Perspective Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 10, 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.
Sep 30, 2025 · Filed Nov 10, 2025
CATX$0.84+6.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0000950170-25-107619
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001193125-25-274328
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 143 previous paragraphs and 143 current paragraphs.
114 unchanged; 21 reworded; 8 added; 8 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 2 previous and 2 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 (8)
Current report
During October 2025, updated interim results from our ongoing Phase 1/2a clinical trial (NCT05636618) of [212 Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs with a data cut-off date of September 12, 2025, were presented at the European Society for Medical Oncology (ESMO) Congress 2025, the 2025 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
Current report
In this analysis, 55 patients across three dose cohorts received at least one treatment of VMT-α-NET. Two patients in Cohort 1 and 23 patients in Cohort 2 had at least nine months of follow up since their initial treatment.
Current report
Safety findings based on the 55 patients who received at least one treatment demonstrated that [212 Pb]VMT-α-NET continued to be well tolerated. There were no DLTs, no treatment-related discontinuations, no grade 4 or 5 treatment-emergent AEs, no serious renal complications and no clinically significant treatment-related myelosuppression. There was no dysphagia of any grade observed.
Current report
Anti-tumor activity based on all patients in Cohort 1 and half of the patients enrolled in Cohort 2 showed that out of these 25 patients, 20, or 80.0%, were progression free. Eight patients achieved confirmed responses according to investigator-assessed RECIST v1.1, all of which occurred in Cohort 2. While all 23 Cohort 2 patients had at least one tumor expressing SSTR2, 16 patients in Cohort 2 had SSTR2 expression in all of their tumors. Among the 16 patients with SSTR2 expression in all of their tumors, seven (44%) achieved confirmed responses and 14 (87.5%) remained progression free and on study with a median follow up of 41 weeks. Initial anti-tumor activity observations for an additional 23 patients in Cohort 2 and eight patients in Cohort 3 are expected to be submitted for presentation at a future medical conference in 2026.
Current report
In September 2025, we announced that the first patient received [212 Pb]VMT01 at 3.0 mCi in combination with nivolumab, as part of a new cohort. Additionally, the [212 Pb]VMT01 3.0 mCi monotherapy cohort reopened for enrollment. The SMC recommended evaluating [212 Pb]VMT01 at a higher dose based on its review of five patients dosed with [212 Pb]VMT01 at 1.5 mCi in the monotherapy cohort and two patients dosed with [212 Pb]VMT01 at 1.5 mCi together with nivolumab.
Current report
Since then, five patients had received VMT01 treatment as of October 31, 2025. Three patients received VMT01 at 3.0 mCi in combination with nivolumab. Two patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023.
Current report
We plan to submit to medical conferences data on each cohort after all patients in the cohort have had the opportunity for at least 24 weeks of follow up after their initial doses, which is sufficient time to receive at least one scan after their full treatment (up to three doses every eight weeks), if they receive all three doses of treatment per protocol.
Current report
In October 2025, we entered into an agreement with a general contractor to begin building modifications at our facility in the Chicago, IL metropolitan area along with preparations for the eventual installation of some of the Comecer manufacturing equipment and associated clean rooms.
Removed paragraphs (8)
Previous report
At the 2025 American Society of Clinical Oncology Annual Meeting, which took place May 30 to June 3 in Chicago, IL (2025 ASCO), we presented safety data and announced updated interim results from our multi-center open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212 Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapy and have shown radiological evidence of disease progression in the 12 months prior to enrollment.
Previous report
As of the data cut-off date of April 30, 2025, no dose limiting toxicities (DLTs), no discontinuations due to adverse events (AEs), no grade 4 or 5 treatment-emergent AEs, and no deaths were reported among the 42 patients who had received at least one treatment since the start of the study. Ten patients experienced at least one Grade 3 treatment emergent AEs, although the majority of the Grade 3 treatment AEs were deemed unrelated to [212 Pb]VMT-α-NET. Two patients experienced serious AEs, both of which were deemed unrelated to [212 Pb]VMT-α-NET. A modest number of patients experienced low-grade hematologic toxicities. Observations of lymphocyte count decrease were generally low grade, with three events at Grade 3 and none at Grades 4 or 5. Increases in blood creatinine levels were all at Grade 1. No dysphagia or serious renal complications were reported.
