Aptose Reports Results for the Third Quarter 2024
Aptose Biosciences (NASDAQ: APTO, TSX: APS) announced Q3 2024 financial results and updates on tuspetinib development. The company received a $10 million loan from Hanmi Pharmaceutical for tuspetinib development. Net loss decreased to $7.0 million compared to $11.4 million in Q3 2023. Total cash and investments were $8 million as of September 30, 2024, expected to fund operations through January 2025. The company is advancing tuspetinib as part of a triplet therapy with azacitidine and venetoclax for newly diagnosed AML patients. Aptose is currently addressing Nasdaq listing compliance issues regarding stockholders' equity and minimum bid price requirements.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) ha annunciato i risultati finanziari del terzo trimestre 2024 e aggiornamenti sullo sviluppo di tuspetinib. L'azienda ha ricevuto un prestito di 10 milioni di dollari dalla Hanmi Pharmaceutical per lo sviluppo di tuspetinib. La perdita netta è diminuita a 7,0 milioni di dollari rispetto agli 11,4 milioni di dollari del terzo trimestre 2023. Il totale di liquidità e investimenti ammontava a 8 milioni di dollari al 30 settembre 2024, previsto per finanziare le operazioni fino a gennaio 2025. L'azienda sta sviluppando tuspetinib come parte di una terapia tripla con azacitidina e venetoclax per pazienti recentemente diagnosticati con AML. Aptose sta attualmente affrontando questioni di conformità relative alla quotazione Nasdaq riguardanti l'equità degli azionisti e i requisiti di prezzo minimo d'offerta.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) anunció los resultados financieros del tercer trimestre de 2024 y actualizaciones sobre el desarrollo de tuspetinib. La compañía recibió un préstamo de 10 millones de dólares de Hanmi Pharmaceutical para el desarrollo de tuspetinib. La pérdida neta se redujo a 7,0 millones de dólares en comparación con 11,4 millones de dólares en el tercer trimestre de 2023. El total de efectivo e inversiones fue de 8 millones de dólares al 30 de septiembre de 2024, y se espera que financie operaciones hasta enero de 2025. La empresa está avanzando en tuspetinib como parte de una terapia triple con azacitidina y venetoclax para pacientes con AML recién diagnosticados. Aptose está abordando actualmente problemas de cumplimiento de cotización en Nasdaq relacionados con el capital de los accionistas y los requisitos de precio mínimo de oferta.
Aptose Biosciences (NASDAQ: APTO, TSX: APS)는 2024년 3분기 재무 결과와 tuspetinib 개발 업데이트를 발표했습니다. 회사는 tuspetinib 개발을 위해 Hanmi Pharmaceutical로부터 1천만 달러의 대출을 받았습니다. 순손실은 2023년 3분기 1,140만 달러에 비해 700만 달러로 감소했습니다. 2024년 9월 30일 기준 총 현금 및 투자금은 800만 달러로, 2025년 1월까지 운영 자금을 지원할 것으로 예상됩니다. 회사는 AML을 새롭게 진단받은 환자를 위해 azacitidine 및 venetoclax와 함께 tuspetinib을 삼중요법으로 발전시키고 있습니다. Aptose는 현재 주주 자본 및 최소 청구 가격 요건과 관련된 Nasdaq 상장 준수 문제를 다루고 있습니다.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour sur le développement de tuspetinib. La société a reçu un prêt de 10 millions de dollars de Hanmi Pharmaceutical pour le développement de tuspetinib. La perte nette a diminué à 7,0 millions de dollars par rapport à 11,4 millions de dollars au troisième trimestre 2023. Le total de liquidités et d'investissements était de 8 millions de dollars au 30 septembre 2024, prévu pour financer les opérations jusqu'en janvier 2025. La société fait progresser tuspetinib dans le cadre d'une thérapie triple avec azacitidine et venetoclax pour des patients récemment diagnostiqués avec une LMA. Aptose traite actuellement des problèmes de conformité liés à la cotation Nasdaq concernant les capitaux propres des actionnaires et les exigences de prix d'offre minimum.
