Allarity Therapeutics Outlines Company’s 2024 Progress and Objectives
Allarity Therapeutics (NASDAQ: ALLR) has announced significant progress in 2024, highlighting a strong financial position with a $20 million cash balance expected to provide runway into 2026. The company plans to pause its ATM offering and has consolidated its capitalization table. Allarity is focusing resources on stenoparib, which shows extended clinical benefit in a Phase 2 trial for ovarian cancer.
However, Allarity received a Wells Notice from the SEC regarding disclosures about FDA meetings for Dovitinib. The company is proposing a reverse stock split to maintain NASDAQ listing compliance, which is important for investor confidence and stock liquidity.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato progressi significativi nel 2024, evidenziando una solida posizione finanziaria con un saldo di cassa di 20 milioni di dollari previsto per garantire la continuità fino al 2026. L'azienda prevede di sospendere la sua offerta ATM e ha consolidato il suo capitolo di capitalizzazione. Allarity sta concentrando le risorse su stenoparib, che mostra un beneficio clinico prolungato in uno studio di Fase 2 per il cancro ovarico.
Tuttavia, Allarity ha ricevuto un Wells Notice dalla SEC riguardo alle comunicazioni sulle riunioni con la FDA per Dovitinib. L'azienda sta proponendo uno scissione azionaria inversa per mantenere la conformità con le normative di quotazione NASDAQ, che è importante per la fiducia degli investitori e la liquidità delle azioni.
Allarity Therapeutics (NASDAQ: ALLR) ha anunciado avances significativos en 2024, destacando una sólida posición financiera con un saldo de efectivo de 20 millones de dólares que se espera que proporcione margen hasta 2026. La compañía planea pausar su oferta ATM y ha consolidado su tabla de capitalización. Allarity está enfocando sus recursos en stenoparib, que muestra un beneficio clínico prolongado en un ensayo de Fase 2 para el cáncer de ovario.
No obstante, Allarity recibió un Wells Notice de la SEC con respecto a divulgaciones sobre reuniones de la FDA para Dovitinib. La compañía está proponiendo una división de acciones al revés para mantener la conformidad con la cotización en NASDAQ, lo cual es importante para la confianza de los inversores y la liquidez de las acciones.
Allarity Therapeutics (NASDAQ: ALLR)는 2024년에 중요한 발전을 이뤘다고 발표하며, 2천만 달러의 현금 잔고를 확보하여 2026년까지의 운영 자금을 확보할 수 있음을 강조했습니다. 회사는 ATM 제공을 일시 중단할 계획이며 자본금 명세서를 통합했습니다. Allarity는 stenoparib에 자원을 집중하고 있으며, 이 약물은 난소암에 대한 2상 시험에서 장기적인 임상 혜택을 보이고 있습니다.
그러나 Allarity는 Dovitinib에 대한 FDA 회의 발표와 관련하여 SEC로부터 Wells Notice를 받았습니다. 회사는 NASDAQ 상장 요건을 유지하기 위해 주식분할을 제안하고 있으며, 이는 투자자 신뢰와 주식 유동성에 중요합니다.
Allarity Therapeutics (NASDAQ: ALLR) a annoncé des progrès significatifs en 2024, soulignant une solide position financière avec un solde de trésorerie de 20 millions de dollars prévu pour assurer un fonctionnement jusqu'en 2026. L'entreprise prévoit de mettre en pause son offre ATM et a consolidé son tableau de capitalisation. Allarity concentre ses ressources sur stenoparib, qui montre un bénéfice clinique prolongé lors d'un essai de Phase 2 pour le cancer de l'ovaire.
Cependant, Allarity a reçu un Wells Notice de la SEC concernant les divulgations relatives aux réunions de la FDA pour Dovitinib. L'entreprise propose une division d'actions inversée pour maintenir la conformité avec les exigences de cotation NASDAQ, ce qui est important pour la confiance des investisseurs et la liquidité des actions.
