Tyra Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights
- TYRA reported positive financial results and recent corporate progress for 2023 and the start of 2024.
- The company closed a $200 million Private Placement Financing in February 2024, strengthening its financial position.
- TYRA-300 received FDA Rare Pediatric Disease Designation for the treatment of Achondroplasia.
- The SURF301 Phase 1/2 Study for Oncology is advancing, with initial results expected to be reported in the second half of 2024.
- TYRA is planning to initiate a Phase 2 Achondroplasia (ACH) Study and has already initiated the Phase 1 SURF201 Study for TYRA-200.
- The company's in-house precision medicine discovery engine, SNÅP, continues to progress in developing therapies for targeted oncology and genetically defined conditions.
- TYRA's financial data for the fourth quarter and full year 2023 showed increased net loss and expenses compared to the previous year.
- As of December 31, 2023, TYRA had cash, cash equivalents, and marketable securities of $203.5 million, which increased to approximately $403.5 million after the PIPE financing in February 2024.
- - TYRA reported increased net loss and expenses for the fourth quarter and full year 2023 compared to the same periods in 2022.
- - The company's financial results indicate a growing need for capital to support its clinical and operational milestones through at least 2026.
Insights
The recent announcement by Tyra Biosciences, Inc. regarding their financial results and ongoing clinical studies presents a multifaceted perspective on the company's current status and future prospects. The substantial Private Placement Financing (PIPE) of approximately $200 million is a significant liquidity event, underscoring investor confidence and expanding the company's runway. This capital infusion, bolstering the pro-forma cash position to over $400 million, is pivotal for a biotech firm like Tyra, as it ensures adequate funding for their research and development activities through at least 2026.
From a financial standpoint, the increased R&D expenses, which rose to $62.5 million in 2023 from $43.0 million in 2022, reflect the company's aggressive investment in its pipeline. This is particularly relevant for investors as it signals a strategic allocation of resources towards potential high-value indications, such as achondroplasia and various cancers, with the TYRA-300 and TYRA-200 compounds. However, the reported net loss widening from $55.3 million to $69.1 million year-over-year indicates that the company is still in a heavy investment phase, which is typical for clinical-stage biotech companies. Investors should weigh the potential long-term benefits of the company's current R&D spending against the short-term financial performance.
The progression of Tyra Biosciences' oncology studies, particularly the SURF301 and SURF201 Phase 1 studies, represents a critical step in the company's efforts to address unmet medical needs within oncology. The Fibroblast Growth Factor Receptor (FGFR) biology is a promising target in cancer treatment and the company's focus on developing precision medicines in this area could potentially lead to breakthrough therapies. The ongoing trials aim to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), which are important for the subsequent stages of clinical development.
Furthermore, the Rare Pediatric Disease (RPD) Designation received from the FDA for TYRA-300 for achondroplasia treatment is noteworthy. This designation, along with the Orphan Drug Designation (ODD), could provide certain regulatory and financial incentives, including a possible priority review voucher upon marketing approval. These designations are significant as they reflect regulatory acknowledgment of the potential benefit of TYRA-300 for a rare and serious condition, which could lead to expedited development and review processes.
Investor sentiment towards Tyra Biosciences appears strong, considering the successful completion of a sizable PIPE and the participation of notable investors such as RA Capital Management and OrbiMed. The biotech sector often sees heightened investor interest in companies that demonstrate a clear path to clinical milestones and possess a robust pipeline with potential blockbuster therapies. Tyra's focus on FGFR biology taps into a niche but growing segment of precision medicine in oncology, which is gaining traction due to its promise of more effective and personalized treatments.
Moreover, the company's in-house precision medicine discovery engine, SNÅP, could be a key differentiator in the long term, potentially enabling the rapid development of targeted therapies. As the industry continues to shift towards precision medicine, Tyra's technological capabilities and strategic focus might position it well within the competitive landscape. However, the market will be closely monitoring the upcoming data readouts in 2024, which will be pivotal in assessing the clinical viability of Tyra's pipeline and could significantly influence the company's valuation and stock performance.
- Advanced SURF301 Phase 1 oncology study; Initial Phase 1 results to be reported in 2H 2024 -
- TYRA-300 Phase 2 ACH IND submission on track for 2H 2024 -
- Initiated SURF201 Phase 1 study and dosed first patient with TYRA-200 -
- Strengthened balance sheet with approximately
"2023 was an outstanding year for TYRA and we are pleased to have positive momentum at the start of 2024," said Todd Harris, CEO of TYRA. "We have strong conviction in our pipeline and believe our lead program TYRA-300 has the potential to become a best-in-class agent for multiple high-value indications. TYRA-300 remains our top priority and we are focused on submitting our Phase 2 IND for achondroplasia, while optimizing dose in SURF301 in preparation for Phase 2 studies in NMIBC and metastatic urothelial carcinoma."
"TYRA is in our strongest financial position to date, with a pro-forma cash position of over
Fourth Quarter 2023 and Recent Corporate Highlights
- Closed a
$200M $200 million
TYRA-300
- Received FDA Rare Pediatric Disease Designation for the Treatment of Achondroplasia. In January 2024, TYRA-300 was granted Rare Pediatric Disease (RPD) Designation for the treatment of achondroplasia from the
U.S. Food and Drug Administration (FDA). TYRA-300 has also received Orphan Drug Designation (ODD) for the treatment of achondroplasia from the FDA. - SURF301 Phase 1/2 Study for Oncology Continued to Advance. The SURF301 Phase 1 study for oncology (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) continues to advance. The study is a multi-center, open label study designed to determine the optimal and maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. TYRA expects that the Phase 1 portion of SURF301 will provide data to inform multiple doses and schedules of TYRA-300 in future studies in metastatic urothelial carcinoma (mUC), non-muscle invasive bladder cancer (NMIBC) and achondroplasia. As of March 2024, the Part A Phase 1 portion of SURF301 has completed dose escalation, and the current expansion cohorts in Part B are evaluating potentially therapeutic once daily and twice daily doses. TYRA expects to submit initial results from its SURF301 Phase 1 portion for presentation at a scientific congress in the second half of 2024.
