# EDGAR Filing Document

**Accession Number:** 0001498382
**File Stem:** 0000950170-23-002808
**Filing Date:** 2023-2
**Character Count:** 14838
**Document Hash:** b440929482f99157c3ff2cd247a3d482
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-23-002808.hdr.sgml**: 20230214

**ACCESSION NUMBER**: 0000950170-23-002808

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230214

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230214

**DATE AS OF CHANGE**: 20230214

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Kintara Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001498382
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 990360497
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37823
- **FILM NUMBER:** 23631363

**BUSINESS ADDRESS:**
- **STREET 1:** 9920 PACIFIC HEIGHTS BLVD, SUITE 150
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** (858) 350-4364

**MAIL ADDRESS:**
- **STREET 1:** 9920 PACIFIC HEIGHTS BLVD, SUITE 150
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** DelMar Pharmaceuticals, Inc.
- **DATE OF NAME CHANGE:** 20130123

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Berry Only Inc.
- **DATE OF NAME CHANGE:** 20100805

?xml version="1.0" encoding="ASCII"? 8-K

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549** 

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**FORM** 8-K

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**CURRENT REPORT** 

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

**the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** February 14, 2023

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KINTARA THERAPEUTICS, INC.

**(Exact name of Registrant as Specified in Its Charter)** 

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| | | |
|:---|:---|:---|
| Nevada | 001-37823 | 99-0360497 |
| **(State or other jurisdiction**<br>**of incorporation)** | **(Commission File Number)** | **(IRS Employer**<br>**Identification No.)** |
|  | &nbsp;&nbsp;9920 Pacific Heights Blvd**,** Suite 150 <br>San Diego**,** CA 92121 |  |
|  | &nbsp;&nbsp;&nbsp;**(Address of principal executive offices)** |  |

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**Registrant's Telephone Number, Including Area Code:** (858) 350-4364

 **(Former name or former address, if changed since last report)** 

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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:

☐ 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©) 

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

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br>**Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock | KTRA | **The** Nasdaq **Capital Market** |

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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. ☐

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**Item 2.02 Results of Operations and Financial Condition.** 

Kintara Therapeutics, Inc. (the "Company") issued a press release on February 14, 2023, disclosing financial information and operating metrics for the second fiscal quarter ended December 31, 2022, and providing a corporate update. A copy of the Company's press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

**Item 7.01 Regulation FD Disclosure.** 

See "Item 2.02 Results of Operation and Financial Condition" above.

The information in this Current Report on Form 8-K under Items 2.02 and 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by a specific reference in such filing.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits.

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [<u>Press Release of Kintara Therapeutics, Inc. issued February 14, 2023</u>](ktra-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**SIGNATURES**

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

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| | | |
|:---|:---|:---|
|  | **KINTARA THERAPEUTICS, INC.** | **KINTARA THERAPEUTICS, INC.** |
| Date: February 14, 2023 | By: | /s/ Scott Praill |
|  |  | Name: Scott Praill |
|  |  | Title: Chief Financial Officer |

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## Ex-99

![img40499469_0.jpg](img40499469_0.jpg)

**Exhibit 99.1**

**Kintara Therapeutics Announces Fiscal 2023 Second Quarter Financial Results and Provides Corporate Update**

SAN DIEGO, February 14, 2023 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced financial results for its fiscal second quarter ended December 31, 2022 and provided a corporate update.

**RECENT CORPORATE DEVELOPMENTS**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced that Kintara had received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma, a rare and highly aggressive childhood brain cancer (December).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Received formal notice from The Nasdaq Stock Market LLC stating that Kintara had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market LLC ("Nasdaq") (November).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced that the FDA had granted Fast Track Designation for Kintara's REM-001 therapy, which consists of three parts, the laser light source, the light delivery device, and the REM-001 drug product, for the treatment of patients with cutaneous metastatic breast cancer (CMBC) (November).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Completed a 1-for-50 reverse stock split of the Company's outstanding and authorized common stock, which began trading on a reverse stock split-adjusted basis on Nasdaq on November 14, 2022 (November).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Announced that the REM-001 program in CMBC was paused to conserve cash which will be used to support the funding of the Company's ongoing international registrational study for VAL-083 in glioblastoma (GBM). By pausing the REM-001 program, Kintara expects to save approximately $3.0 million through calendar 2023 (October).