Previous report
Additionally, updated interim efficacy data were presented for the first nine patients: two patients in Cohort 1 and seven patients in Cohort 2. Incremental anti-tumor activity was observed with longer follow up, with three confirmed responses as defined by response evaluation criteria in solid tumors (RECIST) v1.1 and one additional unconfirmed response in Cohort 2. Seven out of the nine patients in Cohorts 1 and 2 continued to experience disease control and remained in the study. One patient experienced stable disease for 48 weeks after their first dose prior to experiencing progressive disease. One patient was previously reported to have progressive disease after one dose under RECIST v1.1 by unambiguous progression of non-target lesions.
Previous report
As of the April 30, 2025 data cut-off date, the first patient who experienced a confirmed objective response had been in response for over 10 months and remained in the study. This patient received the first two [212 Pb]VMT-α-NET doses at administered dose of 5.0 mCi (equivalent to 84.6 µCi/kg), then received the remaining two doses at the next lower activity level of 2.5 mCi (equivalent to 42.4 µCi/kg).
Previous report
Two patients experienced initial responses after the end of their treatment periods as of the data cut-off date for the January 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. Those responses were confirmed in subsequent scans. They remained in response and on study. These patients received four doses of 5.0 mCi (equivalent to 68.7 µCi/kg and 31.7 µCi/kg) of [212 Pb]VMT-α-NET.
Previous report
A fourth patient was observed to experience an initial (unconfirmed) response in the seventh scan at 48 weeks after their first dose, which was the third scan conducted after the end of their treatment period. This patient received four doses of 5.0 mCi (equivalent to 49.1 µCi/kg) of [212 Pb]VMT-α-NET.
Previous report
At the Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting, which took place in June 2025 in New Orleans, Louisiana, data regarding a dosimetry sub-study using [212 Pb]VMT‑α‑NET was presented as a poster presentation. The findings of the sub-study suggested that [212 Pb]VMT‑α‑NET dosimetry using [203 Pb]VMT‑α‑NET as an imaging surrogate is feasible and should be considered as a valuable adjunct to this trial’s clinical data and that, in general, the dosimetric approach can be a useful, complementary tool in the clinical development of 212 Pb‑based therapies delivered with our proprietary chelator for 212 Pb and 203 Pb. The presentation noted that [212 Pb]VMT-α-NET was well tolerated among all patients treated, many with long-term follow up. Therefore, according to the presentation, the reported estimated cumulative absorbed doses of radiation to organs of interest in this analysis likely represented tolerable levels for [212 Pb]VMT-α-NET. The presentation noted that dose escalation and further clinical observations are needed to establish the appropriate threshold levels of cumulative absorbed doses and appropriate Relative Biological Effectiveness factor of 212 Pb delivered with our proprietary chelator.
Previous report
On July 24, 2025, we announced that data on [212 Pb]VMT‑α‑NET was accepted as a Mini Oral presentation at the European Society of Medical Oncology Congress 2025, which will take place between October 17 and 21, 2025 in Berlin, Germany.
Reworded paragraphs (21)
Previous wording
We initially dosed two patients in Cohort 1 (treated at 2.5 mCi per dose) and seven patients in Cohort 2 (treated at 5.0 mCi per dose) of our Phase 1/2a study of [212 Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs, regardless of body weight. Subsequent review for dose-limiting toxicity (DLT) during the safety observation period in these seven patients in Cohort 2 by the Safety Monitoring Committee (SMC) led the SMC to recommend escalating further in a third cohort and enrolling additional patients at 5 mCi to better understand efficacy and safety. During the second quarter of 2025, enrollment for Cohort 2 closed with an additional 39 patients having received at least one treatment, for a total of 46 patients including the seven who were enrolled for DLT observation. In late June 2025, we announced the opening of Cohort 3 in which patients will receive up to four fixed administered doses of [212 Pb]VMT-α-NET at 6 mCi every eight weeks if they weigh more than 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg. As of July 31, 2025, two patients in Cohort 3 have commenced treatment with VMT-α-NET. As data from Cohort 3 emerge, we will evaluate whether to add additional patients to this cohort after completion of enrolling and observations for the DLT patients (up to eight) or explore alternative dose regimens before nominating a recommended Phase 2 dose.
