Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO,
TSX: APS), a clinical-stage precision oncology company developing
highly differentiated oral targeted agents to treat hematologic
malignancies, today announced financial results for the three
months ended June 30, 2024, and provided a corporate update.
“We are pleased that our triplet protocol of
tuspetinib with venetoclax and azacitidine (TUS+VEN+AZA) has been
allowed to proceed at the 40 mg dose of tuspetinib, a dose that as
a single agent and in doublet therapy has been shown to be safe and
active,” said William G. Rice, Ph.D., Chairman, President and Chief
Executive Officer of Aptose. “We – along with our board and outside
scientific advisors – strongly believe tuspetinib is an ideal drug
for frontline triplet therapy and we remain committed to securing
financing to pursue its development for the newly diagnosed AML
patient population in desperate need of an improved frontline
therapy.”
Key Corporate Highlights
- Tuspetinib Protocol Now
Ready for Triplet Therapy Study – Aptose’s
company-sponsored phase 1/2 TUS+VEN+AZA triplet study is designed
to test tuspetinib in combination with standard of care dosing of
azacitidine and venetoclax as frontline therapy in newly diagnosed
AML patients unfit for chemotherapy. The planned study will dose
VEN-naïve, FLT3i-naïve, and HMA-naïve patients, a group expected to
be highly responsive to the TUS+VEN+HZA triplet regimen. Current
triplet therapies containing kinase inhibitors can be limited by
toxicities often requiring dose reductions of all three agents and
may not be effective in the larger FLT3-unmutated AML population.
The U.S. Food and Drug Administration (FDA) has allowed TUS to be
administered as part of the triplet at 40 mg daily, at an initial
dose shown active as a single agent in relapsed or refractory AML
patients.
- ASH Abstract – On
July 31, 2024, Aptose submitted an abstract for presentation at the
2025 Annual Meeting of the American Society of Hematology (ASH) in
December 2024. Lead author Navel Daver, MD, University of Texas MD
Anderson Cancer Center, Houston, TX and research team explore the
safety and efficacy results that support the upcoming combination
study of TUS+VEN+AZA as a triplet drug combination frontline
therapy in newly diagnosed AML patients ineligible for intensive
chemotherapy, independent of FLT3 mutation status, which is an
important differentiator for tuspetinib.
- Nasdaq – On July
19, 2024, Aptose announced that it had received a deficiency letter
(the “Deficiency Letter”) from the Nasdaq Listing Qualifications
Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the
Company that, for the last thirty (30) consecutive business days,
the closing bid price for the Company's common shares had been
below the minimum $1.00 per share required for continued listing on
The Nasdaq Capital Market pursuant to Nasdaq Listing Rule
5550(a)(2) (the “Minimum Bid Price Requirement”). The Deficiency
Letter has no immediate effect on the listing of the Company's
common shares, and its common shares will continue to trade on The
Nasdaq Capital Market under the symbol “APTO” at this time. The
Company's common shares continue to trade on the Toronto Stock
Exchange (“TSX”) under the symbol “APS”. The Company's listing on
the TSX is independent and will not be affected by the Nasdaq
listing status.
In accordance with Nasdaq Listing Rule
5810(c)(3)(A), the Company has been given one hundred and eighty
(180) calendar days, or until January 10, 2025, to regain
compliance with the Minimum Bid Price Requirement. If at any time
before January 10, 2025, the bid price of the Company's common
shares closes at $1.00 per share or more for a minimum of ten (10)
consecutive business days, the Staff will provide written
confirmation that the Company has achieved compliance. If the
Company does not regain compliance with the Minimum Bid Price
Requirement by January 10, 2025, the Company may be afforded a
second one hundred and eighty (180) calendar day period to regain
compliance. The Company intends to monitor the closing bid
price of its common shares and may, if appropriate, consider
available options to regain compliance with the Minimum Bid Price
Requirement. However, there can be no assurance that the Company
will be able to regain compliance with the Minimum Bid Price
Requirement or will otherwise be in compliance with other Nasdaq
Listing Rules.
