0000950170-22-014777.txt : 20220804 0000950170-22-014777.hdr.sgml : 20220804 20220804162304 ACCESSION NUMBER: 0000950170-22-014777 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220804 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220804 DATE AS OF CHANGE: 20220804 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Tyra Biosciences, Inc. CENTRAL INDEX KEY: 0001863127 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 831476348 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40800 FILM NUMBER: 221136972 BUSINESS ADDRESS: STREET 1: 2656 STATE STREET CITY: CARLSBAD STATE: CA ZIP: 92008 BUSINESS PHONE: (619) 728-4760 MAIL ADDRESS: STREET 1: 2656 STATE STREET CITY: CARLSBAD STATE: CA ZIP: 92008 8-K 1 tyra-20220804.htm 8-K 8-K
0001863127false00018631272022-08-042022-08-04

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 04, 2022

 

 

Tyra Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40800

83-1476348

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

2656 State Street

 

Carlsbad, California

 

92008

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (619) 728-4760

 

 

(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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

TYRA

 

NASDAQ Global Select Market

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

 

Press Release Issued on August 4, 2022

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
Chief Financial Officer

 


EX-99.1 2 tyra-ex99_1.htm EX-99.1 EX-99.1

 

Exhibit 99.1

 

img74818929_0.jpg 

 

 

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

 

IND Clearance Received for TYRA-300. The U.S. Food and Drug Administration (FDA) cleared TYRA to proceed with its Phase 1/2 SURF301 clinical study of TYRA-300, an FGFR3-selective inhibitor, in patients with metastatic urothelial carcinoma of the bladder and urinary tract. SURF301 is a two-part study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300.

 

IND for TYRA-200 on Track. TYRA continued to advance TYRA-200, an FGFR2 inhibitor with an initial focus on patients with intrahepatic cholangiocarcinoma. TYRA remains on track to submit an IND with the FDA for TYRA-200 in the second half of 2022.

 

Pipeline Progression. TYRA continued to progress its pipeline including programs targeting achondroplasia and other FGFR3-related skeletal dysplasias, FGFR4-related cancers, and REarranged during Transfection kinase (RET).

 

Strengthened Leadership Team with Key Hires. During the second quarter of 2022, TYRA made key senior appointments to its leadership team of Sarah Honig as Vice President, Corporate Development and Strategy, and Ali Fawaz as General Counsel and Secretary.

 

Second Quarter 2022 Financial Results

 

Second quarter 2022 net loss was $15.1 million compared to $5.5 million for the same period in 2021.
Second quarter 2022 research and development expenses were $12.0 million compared to $4.4 million for the same period in 2021.
Second quarter 2022 general and administrative expenses were $3.4 million compared to $1.1 million for the same period in 2021.
As of June 30, 2022, TYRA had cash and cash equivalents of $275.1 million.

 

 


 

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
   net loss per share, basic and diluted

 

 

41,777,206

 

 

 

2,267,113

 

 

 

41,665,155

 

 

 

2,139,889

 

 

 


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