Aptose Biosciences (NASDAQ: APTO, TSX: APS) hat die finanziellen Ergebnisse für das dritte Quartal 2024 und Updates zur Entwicklung von tuspetinib bekannt gegeben. Das Unternehmen erhielt einen Kredit in Höhe von 10 Millionen Dollar von Hanmi Pharmaceutical für die Entwicklung von tuspetinib. Der Nettoverlust verringerte sich auf 7,0 Millionen Dollar im Vergleich zu 11,4 Millionen Dollar im dritten Quartal 2023. Zum 30. September 2024 belief sich der Gesamtkassenstand und die Investitionen auf 8 Millionen Dollar, was voraussichtlich ausreicht, um die Geschäfte bis Januar 2025 zu finanzieren. Das Unternehmen entwickelt tuspetinib als Teil einer Dreifachtherapie mit Azacitidin und Venetoclax für neu diagnostizierte AML-Patienten. Aptose arbeitet derzeit an der Einhaltung der Nasdaq-Listenanforderungen in Bezug auf das Eigenkapital der Aktionäre und die Mindestgebotsanforderungen.
- Net loss decreased by $4.5 million to $7.0 million in Q3 2024 vs $11.4 million in Q3 2023
- Secured $10 million loan from Hanmi Pharmaceutical
- Research and development expenses decreased by $3.6 million to $4.7 million in Q3 2024
- Cash position of $8 million only funds operations through January 2025
- Stockholders' equity deficit of $9.1 million as of September 30, 2024
- Risk of Nasdaq delisting due to non-compliance with listing requirements
- Working capital decreased to $477,000 from negative $3.4 million in December 2023
Insights
The Q3 results reveal significant financial challenges.
Two critical Nasdaq compliance issues threaten listing status: failure to maintain
The tuspetinib development strategy shows promise through demonstrated broad clinical activity against multiple mutations in AML. The planned triplet therapy combining tuspetinib with venetoclax and azacitidine for newly diagnosed AML represents a potentially significant advancement, particularly given tuspetinib's favorable safety profile compared to competitors.
However, the substantially reduced R&D spending (
Aptose and Hanmi Pharmaceutical Co-developing Triplet Therapy of Tuspetinib with Azacitidine and Venetoclax for Newly Diagnosed AML
SAN DIEGO and TORONTO, Nov. 08, 2024 (GLOBE NEWSWIRE) -- 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 September 30, 2024, and provided a corporate update.
"Triple drug therapies (triplets) that build on the standard of care in AML have yielded higher response rates yet are limited to specific subpopulations and often cause myelosuppression and other toxicities,” said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. “Tuspetinib, with its breadth of activity and unique safety profile, is a potential game-changer as part of a triplet therapy regimen and we continue to advance its development.”
Key Corporate Highlights
- Aptose Facility Agreement with Hanmi – During the quarter, Aptose announced that it received a
$10 million loan through a Facility Agreement with Hanmi Pharmaceutical Co. (“Hanmi”), and that the companies are actively negotiating a new tuspetinib co-development collaboration agreement intended to provide additional support to accelerate the clinical development of tuspetinib. The loan is convertible as prepayment of milestone obligations under the future collaboration agreement or repayable after the expected completion of a triple drug combination trial with tuspetinib in newly diagnosed AML patients. Aptose plans to use the proceeds from such loan for the development of tuspetinib. - Tuspetinib Data Drives Interest as Treatment Paradigm for AML Shifts to Triplet Therapy – During our APTIVATE trial, tuspetinib (TUS) as a monotherapy and in combination treatment with venetoclax in a very ill AML patient population safely demonstrated broad clinical activity in AML patients with diverse mutation profiles, including those with adverse genetics. As presented at the European Hematology Association (EHA) 2024 Congress in June, tuspetinib potently targets SYK, FLT3, mutated KIT, JAK1/2, and RSK2 kinases, yet avoids many typical toxicities, drug-related discontinuations, and deaths observed with other agents. In the APTIVATE trial, TUS achieved broad activity across AML patients with a diverse array of mutations, both as a single agent (TUS) and in combination with venetoclax (TUS+VEN) in very ill relapsed/refractory (R/R) and heavily pre-treated AML populations. Responses were observed in patients with Prior-VEN, Prior-FLT3 inhibitor (FLT3i), and Prior-HSCT therapies, those with highly adverse genetics, including mutations in TP53 and RAS genes, and those with mutated or unmutated (wildtype) FLT3 genes. Patients naïve to VEN therapy achieved higher response rates. TUS appears to be an ideal third agent to add to a venetoclax and hypomethylating agent regimen. These data support the launch of the triplet therapy trial in newly diagnosed AML patients who are ineligible to receive induction chemotherapy, irrespective of their FLT3 mutation status. Other triplet therapies in development can achieve high response rates but are limited by toxicities and inability to treat certain AML populations, leaving an unmet need that may be addressed with the addition of tuspetinib. With Hanmi’s support, Aptose plans to initiate its planned triplet combination study during the quarter and to treat patients with and without FLT3 mutations. In addition, the company is evaluating other co-development opportunities to further expand the role of tuspetinib in other settings.
