Allarity Therapeutics Reports Third Quarter 2024 Financial Results and Provides Recent Operational Highlights
Allarity Therapeutics (NASDAQ: ALLR) reported Q3 2024 financial results with cash position of $18.5 million, extending runway into 2026. The company highlighted encouraging Phase 2 trial results for stenoparib in ovarian cancer, with two patients exceeding one year of treatment. Key developments include securing a European patent for stenoparib DRP®, regaining NASDAQ compliance, and strengthening leadership with new appointments. Q3 financials show R&D expenses of $1.0 million (down from $1.9M YoY), G&A expenses of $1.6 million (down from $2.5M YoY), and a net loss of $12.2 million, primarily due to a $9.7 million non-cash impairment charge.
Allarity Therapeutics (NASDAQ: ALLR) ha riportato i risultati finanziari del terzo trimestre 2024, con una posizione di liquidità di 18,5 milioni di dollari, estendendo la propria operatività fino al 2026. L'azienda ha evidenziato risultati incoraggianti della fase 2 degli studi per stenoparib nel tumore ovarico, con due pazienti che hanno superato un anno di trattamento. Sviluppi chiave includono l'ottenimento di un brevetto europeo per stenoparib DRP®, il ripristino della conformità con NASDAQ e il rafforzamento della leadership con nuove nomine. I risultati finanziari del terzo trimestre mostrano spese in R&S di 1,0 milioni di dollari (in calo rispetto a 1,9 milioni di dollari rispetto all'anno precedente), spese generali e amministrative di 1,6 milioni di dollari (in calo rispetto a 2,5 milioni di dollari rispetto all'anno precedente) e una perdita netta di 12,2 milioni di dollari, principalmente a causa di un'imparità non monetaria di 9,7 milioni di dollari.
Allarity Therapeutics (NASDAQ: ALLR) informó sobre los resultados financieros del tercer trimestre de 2024, con una posición de efectivo de 18,5 millones de dólares, extendiendo su operatividad hasta 2026. La compañía destacó resultados alentadores de los ensayos de fase 2 para stenoparib en cáncer de ovario, con dos pacientes que superaron un año de tratamiento. Los desarrollos clave incluyen la obtención de una patente europea para stenoparib DRP®, la recuperación de la conformidad con NASDAQ y el fortalecimiento de la dirección con nuevos nombramientos. Los resultados financieros del tercer trimestre muestran gastos en I+D de 1,0 millones de dólares (una disminución de 1,9 millones de dólares en comparación con el año anterior), gastos generales de 1,6 millones de dólares (una disminución de 2,5 millones de dólares en comparación con el año anterior) y una pérdida neta de 12,2 millones de dólares, principalmente debido a un cargo por deterioro no monetario de 9,7 millones de dólares.
올라리티 테라퓨틱스 (NASDAQ: ALLR)는 2024년 3분기 재무 결과를 보고하며 1850만 달러의 현금 보유고로 2026년까지 운영을 연장했습니다. 회사는 난소암을 위한 스테노파립의 2상 시험 결과가 고무적이며, 두 명의 환자가 1년 이상 치료를 받았다고 강조했습니다. 주요 개발 사항으로는 스테노파립 DRP®에 대한 유럽 특허 확보, NASDAQ 준수 회복, 새로운 임명으로 리더십 강화 등이 있습니다. 3분기 재무 결과는 연구개발(R&D) 비용이 100만 달러(전년 대비 190만 달러 감소), 일반관리(G&A) 비용이 160만 달러(전년 대비 250만 달러 감소), 그리고 순손실이 1220만 달러로, 주로 970만 달러의 비현금 손상 비용 때문입니다.
