Perspective Therapeutics, Inc.

Previous wording

We are a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212 Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This theranostic approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.

Current wording

We are a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212 Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimizes patient outcomes. This theranostic approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.

Previous wording

We designed VMT-α-NET to target and deliver 212 Pb to target cancer-specific receptors on tumor cells expressing somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers. [212 Pb]VMT-α-NET is a targeted alpha therapy (TAT) in development for patients with unresectable or metastatic SSTR2-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy, such as Lutathera. NETs are a group of rare, heterogeneous tumors that develop in different organs of the body and arise from specialized cells in the neuroendocrine system.

Current wording

We designed VMT-α-NET to target and deliver 212 Pb to cancer-specific receptors on tumor cells expressing somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers. [212 Pb]VMT-α-NET is a targeted alpha therapy (TAT) in development for patients with unresectable or metastatic SSTR2-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy. NETs are a group of rare, heterogeneous tumors that develop in different organs of the body and arise from specialized cells in the neuroendocrine system.

Previous wording

We have initiated dosing of patients in Cohorts 1 and 2 of our Phase 1/2a study of [212 Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs. In January 2025, at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, we 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. The data cut-off date was January 10, 2025. All nine patients in Cohort 1 and Cohort 2 had completed treatments per the study protocol, and the study team had at least one scan for all patients after their final treatments. No dose limiting toxicities (DLTs), grade 4 or 5 treatment emergent or serious adverse events (AEs) were reported since the start of the study. No new grade 3 AEs were observed aside from the two events that were disclosed at an earlier data cutoff of October 2024 - one case of diarrhea and one case of syncope. No decline in renal function was observed. Hematologic AEs, such as decreased lymphocyte count and anemia, were all grades 1 and 2. No treatment discontinuations due to AEs occurred.

Current wording

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 wording

Five patients continued to have stable disease. One patient was deemed to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions.

Current wording

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 wording

Further anti-tumor activities have been observed with longer follow up, and there were two unconfirmed responses and one confirmed response as defined by response evaluation criteria in solid tumors (RECIST) v1.1 in Cohort 2. As of the January 10, 2025 data cut-off date, the patient who experienced a confirmed objective response has been in response for 17 weeks and remains 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) due to an adverse event that was determined by the investigator to be unrelated to [212 Pb]VMT-α-NET.

Current wording

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 wording

A third patient was observed to experience an initial (unconfirmed (as of January 10, 2025)) response in the seventh scan 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 31.7 µCi/kg) of [212 Pb]VMT-α-NET. Gradual tumor regression was first observed in the fifth scan after their first dose, with the magnitude of change meeting the criteria for response on their most recent scan.

Current wording

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 wording

On April 23, 2025, we announced that data on [212 Pb]VMT-α-NET have been accepted for presentation at the 2025 American Society of Clinical Oncology Annual Meeting, which will take place May 30 to June 3 in Chicago, IL (2025 ASCO).

Current wording

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.

Previous wording

The SMC reviewed these findings and recommended exploring a lower dose level of 1.5 mCi per dose, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC’s recommendation would allow for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy has been approved, and Cohort 3 at 1.5 mCi per dose is active and open for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab is also active and open for enrollment. On March 17, 2025, we announced that the first patient was dosed in the combination cohort, and on April 11, 2025, we announced that the first patient was dosed in the monotherapy cohort. As of April 30, 2025, a total of four patients had received their initial monotherapy treatments. On April 23, 2025, we announced that data on [212 Pb]VMT01 have been accepted as a poster presentation at 2025 ASCO.

Current wording

The SMC reviewed these findings and recommended exploring a lower dose level of 1.5 mCi per dose, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC’s recommendation allows for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy was approved, and Cohort 3 at 1.5 mCi per dose was opened for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab was also opened for enrollment. The first patients in the combination and monotherapy cohorts received their first treatments in March and April 2025, respectively. As of July 31, 2025, a total of five patients had received their initial monotherapy treatments of VMT01 at 1.5 mCi per dose, once every eight weeks for up to three doses. Additionally, two patients had received VMT01 1.5 mCi with nivolumab. Both cohorts remain open for enrollment.

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.

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. 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.

Previous wording

Our discovery team is preparing multiple additional novel constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit. If and when these constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities.

Current wording

Our discovery team is preparing multiple additional novel constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit, including our pre-targeting platform license from Stony Brook University. If and when these constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities.

Previous wording

We have recently received allowance for two patent applications on our key assets. The first patent application, allowed by the U.S. Patent and Trademark Office (USPTO), pertains to our wholly owned, proprietary technology for generation of 212 Pb at scale. The full term of this patent (once issued) expires in August 2044. The second patent application, also allowed by the USPTO, 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 (once issued) expires in January 2041.

Current 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.

Previous wording

continue the development of our clinical-stage assets, including VMT01, VMT-α-NET and PSV359;

Current wording

continue the development of our clinical-stage assets, including VMT-α-NET, VMT01 and PSV359;

Previous wording

As of March 31, 2025, we had cash, cash equivalents and short-term investments of $211.7 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations 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 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.

Previous wording

Management’s discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an ongoing basis, management evaluates critical accounting estimates and judgments. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies and related risks described in Part II, Item 7 and Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements included in Part II, Item 8 of the 2024 Form 10-K are those that depend most heavily on these judgments and estimates. As of March 31, 2025, there have been no material changes to any of the critical accounting policies and estimates contained therein.

Current wording

Management’s discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an ongoing basis, management evaluates critical accounting estimates and judgments. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies and related risks described in Part II, Item 7 and Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements included in Part II, Item 8 of the 2024 Form 10-K are those that depend most heavily on these judgments and estimates.

Previous wording

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 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.

Previous wording

General and administrative expenses were $7.8 million for the three months ended March 31, 2025, compared to $5.9 million for the three months ended March 31, 2024, an increase of $2.0 million. The increase in general and administrative expenses for the three months ended March 31, 2025 was primarily due to increased personnel costs, partially offset by decreased fees for professional services.

Current 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.

Previous wording

Net cash provided by financing activities of $10.0 million in the three months ended March 31, 2025, was primarily related to the proceeds received from the sale of Common Stock pursuant to the 2024 ATM Agreement.

Current 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.

Previous wording

continue the development of our clinical-stage assets, including VMT01, VMT-α-NET and PSV359;

Current wording

continue the development of our clinical-stage assets, including VMT-α-NET, VMT01 and PSV359;

Previous wording

At March 31, 2025, we had cash, cash equivalents and short-term investments of $211.7 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations and capital investments into late 2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement our strategy to advance our clinical assets in our clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase of expenses, particularly in research and development, as we undertake these activities.

Current 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.

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 three months ended March 31, 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 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.