Perspective Therapeutics, Inc. (formerly known as Isoray, Inc.)
(NYSE AMERICAN: ISR), a precision oncology company developing
alpha-particle therapies and complementary diagnostic imaging
agents and an innovator in seed brachytherapy powering expanding
treatment options for multiple cancers, today announced unaudited
financial results for the three months ended December 31, 2022.
“The fourth quarter represented a transformational period
leading up to the completed merger between Isoray and Viewpoint
Molecular Targeting. In the Company’s core brachytherapy
business lack of orders from our largest customer and post-COVID
recovery efforts resulted in a sales decline. We will continue to
advocate for awareness of the long-term benefits of Cesium-131
brachytherapy treatment across respective indications and in
particular for prostate cancer as an alternative to radical
prostatectomy,” said Perspective Therapeutics CEO Thijs Spoor.
“Looking forward, as we advance the mission of the combined
companies, we are introducing a new wave of alpha-particle
radiotherapy that represents an entirely new class of theranostics
developed to treat a broad class of cancers. Strong scientific
fundamentals continue to build a mounting body of supporting
evidence for Perspective’s targeted alpha therapy (TAT) precision
oncology approach to changing the treatment landscape for melanoma
and neuroendocrine tumors. Perspective Therapeutics’ two-step
approach utilizing targeted peptides to diagnose and deliver
extremely powerful radiotherapy holds the promise of delivering
precision targeted medicine from the inside out. We firmly believe
that by improving efficacy and reducing toxicity across a broad
class of cancer treatments, we will not only unlock shareholder
value in the Company but also transform the radiotherapy treatment
paradigm for patients. I am confident the best is yet to come,”
concluded Perspective Therapeutics CEO Thijs Spoor.
Development Highlights in 2022 for the targeted alpha
therapy (TAT) subsidiary Viewpoint Molecular Targeting
Melanoma
- Based off of extraordinary pre-clinical results utilizing
combination therapies published as, Targeted Alpha-Particle
Radiotherapy and Immune Checkpoint Inhibitors Induces Cooperative
Inhibition on Tumor Growth of Malignant Melanoma, December 2021,
(Li. et al) the Company received an additional $2 million grant
awarded from NCI to pursue combination therapies
- Closed out first human imaging study: (“TIMAR1”) study at Mayo
Clinic in metastatic melanoma
- No safety concerns observed during first human evaluation of
compound in the imaging only setting
- Received safe to proceed from U.S. FDA for imaging and therapy
study using 203Pb/212Pb
- Publication of TIMAR1 study results expected later this
year
- First patients enrolled in melanoma study expected middle of
this year
Neuroendocrine
- Extraordinary head-to-head results seen in a pre-clinical model
comparing a-NET to standard of care
- [212Pb]VMT-α-NET granted U.S. FDA Fast Track designation for
the treatment of neuroendocrine tumors
- Received safe to proceed letter from U.S. FDA for imaging and
therapy study using 203Pb/212Pb
- Additional human imaging in compassionate use achieved
- Investigator initiated human studies of the diagnostic agent
initiated in the US, no safety issues observed
- First patients treated in compassionate use setting; no safety
issues observed to date
Isotopes / Generator
- Enabling technology for daily supply of 212Pb which allows
physicians globally to reliably access therapeutic isotope
- Major collaborations with University of Alberta and University
of Alabama for reliable production of pure isotope, publication in
leading journal
- Supported 203Pb user group to allow the medical community to
learn how to adopt and use 203Pb which has now been taken over by
the DOE
Pipeline
- Significantly increased R&D productivity, shortening time
from target identification to lead candidate
- Developed strong pipeline of peptide derived targets across
multiple solid tumor targets
Financial Results for Isoray, Inc. for the Quarter Ended
December 31, 2022
Revenue for the three months ended December 31, 2022 decreased
35% to $1.84 million versus $2.82 million in the prior year
comparable period. The year over year decline in revenue was the
result of sales to treat prostate cancer which declined 50% year
over year primarily due to a lack of orders from our largest
customer during the quarter. Prostate brachytherapy represented 58%
of total revenue for the three months ended December 31, 2022
compared to 76% in the prior year comparable period. Non-prostate
brachytherapy revenue increased 14% versus the prior year
comparable period. The majority of non-prostate brachytherapy
revenue in the three-month period was comprised of sales to treat
brain cancer, including sales of GammaTile® Therapy.
Gross profit as a percentage of revenues was 22.0% for the three
months ended December 31, 2022 versus 43.3% in the prior year
comparable period. Gross profit decreased to $0.40 million versus
$1.22 million in the comparable year ago quarter. The year over
year decrease was primarily the result of the decrease in core
prostate sales resulting from lower order volumes.
Total operating expenses in the three months ended December 31,
2022 were $3.70 million compared to $2.86 million in the prior year
period. Total research and development expenses increased 15%
versus the prior year comparable period. The increase in research
and development expenses was primarily the result of increased
payroll expense due to annual merit increases and travel related
expenses versus the prior year comparable period.