Multiple Planned Value-creating
Milestones Ahead
- Frontline therapy triplet pilot dose
initiation planned in newly diagnosed (ND) AML: 2H 2024
- Triplet pilot dose escalation planned
with early data in ND AML: ASH 2024
- Triplet pilot completed with CR/MRD
data and dose selection: EHA 2025
- Triplet Ph2/Ph3 pivotal program
planned initiation: 2H 2025
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FINANCIAL RESULTS OF OPERATIONSAptose Biosciences
Inc.Statements of Operations Data(unaudited)($ in thousands, except
per share data) |
|
|
|
|
Three months ended June 30, |
|
Six months endedJune 30, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,413 |
|
|
$ |
10,582 |
|
|
$ |
10,858 |
|
|
$ |
19,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
2,932 |
|
|
|
3,870 |
|
|
|
6,247 |
|
|
|
9,155 |
|
|
Operating expenses |
|
7,345 |
|
|
|
14,452 |
|
|
|
17,105 |
|
|
|
28,548 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
93 |
|
|
|
323 |
|
|
|
213 |
|
|
|
743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss |
$ |
(7,252 |
) |
|
$ |
(14,129 |
) |
|
$ |
(16,892 |
) |
|
$ |
(27,805 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net Loss per share, Basic and diluted |
$ |
(0.43 |
) |
|
$ |
(2.27 |
) |
|
$ |
(1.13 |
) |
|
$ |
(4.47 |
) |
|
Weighted average number of commonshares outstanding used in
computingnet loss per share, basic and diluted(in thousands) |
|
16,755 |
|
|
|
6,234 |
|
|
|
14,944 |
|
|
|
6,219 |
|
|
|
|
Net loss for the three-month period ended June
30, 2024 decreased by $6.9 million to $7.3 million, as compared to
$14.1 million for the comparable period in 2023. Net loss for the
six-month period ended June 30, 2024 decreased by $10.9 million to
$16.9 million, as compared to $27.8 million for the comparable
period in 2023. Components of net loss are presented below:
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Aptose Biosciences Inc.Balance Sheet Data(unaudited)($ in
thousands) |
|
|
|
|
June 30,2024 |
|
|
December 31,2023 |
|
|
Cash, cash equivalents and short-term investments |
$ |
8,330 |
|
|
$ |
9,252 |
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
(2,552 |
) |
|
|
(3,375 |
) |
|
Total assets |
|
10,949 |
|
|
|
12,989 |
|
|
Long-term liabilities |
|
414 |
|
|
|
621 |
|
|
Accumulated deficit |
|
(532,429 |
) |
|
|
(515,537 |
) |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
(2,176 |
) |
|
|
(2,901 |
) |
|
|
|
- Total cash and cash equivalents and
investments as of June 30, 2024, were $8.3 million. Based on
current operations, the Company expects that cash on hand and
available capital provides the Company with sufficient resources to
fund planned Company operations including research and development
through August of 2024.
- As of August 8, 2024, we had
18,109,393 Common Shares issued and outstanding. In addition, there
were 1,347,002 Common Shares issuable upon the exercise of
outstanding stock options and there were 18,341,491 Common Shares
issuable upon the exercise of the outstanding warrants.
RESEARCH AND DEVELOPMENT
EXPENSES
The research and development expenses for the
three months and six months ended June 30, 2024, and 2023 were as
follows:
|
|
|
|
|
|
Three months endedJune 30, |
|
Six months endedJune 30, |
|
(in thousands) |
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Program costs – Tuspetinib |
$ |
2,666 |
|
|
$ |
8,070 |
|
|
$ |
6,589 |
|
|
$ |
12,845 |
|
|
Program costs – Luxeptinib |
|
304 |
|
|
|
706 |
|
|
|
512 |
|
|
|
1,995 |
|
|
Program costs – APTO-253 |
|
(9 |
) |
|
|
19 |
|
|
|
13 |
|
|
|
26 |
|
|
Personnel related expenses |
|
1,379 |
|
|
|
1,506 |
|
|
|
3,333 |
|
|
|
3,584 |
|
|
Stock-based compensation |
|
70 |
|
|
|
271 |
|
|
|
398 |
|
|
|
924 |
|
|
Depreciation of equipment |
|
3 |
|
|
|
10 |
|
|
|
13 |
|
|
|
19 |
|
|
Total |
$ |
4,413 |
|
|
$ |
10,582 |
|
|
$ |
10,858 |
|
|
$ |
19,393 |
|
|
|
|
Research and development expenses decreased by
$6.2 million to $4.4 million for the three-month period ended June
30, 2024, as compared to $10.6 million for the comparative period
in 2023. Changes to the components of our research and development
expenses presented in the table above are primarily as a result of
the following events:
- Program costs for tuspetinib were
$2.7 million for the three-month period ended June 30, 2024,
compared with $8.1 million for the comparative period in 2023. The
lower program costs for tuspetinib in the current period represent
the reduction of activity in our APTIVATE clinical trial, reduced
manufacturing costs, and related expenses. In the comparative
period in 2023, tuspetinib program costs included the healthy
volunteer study, which was completed in 2023.
- Program costs for luxeptinib
decreased by approximately $402 thousand, primarily due to lower
clinical trial and manufacturing activities.
- Program costs for APTO-253
decreased by approximately $28 thousand. The Company discontinued
further clinical development of APTO-253.
- Personnel-related expenses
decreased by $127 thousand, related to fewer employees in the
current three-month period, partially offset by salary
increases.
