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 ...

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 ...

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]

Boston (February 28, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, is pleased to announce that it has been invited to present at Biomarkers 2024. Thomas Jensen, CEO and co-founder of Allarity, will present the company's novel work in developing the drug-specific Drug Response Predictor (DRP®) companion diagnostics (CDx) platform. This work spans from cancer cell line research t ...

Boston (February 28, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, is pleased to announce that it has been invited to present at Biomarkers 2024. Thomas Jensen, CEO and co-founder of Allarity, will present the company's novel work in developing the drug- specific Drug Response Predictor (DRP®) companion diagnostics (CDx) platform. This work spans from cancer cell line research ...

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 ...

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 87-2147982 (State or Other Jurisdiction Of Incorporation or Organization) (I.R.S. Employer Identification Number) 24 School Street, 2 Floor, Boston, MA 02108 (Address of Principal Executive Offices) (Zip Code) Title of Each Class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share ALLR The Nasdaq Stock Market LLC Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated file ...

Business Focus - The company focuses on discovering and developing highly targeted anti-cancer drug candidates using its Drug Response Predictor (DRP) platform [833]. Financial Position - As of December 31, 2022, the company has an accumulated deficit of $82.6 million and cash deposits of $2.0 million, which are insufficient to fund its current operating plan for the next 12 months [852][875]. - The company anticipates that its cash reserves are sufficient for approximately 3 months, raising substantial doubt over its ability to continue as a going concern [875]. - As of the report date, the company does not have sufficient cash to fund its operating expenses and capital expenditure requirements for the next twelve months [889]. Funding and Capital Structure - A bridge loan of $350,000 was received in November 2022, with additional notes totaling $2,316,640 issued to extend cash runway beyond December 31, 2022 [834]. - The company established Series C Preferred Stock with a stated value of $27.00 per share, raising $1.2 million through the sale of 50,000 shares [841]. - A private placement offering for 50,000 shares of Series C Preferred Stock was conducted, raising $1.2 million to fund operating expenses [891]. - The company is actively exploring raising capital through equity and debt financing, but faces limitations if proposals for share increase and reverse stock split are not approved [894]. Expenses and Losses - The company's net losses were $16.1 million for the year ended December 31, 2022, compared to $26.6 million for 2021, indicating a decrease in losses [852]. - Research and development expenses for the year ended December 31, 2022, were $6.93 million, a decrease of $7.27 million from $14.2 million in 2021 [859][863]. - General and administrative expenses decreased by $2.4 million to $9.96 million for the year ended December 31, 2022, compared to $12.36 million in 2021 [859][868]. - The company recognized an impairment charge of $17.57 million for intangible assets due to a Refusal to File from the FDA and a further impairment of $3.6 million in December 2022 [865]. - The company recorded impairment losses of $17.6 million on intangible assets in 2022 [901]. Operational Challenges - COVID-19 has caused unexpected delays in clinical program activities, impacting the company's operations [846]. - The company is subject to risks common in the biotechnology industry, including the need for successful clinical trials and regulatory approvals [845]. - The company has contractual obligations totaling $4.9 million, all due within one year, related to milestone payments [888]. - The company has not yet experienced direct impacts from the Russia-Ukraine war, but clinical supply costs have increased by 5% to 10% due to inflation [850]. Cash Flow and Activities - For the year ended December 31, 2022, the company reported a net cash used in operating activities of $16.8 million, an increase from $14.9 million in 2021 [880][882]. - Cash provided by investing activities was $791 thousand in 2022, down from $1.0 million in 2021, primarily from the sale of intellectual property (IP) [878][884]. - Financing activities resulted in a cash outflow of $1.3 million in 2022, significantly lower than the inflow of $33.8 million in 2021, which included $20 million from the sale of Series A preferred stock [885]. Shareholder Matters - A special meeting of stockholders is scheduled for March 20, 2023, to vote on increasing authorized shares from 30,500,000 to 750,500,000 [844]. - The company amended its Certificate of Designation of Series A Preferred Stock to grant voting rights, which expired on February 28, 2023 [835]. Accounting and Financial Reporting - The Company accounts for certain convertible debt under the fair value option election of ASC 825, with estimated fair value adjustments recognized as other income (expense) in the consolidated statements of operations [904]. - Warrants are classified as equity if indexed to the Company's equity and meet specific conditions; otherwise, they are classified as derivative liabilities and carried at fair value [905]. - The Company does not use derivative instruments to hedge exposures to interest rate, market, or foreign currency risks, and evaluates financial instruments for embedded derivatives [906]. - Share-based compensation is accounted for in accordance with ASC 718, with expenses recognized over the requisite service period based on the fair value of equity-based payment awards [907]. - The Company uses either a graded or straight-line vesting method for option awards, accounting for forfeitures as they occur [909]. - Stock award modifications are reviewed, and incremental fair value is recognized as compensation cost for vested awards [910]. - The fair value of stock options is estimated using the Black-Scholes option-pricing model, which requires subjective assumptions [911]. - The Company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [913].