Current wording
We initially dosed two patients in Cohort 1 (treated at 2.5 mCi per dose) and seven patients in Cohort 2 (treated at 5.0 mCi per dose) of our Phase 1/2a study of [212 Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs, regardless of body weight. Subsequent review for dose-limiting toxicity (DLT) during the safety observation period in these seven patients in Cohort 2 by the Safety Monitoring Committee (SMC) led the SMC to recommend escalating further in a third cohort and enrolling additional patients at 5 mCi to better understand efficacy and safety. During the second quarter of 2025, enrollment for Cohort 2 closed with an additional 39 patients having received at least one treatment, for a total of 46 patients including the seven who were enrolled for DLT observation. As of October 31, 2025, a total of 35 patients in Cohort 2 would have had the opportunity for at least 32 weeks of follow up since beginning treatment, which is sufficient time for them to have completed at least one scan following the full course of treatment. In late June 2025, we announced the opening of Cohort 3 in which patients will receive up to four fixed administered doses of [212 Pb]VMT-α-NET at 6 mCi every eight weeks if they weigh more than 60 kg (133 lb), or 100μCi/kg of body weight if they weigh less than or equal to 60 kg. As of September 30, 2025, eight Cohort 3 patients have commenced treatment with VMT-α-NET and will contribute to DLT observation for this dose level. We are evaluating whether to add additional patients to this cohort or explore alternative dose regimens before nominating a dose for a registration enabling study. We plan to submit to medical conferences relevant updates on patients dosed to date who have had the opportunity to receive at least one scan after their full treatment (up to four doses every eight weeks) for presentation in the next 12 months.
Previous wording
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. We are currently activating clinical sites, and on April 29, 2025, we announced the first patient was treated with [212 Pb]PSV359. As of July 31, 2025, two patients have been treated with [212 Pb]PSV359.
Current wording
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. In April 2025, we announced the first patient was treated with [212 Pb]PSV359. As of October 31, 2025, two patients have been treated with [212 Pb]PSV359 at 2.5 mCi (Cohort 1) and one patient has been treated with [212 Pb]PSV359 at 5.0 mCi (Cohort 2), for a total of three patients. Activation activities are underway for additional sites.
Previous wording
We have recently been granted two U.S. patents and one European patent on our key assets. The first U.S. patent pertains to our wholly owned, proprietary technology for generation of 212 Pb at scale. The full term of this patent expires in August 2044. The second U.S. patent pertains to the VMT-α-NET compound for which we have an exclusive license from the University of Iowa. The full term of this patent expires in January 2041. The newly granted European patent pertains to composition and methods of using the lead-specific chelator for performing chelating reactions, for which we have an exclusive license from the University of Iowa. The full term of this patent expires in April 2039.
Current wording
We have recently been granted one European patent and one Chinese patent on our key assets. The European patent pertains to our wholly owned, novel radiopharmaceutical compounds targeting FAP-α. The full term of this patent expires in May 2044. The Chinese patent pertains to the VMT-α-NET compound for which we have an exclusive license from the University of Iowa. The full term of this patent expires in January 2041.
Previous wording
As of June 30, 2025, we had cash, cash equivalents and short-term investments of $191.6 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments for at least the next 12 months from the date the condensed consolidated financial statements in this report were issued and into late 2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement its strategy to advance our clinical assets in their clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase in expenses, particularly in research and development, as we undertake these activities.
Current wording
As of September 30, 2025, we had cash, cash equivalents and short-term investments of $174.1 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments for at least the next 12 months from the date the condensed consolidated financial statements in this report were issued and into late 2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement its strategy to advance our clinical assets in their clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase in expenses, particularly in research and development, as we undertake these activities.
