Tango Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Highlights
11 Maio 2022 - 8:00AM
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
first quarter ended March 31, 2022 and provided business
highlights.
“We’ve had a strong start to 2022, including IND clearance and
Fast Track Designation from the FDA for TNG908, our lead PRMT5
inhibitor program. We are making good progress advancing TNG908
into the clinic and expect to dose our first patient in the Phase
1/2 clinical trial for the treatment of MTAP-deleted solid tumors
in the second quarter of this year,” said Barbara Weber, M.D.,
President and Chief Executive Officer of Tango Therapeutics.
“Additionally, our development candidates, TNG462, a
next-generation PRMT5 inhibitor for MTAP-deleted solid tumors and
TNG260, an inhibitor of an undisclosed synthetic lethal target that
reverses the immune evasion effect of STK11 loss-of-function
mutations, are in IND-enabling studies. Finally, with a strong
current cash position, we are confident in our ability to advance
our programs into the second half of 2024.”
Recent Business Highlights
- TNG908 IND cleared and granted Fast Track Designation
(FTD); first-in-human clinical trial is now open for
enrollment. As disclosed in February 2022, the U.S. Food
and Drug Administration (FDA) granted FTD to TNG908, a synthetic
lethal small molecule inhibitor of protein arginine
methyltransferase 5 (PRMT5) designed to selectively kill cancer
cells with methylthioadenosine phosphorylase (MTAP) deletions. FTD
is designed to facilitate the development and expedite the review
of drugs to treat serious conditions and fulfill an unmet medical
need, with the potential to allow drugs to reach more patients
faster.As disclosed in January 2022, the FDA cleared the
Investigational New Drug (IND) application for TNG908. The Phase
1/2 clinical trial is now open for enrollment and the Company
expects to have initial safety and efficacy data in the 1H 2023.
Enrollment is limited to patients with confirmed MTAP-deleted solid
tumors. 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 PRMT5 inhibitor, declared a
development candidate in 2Q 2022: Given the large number
of patients with MTAP-deleted cancers, Tango is investing in a
PRMT5 franchise by developing a product candidate with increased
potency, MTAP-deletion selectivity and longer target coverage.
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. Glioblastoma will be excluded
from the clinical trial as TNG462 does not cross the blood-brain
barrier in preclinical non-human primate models.
- TNG260, an inhibitor that reverses the immune evasion
effect of STK11 mutations, declared a development candidate in 2Q
2022: Inhibiting Target 3, an undisclosed synthetic lethal
target, reverses the immune evasion effect of serine-threonine
kinase 11 (STK11) loss-of-function mutations in cancer models. In
syngeneic models with an STK11 mutation and an intact immune
system, the combination of TNG260 with an anti-PD1 antibody
resulted in sustained complete tumor regressions and the induction
of immune memory against re-implantation of tumors. Tango expects
to file an IND for this program in 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.
- Presented preclinical data on TNG908, USP1 inhibitor
program and discovery platform at 2022 American Association for
Cancer Research (AACR) Annual Meeting. Last month, 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
TNG908 and the USP1 (ubiquitin-specific protease 1)
program.
- Presented preclinical TNG908 combination data at 2022
European Society for Medical Oncology (ESMO) Targeted Anticancer
Therapies Congress. In March, the Company presented at the
2022 ESMO Targeted Anticancer Therapies Congress. The posters
highlight the synergy between TNG908 and the KRAS inhibitor,
sotorasib, in xenograft models with MTAP deletion and a KRAS G12C
mutation.
Financial Results
As of March 31, 2022, the Company held $449.9 million in cash,
cash equivalents and marketable securities, which the company
believes to be sufficient to fund operations into the second half
of 2024.
Collaboration revenue was $5.8 million for the three months
ended March 31, 2022, compared to $6.4 million for the same period
in 2021. The decrease was due to lower research costs incurred
under the Gilead collaboration during the three months ended March
31, 2022 resulting in lower collaboration revenue recognition.
Research and development expenses were $24.3 million for the
three months ended March 31, 2022, compared to $15.0 million for
the same period in 2021. The change was primarily due to increased
expenses relating to the advancement of the programs and
personnel-related costs.
