UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGEACT OF 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
(Address of principal executive offices) |
(Zip code) |
Registrant’s telephone number, including area code:
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
per share |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 8, 2023, Tango Therapeutics, Inc. (Tango or the Company) issued a press release relating to its results of operations and financial condition for the quarter ended September 30, 2023. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The press release, and the information set forth therein (including Exhibit 99.1), is being furnished pursuant to Item 2.02 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that Section. Nor shall such document be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in the filing unless specifically stated so therein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 |
104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
TANGO THERAPEUTICS, INC.
Dated: November 8, 2023 By: /s/ Douglas Barry
Name: Douglas Barry
Title: General Counsel
Tango Therapeutics Reports Third Quarter 2023 Financial Results
and Provides Business Highlights
– Dose escalation ongoing in phase 1/2 trials of lead PRMT5 inhibitors TNG908 and TNG462; additional TNG908 clinical data expected 2024 –
– Dose escalation ongoing in phase 1/2 trial of CoREST inhibitor TNG260 and pembrolizumab in patients with STK11 mutant solid tumors –
– FDA Fast Track designation granted for TNG348, a novel USP1 inhibitor, for the treatment of BRCA1/2-mutant breast and ovarian cancer; phase 1/2 clinical trial initiation
expected 1H 2024 –
– Kanishka Pothula, partner at Nextech Ventures, appointed to Board of Directors, replacing Reid Huber, Ph.D., partner at Third Rock Ventures –
– Strong cash position of $360 million; cash runway into 2026 expected to fund all clinical programs through proof-of-concept –
BOSTON, Mass. – November 8, 2023 – 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 third quarter ended September 30, 2023, and provided business highlights.
“We continue to make excellent progress across our precision oncology pipeline, led by our two MTA-cooperative PRMT5 inhibitors for MTAP-deleted cancers. For TNG462, we dosed the first patient in the phase 1/2 trial in July 2023. TNG908 is also actively enrolling patients and remains on track for a clinical update in 2024. Both molecules have the potential to become important treatments for the broad range of patients with MTAP-deleted cancers,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “In addition, in June 2023, we initiated the phase 1/2 trial of TNG260, a first-in-class inhibitor of the CoREST complex for the treatment of STK11-mutant cancers. In September 2023, we received FDA clearance of our IND application for TNG348, a USP1 inhibitor for BRCA1/2 mutant and other HRD+ cancers, and we plan to initiate the clinical trial in the first half of next year. With additional capital resources following our August private placement financing and our dedicated team, we believe we are well-positioned to deliver proof-of-concept data on our four clinical programs."
Recent Business Highlights
Pipeline Update
TNG908 phase 1 dose escalation ongoing
TNG462, a potentially best-in-class MTA-cooperative PRMT5 inhibitor
TNG260, a first-in-class, highly selective CoREST complex inhibitor
TNG348, a novel USP1 inhibitor
Upcoming Milestones
Corporate Updates
Scientific Presentations
Society for NeuroOncology (SNO) 28th Annual Meeting, November 15-19, 2023, Vancouver, Canada
Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, November 1-5, 2023, San Diego, CA
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 11-15, 2023, Boston, MA
Financial Results
As of September 30, 2023, the Company held $359.9 million in cash, cash equivalents and marketable securities, which the Company believes to be sufficient to fund operations into 2026.
Collaboration revenue was $10.7 million for the three months ended September 30, 2023, compared to $6.9 million for the same period in 2022, and $26.1 million for the nine months ended September 30, 2023 compared to $18.4 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 $0 and $5.0 million for the three and nine months ended September 30, 2023, respectively, compared to $0 for both the three and nine months ended September 30, 2022. The year-to-date 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 $27.1 million for the three months ended September 30, 2023, compared to $28.7 million for the same period in 2022, and $83.9 million for the nine months ended September 30, 2023 compared to $76.8 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 September 30, 2023, compared to $8.1 million for the same period in 2022, and $26.4 million for the nine months ended September 30, 2023 compared to $22.1 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 September 30, 2023 was $22.3 million, or $0.23 per share, compared to a net loss of $29.1 million, or $0.33 per share, in the same period in 2022. Net loss for the nine months ended September 30, 2023 was $71.0 million, or $0.78 per share, compared to a net loss of $79.1 million, or $0.90 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), 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 escalation is ongoing in certain Tango clinical trials; additional data from the TNG908 clinical trial is expected in 2024; phase 1/2 clinical trial initiation for TNG348 expected in the first half of 2024 (and the endpoints that the trial will evaluate); cash runway into 2026 expected to fund all clinical programs through proof-of-concept (and cash, cash equivalents and marketable securities are believed to be sufficient to fund operations into 2026); Tango is committed to discovering and delivering the next generation of precision cancer medicines; the Company continues to make excellent progress across its precision oncology pipeline; TNG908 is actively enrolling patients and remains on track for a clinical update in 2024; TNG908 and TNG462 have the potential to become important treatments for the broad range of patients with MTAP-deleted cancers; Tango is well-positioned to deliver proof-of-concept data on its four clinical programs; TNG462 is a potentially best-in-class MTA-cooperative PRMT5 inhibitor; certain pre-clinical data support the ongoing phase 1/2 clinical trial of TNG260 in combination with pembrolizumab; the Fast Track designation of TNG348 and potential benefits resulting from such designation; Tango’s growth as a company and expectations regarding its expected cash runway, uses of capital, expenses, and financial results; 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; 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 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 enrolling and dosing of an adequate number of clinical trial participants) when expected, may not be able to continue dosing (and 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); 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); 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 Fast Track designation (and such designation 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 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 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.
