Tyra Biosciences, Inc.
For the period ended Mar 31, 2025. Filed May 8, 2025.
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.
Mar 31, 2025 · Filed May 8, 2025
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 2024-09-30; filed 2024-11-07.
0000950170-24-123346
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0000950170-25-066942
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 114 previous paragraphs and 124 current paragraphs.
71 unchanged; 17 reworded; 34 added; 24 removed; 2 previous and 2 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 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 (34)
Current report
Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help us design and predict which product candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. We have initially leveraged our SNÅP approach to develop TYRA-300, TYRA-200 and TYRA-430: three clinical-stage, novel small molecules designed to overcome the toxicity and resistance liabilities of first generation pan-FGFR inhibitors.
Current report
Our FGFR3 Programs - TYRA-300 for Bladder Cancer and Skeletal Conditions
Current report
Mutations in the protein receptor FGFR3 are a key driver in two indications with large market opportunities: bladder cancer and skeletal conditions. In bladder cancer, uncontrolled activation of FGFR3 on the cell surface stimulates cellular proliferation. In skeletal conditions, increased activity of FGFR3 expressed in growth plate chondrocytes (cartilage cells) results in excessive limitation of long bone growth.
Current report
Our lead program, TYRA-300, was designed to be more selective for FGFR3 over FGFR1, FGFR2, and FGFR4 to minimize off-target side effects, providing potential clinical advantages over less selective first-generation compounds and potentially addressing key unmet needs across both bladder cancer and skeletal conditions.
Current report
TYRA-300 is expected to be evaluated in three Phase 2 studies: BEACH301, for the treatment of pediatric achondroplasia (ACH); SURF302, for the treatment of non-muscle invasive bladder cancer (NMIBC); and SURF301, for the treatment of metastatic urothelial carcinoma (mUC).
Current report
SURF302 for NMIBC: This study is an open-label Phase 2 clinical trial evaluating the efficacy and safety of TYRA-300 at lower doses (50 and 60mg QD) in participants with FGFR3-altered low-grade, intermediate risk (IR) NMIBC. We expect to dose the first patient in this study in the second quarter of 2025.
Current report
SURF301 for mUC: This ongoing study is an international, multi-center, open label Phase 1/2 clinical trial that 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. In late October 2024, we reported interim data that in patients with FGFR3+ mUC who received doses ≥ 90 mg once daily (QD), 6 out of 11 (54.5%) patients achieved a confirmed partial response. Preliminary data, as of the August 15, 2024 data cutoff, suggested TYRA-300 was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Dose optimization is ongoing in this study.
Current report
Our FGFR2 Program - TYRA-200 for Intrahepatic Cholangiocarcinoma
Current report
FGFR2 is a protein receptor present on the cell surface that promotes cellular proliferation and transformation upon binding of fibroblast growth factor. Activating gene alterations of FGFR2 have been implicated in the tumorigenesis of multiple solid tumor types, with pan-FGFR inhibitors approved for intrahepatic cholangiocarcinoma (ICC).
Current report
TYRA-200 is an FGFR1/2/3 inhibitor designed to be active against nearly all of the clinically identified acquired resistant mutations that arise during treatment with pan-FGFR inhibitors, which we believe is necessary to address the problem of disease progression due to polyclonal resistance. TYRA-200 is currently being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 that is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TYRA-200, determine the optimal dose for further development and the MTD and RP2D, and evaluate preliminary antitumor activity, with a focus on achieving proof-of-concept in a cohort of FGFR2-driven ICC resistant to previous FGFR inhibitors.
Current report
Our FGF19+ Program - TYRA-430 for Hepatocellular Carcinoma
Current report
FGF19 is a post-prandial enterohepatic hormone that signals through FGFR4 and its associated co-receptor Klotho Beta (KLB) to exert its normal cellular functions. In certain cancers, FGF19 is aberrantly expressed due to focal chromosomal amplifications or epigenetic mechanisms, promoting tumor cells to become dependent on the FGFR4/KLB/FGF19 oncogenic axis. Recent insights into FGF/FGFR signaling in HCC have indicated an important bypass mechanism in FGFR3, which shares the Klotho Beta coreceptor.
