Tyra Biosciences Inc
For the period ended Jun 30, 2024. Filed Aug 7, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 7, 2024
TYRA$21.15+1.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0000950170-24-056971
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0000950170-24-092778
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 109 previous paragraphs and 112 current paragraphs.
86 unchanged; 16 reworded; 6 added; 4 removed; 3 previous and 4 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
In July 2024, we announced the expansion of development of TYRA-300 into hypochondroplasia (HCH) based on positive preclinical results. In a preclinical HCH model, TYRA-300 demonstrated increases in long bone length and binding against the HCH altered protein. HCH is a skeletal dysplasia closely related to ACH. HCH is most commonly caused by the N540K mutation (~70-80%) in the FGFR3 gene. The design of TYRA-300 may inhibit the alteration driving FGFR3-related skeletal dysplasias including ACH, HCH and others.
Current report
Results of Operations
Current report
Comparison of the Three Months Ended June 30, 2024 and 2023
Current report
Comparison of the Six Months Ended June 30, 2024 and 2023
Current report
General and administrative expenses were $10.7 million and $7.8 million for the six months ended June 30, 2024 and 2023, respectively. The increase of $2.9 million was primarily due to an increase in stock-based compensation costs of $1.4 million, an increase in professional service costs of $0.9 million, an increase in personnel costs of $0.5 million and an increase in other operating costs of $0.1 million.
Removed paragraphs (4)
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Reworded paragraphs (16)
Previous wording
Resistant FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with locally advanced or metastatic urothelial carcinoma (mUC) and other advanced solid tumors with FGFR3 gene alterations. The Part A, Phase 1 portion of SURF301 has completed dose escalation without determining an MTD, and the current expansion cohorts in Part B are evaluating potentially therapeutic once daily and twice daily doses. We expect to submit initial results from the SURF301 Phase 1 portion for presentation at a scientific congress in the second half of 2024.
Current wording
Our lead product candidate, TYRA-300, is an investigational, oral, FGFR3-selective inhibitor currently being evaluated in an international, multi-center, open label Phase 1 clinical trial, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with locally advanced or metastatic urothelial carcinoma (mUC) and other advanced solid tumors with FGFR3 gene alterations. We expect that the Phase 1 portion of SURF301 will provide data to inform the dosing schedule of TYRA-300 we intend to evaluate in potential future studies in mUC and non-muscle invasive bladder cancer (NMIBC). The Part A, Phase 1 portion of SURF301 has completed dose escalation without determining an MTD, and the current expansion cohorts in Part B are evaluating potentially therapeutic once daily and twice daily doses in preparation for potential future Phase 2 studies in NMIBC and mUC. We expect to submit initial results from the SURF301 Phase 1 portion for presentation at a scientific congress in the second half of 2024.
Previous wording
We nominated our third candidate for clinical development, TYRA-430, an FGFR4/3 selective inhibitor for FGF19+/FGFR4-driven cancers, and are focused on completing IND-enabling studies for this program.
Current wording
We nominated our third candidate for clinical development, TYRA-430, an investigational FGFR4/3 biased inhibitor for FGF19+/FGFR4-driven cancers. In August 2024, we announced that the FDA allowed our IND to proceed with a Phase 1 clinical study of TYRA-430. The Phase 1 study will be a multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431). We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies.
Previous wording
Since the commencement of our operations in 2018, we have devoted substantially all of our resources to organizing and staffing the company, business planning, raising capital, developing our proprietary SNÅP platform, undertaking research and development activities for our development programs, establishing our intellectual property portfolio, and providing general and administrative support for our operations. We have not generated any revenue to date and have funded our operations primarily from our initial public offering (IPO), private placements of our convertible preferred stock, and the issuance of Simple Agreements for Future Equity. Our net losses for the three months ended March 31, 2024 and 2023 were $18.2 million and $11.9 million, respectively. As of March 31, 2024, we had an accumulated deficit of $183.0 million. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $382.5 million.