Allarity Therapeutics (NASDAQ: ALLR) a rapporté les résultats financiers du troisième trimestre 2024, avec une position de trésorerie de 18,5 millions de dollars, prolongeant sa période d'exploitation jusqu'en 2026. L'entreprise a souligné des résultats encourageants des essais de phase 2 pour le stenoparib dans le cancer de l'ovaire, avec deux patientes ayant dépassé un an de traitement. Les développements clés comprennent l'obtention d'un brevet européen pour le stenoparib DRP®, le rétablissement de la conformité avec le NASDAQ et le renforcement de la direction avec de nouvelles nominations. Les résultats financiers du troisième trimestre montrent des dépenses de R&D de 1,0 million de dollars (en baisse par rapport à 1,9 million de dollars d'une année sur l'autre), des dépenses générales et administratives de 1,6 million de dollars (en baisse par rapport à 2,5 millions de dollars d'une année sur l'autre) et une perte nette de 12,2 millions de dollars, principalement en raison d'une charge de dépréciation non monétaire de 9,7 millions de dollars.
Allarity Therapeutics (NASDAQ: ALLR) hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht, mit einer liquiden Mittelposition von 18,5 Millionen Dollar, die den finanzielle Spielraum bis 2026 verlängert. Das Unternehmen hebt ermutigende Ergebnisse aus der Phase-2-Studie zu Stenoparib bei Eierstockkrebs hervor, bei denen zwei Patienten mehr als ein Jahr behandelt wurden. Wichtige Entwicklungen umfassen die Sicherung eines europäischen Patents für Stenoparib DRP®, die Wiederherstellung der NASDAQ-Konformität und die Stärkung der Führung mit neuen Ernennungen. Die Finanzergebnisse des dritten Quartals zeigen F&E-Ausgaben von 1,0 Millionen Dollar (ein Rückgang von 1,9 Millionen Dollar im Vergleich zum Vorjahr), allgemeine Verwaltungskosten von 1,6 Millionen Dollar (ein Rückgang von 2,5 Millionen Dollar im Vergleich zum Vorjahr) und einen Nettoverlust von 12,2 Millionen Dollar, hauptsächlich aufgrund einer nicht zahlungswirksamen Wertminderung von 9,7 Millionen Dollar.
- Strong cash position of $18.5M, providing runway into 2026
- Two patients in Phase 2 stenoparib trial showed durable clinical benefit exceeding one year
- Secured European patent for stenoparib DRP® companion diagnostic
- Regained NASDAQ compliance
- Reduced R&D expenses by 47% YoY to $1.0M
- Decreased G&A expenses by 36% YoY to $1.6M
- Net loss increased to $12.2M in Q3 2024 vs $5.6M in Q3 2023
- $9.7M intangible asset impairment charge recorded in Q3 2024
Insights
The Q3 results reveal a mixed financial picture. While the
Operating expenses show positive cost control with R&D expenses down
Two key clinical developments warrant attention: First, the durability data from Phase 2 stenoparib trial showing two patients exceeding one year of treatment demonstrates promising efficacy in heavily pre-treated ovarian cancer patients. Second, the European patent grant for stenoparib DRP® companion diagnostic strengthens the company's intellectual property position.
The appointment of seasoned oncology experts Dr. Graff and Dr. Iglesias brings important expertise for advancing regulatory strategy. Their focus on preparing FDA-directed trials suggests a clear path toward potential commercialization, particularly important given stenoparib's potential as a dual PARP/tankyrase inhibitor in a market seeking improved treatment options.
- Cash balance at
$18.5 million - Strengthened leadership team with new members driving stenoparib development
- NASDAQ compliance regained
Boston (November 14, 2024)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments using its proprietary, drug-specific patient selection technology, today reported financial results for the third quarter ended September 30, 2024, and provided an update on recent operational highlights.
“This quarter’s progress marks a steady period of advancement for Allarity as we have maintained a strong cash position, achieved record patient duration on stenoparib treatment, and welcomed new members to our leadership team who bring the expertise needed to shape a successful future for the Company," said Thomas Jensen, CEO of Allarity Therapeutics. "We continue to drive the development of our promising, novel dual PARP/tankyrase inhibitor, stenoparib, forward, and we remain optimistic that our efforts will ultimately bring new hope to ovarian cancer patients, especially those who currently have few or no treatment options.”