General and administrative expenses were $6.8 million for the
three months ended March 31, 2022, compared to $3.5 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 March 31, 2022 was $25.2
million, or $0.29 per share, compared to a net loss of $12.1
million, or $0.29 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,
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: the Company believes that it has
sufficient cash balances to fund operations (including to support
advancing discovery and its clinical pipeline) into the second half
of 2024; anticipated milestones in the Company’s research and
development programs; a Phase 1/2 study for TNG908 is now open for
enrollment and we expect to dose a patient in second quarter of
2022; expectations regarding progressing Company development
candidates in 2022 and beyond, including TNG462 and TNG260; the
Company anticipates having preliminary safety and efficacy data in
the TNG908 Phase 1/2 study in the first half of 2023; FTD has the
potential to allow drugs to reach patients earlier; the planned
clinical development path for TNG462 (expected to be similar to
TNG908); Tango plans to evaluate TNG908 in GBM; 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 preliminary 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 when
expected and may not generate results (including final or
preliminary 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
(and Tango or a third-party may not be able to obtain approval or
commercial sales of any combination therapies); 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 and, if so, may not have sufficient cash to fund
operations to the second half of 2024; 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 filed with the SEC on March 28, 2022. 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/Michael Barron
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 March 31, |
|
|
2022 |
|
|
2021 |
|
Collaboration revenue |
$ |
5,758 |
|
|
$ |
6,386 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
24,330 |
|
|
|
15,000 |
|
General and administrative |
|
6,807 |
|
|
|
3,467 |
|
Total operating expenses |
|
31,137 |
|
|
|
18,467 |
|
Loss from operations |
|
(25,379 |
) |
|
|
(12,081 |
) |
Other income (expense): |
|
|
|
|
|
Interest income |
|
218 |
|
|
|
104 |
|
Other expense, net |
|
(47 |
) |
|
|
(55 |
) |
Total other income, net |
|
171 |
|
|
|
49 |
|
Loss before income taxes |
|
(25,208 |
) |
|
|
(12,032 |
) |
Provision for income taxes |
|
- |
|
|
|
(74 |
) |
Net loss |
$ |
(25,208 |
) |
|
$ |
(12,106 |
) |
|
|
|
|
|
|
Net loss per common share – basic
and diluted |
$ |
(0.29 |
) |
|
$ |
(0.29 |
) |
Weighted average number of common
shares outstanding – basic and diluted |
|
87,670,653 |
|
|
|
41,575,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance
Sheets(In thousands)
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
99,909 |
|
|
$ |
142,745 |
|
Marketable securities |
|
349,976 |
|
|
|
342,510 |
|
Accounts receivable |
|
2,000 |
|
|
|
2,000 |
|
Restricted cash |
|
567 |
|
|
|
567 |
|
Prepaid expenses and other current assets |
|
8,202 |
|
|
|
4,516 |
|
Total current assets |
|
460,654 |
|
|
|
492,338 |
|
Property and equipment, net |
|
6,538 |
|
|
|
4,832 |
|
Operating lease right-of-use
assets |
|
894 |
|
|
|
1,254 |
|
Restricted cash, net of current
portion |
|
3,423 |
|
|
|
1,712 |
|
Other assets |
|
16 |
|
|
|
19 |
|
Total assets |
$ |
471,525 |
|
|
$ |
500,155 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
3,367 |
|
|
$ |
3,226 |
|
Accrued expenses and other current liabilities |
|
9,693 |
|
|
|
9,887 |
|
Operating lease liabilities |
|
1,075 |
|
|
|
1,503 |
|
Deferred revenue |
|
25,024 |
|
|
|
26,022 |
|
Income tax payable |
|
52 |
|
|
|
52 |
|
Total current liabilities |
|
39,211 |
|
|
|
40,690 |
|
Operating lease liabilities, net
of current portion |
|
— |
|
|
|
— |
|
Deferred revenue, net of current
portion |
|
111,958 |
|
|
|
114,718 |
|
Other long-term liabilities |
|
— |
|
|
|
— |
|
Total liabilities |
|
151,169 |
|
|
|
155,408 |
|
Total stockholders’ equity |
|
320,356 |
|
|
|
344,747 |
|
Total liabilities and stockholders’ equity |
$ |
471,525 |
|
|
$ |
500,155 |
|
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