Previous wording
In 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical product candidates including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs, such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables. For additional information, see Note 7, Property and Equipment, of the 2024 Form 10-K.
Current wording
In 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical program candidates including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs, such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables. For additional information, see Note 7, Property and Equipment, of the 2024 Form 10-K.
Previous wording
During the three and six months ended June 30, 2025 we recognized $0.2 million for royalties payable to us pursuant to the GT Medical APA for the period from April 2024 to April 2025. In addition, we also reduced our estimated reserve for environmental waste disposal by $0.3 million based on an estimate received from the hazardous waste disposal vendor.
Current wording
During the second quarter of 2025, we recognized $0.2 million in royalties received pursuant to the GT Medical APA for the period from April 2024 to April 2025. In addition, during the second quarter of 2025, we also reduced our estimated reserve for environmental waste disposal by $0.3 million based on an estimate received from the hazardous waste disposal vendor.
Previous wording
Research and development expenses were $16.6 million for the three months ended June 30, 2025, compared to $9.3 million for the three months ended June 30, 2024, an increase of $7.3 million. Research and development expenses were $31.0 million for the six months ended June 30, 2025, compared to $16.7 million for the six months ended June 30, 2024, an increase of $14.2 million. The increase in research and development expenses was primarily related to increased clinical site activities, drug product costs and delivery costs along with higher personnel costs, including share-based compensation, as we have hired employees to perform many functions previously outsourced to clinical research organizations.
Current wording
Research and development expenses were $20.3 million for the three months ended September 30, 2025, compared to $12.0 million for the three months ended September 30, 2024, an increase of $8.3 million. Research and development expenses were $51.3 million for the nine months ended September 30, 2025, compared to $28.8 million for the nine months ended September 30, 2024, an increase of $22.5 million. The increase in research and development expenses was primarily related to increased clinical site activities, drug program costs and delivery costs along with higher personnel costs, including share-based compensation, as we have hired employees to perform many functions previously outsourced to clinical research organizations.
Previous wording
Management believes that research and development expenses will continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and product candidates and expand our manufacturing capabilities. We are investing in equipment and modifications for the three buildings we acquired in 2024 located in the Houston, TX, Chicago, IL, and Los Angeles, CA, metropolitan areas. Upon completion, we intend to use the buildings to manufacture our product candidates. We are also working towards expanding capacity in our second manufacturing facility in Somerset, NJ, following the commencement of shipping of 212 Pb-labeled radiopharmaceuticals in the fourth quarter of 2024. We expect the capital expenditure associated with this capacity expansion to be a small portion of our total capital expenditures.
Current wording
Management believes that research and development expenses will continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and program candidates and expand our manufacturing capabilities. We are investing in equipment and modifications for the three buildings we acquired in 2024 located in the Houston, TX, Chicago, IL, and Los Angeles, CA, metropolitan areas. Upon completion, we intend to use the buildings to manufacture our program candidates. We are also working towards expanding capacity in our second manufacturing facility in Somerset, NJ, following the commencement of shipping of 212 Pb-labeled radiopharmaceuticals in the fourth quarter of 2024. We expect the capital expenditure associated with this capacity expansion to be a small portion of our total capital expenditures.
Previous wording
Management believes that the cost of certain raw materials used in the production of our novel radiopharmaceutical drugs and product candidates may increase in the coming years, including as a result of increased demand for materials required for the production of radiopharmaceuticals. We are also currently evaluating how potential U.S. and international trade policies, including tariffs, might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug product candidates. We currently source much of the raw materials that are used to produce our product candidates in the U.S. Some equipment and other materials that will be used at our manufacturing sites is sourced from outside the U.S. Based on our initial analysis of recently announced tariffs, we do not expect to experience any material incremental tariff-related cost impacts in 2025. We will continue to monitor new tariffs and their implementation dates as we evaluate the potential impacts along with alternatives suppliers.
