Full Press Release Details
Plus Therapeutics Reports Second Quarter 2021 Financial Results and Business Highlights
Management to host conference call today at 5:00 pm ET
AUSTIN, Texas, July 22, 2021 - Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced financial results for the second quarter ended June 30, 2021, and provided an overview of recent business highlights.
"Our focus remains on completion of our Phase 1 dose escalation ReSPECT -GBM trial, which is evaluating the Company's lead investigational drug, Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM), expansion of our 186RNL pipeline, and GMP production of 186RNL to be available in mid-2022 for a potential registrational trial ," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "We believe that the evolving clinical data in ReSPECT shows that high doses of precisely delivered beta radiation in patients with recurrent GBM is both feasible and safe. We intend to provide a comprehensive update on the data later this year."
Rhenium-186 NanoLiposome (186RNL), a novel radiotherapy in development for several rare cancer targets
Recurrent Glioblastoma (GBM)
Leptomeningeal Metastases (LM)
Pediatric Brain Cancer (PBC)
Commercial Manufacturing and Supply Chain
EXPECTED UPCOMING CLINICAL MILESTONES AND EVENTS FOR 2021
During the remainder of 2021, the Company intends to focus on the following key business objectives and milestones:
SECOND QUARTER 2021 FINANCIAL RESULTS
Second Quarter 2021 Results Conference Call
The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.
| Event: | Plus Therapeutics Second Quarter 2021 Results Conference Call |
| Date: | Thursday, July 22, 2021 |
| Time: | 5:00 p.m. Eastern Time |
| Live Call: | 877-876-9174 (toll free); 785-424-1669 (Intl.); Conference ID: PSTVQ221 |
The webcast can be accessed live via the investor section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.
About Plus Therapeutics, Inc.
Plus Therapeutics is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company's drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "will," "believe," "plan," "can," "enable," "design," "intend," "potential," "expect," "estimate," "project," "prospect," "target," "focus," "anticipate," "could," "should," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following:
the Company's anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; the Company's ability to benefit from the NIH/NCI award for continued clinical development of 186RNL for recurrent glioblastoma; the ability of 186RNL to safely and effectively deliver radiation directly to the tumor at high doses; the Company's ability to expand clinical testing of 186RNL to additional sites; the potential size of the market for the Company's product candidates; the Company's research and development efforts; the Company's IP strategy; competition; future development and/or expansion of its product candidates and therapies in its markets; the Company's ability to generate product or development revenue and the sources of such revenue; the amounts that the Company may be obligated to pay under license agreements; the Company's ability to effectively manage its gross profit margins; its ability to obtain
and maintain regulatory approvals; expectations as to the Company's future performance; the Company's need for additional financing and the availability thereof; its ability to fully access its equity line with Lincoln Park; any changes to its interest expenses; the Company's ability to continue as a going concern; its ability to remain listed on the Nasdaq Capital Market; the Company's ability to repay or refinance some or all of its outstanding indebtedness and its ability to raise capital in the future; expectations as to the impact of recently issued or adopted accounting standards; the Company's expectations as to the impact of the COVID-19 pandemic on its business and operating results; the Company's beliefs as to the impact of any liability that may arise as a result of any legal proceedings; and the potential enhancement of the Company's cash position through development, marketing, and licensing arrangements.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to the following: the early stage of the Company's product candidates and therapies, the results of the Company's research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company's liquidity and capital resources and its ability to raise additional cash, the outcome of the Company's partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others; and additional risks described under the heading "Risk Factors" in the Company's Securities and Exchange Commission filings, including in the Company's annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(in thousands, except share and par value data)
