Core Viewpoint - Allarity Therapeutics is advancing its personalized cancer treatment approach through the Drug Response Predictor (DRP®) platform, which is being showcased at Biomarkers 2024, highlighting its ongoing clinical trial for advanced ovarian cancer patients [1][2][3]. Company Overview - Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a dual PARP/Tankyrase inhibitor for advanced ovarian cancer [5]. - The company is headquartered in the U.S. and has a research facility in Denmark, aiming to address significant unmet medical needs in cancer treatment [5]. Drug Response Predictor (DRP®) Platform - The DRP® platform is designed to select patients based on their cancer's expression signature, predicting their likelihood of benefiting from specific drugs [4]. - The platform has shown a statistically significant prediction of clinical outcomes in 37 out of 47 clinical studies reviewed, indicating its effectiveness across various cancer types [4]. Clinical Trials - Allarity is conducting a phase 2 clinical trial (NCT03878849) for stenoparib, utilizing the DRP® to pre-select advanced ovarian cancer patients who are likely to benefit from the treatment [2][5]. - The ongoing trial is being conducted at multiple sites across the U.S. and Europe, emphasizing the company's commitment to rigorous clinical validation [2]. Presentation at Biomarkers 2024 - CEO Thomas Jensen will present at Biomarkers 2024, discussing a gene expression-based biomarker for predicting treatment response, scheduled for February 29, 2024, in London, UK [3]. - Attendees are encouraged to schedule one-on-one meetings with Mr. Jensen to explore business development opportunities [3].

Core Insights - Allarity Therapeutics, Inc. has been invited to present at Biomarkers 2024, showcasing its advancements in personalized cancer treatments [1][2] Group 1: Company Overview - Allarity Therapeutics is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a dual PARP/Tankyrase inhibitor for advanced ovarian cancer [5] - The company utilizes its Drug Response Predictor (DRP®) companion diagnostic platform to select patients likely to benefit from specific treatments, enhancing therapeutic benefit rates [4][5] Group 2: Presentation Details - Thomas Jensen, CEO and co-founder, will present on a gene expression-based biomarker for predicting treatment response at Biomarkers 2024 on February 29, 2024, in London, UK [3] - The presentation will cover the development of the DRP® platform, which has shown statistically significant predictions of clinical outcomes in 37 out of 47 clinical studies [4] Group 3: Clinical Trials - An ongoing phase 2 clinical trial (NCT03878849) is investigating the efficacy of stenoparib in advanced ovarian cancer patients, utilizing the DRP® for patient selection [2][5] - The trial is being conducted at multiple sites across the US and Europe, emphasizing the company's commitment to addressing unmet medical needs in cancer treatment [2][5]

As filed with the Securities and Exchange Commission on December 15, 2023. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 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 | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Numb ...

As filed with the Securities and Exchange Commission on December 6, 2023. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 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 | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Numbe ...

As filed with the Securities and Exchange Commission on December 4, 2023. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 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 | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Numbe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-41160 ALLARITY THERAPEUTICS, INC. (Exact Name of Registrant as Specified in Its Charter) | --- | --- | |-----------------------------------------|-------| | Del ...

As filed with the Securities and Exchange Commission on October 30, 2023. Registration No. 333-___________ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Allarity Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Delaware 2834 87-2147982 (I.R.S. Employer Identification No.) 24 School Street, 2nd Floor Bos ...