"While we continue to look for ways to restart our REM-001 program in cutaneous metastatic breast cancer without reducing our cash runway, we are encouraged by the recent progress of our lead asset in brain cancer, VAL-083, and look forward to announcing top-line data in the international registrational GBM AGILE Study before the end of calendar 2023," commented Robert E. Hoffman, Kintara's President and Chief Executive Officer. "There has been a significant lack of progress in the development of treatments for GBM in the last decades so we are devoted to advancing our novel brain-penetrant small molecule chemotherapy agent, VAL-083, closer to patients and physicians in dire need of new treatment options for this devastating disease."

**SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 SECOND QUARTER ENDED DECEMBER 31, 2022**

As of December 31, 2022, Kintara had cash and cash equivalents of approximately $4.9 million.

For the three months ended December 31, 2022, Kintara reported a net loss of approximately $3.5 million, or $2.10 per share, compared to a net loss of approximately $5.9 million, or $6.07 per share, for the three months ended December 31, 2021. For the six months ended December 31, 2022, Kintara reported a net loss of approximately $8.1 million, or $5.42 per share, compared

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to a net loss of approximately $11.9 million, or $17.30 per share, for the six months ended December 31, 2021. The decreased net losses for the three and six months ended December 31, 2022 compared to the three and six months ended December 31, 2021 was largely due lower research and development expenses as well as lower general and administrative costs.

Selected Balance Sheet Data (in thousands)

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| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2022** | **June 30, 2022** |
|  | $ | $ |
| Cash and cash equivalents | 4874 | 11780 |
| Working capital | 5939 | 9268 |
| Total assets | 9917 | 15948 |
| Total stockholders' equity | 6598 | 11795 |

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Selected Statement of Operations Data (in thousands, except per share data)

**For the three months ended** 

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| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2022** | **December 31,**<br>**2021** |
|  | $ | $ |
| Research and development | 2059 | 3902 |
| General and administrative | 1440 | 1993 |
| Other income | (45) | (2) |
| Net loss for the period | (3454) | (5893) |
| Series A Preferred cash dividend | (2) | (2) |
| Net loss for the period attributable to common stockholders | (3456) | (5895) |
| Basic and fully diluted weighted average number of shares | 1643 | 971 |
| Basic and fully diluted loss per share | (2.10) | (6.07) |

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**For the six months ended** 

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| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2022** | **December 31,**<br>**2021** |
|  | $ | $ |
| Research and development | 5230 | 7695 |
| General and administrative | 2915 | 4171 |
| Other income | (95) | (7) |
| Net loss for the period | (8050) | (11859) |
| Series A Preferred cash dividend | (4) | (4) |
| Series C Preferred stock dividend | (362) | (2462) |
| Net loss for the period attributable to common stockholders | (8416) | (14325) |
| Basic and fully diluted weighted average number of shares | 1554 | 828 |
| Basic and fully diluted loss per share | (5.42) | (17.30) |

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Kintara's financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company's website at: http://ir.kintara.com/sec-filings<u>.</u>

**ABOUT KINTARA**

Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing two late-stage therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 Therapy for CMBC.

VAL-083 is a 'first-in-class', small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently advancing VAL-083 in the Global Coalition for Adaptive Research registrational Phase 2/3 clinical trial titled Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study to support the development and commercialization of VAL-083 in GBM.

Kintara also has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications. Kintara has paused the REM-001 CMBC program to conserve cash resources.

For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin<u>.</u>

**SAFE HARBOR STATEMENT**

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials and the GBM AGILE Study. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; global unrest; and the continued impact of the COVID-19 pandemic. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for

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the year ended June 30, 2022, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

**CONTACTS**

**Investors**<br> LifeSci Advisors <br>Mike Moyer, Managing Director

617.308.4306 <br>

**Media Inquiries**<br>David Schull or Ignacio Guerrero-Ros, Ph.D.<br>Russo Partners<br>858.717.2310<br>646.942.5604

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