CATX Perspective Therapeutics Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 24, 2025

 

 

Perspective Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-33407	41-1458152
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
c/o Perspective Therapeutics, Inc. 2401 Elliott Avenue Suite 320
Seattle, Washington				98121
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (206) 676-0900

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		CATX		NYSE American LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 8.01 Other Events.

On January 24, 2025, Perspective Therapeutics, Inc. issued a press release and posted to its website a presentation announcing certain initial results from its Phase 1/2a study of [212Pb]VMT-α-NET for the treatment and diagnosis of patients with somatostatin receptor subtype 2-expressing neuroendocrine tumors (NETs) that are being presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium taking place from January 23-25, 2025 in San Francisco, California. A copy of the press release is filed herewith as Exhibit 99.1, and a copy of the presentation is filed herewith as Exhibit 99.2, and each is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release dated January 24, 2025.
99.2		Investor Presentation.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			PERSPECTIVE THERAPEUTICS, INC.
Date:	January 24, 2025	By:	/s/ Johan (Thijs) Spoor
			Johan (Thijs) Spoor Chief Executive Officer

 

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Perspective Therapeutics Continues to Pursue Dose Escalation of [212Pb]VMT-α-NET in its Ongoing Phase 1/2a Clinical Trial Based on Updated Interim Data Presented at the 2025 ASCO Gastrointestinal Cancers Symposium

 

 

SEATTLE, WASHINGTON – January 24, 2025 – Perspective Therapeutics, Inc. (“Perspective” or the “Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, announced updated interim results from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET that are being presented as a poster presentation at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) taking place January 23-25, 2025 in San Francisco, CA.

 

This Phase 1/2a clinical trial is a multi-center open-label dose escalation and dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapy (RPT) and whose tumors have shown radiological evidence of disease progression in the 12 months prior to enrollment.

 

Two patients in Cohort 1 and seven patients in Cohort 2 received [212Pb]VMT-α-NET treatment prior to Cohort 2 being reopened in August 2024. These patients were enrolled for dose limiting toxicities observations. Initial results as of a data cut-off date of October 31, 2024 were previously presented at the 2024 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium in November 2024.

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As of the data cut-off date for the ASCO-GI poster presentation of January 10, 2025, all nine patients had completed treatments per the study protocol, and at least one scan for all patients after their final treatments was available to the study team.

 

 

 

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 [212Pb]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 [212Pb]VMT-α-NET.

 

One patient was observed to experience an initial (unconfirmed) response in the fifth scan after their first dose, which was the first scan conducted after the end of their treatment period. This patient experienced gradual tumor regression throughout the study, with the magnitude of change meeting the criteria for response on their most recent scan. This patient received four doses of 5.0 mCi (equivalent to 68.7 µCi/kg) of [212Pb]VMT-α-NET.

 

A third patient was observed to experience an initial (unconfirmed) 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 [212Pb]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.

 

Five patients continue 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.

 

As stated in our August 12, 2024 business update for the second quarter of 2024, the observation period was completed for dose limiting toxicity (DLT) in seven patients enrolled in Cohort 2 during the second quarter of 2024. Subsequently, the Safety Monitoring Committee (SMC) determined that safety observations during the DLT period supported proceeding with dose escalation to Cohort 3 and increasing the number of patients dosed at 5 mCi (up to 40 more patients).

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"I am excited to see a signal of deepening of anti-tumor activity for [212Pb]VMT-α-NET at the dose level used in Cohort 2 with longer follow-up, while [212Pb]VMT-α-NET remains well-tolerated," said Richard L. Wahl, MD, Professor of Radiology, Mallinckrodt Institute of Radiology at Washington University School of Medicine. “I look forward to sharing these results with a broader physician community at ASCO-GI and participating in the continuation of this study.”

 

Markus Puhlmann, Chief Medical Officer of Perspective, commented, “The dose finding study for [212Pb]VMT-α-NET is progressing well, with robust participation in the re-opened Cohort 2. In keeping with the commitment we made to the FDA prior to the start of dosing in this study, we commenced engagement with the FDA to pursue dose escalation while continuing to enroll patients into Cohort 2. An update will be provided once alignment is reached with the agency.”