Current wording
Management believes that the cost of certain raw materials used in the production of our novel radiopharmaceutical drugs and program candidates may increase in the coming years, including as a result of increased demand for materials required for the production of radiopharmaceuticals. We are also currently evaluating how potential U.S. and international trade policies, including tariffs, might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug program candidates. We currently source much of the raw materials that are used to produce our program candidates in the U.S. Some equipment and other materials that will be used at our manufacturing sites is sourced from outside the U.S. Based on our analysis of recently announced tariffs, we do not expect to experience any material incremental tariff-related cost impacts in 2025. We will continue to monitor policy developments related to tariffs and the implementation dates of new tariffs, as well as potential opportunities to source materials and equipment from alternative suppliers, as we continue to evaluate the potential impacts of tariffs.
Previous wording
General and administrative expenses were $7.7 million for the three months ended June 30, 2025, compared to $5.5 million for the three months ended June 30, 2024, an increase of $2.2 million. General and administrative expenses were $15.6 million for the six months ended June 30, 2025, compared to $11.4 million for the six months ended June 30, 2024, an increase of $4.2 million. The increase in general and administrative expenses was primarily due to increased personnel costs, including share-based compensation.
Current wording
General and administrative expenses were $7.7 million for the three months ended September 30, 2025, compared to $7.0 million for the three months ended September 30, 2024, an increase of $0.8 million. General and administrative expenses were $23.3 million for the nine months ended September 30, 2025, compared to $18.4 million for the nine months ended September 30, 2024, an increase of $4.9 million. The increase in general and administrative expenses was primarily due to increased personnel costs, including share-based compensation.
Previous wording
Operating Activities: The increase of $46.5 million in net cash used in operating activities for the six months ended June 30, 2025, compared to the same period in 2024 was primarily due to changes of $33.2 million in operating assets and liabilities and an increase of $15.7 million in net loss.
Current wording
Operating Activities: The increase of $66.1 million in net cash used in operating activities for the nine months ended September 30, 2025, compared to the same period in 2024 was primarily due to changes of $42.2 million in operating assets and liabilities and an increase of $26.5 million in net loss.
Previous wording
Investing Activities: The decrease of $49.3 million in net cash used in investing activities for the six months ended June 30, 2025, as compared to the same period in 2024 was primarily due to an increase of $33.3 million in maturities of short-term investments, a decrease of $11.6 million in purchases of short-term investments and a decrease of $4.4 million in additions to property and equipment.
Current wording
Investing Activities: The increase of $93.0 million in net cash provided by investing activities for the nine months ended September 30, 2025, as compared to the same period in 2024 was primarily due to an increase of $81.5 million in maturities of short-term investments and a $32.1 million decrease in additions to property and equipment, partially offset by a $20.5 million increase in purchases of short-term investments.
Previous wording
Financing Activities: Net cash provided by financing activities for the six months ended June 30, 2025 primarily related to the proceeds received from the sale of Common Stock pursuant to the 2024 ATM Agreement. Net cash provided by financing activities of $288.4 million in the six months ended June 30, 2024, was primarily related to various capital markets transactions and other agreements we entered into.
Current wording
Financing Activities: Net cash provided by financing activities for the nine months ended September 30, 2025 primarily related to the proceeds received from the sale of Common Stock pursuant to the 2024 ATM Agreement (defined below). Net cash provided by financing activities of $289.0 million in the nine months ended September 30, 2024, was primarily related to various capital markets transactions and other agreements we entered into.
Previous wording
The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The May 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of May 2024 Pre-funded Warrants may not exercise such May 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the May 2024 Pre-funded Warrants. A holder of May 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us. The holders of the pre-funded warrants exercised all of the May 2024 Pre-funded Warrants during the second quarter of 2025 by means of the cashless exercise provision and within the other constraints noted above.
Current wording
The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 Pre-funded Warrant were subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The May 2024 Pre-funded Warrants did not have an exercise date and were exercisable in cash or by means of a cashless exercise. A holder of the May 2024 Pre-funded Warrants could not exercise such May 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would have been more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the May 2024 Pre-funded Warrants. A holder of May 2024 Pre-funded Warrants could increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us. The holders of the pre-funded warrants exercised all of the May 2024 Pre-funded Warrants during the second quarter of 2025 by means of the cashless exercise provision and within the other constraints noted above.
