- Phase 1b/2a clinical trial of AJ201 remains on track to report topline data in second quarter of 2024 -
- Positive BAER-101 preclinical data accepted for presentation at
- Agreement reached with
- Raised
“In the third quarter, Avenue continued to successfully execute across our pipeline of innovative CNS treatments," said
Recent Corporate Highlights:
AJ201 (Nrf1 and Nrf2 activator, androgen receptor degradation enhancer for SBMA)
- Avenue presented trial-in-progress posters for the Phase 1b/2a clinical trial of AJ201 for the treatment of SBMA, also known as Kennedy’s Disease, at three scientific congresses, including the 2023 Neuromuscular Study Group Annual Scientific Meeting in
Orlando ,World Muscle Society in Charleston and the European Neuro Muscular Centre (ENMC) Meeting on SBMA inAmsterdam . The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 is expected to enroll approximately 24 patients, randomly assigned to AJ201 (600 mg/day) or placebo. Topline data for the Phase 1b/2a clinical trial of AJ201 in SBMA are expected in the second quarter of 2024. More information about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603).
BAER-101 (GABAA α2/3 positive allosteric modulator)
- In
August 2023 , Avenue reported preclinical results for BAER-101, a potentially best-in-class selective GABA-A α2,3 positive allosteric modulator, demonstrating that it significantly suppressed seizures in a translational animal model of absence epilepsy. In an in vivo evaluation using the SynapCell's Genetic Absence Epilepsy Rat fromStrasbourg (“GAERS”) model of absence epilepsy, BAER-101 fully suppressed seizure activity with a minimal effective dose of 0.3 mg/kg, PO. The effect was fast in onset and stable throughout the duration of testing. The detailed preclinical results were accepted to be presented in a poster presentation at theAmerican Epilepsy Society (AES) Annual Meeting taking placeDecember 1-5 th inOrlando . The combination of safety and tolerability in hundreds of patients and the preclinical efficacy data support BAER-101’s continued development in a Phase 2a trial.
IV Tramadol
- In
July 2023 , Avenue reached agreement with the FDA on key elements of the Phase 3 safety study, including the primary endpoint and statistical analysis approach for intravenous (“IV”) tramadol, which is in development for the treatment of acute postoperative pain in a medically supervised setting. The non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine. The study will randomize post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Patients will have access to IV hydromorphone for rescue of breakthrough pain. The full study protocol, including the statistical plan, has been submitted to the FDA for final review. Pending additional financing or partnering, Avenue aims to initiate the Phase 3 safety study as soon as feasible.
Financial Results:
- Cash Position: As of
September 30, 2023 , our cash and cash equivalents totaled$0.2 million , compared to$6.7 million atDecember 31, 2022 , a decrease of$6.5 million . InNovember 2023 , we completed a follow-on public offering of our common stock and warrants, raising approximately$5.0 million in gross proceeds. - R&D Expenses: Research and development expenses for the third quarter of 2023 were
$0.9 million , compared to$0.2 million for the third quarter of 2022. - G&A Expenses: General and administrative expenses for the third quarter of 2023 were
$1.2 million , compared to$0.5 million for the third quarter of 2022. - Net Income (Loss): Net income attributable to common stockholders for the third quarter of 2023 was
$0.5 million , or$0.06 per share, compared to a net loss of$0.7 million , or$0.45 per share, for the third quarter of 2022.
