UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(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:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of 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 August 4, 2022, Tyra Biosciences, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
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) |
SIGNATURES
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 thereunto duly authorized.
|
|
|
TYRA BIOSCIENCES, INC. |
|
|
|
|
Date: |
August 4, 2022 |
By: |
/s/ Esther van den Boom |
|
|
|
Esther van den Boom |
Exhibit 99.1
Tyra Biosciences Reports Second Quarter 2022 Financial Results and Highlights
-IND clearance received from FDA to proceed with SURF301 Study of TYRA-300-
-Pipeline on track; IND for TYRA-200 to be filed in 2H 2022-
-Well-capitalized with cash and cash equivalents of $275.1 million as of Q2 2022-
CARLSBAD, Calif., August 4, 2022 – Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, today reported financial results for the quarter ended June 30, 2022 and highlighted recent corporate progress.
“It’s been a very productive second quarter at TYRA, highlighted by the FDA clearance to proceed with our SURF301 study of TYRA-300. I couldn’t be more pleased with the execution our team has demonstrated and we look forward to moving our first precision oncology therapy into the clinic,” said Todd Harris, CEO of TYRA. “We also remain on track to submit an IND for TYRA-200 in the second half of 2022 and continue to advance our pipeline.”
Recent Corporate Highlights
Second Quarter 2022 Financial Results
About Tyra Biosciences
Tyra Biosciences, Inc. is a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer. TYRA’s proprietary in-house discovery platform, SNÅP, enables the rapid and precise refinement of structural design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. Leveraging SNÅP, TYRA is developing a pipeline of selective inhibitors of Fibroblast Growth Factor Receptors (FGFR), which are altered in approximately 7% of all cancers. TYRA-300 is an FGFR3 selective inhibitor for oncology. TYRA-200 is an FGFR2 inhibitor that TYRA is developing initially in intrahepatic cholangiocarcinoma. TYRA is also targeting achondroplasia and other FGFR3 related skeletal dysplasias, FGFR4-related cancers, and RET. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn.
Forward-Looking Statements
TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the potential to develop purpose-built therapies that improve clinical outcomes; and the expected IND submission timing for TYRA-200. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: we are early in our development efforts, have not tested any of our product candidates in clinical trials and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, enrollment, and completion of preclinical studies and clinical trials; our dependence on third parties in connection with manufacturing, research and preclinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; unfavorable results from preclinical studies; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or disrupting our preclinical studies, manufacturing, and supply chain; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; we may use our capital resources sooner than we expect; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Amy Conrad
aconrad@tyra.bio
Tyra Biosciences, Inc.
Balance Sheet Data
(in thousands)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
|
|
|
|
|
|
|
||
Balance Sheet Data: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
275,107 |
|
|
$ |
302,182 |
|
Working capital |
|
|
271,844 |
|
|
|
300,441 |
|
Total assets |
|
|
287,118 |
|
|
|
306,701 |
|
Accumulated deficit |
|
|
(70,292 |
) |
|
|
(40,371 |
) |
Total stockholders’ equity |
|
|
278,853 |
|
|
|
301,737 |
|
Tyra Biosciences, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
12,047 |
|
|
$ |
4,381 |
|
|
$ |
21,692 |
|
|
$ |
7,902 |
|
General and administrative |
|
|
3,381 |
|
|
|
1,127 |
|
|
|
8,570 |
|
|
|
1,816 |
|
Total operating expenses |
|
|
15,428 |
|
|
|
5,508 |
|
|
|
30,262 |
|
|
|
9,718 |
|
Loss from operations |
|
|
(15,428 |
) |
|
|
(5,508 |
) |
|
|
(30,262 |
) |
|
|
(9,718 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
346 |
|
|
|
4 |
|
|
|
364 |
|
|
|
5 |
|
Other expense |
|
|
(13 |
) |
|
|
(8 |
) |
|
|
(23 |
) |
|
|
(8 |
) |
Total other income (expense) |
|
|
333 |
|
|
|
(4 |
) |
|
|
341 |
|
|
|
(3 |
) |
Net loss and comprehensive loss |
|
$ |
(15,095 |
) |
|
$ |
(5,512 |
) |
|
$ |
(29,921 |
) |
|
$ |
(9,721 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(2.43 |
) |
|
$ |
(0.72 |
) |
|
$ |
(4.54 |
) |
Weighted-average shares used to compute |
|
|
41,777,206 |
|
|
|
2,267,113 |
|
|
|
41,665,155 |
|
|
|
2,139,889 |
|