- Nasdaq – Aptose has a scheduled meeting with the Nasdaq Listing Qualifications during the current quarter to address compliance with the minimum requirement of
$2.5 million in stockholders’ equity (the "Stockholders’ Equity Requirement") and Aptose continues to work on its compliance with minimum$1.00 per share closing bid price for thirty (30) consecutive business days, needed for continued listing on Nasdaq (the "Minimum Bid Price Requirement").
On April 2, 2024, the Company received a deficiency letter from Nasdaq stating that the Company was not in compliance with the Stockholders’ Equity Requirement. The Company submitted a Compliance Plan to Nasdaq on this issue on May 17, 2024 and received an extension to meet this Nasdaq requirement by September 30, 2024. On October 1, 2024, the Company received a letter from Nasdaq stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain compliance. On October 8, 2024, the Company requested an appeal and hearing; such hearing is scheduled for November 21, 2024.
On July 16, 2024, Aptose announced that it had received a deficiency letter notifying the Company that was not in compliance with the Minimum Bid Price Requirement. This 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 13, 2025, to regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance with the Minimum Bid Price Requirement by January 13, 2025, the Company may, at Nasdaq’s discretion, be afforded a second one hundred and eighty (180) calendar day period to regain compliance, but if Nasdaq does not grant such extension, the Company’s common shares could be delisted from Nasdaq.
Multiple Planned Value-creating Milestones Ahead
2024: Q4
- Initiate dosing of TUS+VEN+AZA triplet in newly diagnosed AML
- Completion of Hanmi/Aptose Collaboration ~ Year-end 2024
2024: ASH
- Report CR/Safety data from APTIVATE TUS+VEN doublet study
- Report dosing accrual from TUS+VEN+AZA triplet study
2025: 1H
- Enroll two dose cohorts in TUS+VEN+AZA triplet study
- Report CR/MRD/Safety data from TUS+VEN+AZA triplet study
2025: EHA
- Report maturing data readout from TUS+VEN+AZA triplet study
2025: ASH
- Select TUS dose for TUS+VEN+HMA triplet Ph 2/3 PIVOTAL trials
- Prepare for Ph 2 portion of Ph 2 / Ph 3 pivotal program
| FINANCIAL RESULTS OF OPERATIONS Aptose Biosciences Inc. Statements of Operations Data (unaudited) ($ in thousands, except per share data) | |||||||||||||
| Three months ended | Nine months ended | ||||||||||||
| September 30, | September 30, | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||
| Expenses: | |||||||||||||
| Research and development | $ | 4,702 | $ | 8,256 | $ | 15,560 | $ | 27,649 | |||||
| General and administrative | 2,263 | 3,425 | 8,510 | 12,580 | |||||||||
| Operating expenses | 6,965 | 11,681 | 24,070 | 40,229 | |||||||||
| Other income, net | 12 | 234 | 225 | 977 | |||||||||
| Net loss | $ | (6,953 | ) | $ | (11,447 | ) | $ | (23,845 | ) | $ | (39,252 | ) | |
| Net Loss per share, Basic and diluted | $ | (0.37 | ) | $ | (1.76 | ) | $ | (1.48 | ) | $ | (6.14 | ) | |
| Weighted average number of common shares outstanding used in computing net loss per share, basic and diluted (in thousands) | 18,560 | 6,495 | 16,107 | 6,391 | |||||||||
Net loss for the three-month period ended September 30, 2024 decreased by
| Aptose Biosciences Inc. Balance Sheet Data (unaudited) ($ in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents and short-term investments | $ | 7,962 | $ | 9,252 | ||||
