Form 8-K - Current report
11 October 2024 - 11:31PM
Edgar (US Regulatory)
false 0000728387 0000728387 2024-10-11 2024-10-11
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): October 11, 2024
Perspective Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
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001-33407 |
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41-1458152 |
(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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2401 Elliott Avenue, Suite 320 |
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Seattle, Washington |
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98121 |
(Address of Principal Executive Offices) |
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Common Stock, $0.001 par value |
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CATX |
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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. ☐
On October 11, 2024, Perspective Therapeutics, Inc. (the “Company”) issued a press release announcing certain initial results from its Phase 1/2a study of [212Pb]VMT01 for the treatment of metastatic melanoma that are being presented at the 21st International Congress of the Society for Melanoma Research being held on October 10-13, 2024 in New Orleans, Louisiana. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
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.
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PERSPECTIVE THERAPEUTICS, INC. |
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Date: October 11, 2024 |
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By: |
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/s/ Johan (Thijs) Spoor |
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Johan (Thijs) Spoor Chief Executive Officer |
Exhibit 99.1
Perspective Therapeutics to Advance Investigation of Potential First-In-Class
Radiopharmaceutical Therapy
[212Pb]VMT01 Based on Data Presented at the 21st
International Congress of the Society for Melanoma Research
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[212Pb]VMT01 was observed to be safe, and
no dose-limiting toxicities were observed at the two doses tested (3.0 and 5.0 mCi) |
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Prolonged progression-free survival and tumor response were observed in heavily pretreated patients who
received the low (3.0 mCi) dose of [212Pb]VMT01, consistent with preclinical findings |
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Trial is progressing with testing
[212Pb]VMT01 at a lower (1.5mCi) dose to further elucidate the optimal dose for immunostimulatory activities on the tumor microenvironment in melanoma both as monotherapy and in
combination with nivolumab |
SEATTLE October 11, 2024 Perspective Therapeutics, Inc.
(Perspective or the Company) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced that initial results from its Phase 1/2a
study of [212Pb]VMT01 are being presented at the 21st International Congress of the Society for Melanoma Research (SMR), being held
on October 10-13, 2024 in New Orleans, Louisiana.
VMT01 is a MC1R-targeted radiopharmaceutical therapy (RPT) that
can be radiolabeled with either 203Pb for patient selection and dosimetry assessments, or 212Pb for alpha particle therapy. In preclinical
experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory
low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors (ICIs).1 On the basis of these results, the U.S.
Food and Drug Administration granted Fast Track Designation for the clinical development of [212Pb]VMT01.
This study is a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with
histologically confirmed melanoma and MC1R-positive imaging scans. Patients were required to have already received standard of care. Eligible patients may receive up to three treatments with
[212Pb]VMT01, eight weeks apart.
Three patients were enrolled in Cohort 1, while seven patients were enrolled in Cohort 2. Patients in each
cohort received a median of five prior lines of systematic therapy, including a median of three prior lines of immunotherapy.
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Safety findings: No dose limiting toxicities were observed among any patients, and no adverse events led
to treatment discontinuation. Treatment emergent adverse events (TEAEs) were mostly Grades 1 and 2. None of the four cases of grade 3 TEAEs were deemed to be treatment related. There were no grade 4 or 5 TEAEs. |
No renal toxicities have been reported to date (there were no clinically significant changes in serum BUN or creatinine) in spite of dosimetry
estimated renal radiation that approached the higher end of conventional dosing.
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Efficacy findings: All patients in Cohort 1 completed three treatments, with one patient experiencing a
RECIST version 1.1 objective response after completion of treatment, and two patients experiencing stable disease at 9 and 11 months from the start of treatment, respectively. In Cohort 2, patients progressed after either the first cycle (3
patients) or the second cycle (4 patients). These findings are consistent with published and ongoing preclinical studies showing immunostimulatory effects at lower radiation doses. |
The Safety Monitoring Committee (SMC) has reviewed these findings. The SMC recommended exploring a lower dose level of 1.5 mCi per dose, which is
lower than the dose administered in Cohort 1, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC recommendation would allow for
the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy is planned. The combination cohort at 1.5 mCi per dose with nivolumab is active and now open for enrollment.
