Full Press Release Details
Allarity Therapeutics
Reports Second Quarter 2022 Financial Results,
Provides Recent Operational Highlights, and Regains Compliance
with NASDAQ Listing Requirements
Cambridge, MA U.S.A. (October 11, 2022)
- Allarity Therapeutics, Inc. ("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
reported financial results for the second quarter ended June 30, 2022.
On October 7, 2022, Allarity filed its Quarterly
Report on Form 10-Q for the second quarter ended June 30, 2022. With this filing, the Company has addressed the cause of the non-compliant
status with Nasdaq Listing Rule 5250(c)(1), as previously announced on August 26, 2022. On October 10, 2022, Nasdaq provided confirmation
that upon the filing of the Company's Form 10-Q has regained compliance with Nasdaq Listing Rule 5250(c)(1) and the matter is now
"We are very pleased to have completed
the necessary Q2 filings and to have regained compliance with Nasdaq's listing requirements," said James G. Cullem, Chief
Executive Officer at Allarity. "We are now eagerly looking forward to focusing on advancing the important work of leveraging
DRP companion diagnostics to develop truly personalized medicines for cancer patients who need better options."
Second Quarter and Recent Operational Highlights
Allarity Therapeutics, Inc.
| 210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
Second Quarter Financial Results
Balance Sheet: As of June 30, 2022, Allarity's
cash was $7.7 million, as compared to $19.6 million as of December 31, 2021.
R&D Expenses: Research and Development
(R&D) expenses were $1.7 million for the three months ended June 30, 2022 as compared to $2.3 million for the three months ended June
Impairment of Intangible Assets: Impairment
of Intangible Assets was zero for the three months ended June 30, 2022, and June 30, 2021.
G&A Expenses: General and Administrative
(G&A) expenses were $3.1 million for the three months ended June 30, 2022, as compared to $2.1 million for the three months ended
Net Loss: Net loss was $5.1 million for
the three months ended June 30, 2022, compared to $5.4 million for the comparable period in 2021.
About the Drug Response Predictor -
DRP Companion Diagnostic
Allarity uses its drug-specific DRP
to select those patients who, by the genetic signature of their cancers, may have a high likelihood of responding to a specific drug.
By screening patients before treatment, and treating those patients with sufficiently high DRP scores, the therapeutic
response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. 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 platform has proven 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 .
The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively
published in peer reviewed literature.
Allarity Therapeutics, Inc. | 210 Broadway, #201 | Cambridge,
MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops
drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP
platform. The Company has a mature portfolio of five drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian
cancer; dovitinib, a post-Phase 3 pan-tyrosine kinase inhibitor; IXEMPRA (Ixabepilone), a microtubule inhibitor approved
in the U.S. for the treatment of second-line metastatic breast cancer and in Phase 2 development in Europe for the same indication; and
2X-111, a liposomal formulation of doxorubicin in Phase 2 development 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. LiPlaCis ,
a liposomal formulation of cisplatin and its accompanying DRP is being developed via a partnership with Chosa ApS, an
affiliate of Smerud Medical Research International, 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
Follow Allarity on Social Media
Facebook: https://www.facebook.com/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 clinical and commercial potential
due to the Company advancing dovitinib in combination with 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 for the treatment of metastatic breast cancer, and statements
relating to the effectiveness of the Company's DRP companion diagnostics platform in predicting whether a particular patient
is likely to respond to a specific drug. Any forward-looking statements in this press release are based on management's current
expectations of future events and are subject to a number of 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 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 S-1 registration statement 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
