UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 7, 2024, Tyra Biosciences, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2024. 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. |
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Description |
99.1 |
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104 |
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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.
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TYRA BIOSCIENCES, INC. |
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Date: |
August 7, 2024 |
By: |
/s/ Alan Fuhrman |
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Alan Fuhrman |
Exhibit 99.1
Tyra Biosciences Reports Second Quarter 2024 Financial Results and Highlights
- SURF301 Ph1 initial results and ACH IND submission expected in 2H24 -
- Reported preclinical proof-of-concept with TYRA-300 in HCH, demonstrating increases in long bone length and binding against the HCH altered protein -
-IND cleared for TYRA-430, an FGFR4/3 biased inhibitor for HCC -
- Announced Chief Medical Officer transition plan; search for an external candidate underway with guidance from Science & Technology (S&T) Committee of the Board, including recent additions Dr. Susan Moran and Dr. S. Michael Rothenberg -
- Cash, cash equivalents, and marketable securities of $373.8 million at Q2 2024 -
CARLSBAD, Calif., August 7, 2024 – Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today reported financial results for the quarter ended June 30, 2024, and highlighted recent corporate progress.
“This is an exciting time at TYRA. With the recent clearance of our IND for TYRA-430, our FGFR4/3 biased inhibitor, we are well positioned with three potentially best-in-class precision molecules in the clinic for oncology. In skeletal dysplasias, we made great progress with preclinical proof-of-concept data in hypochondroplasia and continued execution towards the filing of our IND anticipated in the second half of 2024 to support our planned Phase 2 study in achondroplasia,” said Todd Harris, CEO of TYRA.
Mr. Harris continued, “We also announce today the transition of our Chief Medical Officer position by the end of the year. We thank Hiroomi for his many contributions to TYRA over the past four years. He was instrumental in the translation of our SNÅP drug discovery platform into a robust pipeline of product candidates. As we move forward, I am delighted to have the support of our S&T Committee, including recent additions to our Board Susan Moran and Michael Rothenberg, whose collective expertise in solid tumors and achondroplasia will be invaluable.”
Dr. Moran added, “I am pleased to have the opportunity to support the TYRA team as we prepare to advance multiple early-stage clinical programs into later-stage clinical development and evaluate the broad potential of our precision molecules in oncology and rare diseases.”
Second Quarter 2024 and Recent Corporate Highlights
TYRA-300
TYRA-200
TYRA-200 is an investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.
TYRA-430
Corporate
Dr. Tada joined TYRA in 2020 as CMO prior to the Company’s initial public offering. He was integral in the development of the Company’s clinical strategy and building the in-house clinical operations group who have advanced multiple product candidates into clinical development.
SNÅP Platform and Pipeline
Second Quarter 2024 Financial Results
About TYRA-300
TYRA-300 is the Company's lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasias, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors), which was designed to determine the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate preliminary antitumor activity. In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia, and the Company expects to submit an IND in the second half of 2024 for the initiation of a Phase 2 clinical study in pediatric achondroplasia. In July 2023 and January 2024, the FDA granted Orphan Drug Designation (ODD) and Rare Pediatric Designation (RPD) to TYRA-300, respectively, for the treatment of achondroplasia.
About TYRA-200
TYRA-200 is an investigational, oral, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations currently in development for the treatment of cancer. TYRA-200 is being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors). SURF201 (NCT06160752) was designed to determine the optimal and MTD and the RP2D of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.
About Tyra Biosciences
Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company’s in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA’s initial focus is on applying its accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions. 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 next-generation and potentially best-in-class precision medicines and the potential safety and therapeutic benefits of TYRA-300, TYRA-200, TYRA-430 and other product candidates; the ability to advance multiple early-stage clinical programs into later-stage clinical development; the sufficiency of our cash position to support our clinical and operational plans; expected cash runway; the expected timing and phase of clinical development of TYRA-300, TYRA-200, and TYRA-430, including timing of a submission of an IND for TYRA-300 in pediatric achondroplasia, design of our planned Phase 2 study in achondroplasia and the presentation of SURF301 clinical data at a scientific congress; and the potential for SNÅP to develop therapies in targeted oncology and genetically defined conditions. 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 only recently begun testing TYRA-300 and TYRA-200 for oncology 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, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; potential difficulty or delay in transitioning the CMO position and any resulting adverse impacts on our development programs or otherwise; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of TYRA-300 in pediatric achondroplasia and hypochondroplasia; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; later developments with the FDA may be inconsistent with the minutes from our prior meetings, including with respect to the proposed design of our planned Phase 2 study of TYRA-300 in ACH; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; we may not realize the benefits associated with ODD, including that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained, or from the RPD Designation, including receipt of a Priority Review Voucher or any value therefrom; 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; unstable market and economic conditions and military conflict may adversely affect our business and financial condition and the broader economy and biotechnology industry; 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.
Condensed Balance Sheet Data
(in thousands)
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June 30, |
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December 31, |
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2024 |
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2023 |
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(unaudited) |
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Balance Sheet Data: |
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Cash, cash equivalents and marketable securities |
$ |
373,796 |
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$ |
203,469 |
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Working capital |
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368,192 |
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196,338 |
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Total assets |
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392,461 |
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225,857 |
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Accumulated deficit |
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(201,724 |
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(164,830 |
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Total stockholders’ equity |
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376,043 |
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204,262 |
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Tyra Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
17,997 |
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$ |
12,162 |
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$ |
35,199 |
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$ |
22,570 |
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General and administrative |
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5,535 |
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3,852 |
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10,654 |
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7,778 |
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Total operating expenses |
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23,532 |
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16,014 |
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45,853 |
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30,348 |
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Loss from operations |
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(23,532 |
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(16,014 |
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(45,853 |
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(30,348 |
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Other income: |
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Interest and other income, net |
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4,830 |
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2,742 |
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8,959 |
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5,196 |
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Total other income |
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4,830 |
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2,742 |
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8,959 |
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5,196 |
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Net loss |
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(18,702 |
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(13,272 |
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(36,894 |
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(25,152 |
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Unrealized loss on marketable securities |
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(178 |
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— |
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(565 |
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— |
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Comprehensive loss |
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$ |
(18,880 |
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$ |
(13,272 |
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$ |
(37,459 |
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$ |
(25,152 |
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Net loss per share, basic and diluted |
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$ |
(0.32 |
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$ |
(0.31 |
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$ |
(0.67 |
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$ |
(0.59 |
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Weighted-average shares used to compute net loss |
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58,668,712 |
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42,589,213 |
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55,448,823 |
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42,492,377 |
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