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 second quarter ended June 30, 2023,
and provided business highlights.
“We have significantly advanced our pipeline since
the first quarter, including bringing two novel agents into phase
1/2 clinical trials. In July, the first patient was dosed with
TNG462, our next-generation MTA-cooperative PRMT5 inhibitor for
MTAP-deleted cancers, and TNG908, our brain-penetrant
MTA-cooperative PRMT5 inhibitor, continues to progress in dose
escalation. These two trials underscore our commitment to
delivering important treatments for the broad range of patients
with MTAP-deleted cancers. Additionally, we dosed the first patient
in our phase 1/2 trial of TNG260, a first-in-class CoREST complex
inhibitor, in patients with STK11-mutant cancers, the large
majority of which are inherently resistant to immune checkpoint
inhibitor therapy,” said Barbara Weber, M.D., President and Chief
Executive Officer of Tango Therapeutics.
“Also of note, Alan Huang, Ph.D., will step down from his
full-time role as Chief Scientific Officer and become a resident
Science Advisor to Tango in early October. Alan plans to start a
new company outside of our focus, which will incubate in Tango
labs, facilitating his advisor role to Tango. Alan played a pivotal
role founding Tango and has been an integral part of the Company
from inception. He was central to creating and launching the
Company, building a state-of-the-art CRISPR-based target discovery
platform and our deep pipeline of novel programs. Jannik Andersen
Ph.D., currently Head of Biology, will assume the role of Chief
Scientific Officer, effective October 9. Jannik joined the Company
in January 2019, and his leadership of our biology team has had
tremendous impact on the Tango pipeline, including leading multiple
programs from drug discovery into clinical development and
advancing our pipeline of synthetic lethal precision oncology
programs. As an internal candidate, Jannik will ensure the
continuity of our preclinical work,” continued Dr. Weber.
Recent Business Highlights
Pipeline Update
TNG908 phase 1 dose escalation ongoing
- As of May 9, 2023, 16 patients with MTAP-deleted solid tumors
representing 12 histologies across four cohorts had been treated
and dose escalation is continuing. Proof-of-mechanism for TNG908 as
an MTA-cooperative PRMT5 inhibitor was 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.
- TNG908 demonstrated favorable pharmacokinetics with
dose-proportional increases in exposure across cohorts, and
pre-treatment and on-treatment biopsies demonstrated dose-dependent
decreases in tumor SDMA with minimal or no decrease in normal
tissue.
- 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
- The first patient has been dosed in the TNG462 phase 1/2
clinical trial. The trial is evaluating TNG462 in patients with
MTAP-deleted solid tumors. Unlike the TNG908 trial, glioblastoma
will be excluded from the TNG462 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, highly selective CoREST
complex inhibitor
- The first patient has been dosed in the TNG260 phase 1/2
clinical trial. The trial is evaluating the safety,
pharmacokinetics (PK), pharmacodynamics and efficacy of TNG260 in
combination with pembrolizumab, with a one cycle single agent
run-in phase to evaluate the safety and PK of TNG260 in patients
with locally advanced or metastatic solid tumors with an STK11
loss-of-function mutation.
- The CoREST (Co-repressor of Repressor Element-1
Silencing Transcription) 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, restoring sensitivity to an
anti-PD-1 antibody, inducing complete remissions in the majority of
animals and creating immune memory that prevents re-implantation
and regrowth of the tumor.
- In April 2023, the U.S. Food and Drug Administration (FDA)
granted Fast Track Designation for TNG260 in combination with an
anti-PD-1 antibody for the treatment of patients with previously
treated advanced NSCLC with STK11-mutations.
- 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
- TNG348 Investigational New Drug (IND) filing expected
mid-2023.
- Additional data from the ongoing TNG908 clinical trial expected
2024.
Leadership Update
- Alan Huang, Ph.D., will step down as Chief Scientific Officer
of Tango in October to become CEO of and launch a new company,
unrelated to Tango’s focus. Tango President and CEO, Barbara Weber,
M.D., and Alexis Borisy, Tango Board chairman, will serve on the
newco Board of Directors. Tango received an equity stake in the
newco in exchange for providing space and resources for the early
phases of company development within Tango. The new company is
currently in stealth mode and will operate in a distinct,
non-competitive space.
- Jannik Andersen, Ph.D., currently Senior Vice President of
Biology, will be promoted to Chief Scientific Officer of Tango. Dr.
Andersen, who joined the Company in January 2019, is a leading
expert in basic and applied cancer research. Dr. Andersen has led
the drug discovery efforts of multiple programs at Tango, including
TNG908, TNG462, TNG260 and TNG348.
- Dr. Huang will serve as a resident Senior Advisor, focusing on
functional genomics platform evolution, target discovery and
validation.
- Both changes will become effective in October 2023.
Financial Results
As of June 30, 2023, the Company held $310.7 million in
cash, cash equivalents and marketable securities, which the Company
believes to be sufficient to fund operations into 2026.
