- Continued progress enrolling in its VMT-α-NET and VMT01 clinical trials
- Disclosed a new internally discovered molecule that targets fibroblast activation protein-α
- Announced the in-licensing of a technology that enables the use of antibodies to direct radiolabeled ligands to tumor sites
- Raised
$177.2 million in gross proceeds through various financing transactions and raised an additional$49.5 million subsequent toMarch 31 st under our ATM Agreement.
“I am proud of the progress we are making with our clinical-stage proprietary radiopharmaceuticals,” said
Program Highlights
VMT-α-NET
Company-sponsored Phase 1/2a trial of [212Pb]VMT-α-NET
Perspective is conducting a multi-center open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 ("SSTR2")-positive neuroendocrine tumors ("NETs") who have not received prior peptide receptor radionuclide therapies (“PRRT”). The Company received Fast Track Designation for this program from the
- As of
May 15, 2024 , the Company initiated dosing of nine patients in Cohorts 1 and 2 of its Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs. A total of seven patients received activities of 185 MBq (5mCi) of [212Pb]VMT-α-NET in Cohort 2.
This program has been selected by the FDA to participate in the Chemistry, Manufacturing, and Controls ("CMC") Development and Readiness Pilot ("CDRP") program.FDA's CDRP Program was initiated in 2022 to facilitate alignment of CMC development of novel products under investigational new drug (“IND”) applications with expedited clinical development timeframes based upon the anticipated clinical benefits of earlier patient access.1 - Updated results from Cohorts 1 and 2 of the Phase 1/2a trial are expected in the second half of 2024. Concurrently, the Company is evaluating appropriate scientific forums to present these updates.
- Next steps will be determined based on recommendations from the Safety Monitoring Committee (“SMC”) for the study and in consultation with the FDA. Data informing the SMC’s recommendation and FDA consultation is expected to be submitted to an upcoming scientific forum.
1 Chemistry, Manufacturing, and
Investigator-initiated clinical research of [212Pb]VMT-α-NET
Perspective is collaborating with a number of thought leaders to further elucidate the clinical profile of [212Pb]VMT-α-NET through investigator-initiated studies in the
Investigator Led Study in
The investigator enrolled adult patients with histologically confirmed NETs and metastatic medullary thyroid carcinomas. The Company was informed by the investigator that updated results from 12 patients have been accepted for presentation at the
- The most recent scientific conference presentation by the investigator was during the 36th Annual
Congress of theEuropean Association of Nuclear Medicine (EANM) inSeptember 2023 . Ten patients whose disease progressed after at least one prior line of standard of care therapy received [212Pb]VMT-α-NET therapy, with initial responses observed in seven of nine evaluable patients; responses were observed across both PRRT-naïve and PRRT-refractory disease; no significant renal or hepatic function adverse events were observed to date; most adverse events were mild and usually resolved within one week of [212Pb]VMT-α-NET administration; and two patients experienced serious adverse events that were deemed unrelated to [212Pb]VMT-α-NET treatment.
PRRT refractory patients at the
This is a single site Phase 1 trial evaluating the safety of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs (clinicaltrials.gov identifier NCT06148636). Patients being enrolled in the study have either progressed or relapsed after previous therapies, including currently approved PRRT. The Company was informed by the investigator that preliminary data readout is expected in the second half of 2024.
VMT01
Perspective designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor ("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.
- As of
May 15, 2024 , the Company continues to dose patients in Cohort 1 and in Cohort 2 of the Phase 1/2a clinical study of [212Pb]VMT01 in patients with progressive MC1R-positive metastatic melanoma. As ofMarch 31, 2024 , [212Pb]VMT01 was well tolerated with no unexpected adverse events. - Updated results from Cohorts 1 and 2 of the Phase 1/2a study are expected in the second half of 2024. Concurrently, the Company is evaluating appropriate scientific forums to present these updates.