Drug Development - The company focuses on developing targeted anti-cancer drug candidates, with three lead candidates: dovitinib, stenoparib, and IXEMPRA [173] - Stenoparib is now the lead clinical asset, advancing in two out of three ongoing clinical trials [175] - The company continues to support the clinical development of IXEMPRA and dovitinib, which are believed to have substantial potential [175] - The company expects to incur substantial expenses for the development and commercialization of drug candidates, requiring additional funding in the future [237] Financial Performance - The company incurred net losses of $5.7 million and $8.2 million for the six months ended June 30, 2023, and 2022, respectively, with an accumulated deficit of $88.3 million as of June 30, 2023 [217] - Cash balance as of June 30, 2023, was $420 thousand, indicating limited liquidity for ongoing operations [217] - Total operating costs and expenses for the six months ended June 30, 2023, were $7.824 million, a decrease of $15.327 million compared to $23.151 million for the same period in 2022 [224] - Research and development expenses for the three months ended June 30, 2023, were $1.105 million, a decrease of $591 thousand from $1.696 million in the same period in 2022 [224] - General and administrative expenses for the six months ended June 30, 2023, were $5.292 million, a decrease of $867 thousand from $6.159 million in the same period in 2022 [224] - Other income for the three months ended June 30, 2023, was $1,776, compared to a loss of $257 for the same period in 2022, reflecting a significant improvement [231] - For the six months ended June 30, 2023, other income was $2,092, up from $13,745 in the same period of 2022, primarily due to a fair value adjustment to derivative liabilities [233] Funding and Capital Structure - The company raised approximately $11 million from a public offering on July 10, 2023, selling 357,223 shares of common stock at an effective price of $4.50 per share [190] - The conversion price of Series A Preferred Stock was reduced to $4.50 following the July offering [191] - The company redeemed 4,630 shares of Series A Preferred Stock for $5,000,400 in cash on July 10, 2023 [189] - The company received a loan of $350,000 from 3i on April 19, 2023, which was converted into shares of Series A Preferred Stock [183] - The company entered into a series of agreements with 3i, including a modification of the Series A Preferred Stock terms and a cancellation of debt agreement [184] - The number of shares exercisable under the Exchange Warrant was adjusted to 3,134,693 shares with an exercise price of $3.0155 per share following the July Offering [192] - The Company secured a promissory note of $350,000 from 3i with a 5% annual interest rate, which was fully redeemed for $350,886 in cash on July 10, 2023 [194] - Following a public offering on July 10, 2023, the company raised approximately $11 million, but the net proceeds of about $4.7 million are insufficient to fund operations for more than three months [235] - The company plans to mitigate funding challenges through additional public equity, private equity, and debt financing, but there are no assurances of success [236] Compliance and Governance - The board of directors was restructured with the appointment of new independent directors, ensuring compliance with Nasdaq requirements [178] - The company regained compliance with Nasdaq listing requirements as of July 14, 2023, and will be subject to a panel monitor for one year [213] - The Company filed an appeal with Nasdaq after being notified of potential delisting due to non-compliance with listing rules [209] - The company intends to seek further clarification from the Nasdaq hearings panel regarding compliance conditions [212] Stock and Shareholder Information - The June Reverse Stock Split reduced the outstanding shares of Common Stock from 20,142,633 to approximately 503,566 shares at a ratio of 1-for-40 [195] - From March 31, 2023 to August 14, 2023, the Company issued 223,857 shares of Common Stock upon the conversion of 8,214 shares of Series A Preferred Stock [200] - The exercise price of the April 2023 Common Warrants was reduced to $4.50 per share and the termination date extended to July 10, 2028 [199] - As of June 30, 2023, the company had $420 in cash and an accumulated deficit of $88.3 million, with a working capital deficit of $9 million [234] Operational Challenges - The company expects to continue incurring significant expenses and increasing operating losses over the next several years due to ongoing research and development activities [217] - Manufacturing and supplies expenses increased by $365 thousand for the three months ended June 30, 2023, primarily due to increased drug manufacturing costs [228] - As of August 11, 2023, the company had a cash position of approximately $1.2 million, which is insufficient to fund operations for the next twelve months [245] - For the six months ended June 30, 2023, net cash used in operating activities was approximately $5.7 million, a decrease of $4.2 million compared to the same period in 2022 [242] - Net cash provided by financing activities for the six months ended June 30, 2023, was approximately $4 million, compared to a cash outflow of $2.3 million in the same period of 2022 [244]

As filed with the Securities and Exchange Commission on June 30, 2023. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Allarity Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Delaware 2834 87-2147982 (I.R.S. Employer Identification No.) Classification Code Number) 24 School Street, 2n ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 As filed with the Securities and Exchange Commission on June 7, 2023. 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 No.) 24 School Street, 2nd Floor Boston, MA 0 ...