Allarity Therapeutics (NASDAQ: ALLR) hat bedeutende Fortschritte im Jahr 2024 angekündigt und hebt eine starke finanzielle Position mit einem Barbestand von 20 Millionen Dollar hervor, der bis 2026 Spielraum bieten soll. Das Unternehmen plant, sein ATM-Angebot auszusetzen und hat sein Kapitalisierungsdiagramm konsolidiert. Allarity konzentriert seine Ressourcen auf stenoparib, welches in einer Phase-2-Studie bei Eierstockkrebs einen verlängerten klinischen Nutzen zeigt.
Allerdings erhielt Allarity eine Wells Notice von der SEC bezüglich der Offenlegungen zu FDA-Meetings für Dovitinib. Das Unternehmen plant, einen Aktienrücksplit vorzuschlagen, um die Einhaltung der NASDAQ-Listungsanforderungen aufrechtzuerhalten, was für das Vertrauen der Investoren und die Liquidität der Aktien wichtig ist.
- $20 million cash balance providing runway into 2026
- Pausing ATM offering program
- Consolidated capitalization table, eliminating variable-priced convertible securities
- Stenoparib showing extended duration of clinical benefit in Phase 2 trial
- Strategic focus on stenoparib development
- Received Wells Notice from SEC regarding disclosures about FDA meetings
- Potential NASDAQ delisting if reverse stock split is not approved
- Ongoing SEC investigation into company disclosures
Insights
Allarity Therapeutics has made significant strides in strengthening its financial position, which is important for a clinical-stage pharmaceutical company. With a
The focus on their lead asset, stenoparib, aligns with industry best practices where concentrating resources on the most promising projects increases the likelihood of successful FDA approval. However, the receipt of a Wells Notice from the SEC introduces a degree of uncertainty. While a Wells Notice is not a formal charge, it does indicate potential regulatory challenges that could impact investor confidence and the company’s stock price in the short term.
Allarity’s pivot to concentrate on stenoparib is a strategic move given the promising results from their Phase 2 clinical trial. Stenoparib, a dual PARP and Tankyrase inhibitor, has shown extended clinical benefits for patients with advanced, recurrent ovarian cancer. This therapeutic focus is a rational step forward, as a successful Phase 2 trial provides a strong foundation for accelerated regulatory pathways. The decision to commit resources to an extended follow-on trial indicates confidence in stenoparib’s efficacy and safety profile, which could be pivotal in obtaining FDA approval.
Despite these positive clinical outcomes, the company’s earlier SEC investigation concerning dovitinib remains a point of concern. Such regulatory issues can delay drug development timelines and affect clinical trial funding. It’s important that Allarity resolves these issues swiftly to avoid derailing their clinical progress.
The Wells Notice issued by the SEC is an important aspect that investors should not overlook. While the company maintains that its actions were appropriate and the Wells Notice pertains to activities before 2022, the potential for enforcement action introduces significant legal and regulatory risks. A Wells Notice could lead to penalties, fines, or corrective actions that could financially burden the company and distract from its clinical objectives.
The proposal for a reverse stock split to maintain NASDAQ listing is also critical. NASDAQ delisting would severely affect stock liquidity and potentially lead to a decrease in stock price. Ensuring compliance with NASDAQ requirements is fundamental for investor confidence and accessibility. Shareholders should carefully consider the implications of the reverse split, as its approval is vital for sustaining the company’s market presence.
- Current Cash Balance of
$20 million Expected to Provide Runway Into 2026 - Allarity to Pause Use of ATM
- Cap Table Successfully Cleaned Up
- Allarity’s Stenoparib Shows Extended Duration of Phase 2 Clinical Benefit
Boston (July 22, 2024)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today outlines the Company’s progress in 2024 and future objectives.
Led by New Management Allarity has Materially Strengthened its Finances
The Company’s overall financial situation significantly improved as the Company today announced a new, strong cash balance and pausing of At-The-Market (ATM) offering:
- New Strong Cash Balance: Allarity Therapeutics is pleased to announce that the Company now has a financial runway extending into 2026 at its current burn rate with a cash balance of
$20M as of July 19, 2024. - Pausing the ATM: In line with this newly achieved financial position, Allarity plans to pause its ATM offering program for the foreseeable future.