 

Thijs Spoor, Chief Executive Officer of Perspective, commented, “As we continue to advance as a clinical-stage oncology company, we will be able to apply learnings from our lead clinical programs to new programs and potential new medicines based on our next generation targeted radiopharmaceutical technology platform. Meanwhile, in-sourcing clinical operations and other functions allows us to execute better and share clinical updates regularly with key stakeholders. We look forward to making progress in advancing our clinical pipeline and supporting infrastructure to serve more patients.”

 

Perspective will webcast a conference call on Friday, January 24, 2025 at 8:00 am ET to discuss the data to be presented at the ASCO-GI symposium. Webcast details are available on the Events page of the Company's website. The lead investigator of the study, Richard L. Wahl, MD (Professor of Radiology, Mallinckrodt Institute of Radiology at Washington University School of Medicine) will participate, along with members of Perspective's management team. A live question and answer session will follow the formal presentation.

 

About VMT-α-NET

VMT-α-NET is a clinical-stage, targeted alpha-particle therapy (TAT) radiopharmaceutical being developed for the treatment and diagnosis of patients with somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors (NETs), which are a rare and difficult-to-treat type of cancer. VMT-α-NET incorporates Perspective's proprietary lead-specific chelator (PSC) to bind 203Pb for SPECT imaging, and 212Pb for alpha-particle therapy. Perspective is conducting a

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multi-center open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapies (RPT). Perspective received Fast Track Designation for this program from the U.S. Food and Drug Administration (FDA) based on preclinical data for SSTR2-positive NETs regardless of prior treatment response. Perspective is also collaborating with a number of thought leaders to further elucidate the clinical profile of [212Pb]VMT-α-NET through investigator-initiated studies in the U.S. as well as overseas.

 

About Neuroendocrine Tumors

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are over 170,000 people living with this diagnosis.

 

About Perspective Therapeutics, Inc.

 

Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has proprietary technology that utilizes the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moeities. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moeities which provide 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.

 

The Company's melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations.

 

For more information, please visit the Company's website at www.perspectivetherapeutics.com.

 

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential," or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking

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statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company’s ability to pioneer advanced treatment applications for cancers throughout the body; the Company’s ability to make progress in developing treatments for neuroendocrine tumors; the Company’s anticipated timing and expectations regarding regulatory communications, requests, interactions, submissions, alignment, and approvals; the Company’s activities and plans to pursue dose escalation and enrollment in a third cohort for its Phase 1/2a clinical trial of [212Pb]VMT-α-NET; the Company’s expected timing for the receipt and disclosure of additional data regarding the Company’s Phase 1/2a clinical trial of [212Pb]VMT-α-NET; the Company’s ability to apply learnings from its lead clinical programs to new programs and potential new medicines based on the Company’s targeted radiopharmaceutical technology platform; the potential benefits of the Company in-sourcing clinical operations and other functions; the Company’s ability to make progress in advancing its clinical pipeline and supporting infrastructure to serve more patients; the Company’s ability to provide targeted and effective treatment options for cancer patients; the ability of the Company’s proprietary technology utilizing the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides; the Company’s prediction that complementary imaging diagnostics that incorporate certain targeting peptides provide the opportunity to personalize treatment and optimize patient outcomes; the Company’s belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company’s ability to develop a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations; the Company’s clinical development plans and the expected timing thereof; the expected timing for availability and release of data in connection with its clinical trials; expectations regarding the potential market opportunities for the Company’s product candidates; the potential functionality, capabilities, and benefits of the Company’s product candidates and the potential application of these product candidates for other disease indications; the Company’s expectations, beliefs, intentions, and strategies regarding the future; the Company’s intentions to improve important aspects of care in cancer treatment; and other statements that are not historical fact.