Immunotherapies have transformed the care of patients with cancer, and these treatments are particularly beneficial for some patients with metastatic
melanoma, said Dr. Zachary Morris, lead investigator of the VMT01 Phase 1/2a study and Associate Professor and Chair of the Department of Human Oncology at the University of Wisconsin School of Medicine and Public Health. However,
many patients do not respond to immunotherapies. Results from the VMT01 study suggest that we are on the right track in understanding how response to immunotherapy may be enhanced by a radiopharmaceutical, and I am hopeful that a combined
treatment approach involving such an agent together with immune checkpoint inhibitors could extend the benefits of immunotherapy to a greater number of patients with metastatic melanoma. I look forward to continued participation in the VMT01
study.
Markus Puhlmann, Chief Medical Officer of Perspective, commented, It is an important first milestone in the development program for
VMT01 to see that the single agent anti-tumor effect observed in this initial clinical trial was consistent with our published preclinical findings. As determined by the Safety Monitoring Committee, safety observations from the study support moving
ahead with the combination cohort with nivolumab, a setting where the encouraging additive effects of combining VMT01 with immunotherapy treatments were seen in preclinical studies.
Thijs Spoor, Chief Executive Officer of Perspective, added, This initial scientific presentation of
clinical data from our VMT01 therapeutic study is very encouraging in this heavily pretreated patient population, who have no other options. We are delighted to have observed efficacy at such a low dose of radiation, as this exciting result has been
seen in our extensive preclinical work with this indication. This data also highlights the versatility of our proprietary alpha-emitter platform, enabling the development of potential new cancer therapies and the exploration of combinations with
established treatments. We remain on track to provide an update this calendar year on the company sponsored Phase 1/2a study of VMT-α-NET for unresectable or
metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors. In the next twelve months, we expect data to continue to accrue for both clinical programs, as well as initiate therapeutic dosing of at least one new pre-IND asset.
About VMT01
Perspective designed VMT01 to target and deliver 212Pb to tumor sites expressing MC1R, a protein that can
be overexpressed in metastatic melanoma tumors. The Company is conducting a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and
MC1R-positive imaging scans. In September 2024, the Company announced that the U.S. Food and Drug Administration granted Fast Track Designation for the development of [212Pb]VMT01 for the
diagnosis and treatment of patients with unresectable or metastatic melanoma and who have demonstrated MC1R tumor expression. The FDAs Fast Track Designation is one of several approaches utilized by the FDA to expedite development and review
of potential medicines for serious conditions and that fulfill unmet medical needs.2
About
Melanoma
Melanoma is a cancer of the skin arising from uncontrollable growth of melanocytes, the melanin producing cells of the body. Metastatic
melanoma is the result of melanoma that has progressed through the layers of skin, infiltrated the blood stream or lymphatic system, and traveled to other areas of the body to metastasize. In the United States, there are approximately 100,000 new
diagnoses of melanoma annually and approximately 8,300 deaths annually from metastatic melanoma.3 Metastatic melanoma has a poor prognosis with limited survival of 50% at 1 year and 25% at 5
years. Recent advances have led to survival improvement, but there remains a high unmet need for additional treatments, particularly for patients with metastatic disease4 who are refractory to
front-line therapy. Median progression free survival (mPFS) for current 2L+ therapies, including lifileucel, remains limited between 2-5 months.5,6,7
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 peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting
peptides, 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 Companys 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 Companys 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 statements contain these identifying
words. Forward-looking statements in this press release include express or implied statements concerning, among other things, the Companys ability to pioneer advanced treatment applications for cancers throughout the body; expectations
regarding the advancement of the Companys clinical development programs, including its plans and anticipated timing with respect to [212Pb]VMT01s clinical development, the release of