Current wording
Since the commencement of our operations in 2018, we have devoted substantially all of our resources to organizing and staffing the company, business planning, raising capital, developing our proprietary SNÅP platform, undertaking research and development activities for our development programs, establishing our intellectual property portfolio, and providing general and administrative support for our operations. We have not generated any revenue to date and have funded our operations primarily from our initial public offering (IPO), private placements of our convertible preferred stock, and the issuance of Simple Agreements for Future Equity. Our net losses for the six months ended June 30, 2024 and 2023 were $36.9 million and $25.2 million, respectively. As of June 30, 2024, we had an accumulated deficit of $201.7 million. As of June 30, 2024, we had cash, cash equivalents, and marketable securities of $373.8 million.
Previous wording
Research and development expenses were $17.2 million and $10.4 million for the three months ended March 31, 2024 and 2023, respectively. The overall increase of $6.8 million was primarily due to an increase in CRO and drug manufacturing costs to support our ongoing and planned clinical trials of $4.5 million, an increase in personnel costs of $1.2 million, an increase in stock-based compensation costs of $1.0 million, and an increase in facilities and other operating costs of $0.5 million. The increase was partially offset by a decrease in preclinical expenses of $0.4 million.
Current wording
Research and development expenses were $18.0 million and $12.2 million for the three months ended June 30, 2024 and 2023, respectively. The overall increase of $5.8 million was primarily due to an increase in CRO and drug manufacturing costs to support our ongoing and planned clinical trials of $3.0 million, an increase in personnel costs of $1.3 million, an increase in stock-based compensation costs of $1.2 million, and an increase in facilities and other operating costs of $0.7 million. The increase was partially offset by a decrease in preclinical expenses of $0.4 million.
Previous wording
General and administrative expenses were $5.1 million and $3.9 million for the three months ended March 31, 2024 and 2023, respectively. The increase of $1.2 million was primarily due to an increase in stock-based compensation costs of $0.7 million, an increase in professional services costs of $0.3 million, and an increase in personnel costs of $0.2 million.
Current wording
General and administrative expenses were $5.5 million and $3.9 million for the three months ended June 30, 2024 and 2023, respectively. The increase of $1.6 million was primarily due to an increase in stock-based compensation costs of $0.7 million, an increase in professional costs of $0.5 million, an increase in personnel costs of $0.3 million and an increase in other operating costs of $0.1 million.
Previous wording
Other income was $4.1 million and $2.5 million for the three months ended March 31, 2024 and 2023, respectively. The increase of $1.6 million was primarily related to the increase in cash, cash equivalents and marketable securities resulting from proceeds received from the 2024 Private Placement, as well as fluctuations in interest rates.
Current wording
Other income was $4.8 million and $2.7 million for the three months ended June 30, 2024 and 2023, respectively. The increase of $2.1 million was primarily related to the increase in cash, cash equivalents, and marketable securities resulting from proceeds received from the 2024 Private Placement, as well as fluctuations in interest rates.
Previous wording
We are not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sales Agreement. No assurance can be given that we will sell any shares of common stock under the Sales
Current wording
We are not obligated to sell, and the Agent is not obligated to buy or sell, any shares of common stock under the Sales Agreement. No assurance can be given that we will sell any shares of common stock under the Sales Agreement, or, if we do, as to the price or amount of shares of common stock that we may sell or the dates when such sales will take place. As of June 30, 2024, we have not sold any shares under the Sales Agreement.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2024 was $22.0 million, consisting primarily of our net loss of $18.2 million, adjusted for $3.0 million of non-cash charges primarily related to stock-based compensation expense and accretion on marketable securities and $6.8 million for net changes in operating assets and liabilities.
Current wording
Net cash used in operating activities for the six months ended June 30, 2024 was $32.3 million, consisting primarily of our net loss of $36.9 million and $1.1 million for net changes in operating assets and liabilities, adjusted for $5.7 million of non-cash charges primarily related to stock-based compensation expense and accretion on marketable securities.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2023 was $9.8 million, consisting primarily of our net loss of $11.9 million, adjusted for $2.5 million of non-cash charges primarily related to stock-based compensation expense and $0.4 million for net changes in operating assets and liabilities.
Current wording
Net cash used in operating activities for the six months ended June 30, 2023 was $19.5 million, consisting primarily of our net loss of $25.2 million, adjusted for $5.1 million of non-cash charges primarily related to stock-based compensation expense and $0.6 million for net changes in operating assets and liabilities.