 

The Company may not actually achieve the plans, intentions, or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company’s actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

 

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Media and Investor Relations Contacts:

 

Perspective Therapeutics IR:

Annie J. Cheng, CFA

ir@perspectivetherapeutics.com

 

Russo Partners, LLC

Nic Johnson

PerspectiveIR@russopr.com

1Wu P, He D, Chang H, Zhang X. Epidemiologic trends of and factors associated with overall survival in patients with neuroendocrine tumors over the last two decades in the USA. Endocr Connect. 2023;12(12):e230331. Published 2023 Nov 23. doi:10.1530/EC-23-0331

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Investor CallASCO-GI 2025 Presentation January 24, 2025 NYSE AMERICAN: CATX

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This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this presentation include statements concerning, among other things, the Company's clinical development plans and the expected timing thereof; the expected timing for availability and release of data; the Company’s timing and expectations regarding regulatory communications, submissions and approvals; expectations regarding the potential market opportunities for the Company’s product candidates; the Company’s expected cash runway; the potential functionality, capabilities and benefits of the Company’s product candidates and the potential application of these product candidates for other disease indications; the potential size of the commercial market for the Company’s product candidates; the Company’s expectations, beliefs, intentions, and strategies regarding the future; the Company’s intentions to improve important aspects of care in cancer treatment; and other statements that are not historical fact. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the potential that regulatory authorities may not grant or may delay approval for the Company’s product candidates; uncertainties and delays relating to the design, enrollment, completion and results of clinical trials; unanticipated costs and expenses; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of regulatory authorities may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company may not be able to maintain regulatory approval for the Company’s product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; the availability or potential availability of alternative products or treatments for conditions targeted by the Company that could affect the availability or commercial potential of its product candidates; the ability of the Company to manage growth; whether the Company can maintain its key employees; the ability of the Company to build out its manufacturing facilities and satisfy manufacturing-related regulatory requirements; whether there is sufficient training and use of the Company’s products and product candidates; the market acceptance and recognition of the Company’s products and product candidates; the Company’s ability to maintain and enforce its intellectual property rights; whether the Company can maintain its therapeutic isotope supply agreement with the DOE; the Company’s ability to maintain and increase its supply, manufacturing and distribution capabilities; whether the Company will continue to comply with the procedures and regulatory requirements mandated by the FDA for additional trials, Phase 1 and 2 approvals, Fast Track approvals, and 510(k) approval and reimbursement codes; and any changes in applicable laws and regulations. Other factors that may cause the Company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this presentation are described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and the Company’s most recent Quarterly Report on Form 10-Q, each filed with the Securities and Exchange Commission (the “SEC”), in the Company’s other filings with the SEC, and in the Company’s future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this presentation are made as of this date, and the Company undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. Legal Disclaimers

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Developing the Next Generation of Targeted Therapies Robust Manufacturing Infrastructure Radioisotope supply strengthened by integrated supply chain Patient coverage via distributed manufacturing infrastructure Ready-to-administer products provided to treatment sites on day of scheduled treatment Innovative Platform Technology Targeting moieties designed for high tumor specificity Ideal isotope (212Pb): Potent tumor cell killing with reduced off-target effect Proprietary chelator designed to minimize kidney re-absorption Pipeline with Broad Potential Three clinical-stage programs Multiple read-outs and milestones expected in the next 12-18 months De-risking via theranostics approach: Patients imaged pre-treatment

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Perspective’s Radiopharmaceutical Platform Optimized for a Broader Therapeutic Window Perspective Therapeutics’ Platform Optimized peptides Highly specific for tumor cell receptors Rapid clearance from blood to reduce off-target effects Ideal isotope Double-stranded breaks  cell death Reduced off-target effects on healthy tissue 203/212Pb pair streamlines dosimetry Improved safety Increased renal clearance Increased retention of daughter isotope Minimum Effective Dose Maximum Tolerated Dose Therapeutic window Minimum Effective Dose Maximum Tolerated Dose Therapeutic window Optimized Proprietary Chelator Engineered Peptides Broader Therapeutic Window Alpha-emitting 212Pb Isotope

