
Other assets |
|
|
19 |
|
|
|
5 |
|
Total assets |
|
$ |
403,773 |
|
|
$ |
436,470 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,296 |
|
|
$ |
4,453 |
|
Accrued expenses and other current liabilities |
|
|
10,692 |
|
|
|
17,495 |
|
Operating lease liabilities |
|
|
2,638 |
|
|
|
1,770 |
|
Deferred revenue |
|
|
34,011 |
|
|
|
31,792 |
|
Income tax payable |
|
|
35 |
|
|
|
35 |
|
Total current liabilities |
|
|
53,672 |
|
|
|
55,545 |
|
Operating lease liabilities, net of current portion |
|
|
38,735 |
|
|
|
39,361 |
|
Deferred revenue, net of current portion |
|
|
84,102 |
|
|
|
92,088 |
|
Total liabilities |
|
|
176,509 |
|
|
|
186,994 |
|
Total stockholders’ equity |
|
|
227,264 |
|
|
|
249,476 |
|
Total liabilities and stockholders’ equity |
|
$ |
403,773 |
|
|
$ |
436,470 |
|
Tango Therapeutics (NASDAQ:TNGX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Tango Therapeutics (NASDAQ:TNGX)
Historical Stock Chart
From Jul 2023 to Jul 2024