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,161 | $ | 8,346 | ||||
| Other current assets | 840 | 829 | ||||||
| Total current assets | 18,001 | 9,175 | ||||||
| Property and equipment, net | 1,738 | 1,820 | ||||||
| Operating lease right-of-use assets | 638 | 636 | ||||||
| Goodwill | 372 | 372 | ||||||
| Intangible assets, net | 69 | 86 | ||||||
| Other assets | 16 | 16 | ||||||
| Total assets | $ | 20,834 | $ | 12,105 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 1,609 | $ | 2,081 | ||||
| Operating lease liability | 127 | 123 | ||||||
| Term loan obligations, net of discount | 6,618 | 6,335 | ||||||
| Total current liabilities | 8,354 | 8,539 | ||||||
| Noncurrent operating lease liability | 530 | 528 | ||||||
| Warrant liability | 5 | 7 | ||||||
| Total liabilities | 8,889 | 9,074 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 and 1,954 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 12,087,525 and 6,749,028 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 12 | 7 | ||||||
| Additional paid-in capital | 450,964 | 436,535 | ||||||
| Accumulated deficit | (439,031 | ) | (433,511 | ) | ||||
| Total stockholders' equity | 11,945 | 3,031 | ||||||
| Total liabilities and stockholders' equity | $ | 20,834 | $ | 12,105 |
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Development revenues: | ||||||||||||||||
| Government contracts and other | $ | - | $ | 185 | $ | - | $ | 303 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,106 | 327 | 2,233 | 1,268 | ||||||||||||
| In process research and development acquired from NanoTx | - | 781 | - | 781 | ||||||||||||
| General and administrative | 1,469 | 1,429 | 2,821 | 3,047 | ||||||||||||
| Total operating expenses | 2,575 | 2,537 | 5,054 | 5,096 | ||||||||||||
| Loss from operations | (2,575 | ) | (2,352 | ) | (5,054 | ) | (4,793 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 4 | 9 | 8 | 45 | ||||||||||||
| Interest expense | (229 | ) | (252 | ) | (476 | ) | (601 | ) | ||||||||
| Change in fair value of warrants | - | 756 | 2 | 2,423 | ||||||||||||
| Total other income (expense) | (225 | ) | 513 | (466 | ) | 1,867 | ||||||||||
| Net loss | $ | (2,800 | ) | $ | (1,839 | ) | $ | (5,520 | ) | $ | (2,926 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.25 | ) | $ | (0.45 | ) | $ | (0.56 | ) | $ | (0.74 | ) | ||||
| Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders | 11,296,816 | 4,053,242 | 9,790,726 | 3,967,392 |
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
| For the Six Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Cash flows used in operating activities: | ||||||||
| Net loss | $ | (5,520 | ) | $ | (2,926 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 179 | 188 | ||||||
| Amortization of deferred financing costs and debt discount | 283 | 275 | ||||||
| In process research and development acquired from NanoTx Therapeutics | - | 781 | ||||||
| Noncash lease expenses | 4 | 9 | ||||||
| Change in fair value of warrants | (2 | ) | (2,423 | ) | ||||
| Stock-based compensation expense | 245 | 55 | ||||||
| Increases (decreases) in cash caused by changes in operating assets and liabilities: | ||||||||
| Accounts receivable | - | 218 | ||||||
| Other current assets | (11 | ) | 487 | |||||
| Other assets | - | 54 | ||||||
| Accounts payable and accrued expenses | (583 | ) | 371 | |||||
| Net cash used in operating activities | (5,405 | ) | (2,911 | ) | ||||
| Cash flows used in investing activities: | ||||||||
| Purchases of property and equipment | (80 | ) | (23 | ) | ||||
| In process research and development acquired from NanoTx Therapeutics | - | (400 | ) | |||||
| Net cash used in investing activities | (80 | ) | (423 | ) | ||||
| Cash flows provided by (used in) financing activities: | ||||||||
| Principal payments of long-term obligations | - | (5,307 | ) | |||||
| Payment of financing lease liability | (8 | ) | (51 | ) | ||||
| Proceeds from exercise of warrants | 2,017 | 366 | ||||||
| Proceeds from sale of common stock, net | 12,291 | - | ||||||
| Net cash provided by (used in) financing activities | 14,300 | (4,992 | ) | |||||
| Net increase (decrease) in cash and cash equivalents | 8,815 | (8,326 | ) | |||||
| Cash and cash equivalents at beginning of period | 8,346 | 17,592 | ||||||
| Cash and cash equivalents at end of period | 17,161 | 9,266 | ||||||
| Supplemental disclosure of cash flows information: | ||||||||
| Cash paid during period for: | ||||||||
| Interest | $ | 290 | $ | 372 | ||||
| Supplemental schedule of non-cash investing and financing activities: | ||||||||
| Common stock issued in payment for in process research and development | $ | - | $ | 381 | ||||
| Unpaid offering cost | $ | 119 | $ | - | ||||
| Right-of-use asset obtained in exchange for lease liabilities | $ | 81 | $ | - |