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Program (Target) Target Disease Candidate evaluation Human Clinical Imaging Phase 1/2 Registration Enabling Study Status VMT01/02 (MC1R) Melanoma (MC1R imaging & therapy)       Next cohort is open for enrollment       Open for enrollment VMT-⍺-NET (SSTR2) Neuroendocrine tumors       Cohort 2: enrolling Cohort 3: Pending FDA alignment Other SSTR2 expressing tumors Under evaluation PSV359 (FAP-α) Multiple solid tumors IND filed in late 2024 Expect to initiate dosing in mid-2025 PSV40X (Small Molecule) (PSMA) Prostate (PSMA imaging & therapy)   Under evaluation Undisclosed Program 5 Multiple Solid Tumors Under evaluation Undisclosed Program 6 Multiple Solid Tumors Under evaluation Undisclosed Program 7 Multiple Solid Tumors Under evaluation Pre-Targeting Platform Multiple solid tumors   Under evaluation Monotherapy Broad Proprietary Pipeline Three lead programs in clinic with multiple programs in preclinical development Combination with Nivolumab

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Radiopharmaceutical Therapy Poised to Revolutionize Oncology TreatmentPerspective’s pipeline and platform has the potential to significantly expand the breadth of tumors addressed by RPT Bars representative of relative size of the addressable market (both current and potential future) but not to scale. For all bars, potential addressable population is not indicative of current or expected market penetration. The safety and efficacy of these products have not been established in these future potential indications, and future regulatory approval or commercial availability is not guaranteed. Incidence data sourced from SEER, accessible at https://seer.cancer.gov/statfacts/html/common.html and https://seer.cancer.gov/statistics-network/explorer/ . RPT potential in additional solid tumors Estimated patient coverage by approved RPTs Estimated patient coverage by Perspective’s ongoing therapeutics trials Potential patient coverage by trials being contemplated for Perspective’s clinical and preclinical assets VMT-α-NET Designed for a more balanced benefit to risk profile In dose-finding study, with escalation supported by well tolerated safety profile VMT01 Potential first-in-class, with or without immune Checkpoint Inhibitors PoC for synergistic combination of ICI and 212Pb RPT in and beyond melanoma Other NETs SCLC ER+ BC Meningioma GEP-NETs Additional SSTR2+ tumors: Currently being studied ICI combo with 212Pb RPTs 1st line (ICI combo) Currently being studied (2nd line+ melanoma) Beyond MC1R

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Neuroendocrine Tumors: VMT-⍺-NET Targeting the somatostatin receptor to treat rare neuroendocrine-type cancers

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Whole body SPECT scan of NETs patient imaged with [203Pb]VMT-𝛼-NET Neuroendocrine Tumors: VMT-⍺-NET Targeting the somatostatin receptor to treat neuroendocrine and other cancers Neuroendocrine cells are specialized cells that secrete hormones and other bioactive substances Most neuroendocrine tumors highly express somatostatin receptor type 2 (SSTR2) Often grow in the pancreas or other areas of the gut; also widely expressed in a broad range of tumors including SCLC, breast cancer, meningioma, head & neck cancer ~12K new diagnoses annually in the US; ~170,000 people are living with this diagnosis in the US1 Existing radiopharmaceutical treatment LUTATHERA® (Novartis) has an overall response rate (ORR) of only 13–17%, and no overall survival (OS) benefit2 Broad acknowledgment that targeted alpha therapies are needed to improve care3 1Wu P, He D, Chang H, Zhang X. Epidemiologic trends of and factors associated with overall survival in patients with neuroendocrine tumors over the last two decades in the USA. Endocr Connect. 2023;12(12):e230331. Published 2023 Nov 23. doi:10.1530/EC-23-0331; 2LUTATHERA PI; 3Navalkissoor et al (2019) Program Overview Unmet Need Disease Overview Fast Track Designation for SSTR2+ NETs regardless of prior treatment response Ongoing CATX-sponsored therapeutic dose-finding trial currently recruiting in PRRT-naïve setting throughout the US Investigator sponsored studies in India and University of Iowa in PRRT- refractory patients