an update on the Company-sponsored Phase 1/2a study of VMT-α-NET for unresectable or metastatic SSTR2-positive neuroendocrine tumors, the accrual of additional data
for the Companys [212Pb]VMT01 and VMT-α-NET programs, and the initiation of therapeutic dosing of a new pre-IND asset; the potential for [212Pb]VMT01 to be administered as a single agent or in combination with other agents and for the Company to explore different
dose levels in connection with its [212Pb]VMT01 trial; expectations regarding the potential benefits conferred by the Fast Track Designation of
[212Pb]VMT01, which was based on non-clinical results submitted by the Company; the belief that the Company is on the right track in understanding how
response to immunotherapy may be enhanced by a radiopharmaceutical and the potential for a combined treatment approach involving a radiopharmaceutical with immune checkpoint inhibitors to extend the benefits of immunotherapy to a greater
number of patients with metastatic melanoma; the versatility of the Companys alpha-emitter platform and its ability to enable the development of potential new cancer therapies and the exploration of combinations with established
treatments; expectations regarding the therapeutic benefits of the Companys programs; the ability of the Companys proprietary technology that utilizes the alpha-emitting isotope 212Pb
to deliver powerful radiation specifically to cancer cells via specialized targeting peptides; the opportunity to personalize treatment and optimize patient outcomes using the
Companys complementary imaging diagnostics that incorporate the same targeting peptides; the Companys expectation that its theranostic approach enables the ability to see
specific tumors and then treat them to potentially improve efficacy and minimize toxicity; the Companys ability to develop a proprietary 212Pb generator to secure key isotopes for clinical
trial and commercial operations; expectations regarding the potential market opportunities for the Companys product candidates; the potential functionality, capabilities, and benefits of the Companys product candidates and the potential
application of these product candidates for other disease indications; the Companys expectations, beliefs, intentions, and strategies regarding the future; the Companys 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 Companys actual results to differ materially from the
results described in or implied by the forward-looking statements. Certain factors that may cause the Companys 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 Companys most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (the SEC), in the Companys other filings with the SEC, and in the Companys 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.
Media and Investor Relations Contacts:
Perspective
Therapeutics IR
Annie Cheng
ir@perspectivetherapeutics.com
Russo Partners, LLC
Nic Johnson
perspectivetx@russopr.com
1 |
Li M, Liu D, Lee D, et al. Targeted Alpha-Particle Radiotherapy and Immune Checkpoint Inhibitors Induces
Cooperative Inhibition on Tumor Growth of Malignant Melanoma. Cancers (Basel). 2021;13(15):3676. Published 2021 Jul 22. doi:10.3390/cancers13153676 |
2 |
Guidance for Industry Expedited Programs for Serious Conditions Drugs and Biologics.
https://www.fda.gov/media/86377/download?attachment. Accessed August 25, 2024. |
3 |
Cancer Stat Facts: Melanoma of the Skin. https://seer.cancer.gov/statfacts/html/melan.html. Accessed
August 25, 2024. |
4 |
Su DG, Djureinovic D, Schoenfeld D, et al. Melanocortin-1 Receptor
Expression as a Marker of Progression in Melanoma. JCO Precis Oncol. 2024;8:e2300702. doi:10.1200/PO.23.00702. |
5 |
Ascierto PA, Lipson EJ, Dummer R, et al. Nivolumab and Relatlimab in Patients With Advanced Melanoma That Had
Progressed on Anti-Programmed Death-1/Programmed Death Ligand 1 Therapy: Results From the Phase I/IIa RELATIVITY-020 Trial. J Clin Oncol. 2023;41(15):2724-2735.
doi:10.1200/JCO.22.02072 |
6 |
Arance A, de la Cruz-Merino L, Petrella TM, et al. Phase II LEAP-004
Study of Lenvatinib Plus Pembrolizumab for Melanoma With Confirmed Progression on a Programmed Cell Death Protein-1 or Programmed Death Ligand 1 Inhibitor Given as Monotherapy or in Combination [published
correction appears in J Clin Oncol. 2023 May 1;41(13):2454. doi: 10.1200/JCO.23.00439]. J Clin Oncol. 2023;41(1):75-85. doi:10.1200/JCO.22.00221 |
7 |
Chesney J, Lewis KD, Kluger H, et al. Efficacy and safety of lifileucel, a
one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive
cohorts of the C-144-01 study. J Immunother Cancer. 2022;10(12):e005755. doi:10.1136/jitc-2022-005755 |
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