| Working capital | 477 | (3,375 | ) | |||||
| Total assets | 10,929 | 12,989 | ||||||
| Long-term liabilities | 10,305 | 621 | ||||||
| Accumulated deficit | (539,382 | ) | (515,537 | ) | ||||
| Stockholders’ equity | (9,134 | ) | (2,901 | ) | ||||
- Total cash and cash equivalents and investments as of September 30, 2024, were
$8 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 to January 2025. - As of November 8, 2024, we had 19,521,183 Common Shares issued and outstanding. In addition, there were 1,212,355 Common Shares issuable upon the exercise of outstanding stock options and there were 16,946,491 Common Shares issuable upon the exercise of the outstanding warrants.
RESEARCH AND DEVELOPMENT EXPENSES
The research and development expenses for the three months and nine months ended September 30, 2024, and 2023 were as follows:
| Three months ended | Nine months ended | ||||||||||||
| September 30, | September 30, | ||||||||||||
| (in thousands) | 2024 | 2023 | 2024 | 2023 | |||||||||
| Program costs – Tuspetinib | $ | 4,067 | $ | 5,814 | $ | 10,656 | $ | 18,659 | |||||
| Program costs – Luxeptinib | (225 | ) | 648 | 287 | 2,643 | ||||||||
| Program costs – APTO-253 | - | 2 | 13 | 28 | |||||||||
| Personnel related expenses | 941 | 1,523 | 4,274 | 5,108 | |||||||||
| Stock-based compensation | (81 | ) | 259 | 317 | 1,182 | ||||||||
| Depreciation of equipment | - | 10 | 13 | 29 | |||||||||
| Total | $ | 4,702 | $ | 8,256 | $ | 15,560 | $ | 27,649 | |||||
Research and development expenses decreased by
- Program costs for tuspetinib were
$4.1 million for the three-month period ended September 30, 2024, compared with$5.8 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
$873 thousand , primarily due to lower clinical trial and manufacturing activities. - Program costs for APTO-253 decreased by approximately
$2 thousand . The Company discontinued further clinical development of APTO-253. - Personnel-related expenses decreased by
$582 thousand , related to fewer employees in the current three-month period. - Stock-based compensation decreased by approximately
$340 thousand in the three months ended September 30, 2024, compared to the three months ended September 30, 2023, primarily due to stock options granted with lower grant date fair values in the current period and option forfeitures recorded in the current period.
Research and development expenses decreased by
- Program costs for tuspetinib were
$10.7 million for the nine-month period ended September 30, 2024, a decrease of$8 million compared with$18.7 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
$2.4 million to$287 thousand for the nine months ended September 30, 2024, as compared to$2.6 million in the comparative period, primarily due to lower clinical trial and manufacturing activities. - Program costs for APTO-253 decreased by approximately
$15 thousand , due to the Company’s decision on December 20, 2021 to discontinue further clinical development of APTO-253. - Personnel-related expenses decreased by
$834 thousand , related to fewer employees in the current six-month period and partially offset by salary increases. - Stock-based compensation decreased by approximately
$865 thousand in the nine months ended September 30, 2024, compared to the nine months ended September 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 Pietropaolo
Corporate Communications & Investor Relations
201-923-2049
spietropaolo@aptose.com
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