Current report
TYRA-430 was designed to be biased for FGFR4 and FGFR3 over the FGFR1 and FGFR2 isoforms specifically to address the FGF19 signaling pathway, while also potentially limiting side effects due to inhibition of FGFR1 and FGFR2, as well as to address acquired resistance mutations that have limited the efficacy of previous FGFR4-specific inhibitors. TYRA-430 is currently being evaluated in a global Phase 1 multicenter, open-label study, SURF431, that is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TYRA-430 and determine the maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-430. TYRA-430 is initially being studied in advanced HCC and other solid tumors with activating FGF/FGFR pathway aberrations. In April 2025, we commenced patient dosing in this study.
Current report
Financial Overview
Current report
Research and Development Expenses
Current report
o
Current report
o
Current report
o
Current report
o
Current report
o
Current report
o
Current report
o
Current report
General and Administrative Expenses
Current report
Other income consist primarily of interest income from cash, cash equivalents and marketable securities and accretion income from marketable securities.
Current report
Research and Development Expenses
Current report
We track most external development costs by development program. We do not allocate internal costs, such as personnel-related expenses, stock-based compensation expense, facility, supplies and certain external consultant costs, to individual development programs.
Current report
Research and development expenses were $25.0 million and $17.2 million for the three months ended March 31, 2025 and 2024, respectively. The overall increase of $7.8 million was primarily driven by:
Current report
$5.6 million increase in clinical costs primarily for start-up activities related to BEACH301, SURF302 and SURF431 study launches and CMC activities; and
Current report
$2.1 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.2 million, driven by headcount growth.
Current report
General and Administrative Expenses
Current report
General and administrative expenses were $6.9 million and $5.1 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $1.8 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.1 million, driven by headcount growth.
Current report
Other income was $3.7 million and $4.1 million for the three months ended March 31, 2025 and 2024, respectively. The decrease of $0.4 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
Current report
Material Cash Requirements
Current report
Our material cash requirements consist of expected operating expenses to conduct our clinical trials and other research and development activities, personnel-related expenses and operating lease obligations.
Removed paragraphs (24)
Previous report
In oncology, the widespread availability of approved targeted treatments, such as kinase inhibitors, has transformed the cancer treatment landscape. Despite the therapeutic benefit that targeted oncology treatments have created for some patients, the response rate and duration of efficacy is often limited by acquired drug resistance, off-target toxicities and other shortcomings of existing therapies. We are using our proprietary SNÅP platform in order to generate novel product candidates that are specifically designed to limit off-target toxicities and address acquired drug resistance to provide next-generation treatment options.
Previous report
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. In October 2024, we announced that we plan to submit an Investigational New Drug (IND) application for a Phase 2 study of TYRA-300 in NMIBC by year-end 2024.
Previous report
In October 2024, we also announced interim clinical proof-of-concept data for TYRA-300 in patients with mUC from our ongoing SURF301 Phase 1/2 study. These data were presented at a late-breaking oral presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. As of the August 15, 2024 data cutoff, 41 patients were enrolled in the Phase 1 portion of the SURF301 Phase 1/2 study. Eligible participants were adults with advanced malignancies with or without FGFR3 alterations, including those with prior treatment with Erdafitinib. The enrolled patient population was heavily pre-treated, with 44% of patients receiving ≥ 3 lines of therapy prior to receiving TYRA-300, and 76% of FGFR3+ mUC patients receiving ≥ 3 lines of therapy. Treatment with TYRA-300 was evaluated across six dose levels, ranging from 10 mg-120 mg once daily (QD). Preliminary pharmacokinetics (PK)/pharmacodynamics (PD) analysis in 41 patients as of the data cutoff date was as follows: TYRA-300 plasma concentrations indicate adequate target coverage at ≥90 mg QD, with further pharmacokinetic characterization ongoing.
Previous report
In patients with FGFR3+ mUC who received doses ≥ 90 mg QD, anti-tumor activity was observed in all patients: (i) 6 out of 11 (54.5%) patients at ≥ 90 mg QD achieved a confirmed partial response (PR), 3 of which are still ongoing; (ii) 5 out of 10 (50%) patients at 90 mg QD achieved a PR; (iii) 1 out of 1 (100%) patient at 120 mg QD achieved a PR; and (iv) a 100% disease control rate (DCR) was achieved for all patients at ≥ 90 mg QD (PR + stable disease). TYRA-300 has demonstrated favorable interim safety results as of the data cutoff date: (i) preliminary data from SURF301 suggest TYRA-300 to be generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities; (ii) in doses from 10 mg up to 120 mg QD, there were 4 (10%) serious adverse events related to TYRA-300, 1 dose-limiting toxicity (DLT) of grade (Gr) 3 diarrhea at 90 mg QD, and 1 treatment-related adverse event (TRAE) leading to discontinuation of treatment (Gr3 ALT, 90 mg QD); (iii) there were no ≥ Gr4 TRAEs; and (iv) the 120 mg QD dose was the highest dose evaluated with no DLTs reported.