- In
March 2024 , the Company entered a clinical trial collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate the safety and tolerability of Perspective’s [212Pb]VMT01 in combination with Bristol Myers Squibb’s nivolumab in patients with histologically confirmed melanoma and positive MC1R imaging scans. The combination arm of the study will be an amendment to the Company’s ongoing Phase 1/2a study of [212Pb]VMT01 in patients with metastatic melanoma which the Company anticipates submitting in the second quarter of 2024. If the study may proceed with the amendment, the first combination cohort would open shortly thereafter.
Highlights from the March Investor Event
Perspective hosted an investor event on
During the investor event, the Company disclosed a novel pre-IND stage asset as well as further details on a new enabling technology platform that broadens the scope of targets addressable by radiopharmaceuticals, in addition to the status of ongoing clinical programs at the beginning of March.
- New target: PSV359 is an internally discovered molecule that targets fibroblast activation protein-α, or FAP-α, associated with a variety of solid tumors. Preclinical imaging and therapy as well as human imaging results suggest the Company’s proprietary targeting ligand has differential levels of target engagement in tumors and healthy tissues that may result in a desirable therapeutic index.
During the investor event, the Company presented data which included analysis of a first-in-human imaging study, under the direction of Dr.Dharmender Malik ofFortis Memorial Research Institute , evaluating the suitability of [203Pb]PSV359 for SPECT/CT imaging of patients with lung adenocarcinoma, NETs and chondroblast osteosarcoma.
Perspective is working to file an IND in late 2024 for this new asset. If the study may proceed, theU.S. Phase I study would commence in 2025. - New platform: Pre-targeting is technology enabling the use of antibodies to direct radiolabeled ligands to tumor sites. Antibodies can bind with high specificity to a wider variety of cancer-specific proteins preferentially expressed on the surface of tumor cells. However, the amount of time required for an adequate amount of antibodies to bind to the cancer-specific proteins may not align with the properties of the desired isotope. By attaching an additional chemical entity to an antibody that would bind to a radioligand, the resultant modified antibodies may be administered separately from and in advance of the radioligand as appropriate.
Further details on our license to this technology are in the “Other Business Highlights” section below.
Status of other pre-IND assets
- PSV40X: The Company has a license agreement with
Mayo Clinic for the rights to Mayo's prostate-specific membrane antigen (“PSMA”) Alpha-PET DoubLET platform technology for the treatment of PSMA-expressing cancers, with an initial focus on prostate. This radiopharmaceutical platform provides detailed PET imaging-based diagnosis and dosimetry using long-lived copper-64 (64Cu) for imaging and alpha-particle targeted therapies using 212Pb. Preclinical studies are ongoing to assess whether this new molecular entity meets the hurdle for progressing into the clinic with potential to achieve best-in-class profile.
Other Business Highlights
- In
January 2024 , the Company entered into strategic agreements with Lantheus Holdings, Inc. and its affiliates (“Lantheus”) (NASDAQ: LNTH). Under the agreements, Lantheus has the option to negotiate for an exclusive license to Perspective’s [212Pb]VMT-α-NET. Lantheus also has the option to co-fund and negotiate for an exclusive license for certain early-stage therapeutic candidates targeting prostate cancer using Perspective’s lead platform technology. - In
February 2024 , the Company announced it entered into an exclusive license agreement withStony Brook University for the rights to its Cuburbit[7]uril-admantane ("CB7-Adma") pre-targeting platform for the diagnosis and treatment of cancer. The exclusive license withStony Brook University covers the global intellectual property rights for the CB7-Adma pre-targeting platform. The Company has applied for the Phase I tranche of a 2.5-yearFastrack Small Business Innovation Research grant (Phase I$400,000 ; total$2.4 million ) from theNational Institutes of Health National Cancer Institute to support the development of the pre-targeting program. - In
March 2024 , the Company closed the acquisition of a state-of-the-art radiopharmaceutical manufacturing facility and associated equipment and systems for the production of its 203Pb- and 212Pb-labeled radiopharmaceuticals inSomerset, New Jersey . Perspective is currently fitting out and adapting the site in accordance with relevant licensing requirements for handling the Company’s materials. Filing is expected in the second half of 2024. - In
April 2024 , the Company closed the divestiture of its brachytherapy business, including its radioactive Cesium-131 seed assets and related business infrastructure, toGT Medical Technologies, Inc. Under the terms of the agreement, Perspective owns 0.5% of outstanding capital stock of GT Medical Technologies, on a fully diluted basis. Perspective is entitled to certain cash royalties on net sales of Cesium-131 seeds and GT Medical’s GammaTile therapy utilizing Cesium-131 over the next four years. The Company disclosed pro forma annual financials for continuing operations in an 8-K datedApril 22, 2024 .
