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Allarity Therapeutics' Stenoparib Shows Clear Clinical Benefit and Achieves Significant Milestone with Early Conclusion of Phase 2 Trial in Advanced Ovarian Cancer
Newsfilter· 2024-05-02 12:00
Core Viewpoint - Allarity Therapeutics has announced the early discontinuation of its Phase 2 clinical trial for stenoparib, a novel PARP inhibitor, due to clear clinical benefits observed in heavily pre-treated ovarian cancer patients, allowing for a focus on developing a follow-on trial with FDA regulatory intent [1][2][3]. Group 1: Clinical Trial Details - The Phase 2 trial of stenoparib demonstrated significant clinical benefits, including tumor shrinkage and long-term disease stability in patients with advanced recurrent ovarian cancer [2]. - The decision to halt further enrollment in the trial is aimed at reallocating financial resources to expedite the development of a follow-on trial [3]. - The patients involved in the trial had undergone multiple prior treatments, often including PARP inhibitors, highlighting the effectiveness of stenoparib in this challenging patient population [3]. Group 2: Drug Response Predictor (DRP®) - Allarity employs its Drug Response Predictor (DRP®) to select patients with a high likelihood of benefiting from stenoparib based on their cancer's gene expression signature [7]. - The DRP® platform has shown its ability to predict clinical outcomes from drug treatment in cancer patients across numerous clinical studies [7]. Group 3: Company Commitment and Future Plans - Allarity is committed to rapidly analyzing trial data and plans to present comprehensive results in a clinical update [4]. - The early conclusion of the trial is seen as a significant milestone in the development of stenoparib, reflecting the company's dedication to addressing the urgent needs of advanced ovarian cancer patients [4]. - The company is focused on advancing stenoparib to meet significant unmet medical needs in cancer treatment [8].
Allarity Therapeutics Regains Compliance with NASDAQ Minimum Bid Price Requirement
Newsfilter· 2024-04-29 11:00
Core Viewpoint - Allarity Therapeutics has regained compliance with Nasdaq's minimum bid price requirement, which is a positive development for the company as it continues to focus on the clinical potential of its lead asset, stenoparib, for advanced ovarian cancer treatment [1][2]. Company Overview - Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a novel PARP/Tankyrase inhibitor for advanced ovarian cancer patients [3]. - The company utilizes its DRP® companion diagnostic for patient selection in its ongoing phase 2 clinical trial, NCT03878849 [3]. Compliance Achievement - On April 27, 2024, Allarity received formal notice from Nasdaq confirming that its stock has maintained a closing bid price above $1.00 per share for more than ten consecutive trading days since April 9, 2024, thus meeting the requirements for regaining compliance with Nasdaq's Listing Rule 5550(a)(2) [1]. CEO's Statement - The CEO of Allarity expressed optimism regarding the clinical potential of stenoparib based on promising early data from the ongoing phase 2 trial and emphasized the company's commitment to addressing the urgent needs of advanced ovarian cancer patients [2].
Allarity Therapeutics(ALLR) - Prospectus(update)
2024-04-17 13:17
As filed with the Securities and Exchange Commission on April 17, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Allarity Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 87-2147982 (State or other jurisdiction of incorporation or organization) William N. Haddad Arif Soto Venable LLP 151 W. 42 Street, Floor 49 New York, NY 10036 (212) 307-5500 Approximate ...
Allarity Therapeutics Receives NASDAQ-Approved Extension to Regain Compliance with Nasdaq Listing Rule 5550(b)(1)
Newsfilter· 2024-04-17 13:10
Core Viewpoint - Allarity Therapeutics has been granted an extension until May 14, 2024, to regain compliance with Nasdaq Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2,500,000 [1][2]. Group 1: Compliance Efforts - The company presented a strategic plan to the Nasdaq Hearings Panel on February 1, 2024, outlining immediate and long-term strategies to regain compliance with Nasdaq Listing Rules 5550(a)(2) and 5550(b) [1]. - Allarity has implemented a 1-for-20 reverse stock split effective April 9, 2024, to regain bid price compliance [3]. - The company has reduced monthly operational expenditures from over $1 million to $400,000 as part of its cost reduction initiatives [3]. Group 2: Financial Strategies - Allarity is pursuing additional capital through various strategic financing options and has started raising new equity using its existing ATM [3]. - The company is negotiating with key stakeholders, including warrant holders, to adjust terms for future capital raising and to reduce major liabilities [3]. Group 3: Drug Development Focus - Allarity is focused on developing stenoparib, a novel PARP/Tankyrase inhibitor for advanced ovarian cancer patients, utilizing its DRP® companion diagnostic for patient selection in an ongoing phase 2 clinical trial [6]. - The DRP® platform has shown a statistically significant prediction of clinical outcomes in 37 out of 47 clinical studies examined, indicating its potential effectiveness in personalized cancer treatment [5]. Group 4: Leadership Statement - CEO Thomas Jensen expressed encouragement regarding Nasdaq's recognition of the company's efforts and the additional time granted to meet the equity requirement, emphasizing the commitment to regulatory compliance and ongoing development of stenoparib [4].