Sales and marketing expenses increased 16% versus the prior year
comparable period. The increase in sales and marketing expenses was
driven primarily by an increase in travel, conventions, and
tradeshow expenses, increased consulting expenses, and increased
payroll and benefits expense due to annual merit increases versus
the prior year comparable period. General and administrative
expenses increased 35% versus the prior year comparable period. The
increases in general and administrative expenses were primarily the
result of legal, proxy solicitation and other public company
related expenses associated with the merger with Viewpoint
Molecular Targeting, Inc. Also contributing to the increase were
payroll and benefits expense due to annual merit increases and
increased travel. In addition, the Company wrote-off some software
implementation costs as the Company will change certain systems due
to the merger.
The net loss for the three months ended December 31, 2022 was
$2.90 million or ($0.02) per basic and diluted share versus a net
loss of $1.60 million or ($0.01) per basic and diluted share
in the comparable prior year period. Basic and diluted per share
results are based on weighted average shares outstanding of
approximately 142.1 million for the three months ended December 31,
2022 versus 142.0 million in the comparable prior year period.
Cash, cash equivalents, and short-term investments as of
December 31, 2022, totaled $43.8 million and the Company had no
long-term debt. Stockholders’ equity totaled $55.0 million.
Subsequent Events
On February 3, 2023, Isoray, Inc. completed the merger with
privately held Viewpoint Molecular Targeting, Inc. Isoray, Inc.
amended its Certificate of Incorporation on February 14, 2023, to
change its name to Perspective Therapeutics, Inc. The Company
currently trades on the NYSE American as Isoray, Inc. under ticker
symbol ISR, which is expected to change to Perspective
Therapeutics, Inc. with the ticker symbol of CATX on February 21,
2023.
On January 31, 2023, the Board of Directors of Isoray, Inc.
approved a change in the fiscal year end of the Company from June
30 to December 31. The Company’s fiscal year will now be the
calendar year pursuant to such change. The Company will file a
transition report on Form 10-KT covering the transition period from
July 1, 2022, to December 31, 2022 and expects to do so by May
2023. As a result, the Company will not be filing a Form 10-Q for
the three-month period ended December 31, 2022 but expects to file
a Form 10-Q for the three-month period ending March 31, 2023 by mid
May 2023.
About Perspective Therapeutics, Inc.Perspective
Therapeutics, Inc., formerly known as Isoray, Inc., is a medical
technology and radiopharmaceutical company that is pioneering
advanced treatment applications for cancers throughout the body.
The Company is the sole producer of Cesium-131 brachytherapy seeds
and has a proprietary technology that utilizes the isotope lead-212
to deliver powerful alpha 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
associated with many other types of cancer treatments.
The Company’s melanoma (VMT01) and neuroendocrine tumor
(VMT-a-NET) programs are entering 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 lead-212 generator to secure isotope
supply for clinical trial and commercial operations. For more
information, please visit the Company’s website at
www.perspectivetherapeutics.com.
Safe Harbor StatementStatements in this news
release about the business and milestones achieved by Viewpoint
Molecular Targeting in calendar year 2022 were accomplished prior
to its merger with Isoray and are not reflected in and have nothing
to do with the performance of Isoray, Inc. (now Perspective
Therapeutics, Inc.) in the quarter ending December 31, 2022.
Statements in this news release about Perspective Therapeutics,
Inc.’s (“Perspective”) and its wholly-owned subsidiary Viewpoint
Molecular Targeting, Inc.’s (“Viewpoint,” and together with
Perspective, the “Company”) future expectations, including: the
ticker symbol change, the anticipated synergies and benefits of the
merger between Perspective and Viewpoint; the anticipated pipeline
of the Company’s programs and products; expectations about the
Company’s addressable markets; the functionality and capabilities
of the Company’s therapies including its targeted alpha-particle
radiotherapy; the potential size of the commercial market for the
Company’s treatment programs; the Company’s expectations, beliefs,
intentions, and strategies regarding the future; and all other
statements in this news release, other than historical facts, are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 (“PSLRA”). This statement
is included for the express purpose of availing the Company of the
protections of the safe harbor provisions of the PSLRA. It is
important to note that actual results and ultimate corporate
actions could differ materially from those in such forward-looking
statements based on such factors as whether and to what extent the
anticipated benefits of the merger are realized; the ability to
raise ongoing capital to fund added costs of research and
development related to the Company’s business; the ability of the
Company to manage growth and successfully integrate its businesses;
whether the Company can maintain its key employees; the risk that
the merger disrupts current plans and operations; the outcome of
any legal proceedings that may be instituted against the Company
following consummation of the merger; whether the results of
studies of targeted alpha-particle radiotherapy or using Cesium-131
in conjunction with immunotherapy combinations are conducted on the
anticipated timelines or are successful; whether the Company’s
anticipated product pipeline is achieved; whether additional
studies are released that reinforce the results of the studies
discussed in this presentation; whether the anticipated benefits of
the Company’s therapies are realized; training and use of the
Company’s products; market acceptance and recognition of the
Company’s products; the Company’s ability to enforce its
intellectual property rights; whether ongoing patient results are
favorable and in line with the conclusions of clinical studies and
initial patient results; successful completion of future research
and development activities; whether we, our distributors, and our
customers will successfully obtain and maintain all required
regulatory approvals and licenses to market, sell, and use our
products in their various forms; the procedures and regulatory
requirements mandated by the FDA for animal trials, human trials,
clinical studies, Phase I and II approvals and 510(k) approval and
reimbursement codes; changes in applicable laws and regulations;
and other risks detailed from time to time in the Company’s reports
filed with the SEC.
