# EDGAR Filing Document

**Accession Number:** 0001860657
**File Stem:** 0001213900-23-021198
**Filing Date:** 2023-3
**Character Count:** 18635
**Document Hash:** dbd027122b872114724abf2984226f17
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-021198.hdr.sgml**: 20230320

**ACCESSION NUMBER**: 0001213900-23-021198

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230320

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230320

**DATE AS OF CHANGE**: 20230320

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Allarity Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001860657
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41160
- **FILM NUMBER:** 23744845

**BUSINESS ADDRESS:**
- **STREET 1:** 24 SCHOOL ST., 2ND FLOOR
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02108
- **BUSINESS PHONE:** 401-426-4664

**MAIL ADDRESS:**
- **STREET 1:** 24 SCHOOL ST., 2ND FLOOR
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02108

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 OR 15(d) of** 

**the Securities Exchange Act of 1934**

Date of Report (Date of earliest event reported): March 20, 2023

**<u>ALLARITY THERAPEUTICS, INC.</u>**

(Exact name of registrant as specified in our charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-41160** | **87-2147982** |
| (State or Other Jurisdiction<br> of Incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification No.) |

---

---

| | |
|:---|:---|
| **24 School Street,**<br> **2nd Floor, Boston, MA** | **02108** |
| (Address of Principal Executive Offices) | (Zip Code) |

---

**<u>(401) 426-4664</u>**

(Registrant's telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (<u>see</u> General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **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 |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 7.01 Regulation FD Disclosure**

On March 20, 2023, Allarity Therapeutics, Inc. (the "Company") issued a press release announcing that it has dosed the first patient in a Phase 1b clinical study evaluating the combination of stenoparib and dovitinib for the treatment of advanced solid tumors, including ovarian cancer. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. and is incorporated herein by reference.

*The information reported under Item 7.01 in this Current Report on Form 8-K, including Exhibit 99.1, is being "furnished" and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information contained herein.*

**Item 9.01 Financial Statements and Exhibits**

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit** | **Exhibit Description** |
| 99.1 | [Press Release dated March 20, 2023](ea175434ex99-1_allarity.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on our behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **Allarity Therapeutics, Inc.** | **Allarity Therapeutics, Inc.** |
|  | By: | /s/ James G. Cullem |
|  |  | James G. Cullem |
|  |  | Chief Executive Officer |
| Dated: March 20, 2023 |  |  |

---

## Exhibit 99.1

**Exhibit 99.1**

![](image_001.jpg)

**Press release** 

**<br>** 

<br> **Allarity Therapeutics Doses First Patient in Phase 1b Clinical Trial Evaluating Dovitinib and Stenoparib Combination in Advanced Solid Tumors**

*Company anticipates that the combination of pan-TKI dovitinib and PARP inhibitor stenoparib may generate synergistic anti-cancer activity* 

 

*Program initiation marks key milestone in Allarity's clinical strategy shift* 

*towards combination therapies*

**BOSTON, Mass** - March 20, 2023 — Allarity Therapeutics, Inc. (Nasdaq: ALLR) ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP® companion diagnostics for personalized cancer care, today announced that it has dosed the first patient in a Phase 1b clinical study evaluating the combination of stenoparib and dovitinib for the treatment of advanced solid tumors, including ovarian cancer.

Currently, approximately 70 percent of patients diagnosed with ovarian cancer will experience recurrences.<sup>[1]</sup> However, PARP inhibitors have improved the treatment outlook for many patients who have completed initial treatment with surgery and platinum-based chemotherapy. The strategy underscoring Allarity's combination of dovitinib and stenoparib is to address the unmet need of ovarian cancer patients, as well as those with other solid tumors, who currently do not benefit from the existing PARP inhibitor treatments.

*"Having investigated novel combinations of anticancer agents, including a PARP inhibitor and an anti-angiogenic therapeutic, we have seen improved efficacy. Combining a PARP inhibitor with a pan-tyrosine kinase (PTK) inhibitor, we are also anticipating efficacy in homologous recombination proficient tumors"* stated Kathleen N. Moore, MD, MS, Associate Director of Clinical Research, Director of the Oklahoma TSET/Sarah Cannon Phase I Drug Development Unit, Professor of the Section of Gynecologic Oncology at the Stephenson Cancer Center, and the Principal Investigator for Allarity's Phase 1b study. *"I look forward to working with patients and the clinical team at Allarity to determine if the particular combination of dovitinib and stenoparib can provide synergistic therapeutic benefits and improve outcomes for patients, including those with ovarian cancer."*

------

<u><sup>[1]</sup></u> Source: Ovarian Cancer Research Alliance

Allarity Therapeutics, Inc. **I** 24 School Street, 2nd Floor **I** Boston, MA **I** U.S.A. **I** NASDAQ: ALLR **I** www.allarity.com

![](image_002.jpg)

***Study Design***

The two-part, open label multicenter Phase 1b program will first evaluate the safety and anti-cancer activity, and determine the maximum tolerated dose (MTD), of stenoparib administered twice a day in participants with advanced solid tumors. The second portion of the study will evaluate safety and anti-cancer activity and determine the MTD of dovitinib when given in combination with the MTD of stenoparib determined in the first cohort.

The Phase 1b trial is designed with a target enrollment of up to 36 patients with advanced solid tumors, focusing on specific tumor types that Allarity anticipates will be most responsive to the drug combination. Researchers will analyze patient tumor samples retrospectively using Allarity's DRP<sup>®</sup> companion diagnostics for stenoparib and dovitinib. The purpose of this analysis is to further validate the DRP<sup>®</sup> companion diagnostics in advance of an anticipated DRP®-guided Phase 2 trial of the dovitinib and stenoparib combination in second line or later metastatic ovarian cancer, targeted for H2 2024.