Third Quarter 2024 and Recent Operational Highlights
- Encouraging Patient Outcomes in Phase 2 Stenoparib Trial: On September 16, 2024, the Company announced that two patients in its Phase 2 trial for stenoparib in advanced ovarian cancer had exceeded one year on treatment, demonstrating durable clinical benefit in this heavily pre-treated population and highlighting the potential of stenoparib as a meaningful treatment option for patients with limited or no alternatives.
- New Leadership to Drive Clinical Development: The Company, led by President and Chief Development Officer Jeremy R. Graff, Ph.D., and Consultant Chief Medical Officer Jose Iglesias, M.D., both appointed in October 2024, is working closely with its scientific advisors to prepare a follow-on trial aimed at FDA regulatory intent. Dr. Graff—a distinguished oncology expert with over 25 years in drug development who previously served as a consultant to Allarity—and Dr. Iglesias—a seasoned leader in oncology clinical trials and former Celgene executive—bring invaluable experience and strategic insight to advance Allarity’s clinical trial efforts.
- Appointment of New CFO: In September 2024, Allarity appointed Alexander Epshinsky as Chief Financial Officer. With nearly a decade of financial leadership experience in the biotech sector, Mr. Epshinsky brings valuable expertise to support the Company’s financial strategy as it advances the development of stenoparib.
- European Patent Secured for Stenoparib DRP®: The Company was granted a European patent in October 2024 for its proprietary DRP® companion diagnostic specific to stenoparib, strengthening Allarity’s market position by securing critical IP protection for this unique diagnostic in an important market. Patent applications are also pending in other key regions, including the U.S., Japan, and China.
- Regained NASDAQ Compliance: In October 2024, the Company received formal notice from The Nasdaq Stock Market LLC confirming that it had regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market, effectively concluding the previously disclosed listing matter.
Third Quarter 2024 Financial Highlights
Cash Position: As of September 30, 2024, Allarity had cash and cash equivalents of
R&D Expenses: Research and development expenses for the third quarter of 2024 were
G&A Expenses: General and administrative expenses for the third quarter of 2024 were
Net Loss: Net loss attributable to common stockholders for the third quarter of 2024 was
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, are found to have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP® platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients dozens of clinical studies (both retrospective and prospective). The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® companion diagnostic for patient selection in the ongoing phase 2 clinical trial, NCT03878849. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com.
Follow Allarity on Social Media
LinkedIn: https://www.linkedin.com/company/allaritytx/
X: https://twitter.com/allaritytx
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, the impact of recent financial and operational achievements on future quarterly performance, potential future financings, and the anticipated regulatory progress of stenoparib following the final outcome of our Phase 2 clinical trial. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to the risks associated with maintaining compliance with Nasdaq's continued listing requirements, obtaining regulatory approval for stenoparib, and potential market fluctuations that could impact our financial stability and the drug's market entry. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the “SEC”) and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, available at the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(U.S. dollars in thousands, except for share and per share data)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 18,463 | $ | 166 | ||||
| Other current assets | 100 | 209 | ||||||
| Prepaid expenses | 151 | 781 | ||||||
| Tax credit receivable | 1,652 | 815 | ||||||