First Quarter 2024 Financial Summary
In
In
The Company has previously presented its results in two segments: Drug Operations and Brachytherapy. Due to the divestiture of its entire brachytherapy segment to GT Medical, the assets and operations of the brachytherapy segment have been classified as discontinued operations in the Company's financials. The comments below pertain to our continuing operations unless otherwise noted.
Grant revenue for the three months ended
Research and development expenses were
General and administrative expenses were
Total operating expenses for the quarter ended
Net loss for the three months ended
Cash, cash equivalents and short-term investments as of
As of
About
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 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 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 it will continue to make progress with its clinical-stage proprietary radiopharmaceuticals; the Company’s discovery team’s ability to continue to generate additional novel molecular entities for future clinical development, in keeping with the Company’s goal of developing potential innovative precision medicines based on alpha-emitting isotopes and peptide optimization; the Company’s expectation that it will provide multiple updates on its progress in building a fully integrated radiopharmaceuticals company in the coming months; the Company’s expectation that data informing its Safety Monitoring Committee’s recommendation and FDA consultation will be submitted to an upcoming scientific forum; the Company’s expectation that the updated [212Pb]VMT-α-NET results from 12 patients will be presented at the
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’s ability to obtain and 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 and successfully integrate its businesses; the Company’s ability to maintain its key employees; sufficient training and use of the Company’s products and product candidates; the market acceptance and recognition of the Company’s programs and program candidates; the Company’s ability to maintain and enforce its intellectual property rights; the Company’s ability to maintain its therapeutic isotope supply agreement with the
Media and Investor Relations Contacts:
Perspective Therapeutics IR
ir@perspectivetherapeutics.com
perspectivetx@russopr.com
Condensed Consolidated Balance Sheets (In thousands) | ||||||||
2024 | 2023 | |||||||
(unaudited) | ||||||||
Cash, cash equivalents and short-term investments | $ | 180,648 | $ | 9,238 | ||||
Total assets | 278,286 | 97,891 | ||||||
Total liabilities | 48,395 | 22,712 | ||||||
Total stockholders' equity | 229,891 | 75,179 | ||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Grant revenue | $ | 325 | $ | 233 | ||||
Operating expenses: | ||||||||
Research and development | 7,452 | 3,309 | ||||||
General and administrative | 5,878 | 6,663 | ||||||
Loss on disposal of property and equipment | - | 22 | ||||||
Total operating expenses | 13,330 | 9,994 | ||||||
Operating loss | (13,005 | ) | (9,761 | ) | ||||
Total non-operating income | 1,180 | 356 | ||||||
Net loss from continuing operations | (11,825 | ) | (9,405 | ) | ||||
Net loss from discontinued operations | (461 | ) | (1,466 | ) | ||||
Gain recognized on classification as held for sale | 2 | - | ||||||
Net loss before income taxes | (12,284 | ) | (10,871 | ) | ||||
Deferred income tax benefit | - | 10,500 | ||||||
Net loss | $ | (12,284 | ) | $ | (371 | ) | ||
Basic and diluted loss per share: | ||||||||
Loss from continuing operations | $ | (0.02 | ) | $ | 0.01 | |||
Loss from discontinued operations | (0.00 | ) | (0.01 | ) | ||||
Basic and diluted loss per share | $ | (0.02 | ) | $ | 0.00 | |||
Weighted average shares used in computing net loss per share: | ||||||||
Basic and diluted | 495,100 | 228,591 |
Source:
2024 GlobeNewswire, Inc., source