Why Is Allarity Therapeutics (ALLR) Stock Up 41% Today?
InvestorPlace· 2024-04-12 12:18
Allarity Therapeutics (NASDAQ:ALLR) stock is heading higher on Friday alongside heavy pre-market trading.Investors will note that this movement comes after the company announced a prospectus supplement. This alters the maximum aggregate offering price of shares sold through prospectus from $1,350,000 to $2,350,000.Allarity Therapeutics notes that it currently has 828,580 shares outstanding with a value of $7,092,593. The amendment mentions that the company has sold $1,348,908 worth of its shares and is elig ...
Allarity Therapeutics(ALLR) - Prospectus(update)
2024-04-05 22:26
As filed with the Securities and Exchange Commission on April 5, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 4 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Allarity Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 2834 87-2147982 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 24 School Street, ...
Allarity Therapeutics Announces 1-for-20 Reverse Stock Split
Newsfilter· 2024-04-04 13:15
Boston (April 4, 2024) — Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced the implementation of a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20 (the "Reverse Stock Split"). The Reverse Stock Split will become effective at 9:30 a.m. Eastern Time on April 9, 2024. The Company's common stock will begin trading on a split-adjusted basis wh ...
Allarity Therapeutics Reports Full Year 2023 Financial Results and Provides a Business Update
Newsfilter· 2024-03-08 12:15
Leadership Changes Led by Appointment of Co-Founder Thomas Jensen as Interim CEO and Jeremy Graff, Ph.D., former Eli Lilly Executive, as Executive AdvisorReduced Net Loss from Operations by 50% and Reduced Net Loss by 26%Announced Data in December 2023 from Advanced Ovarian Cancer Phase 2 Stenoparib Study Showing Significant Clinical Benefit Boston (March 8, 2024) — Allarity Therapeutics, Inc. ("Company") (NASDAQ:ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer tre ...
Allarity Therapeutics(ALLR) - 2023 Q4 - Annual Results
2024-03-07 16:00
Financial Performance - Allarity Therapeutics reduced net loss from operations by 50% to $17.1 million in 2023, compared to $34 million in 2022[7] - The company achieved a net loss of $11.9 million for 2023, a decrease of 26% from $16.1 million in 2022[7] - Research and Development (R&D) expenses increased slightly to $7.1 million in 2023 from $6.9 million in 2022[7] - General and Administrative (G&A) expenses remained stable at $10.0 million for both 2023 and 2022[7] Clinical Development - Early data from the Phase 2 study of stenoparib indicated significant clinical benefit, with 5 evaluable patients showing stable disease and 1 achieving a complete response[3] - The company plans to announce interim data from the DRP-guided Phase 2 clinical trial of stenoparib in advanced ovarian cancer in Q2 2024[6] - The DRP platform has shown a statistically significant prediction of clinical outcomes in 37 out of 47 studies examined[8] - Allarity is focused on addressing unmet medical needs in oncology, particularly through the development of stenoparib[9] Leadership and Structure - Leadership changes include the appointment of Thomas Jensen as Interim CEO and Jeremy Graf, Ph.D., as Executive Advisor[5] - The company is headquartered in the U.S. with a research facility in Denmark, emphasizing its commitment to cancer treatment innovation[9] Financial Position - Total current assets decreased from $4,968 million in 2022 to $1,971 million in 2023, a decline of approximately 60%[18] - Total liabilities increased from $12,654 million in 2022 to $14,613 million in 2023, an increase of about 15.5%[18] - The accumulated deficit rose from $82,550 million in 2022 to $94,451 million in 2023, reflecting an increase of approximately 14.5%[19] - The total stockholders' deficit increased significantly from $113 million in 2022 to $2,751 million in 2023[19] - The company reported a liquidation preference of $17.54 for Series A Preferred Stock as of December 31, 2023[18] - Additional paid-in capital increased from $83,158 million in 2022 to $90,369 million in 2023, a growth of about 8.6%[19] - The number of shares issued and outstanding for Common Stock decreased from 11,356 in 2022 to 5,886,934 in 2023[19] - Intangible assets increased from $9,549 million in 2022 to $9,871 million in 2023, a rise of approximately 3.4%[18] - The company had a cash balance of $166 million as of December 31, 2023, down from $2,029 million in 2022, a decrease of about 91.8%[18] - The current liabilities increased from $11,222 million in 2022 to $14,167 million in 2023, an increase of approximately 26.5%[18]
Allarity Therapeutics(ALLR) - 2023 Q4 - Annual Report
2024-03-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 87-2147982 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to_________ Commission file num ...