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NET Trials 177Lu-DOTATATE Study NETTER-1 (1) (2) RCT; randomized 2:1 N = 229 Dose Level (administered) 4 x Q8W | 200 mCi Patient Population SSTR2+, GEP-NETs Prior PRRT 0% Median time from dx 3.8 years Performance Status Karnofsky Performance Scale Median was 90 Histology Well differentiated G1 (66%), G2 (35%) PFS Median 28.4 vs 8.5 months (3) ORR (CR/PR) 13% (1%/12%) vs. 4% (0%/4%) AEs (>20%) Nausea, vomiting, fatigue, diarrhea, abdominal pain, multiple laboratory abnormalities Grade 3+ (>10%) Lymphopenia (44%), GGT↑ (20%) Other notes 5 Lu-177 treated  patients withdrew due to renal-related events US prescribing information; (2) DOI: 10.1056/NEJMoa1607427; (3) NANETS 2021; (4) DOI: 10.1016/S0140-6736(24)00701-3; (5) ASCO 2024; (6) ASCO 2024 No head-to-head studies between the products have been conducted. Given the different study designs and methods, cross-trial comparisons cannot be made. The information on this slide is not intended to promote the products referenced herein or otherwise influence healthcare prescribing decisions. The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the investigational agents will receive regulatory approval or become commercially available for the uses being investigated. 177Lu-DOTATATE 212Pb-DOTAMTATE 225Ac-DOTATATE NETTER-2 (4) RCT; randomized 2:1 N = 226 Phase I/II (5) Single arm N=44 ACTION-1 Phase Ib/III (6) Phase Ib: Single arm N=17 4 x Q8W | 200 mCi  4 x Q8W | 67 µCi/kg 4 x Q8W | 3.2 uCi/kg  (median 8.3 MBq)(Ph 3 dose is fixed 10.2 MBq) SSTR2+, GEP-NETs SSTR2+, GEP-NETs  SSTR2+, GEP-NETS 0% 0% 100% 1.9 months 5 years 5 years Karnofsky Performance Scale 83% at 90-100 N/A ECOG 0 (59%), 1 (41%) Well differentiated G2 (73%), G3 (27%) Well differentiated G1 (18%), G2 (68%), G3 (7%) Well differentiated G1 (47%), G2 (53%) Median 22.8 vs 8.5 months 74.3% at 24 months NE (95% CI: 12 months, NE) 43% (5%/38%) vs. 9% (0%/9%) 56% 29.4% confirmed 41.2% (6%/35%) w/ unconfirmed Nausea, diarrhea Alopecia, nausea, fatigue, appetite↓, diarrhea, dysphagia, lymphocyte count↓, abdominal pain, vomiting, weight↓, blood glucose↑ Nausea, fatigue, weight↓, hyperglycemia, abdominal pain, constipation, vomiting, multiple laboratory abnormalities TEAE: 35% TEAE: 52% Lymphocyte count↓ (25%) TEAE: 53% Anemia (18%), lymphocyte count↓ (18%), creatinine clearance↓ (12%) Nephrotoxicities 13 (8.8%) vs. (2.0%) Dysphagia treated with Botox injection

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Interim safety and efficacy data of [212Pb]VMT-α-NET in somatostatin receptor 2 (SSTR2) expressing neuroendocrine tumors (NETs) Richard Wahl, Lowell Anthony, Lilja Solnes, Samuel Mehr, Lucia Baratto, Alaa Hanna, Wenjing Yang, Stephen Keefe, Thorvardur Halfdanarson

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Disclosures for Dr. Richard Wahl and FDA Status Abdera: consultant Molecular Targeting Technologies, Inc.: consultant, stock options Siemens Healthineers: consultant Voximetry: consultant, stock options Techspert: consultant Clarity Pharmaceuticals: stockholder Perspective Therapeutics: consultant, research Fusion Pharmaceuticals: research contract Rayze Pharmaceuticals: research contract White Rabbit AI: research contract [212Pb]VMT-α-NET is not FDA approved. It is being used under an FDA IND in a clinical trial