Allarity Therapeutics, Inc. | 210 Broadway, #201 | Cambridge,
MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2022 | December 31, 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash | $ | 7,677 | $ | 19,555 | ||||
| Other current assets | 235 | 625 | ||||||
| Prepaid expenses | 876 | 36 | ||||||
| Tax credit receivable | 1,331 | 838 | ||||||
| Total current assets | 10,119 | 21,054 | ||||||
| Non-current assets: | ||||||||
| Investment in Lantern Pharma Inc. stock | 254 | 350 | ||||||
| Property, plant and equipment, net | 5 | 8 | ||||||
| Operating lease right of use assets | 42 | 86 | ||||||
| Intangible assets, net | 12,811 | 28,135 | ||||||
| Total assets | $ | 23,231 | $ | 49,633 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,555 | $ | 698 | ||||
| Accrued liabilities | 1,429 | 8,590 | ||||||
| Income taxes payable | 23 | 60 | ||||||
| Operating lease liabilities, current | 54 | 98 | ||||||
| Derivative liabilities | 2,882 | - | ||||||
| Warrant liability | 1,519 | 11,273 | ||||||
| Total current liabilities | 11,462 | 20,719 | ||||||
| Non-current liabilities | ||||||||
| Convertible promissory note and accrued interest, net | 1,031 | 979 | ||||||
| Operating lease liabilities, net of current portion | - | 9 | ||||||
| Deferred tax | 656 | 1,961 | ||||||
| Derivative liabilities | - | 7,181 | ||||||
| Total liabilities | 13,149 | 30,849 | ||||||
| Commitments and contingencies (Note 21) | ||||||||
| Redeemable convertible preferred stock | ||||||||
| Series A Convertible Preferred stock | 2,116 | 632 | ||||||
| Stockholders' equity | ||||||||
| Common stock | 1 | 1 | ||||||
| Additional paid-in capital | 83,868 | 85,243 | ||||||
| Accumulated other comprehensive loss | (1,228 | ) | (600 | ) | ||||
| Accumulated deficit | (74,675 | ) | (66,492 | ) | ||||
| Total stockholders' equity | 7,966 | 18,152 | ||||||
| Total liabilities, redeemable convertible preferred stock & stockholders' equity | $ | 23,231 | $ | 49,633 |
Allarity Therapeutics, Inc. | 210 Broadway, #201 | Cambridge,
MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
ALLARITY THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | (Restated) | (Restated) | ||||||||||||||
| Research and development | $ | 1,696 | $ | 2,279 | $ | 2,985 | $ | 3,531 | ||||||||
| Impairment of intangible assets | - | - | 14,007 | - | ||||||||||||
| General and administrative | 3,146 | 2,097 | 6,159 | 3,307 | ||||||||||||
| Total operating expenses | 4,842 | 4,376 | 23,151 | 6,838 | ||||||||||||
| Loss from operations | (4,842 | ) | (4,376 | ) | (23,151 | ) | (6,838 | ) | ||||||||
| Other income (expenses) | ||||||||||||||||
| Income from sale of IP | - | - | 1,780 | - | ||||||||||||
| Interest income | 5 | - | 5 | - | ||||||||||||
| Interest expense | (33 | ) | (166 | ) | (72 | ) | (245 | ) | ||||||||
| Finance expense | - | (393 | ) | - | (480 | ) | ||||||||||
| Loss on investment | (34 | ) | (67 | ) | (70 | ) | (180 | ) | ||||||||
| Foreign exchange losses | (269 | ) | (41 | ) | (538 | ) | (80 | ) | ||||||||
| Change in fair value adjustment of derivative and warrant liabilities | 874 | (25 | ) | 13,440 | 20 | |||||||||||
| Penalty on Series A Preferred stock liability | (800 | ) | - | (800 | ) | - | ||||||||||
| Loss on extinguishment of convertible debt | - | (25 | ) | - | (141 | ) | ||||||||||
| Change in fair value of convertible debt | - | (273 | ) | - | (474 | ) | ||||||||||
| Net other income (loss) | (257 | ) | (990 | ) | 13,745 | (1,580 | ) | |||||||||
| Net loss for the period before tax expense | (5,099 | ) | (5,366 | ) | (9,406 | ) | (8,418 | ) | ||||||||
| Income tax benefit (expense) | (4 | ) | (30 | ) | 1,223 | (63 | ) | |||||||||
| Net loss | (5,103 | ) | (5,396 | ) | (8,183 | ) | (8,481 | ) | ||||||||
| Deemed dividend of 8% on Preferred stock | - | - | (1,572 | ) | - | |||||||||||
| Cash paid on converted Series A Preferred stock | (1,377 | ) | - | (1,511 | ) | - | ||||||||||
| Net loss attributable to common stockholders | $ | (6,480 | ) | $ | (5,396 | ) | $ | (11,266 | ) | $ | (8,481 | ) | ||||
| Basic and diluted net loss per common stock | $ | (0.72 | ) | $ | (1.08 | ) | $ | (1.30 | ) | $ | (1.78 | ) | ||||
| Weighted-average number of common stock outstanding, basic and diluted | 9,016,754 | 5,017,183 | 8,654,574 | 4,776,643 |
Allarity Therapeutics, Inc. | 210 Broadway, #201 | Cambridge,
MA | U.S.A. | NASDAQ: ALLR | www.allarity.com