Previous wording
The Jan. 2024 Pre-funded Warrants were exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 Pre-funded Warrant were subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The Jan. 2024 Pre-funded Warrants did not have an expiration date and were exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants could not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would beneficially own more than 4.99% of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the Jan. 2024 Pre-funded Warrants. A holder of Jan. 2024 Pre-funded Warrants could increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us. The holder of the Jan. 2024 Pre-Funded Warrants exercised all of the Jan. 2024 Pre-Funded Warrants during the fourth quarter of 2024 by means of the cashless exercise provision and within the other constraints noted above.
Current wording
The Jan. 2024 Pre-funded Warrants were exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 Pre-funded Warrant were subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The Jan. 2024 Pre-funded Warrants did not have an expiration date and were exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants could not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would have been more than 4.99% of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the Jan. 2024 Pre-funded Warrants. A holder of Jan. 2024 Pre-funded Warrants could increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us. The holder of the Jan. 2024 Pre-Funded Warrants exercised all of the Jan. 2024 Pre-Funded Warrants during the fourth quarter of 2024 by means of the cashless exercise provision and within the other constraints noted above.
Previous wording
support our marketing and distribution infrastructure to commercialize any future product candidates for which we may obtain marketing approval; and
Current wording
support our marketing and distribution infrastructure to commercialize any future program candidates for which we may obtain marketing approval; and
Previous wording
At June 30, 2025, we had cash, cash equivalents and short-term investments of $191.6 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments into late 2026. Operating expenses are expected to increase for research and development and general and administrative expenses as we work to implement our strategy to advance our clinical assets in our clinical trials and to progress our preclinical assets towards clinical trials. We anticipate a significant increase of expenses, particularly in research and development, as we undertake these activities.
Current wording
At September 30, 2025, we had cash, cash equivalents and short-term investments of $174.1 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments into late 2026. Operating expenses are expected to increase for research and development and general and administrative expenses as we work to implement our strategy to advance our clinical assets in our clinical trials and to progress our preclinical assets towards clinical trials. We anticipate a significant increase of expenses, particularly in research and development, as we undertake these activities.
Previous wording
the potential impact of U.S. and international trade policies, including tariffs, on our costs for supplies, equipment and materials used in the development and production of our TAT drug product candidates;
Current wording
the potential impact of U.S. and international trade policies, including tariffs, on our costs for supplies, equipment and materials used in the development and production of our TAT drug program candidates;
Previous wording
Until such time, if ever, that we can generate program revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, strategic alliances, licensing arrangements, outright sales of program candidates or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we will be required to delay, limit, reduce or terminate our program development or future commercialization efforts or grant rights to develop and market programs or program candidates that we would otherwise prefer to develop and market ourselves.
Current wording
Until such time, if ever, that we can generate program revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, strategic alliances, licensing arrangements, outright sales of program candidates or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or program candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we will be required to delay, limit, reduce or terminate our program development or future commercialization efforts or grant rights to develop and market programs or program candidates that we would otherwise prefer to develop and market ourselves.
Previous wording
Management regularly reviews our research and development and general and administrative functions to evaluate the most efficient deployment of capital to ensure that the appropriate materials, systems and personnel are available to support clinical trials, preclinical activities and product candidate supply.
Current wording
Management regularly reviews our research and development and general and administrative functions to evaluate the most efficient deployment of capital to ensure that the appropriate materials, systems and personnel are available to support clinical trials, preclinical activities and drug program candidate supply.
Previous wording
We presented our other commitments and contingencies in the 2024 Form 10-K. There have been no material changes outside of the ordinary course of business in those obligations during the six months ended June 30, 2025, other than those disclosed in Note 10, Commitments and Contingencies, to the condensed consolidated financial statements in this Form 10-Q.
Current wording
We presented our other commitments and contingencies in the 2024 Form 10-K. There have been no material changes outside of the ordinary course of business in those obligations during the nine months ended September 30, 2025, other than those disclosed in Note 10, Commitments and Contingencies, to the condensed consolidated financial statements in this Form 10-Q.