- Stock-based compensation decreased
by approximately $201 thousand in the three months ended June 30,
2024, compared to the three months ended June 30, 2023, primarily
due to stock options granted with lower grant date fair values in
the current period.
Research and development expenses decreased by
$8.5 million to $10.9 million for the six-month period ended June
30, 2024, as compared to $19.4 million for the comparative period
in 2023. Changes to the components of our research and development
expenses presented in the table above are primarily as a result of
the following events:
- Program costs for tuspetinib were
$6.6 million for the six-month period ended June 30, 2024, a
decrease of $6.3 million compared with $12.8 million for the
comparative period in 2023. The lower program costs for tuspetinib
in the current period represent the reduction of activity in our
APTIVATE clinical trial, reduced manufacturing costs, and related
expenses. In the comparative period in 2023, tuspetinib program
costs included the healthy volunteer study, which was completed in
2023.
- Program costs for luxeptinib
decreased by approximately $1.5 million to $512 thousand for the
six months ended June 30, 2024, as compared to $2.0 million in the
comparative period, primarily due to lower clinical trial and
manufacturing activities.
- Program costs for APTO-253
decreased by approximately $13 thousand, due to the Company’s
decision on December 20, 2021 to discontinue further clinical
development of APTO-253.
- Personnel-related expenses
decreased by $251 thousand, related to fewer employees in the
current six-month period and partially offset by salary
increases.
- Stock-based compensation decreased
by approximately $526 thousand in the six months ended June 30,
2024, compared to the six months ended June 30, 2023, primarily due
to stock options granted with lower grant date fair values, in the
current period.
About Aptose
Aptose Biosciences is a clinical-stage
biotechnology company committed to developing precision medicines
addressing unmet medical needs in oncology, with an initial focus
on hematology. The Company's small molecule cancer therapeutics
pipeline includes products designed to provide single agent
efficacy and to enhance the efficacy of other anti-cancer therapies
and regimens without overlapping toxicities. The Company’s lead
clinical-stage compound tuspetinib (TUS), is an oral kinase
inhibitor that has demonstrated activity as a monotherapy and in
combination therapy in patients with relapsed or refractory acute
myeloid leukemia (AML) and is being developed as a frontline
triplet therapy in newly diagnosed AML. For more information,
please visit www.aptose.com.
Forward Looking Statements
This press release contains forward-looking
statements within the meaning of Canadian and U.S. securities laws,
including, but not limited to, statements regarding the Company’s
clinical development plans, the clinical potential, anti-cancer
activity, therapeutic potential and applications and safety profile
of tuspetinib, clinical trials, the enrollment in clinical trials
and the data therefrom, the submission of a compliance plan to
Nasdaq and available options to regain compliance, upcoming
milestones, financing activities, expectations regarding capital
available to the Company to fund planned Company operations,
maintenance of the Nasdaq and TSX listings and statements relating
to the Company’s plans, objectives, expectations and intentions and
other statements including words such as “continue”, “expect”,
“intend”, “will”, “hope” “should”, “would”, “may”, “potential” and
other similar expressions. Such statements reflect our current
views with respect to future events and are subject to risks and
uncertainties and are necessarily based upon a number of estimates
and assumptions that, while considered reasonable by us, are
inherently subject to significant business, economic, competitive,
political and social uncertainties and contingencies. Many factors
could cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements described in this press release. Such factors could
include, among others: our ability to obtain the capital required
for research and operations; the inherent risks in early stage drug
development including demonstrating efficacy; development time/cost
and the regulatory approval process; the progress of our clinical
trials; our ability to find and enter into agreements with
potential partners; our ability to attract and retain key
personnel; changing market and economic conditions; unexpected
manufacturing defects and other risks detailed from time-to-time in
our ongoing current reports, quarterly filings, annual information
forms, annual reports and annual filings with Canadian securities
regulators and the United States Securities and Exchange
Commission.
Should one or more of these risks or
uncertainties materialize, or should the assumptions set out in the
section entitled “Risk Factors” in our filings with Canadian
securities regulators and the United States Securities and Exchange
Commission underlying those forward-looking statements prove
incorrect, actual results may vary materially from those described
herein. These forward-looking statements are made as of the date of
this press release and we do not intend, and do not assume any
obligation, to update these forward-looking statements, except as
required by law. We cannot assure you that such statements will
prove to be accurate as actual results and future events could
differ materially from those anticipated in such statements.
Investors are cautioned that forward-looking statements are not
guarantees of future performance and accordingly investors are
cautioned not to put undue reliance on forward-looking statements
due to the inherent uncertainty therein.
For further information, please contact:
Aptose Biosciences Inc.Susan
PietropaoloCorporate Communications & Investor
Relations201-923-2049spietropaolo@aptose.com
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