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PRRT = peptide receptor radionuclide therapy | mTPI-2: Modified toxicity probability index For additional details regarding trial parameters, including criteria for patient selection, please refer to slide 68 or https://clinicaltrials.gov/study/NCT05636618. Trial Parameters Dose-finding Population Key Study Features Study Endpoints Advanced/unresectable or metastatic NETs Progressive disease on prior therapy PRRT naïve FDA approved SSTR2 PET/CT avid disease Bayesian mTPI-2 design based on iterative toxicity probability monitoring Dosimetry to be assessed during screening period for cohorts 1 & 2 using 5-7 mCi [203Pb]VMT-α-NET Primary: to measure incidence of DLTs following a single administration of [212Pb]VMT-α-NET in order to determine the MTD and/or MFD, and RP2D Secondary / exploratory: ORR, DOR, PFS, OS by RECIST v1.1 Using dosimetry, estimate selected organ and whole body absorbed radiation doses for [212Pb]VMT-α-NET Expansion Cohort [212Pb]VMT-⍺-NET RP2D mCi x 4 Dose-finding phase Expansion phase Expansion into non-NET indications (eg SCLC) also possible Recommended Phase 2 Dose (RP2D) Recruitment Complete Cohort 1 [212Pb]VMT-⍺-NET n = 2   /   2.5 mCi x 4 Recruited Cohort 2 [212Pb]VMT-⍺-NET n = 7 / 5 mCi x 4 Cohort 3 [212Pb]VMT-⍺-NET n = 3 – 8 / 7.5 mCi x 4 Cohort 4 [212Pb]VMT-⍺-NET n = 3 – 8 / 10 mCi x 4 Intermediate doses or de-escalation possible for Cohort 2 – 4 Added slots: total of up to 47 (recruitment ongoing) Trial Design: [212Pb]VMT-⍺-NET mTPI-2 Phase 1/2a For Neuroendocrine Tumors Pre-agreed FDA interaction before dosing next cohort

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Patient Characteristics (all patients as treated) Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025   All Treated (N = 9 ) Age (years) Median 63 Range 37,78 Sex, n (%) Female 4 (44) Male 5 (56) Race, n (%) White 8 (89) Asian 1 (11) Weight (kg) Mean 84 Median 78 Range 53, 157 Tumor Type, n (%) Pancreatic NET 3 (33) Non-pancreatic NET 6 (66) Grade, n (%) G1 3 (33) G2 6 (66)   All Treated (N = 9 ) Time since diagnosis (months)   Mean 70 Median 37 Range 12, 181 Number of prior systemic therapies Median 1 Range 0, 2 Prior systemic therapies (patients with each) Somatostatin analogues 7 Capecitabine, temozolomide 1 Small molecule (sunitinib, everolimus) 2 ECOG Performance Status, n (%)   0 8 (89) 1 1 (11) Disease at Baseline, median (range) RECIST median sum of target lesions (cm) 6.7 (2.9, 8.7) SUV max SUV mean 41.5 (18, 162) 30 (12, 102)

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Safety Findings Unchanged Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 No DLTs were observed in either cohort No grade 4, grade 5 or serious AEs were observed No decline in renal function was observed Hematologic AEs were few in number and low grade No dysphagia was observed No treatment discontinuations due to AE have occurred