Collaboration revenue was $9.6 million for the three months
ended June 30, 2023, compared to $5.8 million for the same
period in 2022, and $15.4 million for the six months ended
June 30, 2023 compared to $11.5 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 $5.0 million for the three and six months
ended June 30, 2023, compared to $0 for both the three and six
months ended June 30, 2022. The 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 $28.7 million for the
three months ended June 30, 2023, compared to $23.7 million
for the same period in 2022, and $56.7 million for the six months
ended June 30, 2023 compared to $48.1 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 June 30, 2023, compared to $7.2 million for
the same period in 2022, and $17.2 million for the six months ended
June 30, 2023 compared to $14.0 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 June 30, 2023 was $20.7
million, or $0.23 per share, compared to a net loss of $24.9
million, or $0.28 per share, in the same period in 2022. Net loss
for the six months ended June 30, 2023 was $48.7 million, or
$0.55 per share, compared to a net loss of $50.1 million, or $0.57
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), Tango’s
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 phase 1/2
trial of TNG908; intended changes among the Company’s management
team; TNG908 continues to progress in dose escalation; Tango’s
commitment to delivering important treatments for the broad range
of patients with MTAP-deleted cancers; TNG462, a potentially
best-in-class MTA-cooperative PRMT5 inhibitor; the Company believes
its cash, cash equivalents and marketable securities are sufficient
to fund operations into 2026; TNG348 IND filing expected mid-2023;
additional data from the ongoing TNG908 clinical trial expected
2024; the expected benefits of the Company's development candidates
and other product candidates (as monotherapies or in combination);
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, may not be able to continue 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);
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); 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); 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 Therapeuticsmedia@tangotx.com
|
|
Consolidated Statements of Operations(In
thousands, except share and per share data) |
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
|
9,598 |
|
|
|
5,771 |
|
|
|
15,364 |
|
|
|
11,529 |
|
License revenue |
|
|
5,000 |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
Total revenue |
|
|
14,598 |
|
|
|
5,771 |
|
|
|
20,364 |
|
|
|
11,529 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
28,671 |
|
|
|
23,741 |
|
|
|
56,710 |
|
|
|
48,071 |
|
General and administrative |
|
|
9,174 |
|
|
|
7,232 |
|
|
|
17,188 |
|
|
|
14,039 |
|
Total operating expenses |
|
|
37,845 |
|
|
|
30,973 |
|
|
|
73,898 |
|
|
|
62,110 |
|
Loss from operations |
|
|
(23,247 |
) |
|
|
(25,202 |
) |
|
|
(53,534 |
) |
|
|
(50,581 |
) |
Other income, net |
|
|
2,601 |
|
|
|
347 |
|
|
|
4,880 |
|
|
|
518 |
|
Provision for income taxes |
|
|
(64 |
) |
|
|
(3 |
) |
|
|
(64 |
) |
|
|
(3 |
) |
Net loss |
|
$ |
(20,710 |
) |
|
$ |
(24,858 |
) |
|
$ |
(48,718 |
) |
|
$ |
(50,066 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.57 |
) |
Weighted average number of
common shares outstanding – basic and diluted |
|
|
88,354,590 |
|
|
|
87,839,804 |
|
|
|
88,281,368 |
|
|
|
87,775,440 |
|
|
Condensed Consolidated Balance Sheets(In
thousands) |
|
|
|
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
66,052 |
|
|
$ |
59,968 |
|
Marketable securities |
|
|
244,600 |
|
|
|
306,165 |
|
Accounts receivable |
|
|
— |
|
|
|
2,000 |
|
Restricted cash |
|
|
856 |
|
|
|
567 |
|
Prepaid expenses and other current assets |
|
|
9,035 |
|
|
|
6,572 |
|
Total current assets |
|
|
320,543 |
|
|
|
375,272 |
|
Property and equipment,
net |
|
|
10,881 |
|
|
|
10,884 |
|
Operating lease right-of-use
assets |
|
|
45,325 |
|
|
|
46,886 |
|
Restricted cash, net of
current portion |
|
|
2,567 |
|
|
|
3,423 |
|
Other assets |
|
|
12 |
|
|
|
5 |
|
Total assets |
|
$ |
379,328 |
|
|
$ |
436,470 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,793 |
|
|
$ |
4,453 |
|
Accrued expenses and other current liabilities |
|
|
13,185 |
|
|
|
17,495 |
|
Operating lease liabilities |
|
|
1,807 |
|
|
|
1,770 |
|
Deferred revenue |
|
|
33,848 |
|
|
|
31,792 |
|
Income tax payable |
|
|
— |
|
|
|
35 |
|
Total current liabilities |
|
|
53,633 |
|
|
|
55,545 |
|
Operating lease liabilities, net
of current portion |
|
|
38,082 |
|
|
|
39,361 |
|
Deferred revenue, net of current
portion |
|
|
74,668 |
|
|
|
92,088 |
|
Total liabilities |
|
|
166,383 |
|
|
|
186,994 |
|
Total stockholders’ equity |
|
|
212,945 |
|
|
|
249,476 |
|
Total liabilities and stockholders’ equity |
|
$ |
379,328 |
|
|
$ |
436,470 |
|
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