About
Forward-Looking Statements
This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: expectations for increases or decreases in expenses; expectations for the clinical and pre-clinical development, manufacturing, regulatory approval, and commercialization of our pharmaceutical product candidate or any other products we may acquire or in-license; our use of clinical research centers and other contractors; expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities; expectations for generating revenue or becoming profitable on a sustained basis; expectations or ability to enter into marketing and other partnership agreements; expectations or ability to enter into product acquisition and in-licensing transactions; expectations or ability to build our own commercial infrastructure to manufacture, market and sell our product candidates; acceptance of our products by doctors, patients or payors; our ability to compete against other companies and research institutions; our ability to secure adequate protection for our intellectual property; our ability to attract and retain key personnel; availability of reimbursement for our products; estimates of the sufficiency of our existing cash and cash equivalents and investments to finance our operating requirements, including expectations regarding the value and liquidity of our investments; the volatility of our stock price; expected losses; expectations for future capital requirements; and those risks discussed in our filings which we make with the
Contact:
(781) 652-4500
ir@avenuetx.com
Unaudited Condensed Consolidated Balance Sheets ($ in thousands, except for share and per share amounts) | |||||||
2023 | 2022 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 161 | $ | 6,708 | |||
Other receivables - related party | 13 | — | |||||
Deferred financing costs | 310 | — | |||||
Prepaid expenses and other current assets | 18 | 137 | |||||
Total assets | $ | 502 | $ | 6,845 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current Liabilities: | |||||||
Accounts payable and accrued expenses | $ | 1,460 | $ | 949 | |||
Accounts payable and accrued expenses - related party | 264 | 21 | |||||
Warrant liability | 3,300 | 2,609 | |||||
Total current liabilities | 5,024 | 3,579 | |||||
Total liabilities | 5,024 | 3,579 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity (deficit) | |||||||
Preferred stock ( | |||||||
Class A Preferred Stock, 250,000 shares issued and outstanding as of | — | — | |||||
Common stock ( | |||||||
Common shares, 8,964,222 and 4,773,841 shares issued and outstanding as of | 1 | — | |||||
Additional paid-in capital | 87,917 | 84,456 | |||||
Accumulated deficit | (91,568 | ) | (80,551 | ) | |||
Total stockholders’ equity attributed to the Company | (3,650 | ) | 3,905 | ||||
Non-controlling interests | (872 | ) | (639 | ) | |||
Total stockholders’ equity (deficit) | (4,522 | ) | 3,266 | ||||
Total liabilities and stockholders’ equity | $ | 502 | $ | 6,845 |
Unaudited Condensed Consolidated Statements of Operations ($ in thousands, except for share and per share amounts) | |||||||||||||||
For the Three Months Ended | For the Nine Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 907 | $ | 194 | $ | 5,149 | $ | 2,153 | |||||||
Research and development – licenses acquired | — | — | 4,230 | — | |||||||||||
General and administrative | 1,161 | 469 | 3,042 | 1,978 | |||||||||||
Loss from operations | (2,068 | ) | (663 | ) | (12,421 | ) | (4,131 | ) | |||||||
Other income (expense) | |||||||||||||||
Interest income | 9 | 1 | 104 | 4 | |||||||||||
Financing costs – warrant liabilities | — | — | (332 | ) | — | ||||||||||
Change in fair value of warrant liabilities | 2,572 | — | 1,544 | — | |||||||||||
Total other income (expense) | 2,581 | 1 | 1,316 | 4 | |||||||||||
Net income (loss) | $ | 513 | $ | (662 | ) | $ | (11,105 | ) | $ | (4,127 | ) | ||||
Net loss attributable to non-controlling interests | (13 | ) | — | (88 | ) | — | |||||||||
Net loss attributable to common stockholders | $ | 526 | $ | (662 | ) | $ | (11,017 | ) | $ | (4,127 | ) | ||||
Net income (loss) per common share attributable to common stockholders: | |||||||||||||||
Basic | $ | 0.06 | $ | (0.45 | ) | $ | (1.54 | ) | $ | (2.86 | ) | ||||
Diluted | $ | 0.06 | $ | (0.45 | ) | $ | (1.54 | ) | $ | (2.86 | ) | ||||
Weighted average number of common shares outstanding: | |||||||||||||||
Basic | 8,114,155 | 1,465,691 | 7,155,050 | 1,441,542 | |||||||||||
Diluted | 8,200,069 | 1,465,691 | 7,155,050 | 1,441,542 | |||||||||||
Source:
2023 GlobeNewswire, Inc., source