This new financial situation led by a new management that, throughout 2024, has implemented several key actions to improve Allarity’s future outlook:
- Cleaning Up the Capitalization Table: Consolidated to a single class of common stock, eliminating variable-priced convertible securities, including both warrants and Series A Preferred Stock.
- Streamlining Operations and Cutting Costs: Enhancing operational efficiency and reducing the cost base.
- Focusing Resources on Stenoparib: Concentrating all company efforts on advancing stenoparib, a novel dual PARP and Tankyrase inhibitor, the Company’s promising clinical asset.
Stenoparib Continues To Show Extended Duration of Clinical Benefit in Phase 2 Trial
Earlier this year, Allarity Therapeutics made a strategic pivot away from a multi-asset pipeline strategy to accelerate and focus solely on stenoparib.
As previously announced, in its Phase 2 clinical trial in advanced, recurrent ovarian cancer patients, stenoparib continues to show durable clinical benefit when given twice daily as monotherapy, with multiple patients remaining on treatment more than 30 weeks.
These results provided clinical proof of concept for stenoparib, prompting Allarity to focus its resources on developing a follow-on clinical trial to accelerate potential regulatory approval by the FDA of stenoparib.
Company Receives Wells Notice
As Allarity disclosed today in a Form 8-K filing, on July 18, 2024, Allarity received a “Wells Notice” from the Staff of the Securities and Exchange Commission (the “SEC”), relating to the previously disclosed SEC investigation. The Wells Notice relates to the Company’s disclosures regarding meetings with the United States Food and Drug Administration (the “FDA”) regarding our NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. Allarity also understands that three of its former officers received Wells Notices from the SEC relating to the same conduct.
The Company understands that all of the conduct relating to the SEC Staff’s Wells Notice occurred during or prior to fiscal year 2022. A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law. The Wells Notice informed the Company that the SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege certain violations of the federal securities laws. The Company is continuing to cooperate with the SEC and maintains that its actions were appropriate and intends to pursue the Wells Notice process, including submitting a formal response to the SEC.
Proposed Reverse Stock Split Necessary to Maintain NASDAQ Listing
The Company’s board of directors has put a proposal before shareholders for a reverse stock split. Allarity has requested approval of the reverse stock split to regain and sustain compliance with NASDAQ requirements. The reverse split is essential to enabling compliance with this objective. If the Reverse Stock Split is not approved by the Company’s stockholders, the Company’s common stock may be delisted from NASDAQ. Maintaining a NASDAQ listing is crucial for investor confidence and to maintain liquidity in the Company’s common stock. Put simply, a NASDAQ delisting could complicate stockholder’s ability to trade the Company’s common stock, impact its stock price and affect stockholder’s ability to buy or sell when desired. Failure to secure approval for the reverse stock split may hinder management’s ability to execute its strategy, to the detriment of shareholders. Additionally, it may impede strategic initiatives dependent on the issuance of common stock. It is essential to understand that a reverse stock split consolidates existing shares, preserving the Company’s overall value and each shareholder’s respective ownership percentage.
We respectfully request that you vote in favor of the reverse split proposal. If you have already voted, it is not too late to change your vote should you wish to do so. If you have any questions or need help voting, please call Allarity’s proxy solicitor, Sodali & Co, at +1 212 300 2470.
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 clinical and operational achievements on future trial designs and regulatory progress, potential commercial partnerships, planning and execution of registrational intent clinical trials, the anticipated progress of stenoparib following its Phase 2 clinical trial, the potential outcomes of ongoing SEC investigations, the proposal and potential approval of a reverse stock split, and the possibility of Nasdaq listing compliance issues or changes. 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, the trading price of Allarity’s shares of common stock may be volatile and other risks inherent in Allarity’s business including, the risk that the Company is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for stenoparib or any of our other therapeutic candidates and companion diagnostics or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, and the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates, and the possible impact of SEC investigations and Wells Notices, and the possibility of Nasdaq delisting. 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 registration statement filed on April 17, 2024, and our Form 10-K annual report on file with the Securities and Exchange Commission (the “SEC”), 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.
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Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
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