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 September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Collaboration revenue |
|
|
10,732 |
|
|
|
6,920 |
|
|
|
26,096 |
|
|
|
18,449 |
|
License revenue |
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
Total revenue |
|
|
10,732 |
|
|
|
6,920 |
|
|
|
31,096 |
|
|
|
18,449 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
27,149 |
|
|
|
28,744 |
|
|
|
83,859 |
|
|
|
76,815 |
|
General and administrative |
|
|
9,209 |
|
|
|
8,099 |
|
|
|
26,397 |
|
|
|
22,138 |
|
Total operating expenses |
|
|
36,358 |
|
|
|
36,843 |
|
|
|
110,256 |
|
|
|
98,953 |
|
Loss from operations |
|
|
(25,626 |
) |
|
|
(29,923 |
) |
|
|
(79,160 |
) |
|
|
(80,504 |
) |
Other income, net |
|
|
3,386 |
|
|
|
873 |
|
|
|
8,266 |
|
|
|
1,391 |
|
Provision for income taxes |
|
|
(23 |
) |
|
|
— |
|
|
|
(87 |
) |
|
|
(3 |
) |
Net loss |
|
$ |
(22,263 |
) |
|
$ |
(29,050 |
) |
|
$ |
(70,981 |
) |
|
$ |
(79,116 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per common share – basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.90 |
) |
Weighted average number of common shares outstanding – basic and diluted |
|
|
97,033,273 |
|
|
|
87,892,195 |
|
|
|
91,268,133 |
|
|
|
87,868,081 |
|
Condensed Consolidated Balance Sheets
(In thousands)
|
|
September 30, |
|
|
December 31, |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
58,533 |
|
|
$ |
59,968 |
|
Marketable securities |
|
|
301,347 |
|
|
|
306,165 |
|
Accounts receivable |
|
|
— |
|
|
|
2,000 |
|
Restricted cash |
|
|
856 |
|
|
|
567 |
|
Prepaid expenses and other current assets |
|
|
10,155 |
|
|
|
6,572 |
|
Total current assets |
|
|
370,891 |
|
|
|
375,272 |
|
Property and equipment, net |
|
|
10,261 |
|
|
|
10,884 |
|
Operating lease right-of-use assets |
|
|
44,422 |
|
|
|
46,886 |
|
Restricted cash, net of current portion |
|
|
2,567 |
|
|
|
3,423 |
|
Other assets |
|
|
48 |
|
|
|
5 |
|
Total assets |
|
$ |
428,189 |
|
|
$ |
436,470 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,837 |
|
|
$ |
4,453 |
|
Accrued expenses and other current liabilities |
|
|
11,467 |
|
|
|
17,495 |
|
Operating lease liabilities |
|
|
2,040 |
|
|
|
1,770 |
|
Deferred revenue |
|
|
27,072 |
|
|
|
31,792 |
|
Income tax payable |
|
|
— |
|
|
|
35 |
|
Total current liabilities |
|
|
43,416 |
|
|
|
55,545 |
|
Operating lease liabilities, net of current portion |
|
|
37,466 |
|
|
|
39,361 |
|
Deferred revenue, net of current portion |
|
|
70,712 |
|
|
|
92,088 |
|
Total liabilities |
|
|
151,594 |
|
|
|
186,994 |
|
Total stockholders’ equity |
|
|
276,595 |
|
|
|
249,476 |
|
Total liabilities and stockholders’ equity |
|
$ |
428,189 |
|
|
$ |
436,470 |
|