- Announced Thorough Evaluation of a Range of Potential Strategic Opportunities
- Continued GBM Study Start-up Activities
Ended Quarter with$25.9 million in Cash,Cash Equivalents and Marketable Securities
“As previously announced, we formalized our efforts to identify and evaluate strategic opportunities during the third quarter, and with our current assets, including trans sodium crocetinate (“TSC”) and our strong balance sheet, we believe these activities will effectively position us to meet the challenges of this dynamic market,” commented
Business & Development Updates
Commenced Process to Evaluate Potential Strategic Opportunities: In
Announced Plans for a Phase 2 Glioblastoma Trial: In
Financial Updates
Research and development expenses in the third quarter of 2022 were
General and administrative expenses were
As of
About
Forward-Looking Statements
This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including: the timing and potential outcome of the Company’s ongoing strategic alternative review process; the potential therapeutic value of TSC in cancer and non-cancer indications; anticipated timelines for the initiation, completion, and announcement of data from Study 200-208; the Company’s ongoing and planned clinical trials; the Company’s near-term strategic priorities with respect to the development of TSC and otherwise; and the Company’s anticipated cash runway. The Company may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, the Company’s actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s ongoing strategic alternative review process and the Company’s ability to identify, evaluate and execute potential business development transactional opportunities, if any; the novelty of the Company’s Study 200-208 design, the relevance of trends observed in any PET scan data readouts the Company may obtain, and the therapeutic value of TSC; the optimal doses and dosing regimens of TSC in connection with the potential treatment of any particular disease or indication; the Company’s ability to design, initiate, enroll, execute, and complete its ongoing and planned studies evaluating TSC, including Study 200-208; the likelihood and timing of regulatory approval of TSC, if any, for the treatment of solid tumors complicated by hypoxia or any other indication, or the nature of any feedback the Company may receive from the FDA or other regulatory bodies; the impact of global supply chain disruptions on the Company’s drug product manufacturing capabilities, clinical development program, and associated timelines;; the Company’s ability to protect and expand its intellectual property portfolio; the availability of cash resources; general economic, political, business, industry, and market conditions, including the ongoing COVID-19 pandemic, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s filings most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, and other filings with the
Contacts
Investors:
dboateng@tiberend.com
jnugent@tiberend.com
Balance Sheet
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 6,587,018 | $ | 37,313,558 | |||
Marketable securities | 19,270,940 | — | |||||
Prepaid expenses, deposits and other current assets | 464,884 | 510,015 | |||||
Total current assets | 26,322,842 | 37,823,573 | |||||
Other assets | — | 15,578 | |||||
Total assets | $ | 26,322,842 | $ | 37,839,151 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 807,372 | $ | 947,495 | |||
Accrued expenses and other current liabilities | 1,463,280 | 1,980,189 | |||||
Total current liabilities | 2,270,652 | 2,927,684 | |||||
Stockholders’ Equity: | |||||||
Common stock, | 2,039 | 2,038 | |||||
Additional paid-in capital | 165,657,681 | 164,914,540 | |||||
Accumulated other comprehensive loss | (86,955 | ) | — | ||||
Accumulated deficit | (141,520,575 | ) | (130,005,111 | ) | |||
Total stockholders' equity | 24,052,190 | 34,911,467 | |||||
Total liabilities and stockholders' equity | $ | 26,322,842 | $ | 37,839,151 | |||
Statement of Operations
Three Months Ended | Nine Months Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 798,247 | $ | 2,105,815 | $ | 5,332,698 | $ | 6,994,866 | |||||||
Intangible asset impairment charge | - | 8,639,000 | — | 8,639,000 | |||||||||||
General and administrative | 2,124,785 | 1,930,082 | 6,390,663 | 5,510,365 | |||||||||||
Depreciation | - | 19,100 | — | 67,302 | |||||||||||
Loss from operations | 2,923,032 | 12,693,997 | 11,723,361 | 21,211,533 | |||||||||||
Interest income | (124,710 | ) | (50,710 | ) | (207,897 | ) | (146,354 | ) | |||||||
Loss from operations before income tax benefit | (2,798,322 | ) | (12,643,287 | ) | $ | (11,515,464 | ) | $ | (21,065,179 | ) | |||||
Income tax benefit | - | (443,893 | ) | - | (443,893 | ) | |||||||||
Net loss | $ | (2,798,322 | ) | $ | (12,199,394 | ) | $ | (11,515,464 | ) | $ | (20,621,286 | ) | |||
Per share information: | |||||||||||||||
Net loss per share of common stock, basic and diluted | $ | (1.37 | ) | $ | (5.99 | ) | $ | (5.65 | ) | $ | (10.76 | ) | |||
Weighted average shares outstanding, basic and diluted | 2,039,089 | 2,037,978 | 2,038,716 | 1,916,107 | |||||||||||
Comprehensive loss: | |||||||||||||||
Net loss | $ | (2,798,322 | ) | $ | (12,199,394 | ) | $ | (11,515,464 | ) | $ | (20,621,286 | ) | |||
Unrealized loss on marketable securities | (372 | ) | - | (86,955 | ) | - | |||||||||
Comprehensive loss: | $ | (2,798,694 | ) | $ | (12,199,394 | ) | $ | (11,602,419 | ) | $ | (20,621,286 | ) | |||
Source:
2022 GlobeNewswire, Inc., source