Previous report
Beyond oncology, FGFR3 is implicated in many genetically-defined conditions, such as achondroplasia (ACH) and other skeletal dysplasias, due to its role in regulating bone and cartilage formation. In March 2023, we announced we were expanding development of TYRA-300 into ACH based on positive preclinical results demonstrated in a study performed in collaboration with the Imagine Institute in Paris, France. Data from the study showed that TYRA-300 increased body length in mice by 17.9% compared to the vehicle (p<0.0001) and increased the length of the femur (+22.6%), tibia (+33.0%) and L4-L6 (+23.5%) in mice (p<0.0001) (with n=8 for TYRA-300, after excluding two mice from the dataset when molecular analysis showed chimeric incorporation of mutation, and n=10 for vehicle, after excluding one vehicle mouse from the dataset when molecular analysis showed chimeric incorporation of mutation). Achondroplasia, the most common form of dwarfism, is a skeletal dysplasia in which growth plate cartilage is affected, resulting in decreased growth of the long bones, vertebral bodies and skull base. These growth differences can result in health complications such as foramen magnum and spinal stenosis, hydrocephalus, genu varum (bowed legs), and sleep apnea. A specific DNA mutation in FGFR3 causes an estimated 99% of ACH.
Previous 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.
Previous report
Our second oncology product candidate, TYRA-200, is an investigational, oral, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations, as well as clinically important molecular brake and gatekeeper resistance mutations. TYRA-200 is currently 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) (NCT06160752) that is designed to evaluate the safety, tolerability, and PK of TYRA-200 and determine the optimal dose for further development and the MTD and RP2D, as well as evaluate preliminary antitumor activity.
Previous report
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 report
Results of Operations
Previous report
Comparison of the Three Months Ended September 30, 2024 and 2023
Previous report
Research and development expenses were $22.7 million and $19.3 million for the three months ended September 30, 2024 and 2023, respectively. The overall increase of $3.4 million was primarily due to an increase in stock-based compensation costs of $2.5 million, an increase in personnel costs of $1.3 million, an increase in costs to support our ongoing and planned clinical trials of $1.1 million, and an increase in facilities and other operating costs of $0.5 million. The increase was partially offset by a decrease in drug manufacturing and toxicology studies costs of $1.6 million and a decrease in preclinical expenses of $0.4 million.
Previous report
General and administrative expenses were $5.9 million and $4.7 million for the three months ended September 30, 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 personnel costs of $0.4 million, and an increase in other operating costs of $0.1 million.
Previous report
Other income was $4.6 million and $2.8 million for the three months ended September 30, 2024 and 2023, respectively. The increase of $1.8 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.
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report
Research and development expenses were $57.9 million and $41.8 million for the nine months ended September 30, 2024 and 2023, respectively. The overall increase of $16.1 million was primarily due to an increase in CRO and drug manufacturing costs to support our ongoing and planned clinical trials of $7.2 million, an increase in stock-based compensation costs of $4.7 million, an increase of personnel costs of $3.7 million, and an increase in facilities and other operating costs of $1.7 million. The increase was partially offset by a decrease in preclinical expenses of $1.2 million.
Previous report
General and administrative expenses were $16.5 million and $12.5 million for the nine months ended September 30, 2024 and 2023, respectively. The increase of $4.0 million was primarily due to an increase in stock-based compensation costs of $2.0 million, an increase in professional service costs of $0.9 million, an increase in personnel costs of $0.9 million, and an increase in other operating costs of $0.2 million.
Previous report
Other income was $13.5 million and $8.0 million for the nine months ended September 30, 2024 and 2023, respectively. The increase of $5.5 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 report
On September 17, 2021, we completed our IPO and issued 12,420,000 shares of common stock for net proceeds of approximately $181.2 million. Prior to our IPO, we funded our operations primarily through private placements of our convertible preferred stock with net proceeds of $157.2 million excluding issuance costs of $0.4 million.