| Total current assets | 20,366 | 1,971 | ||||||
| Property, plant and equipment, net | 12 | 20 | ||||||
| Intangible assets | — | 9,871 | ||||||
| Total assets | $ | 20,378 | $ | 11,862 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 4,693 | $ | 8,416 | ||||
| Accrued liabilities | 1,322 | 1,309 | ||||||
| Warrant derivative liability | 2 | 3,083 | ||||||
| Income taxes payable | 60 | 59 | ||||||
| Convertible promissory notes and accrued interest, net of debt discount | 1,337 | 1,300 | ||||||
| Total current liabilities | 7,414 | 14,167 | ||||||
| Deferred tax | — | 446 | ||||||
| Total liabilities | 7,414 | 14,613 | ||||||
| Commitments and contingencies (Note 15) | ||||||||
| Stockholders’ equity (deficit) | ||||||||
| Series A Preferred stock | — | 1,742 | ||||||
| Common stock, | — | — | ||||||
| Additional paid-in capital | 125,170 | 90,369 | ||||||
| Accumulated other comprehensive loss | (693 | ) | (411 | ) | ||||
| Accumulated deficit | (111,513 | ) | (94,451 | ) | ||||
| Total stockholders’ equity (deficit) | 12,964 | (2,751 | ) | |||||
| Total liabilities and stockholders’ equity | $ | 20,378 | $ | 11,862 | ||||
| All common share data has been retroactively adjusted to effect the reverse stock splits in 2024. |
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(U.S. dollars in thousands, except for share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 1,021 | $ | 1,948 | $ | 4,249 | $ | 4,480 | ||||||||
| Impairment of intangible assets | 9,703 | — | 9,703 | — | ||||||||||||
| General and administrative | 1,589 | 2,478 | 5,972 | 7,770 | ||||||||||||
| Total operating expenses | 12,313 | 4,426 | 19,924 | 12,250 | ||||||||||||
| Loss from operations | (12,313 | ) | (4,426 | ) | (19,924 | ) | (12,250 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 261 | 12 | 314 | 19 | ||||||||||||
| Interest expense | (50 | ) | (34 | ) | (578 | ) | (268 | ) | ||||||||
| Foreign exchange (losses) gains | 121 | (156 | ) | 69 | (87 | ) | ||||||||||
| Fair value of New September Warrants | — | (4,189 | ) | — | (4,189 | ) | ||||||||||
| Fair value of modification to April & July 2023 Warrants | — | (591 | ) | — | (591 | ) | ||||||||||
| Change in fair value of derivative and warrant liabilities | 14 | 4,937 | 2,676 | 7,187 | ||||||||||||
| Total other income (expense) | 346 | (21 | ) | 2,481 | 2,071 | |||||||||||
| Net loss before tax benefit | (11,967 | ) | (4,447 | ) | (17,443 | ) | (10,179 | ) | ||||||||
| Income tax benefit | 377 | — | 381 | — | ||||||||||||
| Net loss | (11,590 | ) | (4,447 | ) | (17,062 | ) | (10,179 | ) | ||||||||
| Deemed dividend on Series A Preferred Stock | — | (1,105 | ) | (299 | ) | (8,392 | ) | |||||||||
| Deemed dividend on Series A Convertible Preferred Stock | (562 | ) | — | (562 | ) | — | ||||||||||
| Gain on extinguishment of Series A Convertible Preferred Stock | — | — | 222 | — | ||||||||||||
| Deemed dividend on Series C Preferred Stock | — | — | — | (123 | ) | |||||||||||
| Net loss attributable to common stockholders | $ | (12,152 | ) | $ | (5,552 | ) | $ | (17,701 | ) | $ | (18,694 | ) | ||||
| Basic and diluted net loss per common stock | $ | (7.71 | ) | $ | (1,346.09 | ) | $ | (25.33 | ) | $ | (11,630.75 | ) | ||||
| Weighted-average number of common stock outstanding, basic and diluted | 1,575,762 | 4,125 | 698,877 | 1,607 | ||||||||||||
| Other comprehensive loss, net of tax | ||||||||||||||||
| Net loss | $ | (11,590 | ) | $ | (4,447 | ) | $ | (17,062 | ) | $ | (10,179 | ) | ||||
| Change in cumulative translation adjustment | (163 | ) | (92 | ) | (282 | ) | (37 | ) | ||||||||
| Total comprehensive loss attributable to common stockholders | $ | (11,753 | ) | $ | (4,539 | ) | $ | (17,344 | ) | $ | (10,216 | ) | ||||
| All common share data has been retroactively adjusted to effect the reverse stock splits in 2024. |
###
Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
Attachment
FAQ
What was Allarity Therapeutics (ALLR) cash position in Q3 2024?
How did Allarity Therapeutics (ALLR) perform in its Phase 2 stenoparib trial?
What was ALLR's net loss in Q3 2024?
When did Allarity Therapeutics (ALLR) regain NASDAQ compliance?