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[212Pb]VMT-α-NET Was Well Tolerated *The date of one of two episodes of dizziness reported at NANETS was revised to occur >8 weeks following last treatment and therefore no longer meets the definition for treatment-emergent. Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 Number of patients with AE (% of pts treated per cohort) 2.5 mCi (92.5 MBq) (N=2) 5.0 mCi (185 MBq) (N=7) Total (n=9) Grade 1 Grade 2 Grade 3 Grade 1 Grade 2 Grade 3 Grade 1 Grade 2 Grade 3 Fatigue 1 (50) 1 (50)  - 3 (43) 2 (28)  - 4 (44) 3 (33)  - Alopecia 2 (100)  -  - 4 (57)  -  - 6 (66)  -   - Lymphocyte count decreased  - 1 (50)  - 2 (29) 3 (42)  - 2 (22) 4 (44)  - Nausea  - 1 (50)  - 4 (57) 1 (14)  - 4 (44) 2 (22)  - Anaemia  - 2 (100)  - 3 (43)  - - 3 (33) 2 (22)  - Diarrhoea 2 (100) -  - 2 (29) 1 (14) 1 (14) 4 (44) 1 (11) 1 (11) Haematocrit decreased 1 (50) 1 (50)  - 2 (29)  -  - 3 (33) 1 (11)  - Red blood cell count decreased 1 (50) 1 (50)  - 2 (29)  -  - 3 (33) 1 (11)  - White blood cell count decreased 2 (100)  -  - -  -  - 2 (22)  -  - Abdominal pain 1 (50)  -  - 2 (29)  -  - 3 (33)  -  - Hemoglobin decreased  -  -  - 2 (29)  -  - 2 (22)  -  - Hyperglycaemia  -  -  - 2 (29)  -  - 2 (22)  -  - Blood alkaline phosphatase - - - 2 (29) - - 2 (22) - - Constipation - - - 2 (29) - - 2 (22) - - Haematuria - - - 2 (29) - - 2 (22) - - Headache 1 (50)  -  - 1 (14) -  - 2(22)  -  - Lethargy 1 (50)  -  - 1 (14)  -  - 2(22)  -  - Aspartate aminotransferase incr’d 1 (50) - - 1 (14) - - 2(22) - - Dizziness* - - - 1 (14) - - 1 (11) - - Presyncope - - - - 1 (14) - 1 (11) Syncope - - - - - 1 (14) - - 1 (11) Amylase increased - 1 (50) - - - - - 1 (11) - Hypercalcemia - 1 (50) - - - - - 1 (11) - Weight decreased - - - - 1 (14) - - 1 (11) - Treatment Emergent Adverse Events (occurring in ≥ 2 patients and/or Grade ≥ 2)

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No Decline in Renal Function Observed Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 Most recent eGFR versus baseline Most recent on-study eGFR [212Pb]VMT-α-NET 2.5 mCi (92.5 MBq) [212Pb]VMT-α-NET 5.0 mCi (185 MBq) eGFR eligibility cut-off eGFR eligibility cut-off

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Previously Presented at NANETS 2024: Preliminary response assessment by RECIST v1.1 * The full sets of scans following cycle 4 are not yet available to the study team for five patients. Note: Patient 109-103 experienced progressive disease by unambiguous progression of non-target lesions. Wahl RL et al, Presentation at NANETS 2024. Full presentation available here. Data cut off date October 31, 2024 NANETS 2024

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Updated at ASCO-GI 2025: Anti-Tumor Activity Note: Patient 109-103 experienced progressive disease by unambiguous progression of non-target lesions. Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 Preliminary response assessment by RECIST v1.1 showed 3 responses in 7 patients from Cohort 2 Percent change in sum of diameters from baseline [212Pb]VMT-α-NET 2.5 mCi (92.5 MBq) [212Pb]VMT-α-NET 5.0 mCi (185 MBq) PD SD SD SD SD SD uPR uPR PR

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Previously Presented at NANETS 2024: Preliminary Assessment of Disease Control Durability Wahl RL et al, Presentation at NANETS 2024. Full presentation available here. Data cut off date October 31, 2024 NANETS 2024

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Updated at ASCO-GI 2025: Eight of Nine Patients Remain on Study Note: Lighter portions of each line signify transition of the patient to follow-up period (begins 8 weeks after last dose). Response for Patient 103-104 has been confirmed; other responses subject to confirmation. Patient 102-103 had a longer treatment period due to delay in administration of their fourth dose. Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 Preliminary Assessment of Disease Control Durability [212Pb]VMT-α-NET 2.5 mCi (92.5 MBq) [212Pb]VMT-α-NET 5.0 mCi (185 MBq) Disease Progression First Response