Previous report
On February 6, 2024, we completed the 2024 Private Placement for gross proceeds of approximately $200 million, before deducting offering expenses of $0.4 million. On March 19, 2024, we filed a registration statement on Form S-3 registering the resale of the shares of common stock and shares of common stock issuable upon the exercise of pre-funded warrants issued in the private placement, which registration statement was declared effective by the SEC on April 22, 2024.
Previous report
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 September 30, 2024, we have not sold any shares under the Sales Agreement.
Previous report
Net cash used in operating activities for the nine months ended September 30, 2023 was $36.6 million, consisting primarily of our net loss of $46.3 million, adjusted for $9.6 million of non-cash charges primarily related to stock-based compensation expense and $0.1 million for net changes in operating assets and liabilities.
Previous report
Net cash used in investing activities for the nine months ended September 30, 2023 was $0.2 million, consisting of purchases of property and equipment.
Previous report
Net cash provided by financing activities for the nine months ended September 30, 2024 was $201.4 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 $1.9 million.
Previous report
Future Funding Requirements
Reworded paragraphs (17)
Previous wording
We are a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. Our 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. Our initial focus is on applying our accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions.
Current wording
We are a clinical-stage biotechnology company focused on developing next-generation precision medicines for large opportunities in targeted oncology and genetically defined conditions, with an initial focus on Fibroblast Growth Factor Receptor (FGFR) biology.
Previous wording
In October 2024, we announced that the FDA allowed the Company’s IND application for TYRA-300 to proceed with a Phase 2 clinical trial of TYRA-300 for children with achondroplasia (BEACH301). BEACH301 will be a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating TYRA-300 in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. Prior to initiation of Cohorts 1 and 2, the study will enroll a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. The primary objectives of the study will be to assess safety and tolerability in children with achondroplasia and evaluate change from baseline in annualized growth velocity to determine the dose(s) for further development. Secondary objectives will include evaluating change from baseline in height z-score, proportionality and PK. The Company is also planning exploratory assessments of clinical outcomes such as functional improvements, changes in the spine, and quality of life measures. The Company expects to dose the first child with achondroplasia in the BEACH301 study in the first quarter of 2025. In July 2023 and January 2024, the FDA granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to TYRA-300, respectively, for the treatment of ACH.
Current wording
BEACH301 for ACH: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating TYRA-300 at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with ACH with open growth plates. Prior to initiation of the first two cohorts, the study has commenced enrolling a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. We expect to dose the first child in this study in the second quarter of 2025.
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 nine months ended September 30, 2024 and 2023 were $60.9 million and $46.3 million, respectively. As of September 30, 2024, we had an accumulated deficit of $225.7 million. As of September 30, 2024, we had cash, cash equivalents, and marketable securities of $360.1 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, the issuance of Simple Agreements for Future Equity and the issuance of common stock and pre-funded common stock warrants through a private placement. Our net losses for the three months ended March 31, 2025 and 2024 were $28.1 million and $18.2 million, respectively. As of March 31, 2025, we had an accumulated deficit of $279.5 million. As of March 31, 2025, we had cash, cash equivalents and marketable securities of $318.9 million.
Previous wording
Based on our current operating plan, we believe that our cash, cash equivalents, and marketable securities as of September 30, 2024 will be sufficient to fund our operating expenses and capital expenditures through at least 2026. We have never generated any revenue and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Current wording
Based on our current operating plan, we believe that our cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund our operating expenses and capital expenditures through at least 2027. We have never generated any revenue and do not expect to generate any revenue from product sales unless and until we successfully complete the development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Previous wording
the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and third-party manufacturers; and
Current wording
the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and third-party manufacturers; and o
Previous wording
facilities, depreciation and other expenses, which include allocated expenses for rent and maintenance of facilities, and supplies.
Current wording
facilities, depreciation and other indirect expenses, which include allocated expenses for rent and maintenance of facilities, and supplies.
Previous wording
General and administrative expenses consist primarily of personnel-related expenses, including employee salaries, bonuses, benefits, and stock-based compensation charges, for personnel in executive and administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, professional fees for accounting, tax and consulting services and insurance costs. We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities, manufacturing activities, and the increased costs associated with operating as a public company. These increased costs will likely include increased expenses related to hiring of additional personnel, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and the Securities and Exchange Commission (SEC) requirements, director and officer insurance costs, and investor and public relations costs.