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. For
more information regarding risks and uncertainties that could
affect the Company’s results of operations or financial condition,
please review the definitive Proxy Statement filed on November 7,
2022, and our Form 10-K filed on September 28, 2022, with the
SEC.
Isoray, Inc. and
Subsidiaries |
Consolidated Balance
Sheets (Unaudited) |
(In thousands, except
shares) |
|
|
December 31, |
|
|
June 30, |
|
|
|
2022 |
|
|
2022 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
20,993 |
|
|
$ |
55,890 |
|
Short-term investments |
|
|
22,764 |
|
|
|
- |
|
Accounts receivable, net |
|
|
1,363 |
|
|
|
1,608 |
|
Inventory |
|
|
1,618 |
|
|
|
1,396 |
|
Note Receivable |
|
|
6,088 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
727 |
|
|
|
435 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
53,553 |
|
|
|
59,329 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,891 |
|
|
|
1,976 |
|
Right of use asset, net |
|
|
378 |
|
|
|
512 |
|
Restricted cash |
|
|
182 |
|
|
|
182 |
|
Inventory, non-current |
|
|
2,187 |
|
|
|
2,333 |
|
Other assets, net |
|
|
86 |
|
|
|
107 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
58,277 |
|
|
$ |
64,439 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
1,341 |
|
|
$ |
966 |
|
Lease liability |
|
|
276 |
|
|
|
268 |
|
Accrued protocol expense |
|
|
253 |
|
|
|
150 |
|
Accrued radioactive waste disposal |
|
|
129 |
|
|
|
120 |
|
Accrued payroll and related taxes |
|
|
212 |
|
|
|
509 |
|
Accrued vacation |
|
|
285 |
|
|
|
253 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
2,496 |
|
|
|
2,266 |
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Lease liability, non-current |
|
|
116 |
|
|
|
256 |
|
Asset retirement obligation |
|
|
657 |
|
|
|
640 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
3,269 |
|
|
|
3,162 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, $.001 par value; 7,000,000 shares authorized:
Series B: 5,000,000 shares allocated; no shares issued and
outstanding |
|
|
- |
|
|
|
- |
|
Common stock, $.001 par value; 200,000,000 shares
authorized; 142,112,766 and 142,040,266 shares issued and
outstanding |
|
|
142 |
|
|
|
142 |
|
Additional paid-in capital |
|
|
160,432 |
|
|
|
159,732 |
|
Accumulated deficit |
|
|
(105,566 |
) |
|
|
(98,597 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders' equity |
|
|
55,008 |
|
|
|
61,277 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
58,277 |
|
|
$ |
64,439 |
|
Isoray, Inc. and
Subsidiaries |
Consolidated
Statements of Operations (Unaudited) |
(Dollars and shares in
thousands, except for per-share amounts) |
|
|
Three months ended |
|
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
1,835 |
|
|
$ |
2,816 |
|
Cost of sales |
|
|
1,432 |
|
|
|
1,596 |
|
Gross profit |
|
|
403 |
|
|
|
1,220 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
613 |
|
|
|
535 |
|
Sales and marketing |
|
|
814 |
|
|
|
702 |
|
General and administrative |
|
|
2,179 |
|
|
|
1,618 |
|
Loss on equipment disposals |
|
|
98 |
|
|
|
- |
|
Total operating expenses |
|
|
3,704 |
|
|
|
2,855 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(3,301 |
) |
|
|
(1,635 |
) |
|
|
|
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
|
|
|
|
Interest income |
|
|
400 |
|
|
|
31 |
|
Non-operating income |
|
|
400 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,901 |
) |
|
$ |
(1,604 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share |
|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares used
in computing net loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
142,113 |
|
|
|
141,955 |
|
Contacts
Legacy Isoray Investor Relations: Mark Levin (501) 255-1910
Legacy Viewpoint Molecular Targeting Investor Relations: Chuck Padala (917) 741-7792
Media and Public Relations: Sharon Schultz (302) 539-3747
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