Previous wording
Net cash provided by investing activities for the three months ended March 31, 2024 was $18.1 million, consisting of $30.0 million received related to sales and maturities of marketable securities available-for-sale, offset by purchases of marketable securities available-for-sale of $11.8 million and purchases of property and equipment of $0.1 million.
Current wording
Net cash used in investing activities for the six months ended June 30, 2024 was $126.9 million, consisting of purchases of marketable securities available-for-sale of $189.2 million and purchases of property and equipment of $0.6 million, offset by $62.9 million related to sales and maturities of marketable securities available-for-sale.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2023 was $41 thousand, consisting of purchases of property and equipment.
Current wording
Net cash used in investing activities for the six months ended June 30, 2023 was $0.1 million, consisting of purchases of property and equipment.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2024 was $200.3 million, consisting primarily of proceeds from the issuance of common stock and pre-funded warrants from the 2024 Private Placement of $200 million and proceeds from issuances of common stock under benefit plans of $0.5 million, offset by issuance costs paid during the quarter relating to the 2024 Private Placement of $0.2 million.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2024 was $200.7 million, consisting primarily of proceeds from the issuance of common stock and pre-funded warrants from the 2024 Private Placement of $200 million, offset by issuance costs of $0.4 million and proceeds from issuances of common stock under benefit plans of $1.1 million.
Previous wording
Net cash provided by financing activities for the three months ended March 31, 2023 was $0.4 million, related to proceeds from issuances of common stock under benefit plans.
Current wording
Net cash provided by financing activities for the six months ended June 30, 2023 was $0.7 million, related to proceeds from issuances of common stock under benefit plans.
Previous wording
Other than disclosed below, there were no material changes outside the ordinary course of our business during the three months ended March 31, 2024 to the information regarding our contractual obligations that was disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2023 Annual Report.
Current wording
There were no material changes outside the ordinary course of our business during the six months ended June 30, 2024 to the information regarding our contractual obligations that was disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2023 Annual Report.
Previous wording
As of March 31, 2024, total future aggregate operating lease commitments were $9.3 million, with approximately $0.6 million due during 2024, and the remaining due in periods from 2025 through 2033.
Current wording
As of June 30, 2024, total future aggregate operating lease commitments were $9.1 million, with approximately $0.4 million due during 2024, and the remaining due in periods from 2025 through 2033.
Previous wording
There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2024, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2023 Annual Report.
Current wording
There have been no material changes to our critical accounting policies and estimates during the three and six months ended June 30, 2024, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2023 Annual Report.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
The following table summarizes our results of operations for the periods indicated (in thousands):
Current report — wording carried from elsewhere
Research and development expenses were $35.2 million and $22.6 million for the six months ended June 30, 2024 and 2023, respectively. The overall increase of $12.6 million was primarily due to an increase in CRO and drug manufacturing costs to support our ongoing and planned clinical trials of $7.6 million, an increase of personnel costs of $2.4 million, an increase in stock-based compensation costs of $2.2 million, and an increase in facilities and other operating costs of $1.2 million. The increase was partially offset by a decrease in preclinical expenses of $0.8 million.
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses by development program for the six months ended June 30, 2024 and 2023 (in thousands):
Current report — wording carried from elsewhere
Other income was $9.0 million and $5.2 million for the six months ended June 30, 2024 and 2023, respectively. The increase of $3.8 million was primarily related to the increase in cash, cash equivalents, and marketable securities resulting from proceeds received from the 2024 Private Placement, as well as fluctuations in interest rates.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Our lead product candidate, TYRA-300, is an investigational, oral, FGFR3-selective inhibitor currently being evaluated in an international, multi-center, open label Phase 1 clinical trial, SURF301 (Study in Untreated and
Previous report — wording carried elsewhere
Results of Operations for the Three Months Ended March 31, 2024 and 2023
Previous report — wording carried elsewhere
Agreement, or, if we do, as to the price or amount of shares of common stock that we may sell or the dates when such sales will take place. As of March 31, 2024, we have not sold any shares under the Sales Agreement.