- Phase 2 Achondroplasia (ACH) Study On Track. TYRA is planning to initiate a Phase 2 clinical trial testing multiple doses of TYRA-300 to support children with achondroplasia. TYRA expects that the primary objective of this study will be to assess safety and tolerability in children with achondroplasia and determine the dose(s) for further development. TYRA also expects that secondary objectives will include evaluating change in growth velocity, growth proportionality and pharmacokinetics (PK). TYRA is also planning exploratory assessments of clinical outcomes and quality of life measures, and an evaluation of biomarkers to determine dose-response relationships to TYRA-300. TYRA's current expectation is that the study will initially evaluate treatment naïve children ages 5-12 to determine optimal dose ranges and will also include a separate cohort and analysis of children ages 5-12 with achondroplasia who have received and did not tolerate or respond to a prior growth accelerating therapy. TYRA plans to submit an Investigational New Drug (IND) application to the FDA in the second half of 2024 for the initiation of the Phase 2 study.
TYRA-200
- Phase 1 SURF201 Study Initiated. SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) is a multi-center, open label study designed to evaluate the safety, tolerability, and PK of TYRA-200 and determine the optimal and MTD and RP2D, as well as evaluate the preliminary antitumor activity of TYRA-200.
TYRA-200 is an 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.
SNÅP Platform and Pipeline
- TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions including FGF19+/FGFR4-driven cancers and others.
Fourth Quarter and Full Year 2023 Financial Results
- Fourth quarter 2023 net loss was
$22.8 million $12.9 million - Fourth quarter 2023 research and development expenses were
$20.7 million $10.4 million - Fourth quarter 2023 general and administrative expenses were
$5.0 million $4.6 million - Full year 2023 net loss was
$69.1 million $55.3 million - Full year 2023 research and development expenses were
$62.5 million $43.0 million - Full year 2023 general and administrative expenses were
$17.4 million $15.9 million - As of December 31, 2023, TYRA had cash, cash equivalents, and marketable securities of
$203.5 million $200 million $403.5 million
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. 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). SURF301 (NCT05544552) was designed to determine the optimal and MTD and the RP2D of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations. In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results, 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 ODD and RPD Designation 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
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 precision medicines, the potential for TYRA-300 to become a best-in-class agent, and the potential safety and therapeutic benefits of TYRA-300, TYRA-200 and other product candidates; the ability to deliver value for shareholders and patient communities; the sufficiency of our cash position to support clinical and operational milestones; expected cash runway; the potential benefits of regulatory designations; the expected timing and phase of clinical development of TYRA-300 and TYRA-200, 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, and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; 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; 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 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 (PRV) or any value therefrom; regulatory developments in
Contact:
Amy Conrad
aconrad@tyra.bio
Tyra Biosciences, Inc. | |||||||
Condensed Balance Sheet Data | |||||||
(in thousands) | |||||||
December 31, | December 31, | ||||||
2023 | 2022 | ||||||
Balance Sheet Data: | |||||||
Cash, cash equivalents and marketable securities | $ | 203,469 | $ | 251,213 | |||
Working capital | 196,338 | 251,587 | |||||
Total assets | 225,857 | 266,181 | |||||
Accumulated deficit | (164,830) | (95,696) | |||||
Total stockholders' equity | 204,262 | 257,829 | |||||
Tyra Biosciences, Inc. | ||||||||||||||||
Condensed Statements of Operations and Comprehensive Loss | ||||||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 20,677 | $ | 10,400 | $ | 62,518 | $ | 43,008 | ||||||||
General and administrative | 4,957 | 4,618 | 17,427 | 15,919 | ||||||||||||
Total operating expenses | 25,634 | 15,018 | 79,945 | 58,927 | ||||||||||||
Loss from operations | (25,634) | (15,018) | (79,945) | (58,927) | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 2,815 | 2,156 | 10,850 | 3,652 | ||||||||||||
Other expense | (11) | (33) | (39) | (50) | ||||||||||||
Total other income, net | 2,804 | 2,123 | 10,811 | 3,602 | ||||||||||||
Net loss | $ | (22,830) | $ | (12,895) | $ | (69,134) | $ | (55,325) | ||||||||
Unrealized gain on marketable securities | 381 | — | 381 | — | ||||||||||||
Comprehensive loss | $ | (22,449) | $ | (12,895) | $ | (68,753) | $ | (55,325) | ||||||||
Net loss per share, basic and diluted | $ | (0.53) | $ | (0.31) | $ | (1.62) | $ | (1.32) | ||||||||
Weighted-average shares used to compute | 42,965,744 | 42,207,685 | 42,704,876 | 41,883,904 | ||||||||||||
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SOURCE Tyra Biosciences
FAQ
What financial results did Tyra Biosciences, Inc. report for the fourth quarter and full year 2023?
What is the pro-forma cash position of TYRA after the PIPE financing in February 2024?
What FDA designations did TYRA-300 receive?
What studies has TYRA initiated recently?
What is the focus of TYRA's in-house precision medicine discovery engine, SNÅP?
What was the gross proceeds of TYRA's Private Placement Financing in February 2024?
When does TYRA expect to submit initial results from the SURF301 Phase 1 study?
What is the primary objective of the Phase 2 Achondroplasia (ACH) Study?