Current wording
General and administrative expenses consist primarily of personnel-related expenses, including employee salaries, bonuses, benefits, and stock-based compensation charges for personnel in executive, finance and other administrative functions. Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, allocated facility-related costs, professional fees for accounting, tax, business development and consulting services and insurance costs. We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities, manufacturing activities, and the increased costs associated with operating as a public company. These increased costs will likely include increased expenses related to hiring additional personnel, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and the Securities and Exchange Commission (SEC) requirements, director and officer insurance costs, and investor and public relations costs.
Previous wording
The following table summarizes our research and development expenses by development program for the three months ended September 30, 2024 and 2023 (in thousands):
Current wording
The following table summarizes our research and development expenses by development program for the periods indicated (in thousands):
Previous wording
In February 2024, we completed a private placement of 9,286,023 shares of our common stock and pre-funded warrants to purchase an aggregate of 6,087,230 shares of our common stock for gross proceeds of approximately $200 million (the 2024 Private Placement) before deducting offering expenses of $0.4 million.
Current wording
On February 6, 2024, we completed a private placement and issued 9,286,023 shares of our common stock and pre-funded warrants to purchase an aggregate of 6,087,230 shares of our common stock (the 2024 Private Placement) for net proceeds of approximately $199.6 million, excluding issuance costs of $0.4 million.
Previous wording
On October 3, 2022, we entered into an ATM Sales Agreement (the Sales Agreement) with Virtu Americas LLC (the Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. The Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement.
Current wording
On May 8, 2025, we entered into a Sales Agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (the 2025 Sales Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2025 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale or as otherwise agreed with the 2025 Sales Agent. The 2025 Sales Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $50.2 million, consisting primarily of our net loss of $60.9 million and $1.1 million for net changes in operating assets and liabilities, adjusted for $11.8 million of non-cash charges primarily related to stock-based compensation expense and accretion on marketable securities.
Current wording
The increase of $3.4 million in net cash used in operating activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to an increase of $10.0 million in net loss, offset by increases of $2.3 million in non-cash stock-based compensation expense, $0.4 million in non-cash net accretion on marketable securities, and changes in operating assets and liabilities of $3.9 million.
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2024 was $105.4 million, consisting of purchases of marketable securities available-for-sale of $225.6 million and purchases of property and equipment of $0.7 million, offset by $120.9 million related to sales and maturities of marketable securities available-for-sale.
Current wording
The increase of $14.0 million in net cash provided by investing activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to an increase in maturities of marketable securities of $8.9 million, a decrease in purchases of marketable securities of $5.0 million and a decrease in purchases of property and equipment of $0.1 million.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2023 was $1.2 million, related to proceeds from issuances of common stock under benefit plans.
Current wording
The decrease of $198.1 million in net cash provided by financing activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to the $199.8 million in net proceeds from the 2024 Private Placement received during the three months ended March 31, 2024. This decrease was partially offset by an increase of $1.7 million in proceeds from issuances of common stock under benefit plans.
Previous wording
Our primary uses of cash to date have been to fund our research and development activities, including with respect to TYRA-300, TYRA-300 ACH, TYRA430 and TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.
Current wording
Our primary uses of cash to date have been to fund our research and development activities, including with respect to TYRA-300, TYRA-430 and TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.
Previous wording
There were no material changes outside the ordinary course of our business during the nine months ended September 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.
Current wording
Other than disclosed below, there were no material changes outside the ordinary course of our business during the three months ended March 31, 2025 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 2024 Annual Report.
Previous wording
As of September 30, 2024, total future aggregate operating lease commitments were $8.9 million, with approximately $0.2 million due during 2024, and the remaining due in periods from 2025 through 2033.
Current wording
As of March 31, 2025, total future aggregate operating lease commitments were $8.5 million, with approximately $0.7 million due during 2025, and the remaining due in periods from 2026 through 2033.
Previous wording
There have been no material changes to our critical accounting policies and estimates during the three and nine months ended September 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.
Current wording
There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2025, 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 2024 Annual Report.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Results of Operations for the Three Months Ended March 31, 2025 and 2024
Current report — wording carried from elsewhere
On October 3, 2022, we entered into an ATM Sales Agreement (the 2022 Sales Agreement) with Virtu Americas LLC (the 2022 Sales Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2022 Sales Agent. As of March 31, 2025, we have not sold any shares under the 2022 Sales Agreement. In connection with the 2025 Sales Agreement (as defined below), effective May 8, 2025, we terminated the 2022 Sales Agreement.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the periods indicated (in thousands):
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses by development program for the nine months ended September 30, 2024 and 2023 (in thousands):