***Study Rationale***

Stenoparib is a small molecule, dual-targeted inhibitor of Poly ADP-Ribose Polymerases (PARP 1 and 2) and tankyrase 1 and 2. It works by limiting cancer's ability to repair single stranded DNA breaks within tumors, which in turn makes tumor cells more vulnerable to death (apoptosis). Dovitinib is a pan-tyrosine kinase inhibitor (pan-TKI), and its mechanisms of action (MOA) works in part to block the formation of new blood vessels that supply a tumor with nutrients and oxygen (anti-angiogenesis), as well as to alter homologous recombination (HR) proficient to HR deficient tumors by down-regulation of HR. As these combined MOAs serve to promote cancer cell vulnerability and restrict blood flow necessary to fuel cancer growth and repair, Allarity believes the combination may cause synthetic lethality, thereby increasing the chances of cancer cell death and providing synergistic, enhanced anti-tumor activity.

*"I am very pleased that we have initiated our first combination therapy trial, an important milestone in our pipeline strategy focused on identifying unmet needs in which combination therapies may benefit patients with hard-to-treat cancers,"* said James G. Cullem, Allarity's Chief Executive Officer. *"Given that we own both of these assets, the development of this combination benefits from our existing drug supply and manufacturing pathways, and, subject to our ability to raise additional capital to support the study, should enable us to efficiently conduct the Phase 1b dosing portion of the study with an anticipated data readout in the first half of 2024."* Mr. Cullem further noted, *"Our clinical team, together with Dr. Moore and our Scientific Advisory Board, have smartly designed this Phase 1b study to both identify early signs of therapeutic benefit in likely-to-respond tumor types, as well as to assess the ability of Allarity's DRP<sup>®</sup> companion diagnostics for stenoparib and dovitinib to identify responder patients."*

Allarity Therapeutics, Inc. **I** 24 School Street, 2nd Floor **I** Boston, MA **I** U.S.A. **I** NASDAQ: ALLR **I** www.allarity.com

![](image_002.jpg)

The initiation of a new combination trial marks a previously-announced shift in the Company's clinical-stage activities toward development of combination therapies (that are dependent upon the Company's ability to raise sufficient capital to support these new trials), and reflects the Company's commitment to delivering innovative treatments that address unmet medical needs and improve patient outcomes.

Allarity holds exclusive, global commercial rights to both dovitinib and stenoparib.

**About the Drug Response Predictor – DRP<sup>®</sup> Companion Diagnostic** 

Allarity uses its drug-specific DRP® companion diagnostic to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP® score, Allarity believes that the therapeutic response rate can be significantly increased. The DRP® method builds on the comparison of sensitive versus 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 from patient biopsies. The DRP<sup>®</sup> platform has demonstrated its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of stenoparib and IXEMPRA<sup>®</sup>. The DRP® platform, which can be used in all cancer types and is patented for more than 70 anticancer drugs, has been extensively published in peer reviewed literature.

**About Allarity Therapeutics** 

Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of cancer guided by its proprietary and highly developed companion diagnostic technology, the DRP® platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; dovitinib, a pan-tyrosine kinase inhibitor previously developed in renal cancer through Phase 3; and IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, which is currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111, a liposomal formulation of doxorubicin for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis®, a liposomal formulation of cisplatin and its accompanying DRP®, being developed via a partnership with Chosa Oncology AB for late-stage metastatic breast cancer. The Company is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the Company's website at www.Allarity.com.

Allarity Therapeutics, Inc. **I** 24 School Street, 2nd Floor **I** Boston, MA **I** U.S.A. **I** NASDAQ: ALLR **I** www.allarity.com

![](image_002.jpg)

**Follow Allarity on Social Media** 

Facebook: https://www.facebook.com/AllarityTx/

LinkedIn: https://www.linkedin.com/company/allaritytx/

Twitter: 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 Allarity'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, statements related to the expected availability of capital to fund its anticipated clinical trials, statements related to advancing dovitinib in combination with stenoparib or another therapeutic candidate or other approved drug, any statements related to ongoing clinical trials for stenoparib as a monotherapy or in combination with another therapeutic candidate for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA<sup>®</sup> for the treatment of metastatic breast cancer, statements relating to the effectiveness of the Company's DRP<sup>®</sup> companion diagnostics platform in predicting whether a particular patient is likely to respond to a specific drug, and statements related to the Company's ability to regain compliance with the Nasdaq Listing Rule. 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 risk that the Company is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that 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 dovitinib or any of our other therapeutic candidates 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, 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 risk that the current COVID-19 pandemic will impact the Company's current and future clinical trials and the timing of the Company's preclinical studies and other operations. 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 10-K annual report on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission'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 Securities and Exchange Commission. 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.*

###

*Company Contact:*

Thomas Jensen

Senior V.P. of Investor Relations

investorrelations@allarity.com

*U.S. Media Contact:*

Mike Beyer<br> Sam Brown, Inc.<br> +1 (312) 961-2502<br> <u>mikebeyer@sambrown.com</u>

*EU Media Contact:*

Thomas Pedersen

Carrotize PR & Communications

+45 6062 9390

tsp@carrotize.com

Allarity Therapeutics, Inc. **I** 24 School Street, 2nd Floor **I** Boston, MA **I** U.S.A. **I** NASDAQ: ALLR **I** www.allarity.com