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Previously Presented at NANETS 2024: Kinetics of Treatment Response The full sets of scans following cycle 4 are not yet available to the study team for five patients. Notes: Patients had progressive disease prior to enrollment on study, and patient 109-103 experienced progressive disease by unambiguous progression of non-target lesions. Wahl RL et al, Presentation at NANETS 2024. Full presentation available here. Data cut off date October 31, 2024 NANETS 2024

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Updated at ASCO-GI 2025: Signal of Sustained Anti-Tumor Activity Notes: 1 patients had progressive disease prior to enrollment on study, and patient 109-103 experienced progressive disease by unambiguous progression of non-target lesions Patient 102-103 had a longer treatment period due to delay in administration of their fourth dose. Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 Kinetics of Treatment Response: VMT-α-NET Spider Plot Percent change in sum of diameters from baseline [212Pb]VMT-α-NET 2.5 mCi (92.5 MBq) [212Pb]VMT-α-NET 5.0 mCi (185 MBq) Treatment period

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Patient with PR after [212Pb]VMT-α-NET Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 Contrast-Enhanced CT and DOTATATE PET scans show partial response Baseline After cycle 2 After cycle 1 After cycle 3 After cycle 4 Follow up week 36

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Next steps and concluding remarks

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[212Pb]VMT-α-NET was well-tolerated1 1Wahl RL et al, Presentation at ASCO-GI 2025. Full presentation available here. Data cut off date January 10, 2025 No DLTs No grade 4, grade 5 AEs or SAEs No decline in renal function Hematologic AEs were low in number and low grade No treatment discontinuations due to AE have occurred 1 confirmed objective response and 2 unconfirmed objective responses subject to confirmation 8/9 (89%) patients remain on treatment Appreciable activity was observed with treatment at this early timepoint in the study (1) Request submitted to FDA to initiate next dosing cohort and planning for this is in progress An additional 11 patients dosed in Cohort 2 as of December 31, 2024 since re-opening in August 2024 Ongoing evaluation of potential expansion into other SSTR2+ tumor types including breast, SCLC The Safety Monitoring Committee has recommended dose escalation and re-opening of Cohort 2 Conclusion & Next Steps[212Pb]VMT-α-NET was well tolerated, supporting rationale for potential dose escalation

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Q & A

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Backup slides

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Abbreviations AE: adverse event APC: antigen-presenting cell ASCO-GI: ASCO Gastrointestinal Cancers Symposium DAMPs: damage-associated molecular patterns DLT: dose limiting toxicities dsDNA: double-stranded DNA EANM: European Association of Nuclear Medicine eGFR: estimated glomerular filtration rate ER+ BC: estrogen receptor-positive breast cancer FDA: U.S. Food and Drug Administration GEP-NETs: gastroenteropancreatic-NETs GI: gastrointestinal GU: genitourinary GYN: gynecology H&N: head and neck ICI: immune checkpoint inhibitor IND: investigational new drug mAB: monoclonal antibodies MC1R: melanocortin 1 receptor MIP: maximum Intensity Projection NANETS: North American Neuroendocrine Tumor Society NETs: neuroendocrine tumor PD: progressive disease PoC: proof of concept PR: partial response PSMA: prostate specific membrane antigen RPT: radiopharmaceutical therapies SAE: serious adverse event SCLC: small cell lung cancer SD: stable disease SMC: safety monitoring committee SNMMI: Society of Nuclear Medicine and Molecular Imaging SSTR2: somatostatin receptor type 2 TEAE: treatment emergent adverse events TME: tumor microenvironment TRAE: treatment related adverse events

v3.24.4

Document And Entity Information	Jan. 24, 2025
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Jan. 24, 2025
Entity Registrant Name	Perspective Therapeutics, Inc.
Entity Central Index Key	0000728387
Entity Emerging Growth Company	false
Entity File Number	001-33407
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Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	CATX
Security Exchange Name	NYSEAMER

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