Full Press Release Details
Plus Therapeutics, Inc. ("we," "our" or the "Company") is filing this Exhibit 99.1 to our Current Report on Form 8-K (this "Exhibit") to revise and recast our historical consolidated financial statements and other information included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (the "2018 10-K"). The information included in this Exhibit presents the financial results of our former Cell Therapy business and related assets (as described below) as a discontinued operation and retroactively adjusts all share and per share amounts to reflect the August 2019 Reverse Stock Split (as defined below) for all periods presented. These updates are consistent with the presentation of all share and per share disclosures and the presentation of discontinued operations included in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 filed with the Securities and Exchange Commission (the "SEC") on August 15, 2019, and with rules of the SEC requiring the reissuance of prior period financial statements included or incorporated by reference in a registration statement or proxy statement to retrospectively revise and reclassify such pre-event financial statements to reflect accounting changes, such as discontinued operations.
As previously disclosed, on March 30, 2019, the Company entered into an Asset and Share Sale and Purchase Agreement (the "Lorem Purchase Agreement") with Lorem Vascular Pte. Ltd. ("Lorem"), pursuant to which, among other things, Lorem agreed to purchase the Company's UK subsidiary, Cytori Ltd. (the "UK Subsidiary"), and the Company's Cell Therapy assets, excluding such assets used in Japan or relating to the Company's contract with the U.S. Department of Health and Human Service's Biomedical Advanced Research and Development Authority ("BARDA"). Both the Company and Lorem made customary representations, warranties and covenants in the Lorem Purchase Agreement. The transaction was completed on April 24, 2019 and the Company received $4.0 million of cash proceeds, of which $1.7 million was used to pay down principal, interest and fees under the Loan and Security Agreement, dated May 29, 2015 (the "Loan and Security Agreement"), as amended, with Oxford Finance, LLC ("Oxford").
In addition, as previously disclosed, on April 19, 2019, the Company entered into an Asset and Share Sale and Purchase Agreement (the "Shirahama Purchase Agreement") with Seijir Shirahama, pursuant to which, among other things, Mr. Shirahama agreed to purchase the Company's Japanese subsidiary, Cytori Therapeutics, K.K. (the "Japanese Subsidiary"), and substantially all of the Company's Cell Therapy assets used in Japan. Both the Company and Mr. Shirahama made customary representations, warranties and covenants in the Shirahama Purchase Agreement. The transaction was completed on April 25, 2019 and the Company received $3.0 million of cash proceeds, of which $1.4 million was used to pay down principal, interest and fees under the Loan and Security Agreement.
As a result of the Company entering into the Lorem Purchase Agreement and the Shirahama Purchase Agreement, the Cell Therapy business is accounted for as a discontinued operation for all periods presented in this Exhibit.
On July 29, 2019, the Company amended its Certificate of Incorporation with the State of Delaware to change its corporate name from Cytori Therapeutics, Inc. to Plus Therapeutics, Inc. The Company also changed its trading symbol for its common stock on the Nasdaq Capital Market to "PSTV". Additionally, the Company changed its trading symbol for its Series S warrants to "PSTVZ".
In addition, as previously disclosed, on August 5, 2019, following stockholder and Board approval, the Company filed a Certificate of Amendment (the "August 2019 Amendment") to its Amended and Restated Certificate of Incorporation (the "Amendment"), as amended, with the Secretary of State of the State of Delaware to effectuate a one-for-fifty (1:50) reverse stock split (the "August 2019 Reverse Stock Split") of its common stock, par value $0.001 per share, without any change to its par value or authorized number of common stock. The August 2019 Amendment became effective on the filing date. The August 2019 Reverse Stock Split became effective for trading purposes as of the commencement of trading on the Nasdaq Capital Market on August 6, 2019. There was no change in the Company's Nasdaq ticker symbol, "PSTV," as a result of the August 2019 Reverse Stock Split. Upon effectiveness, each 50 shares of issued and outstanding Common Stock were converted into one newly issued and outstanding share of Common Stock. The Company's 5,000,000 shares of authorized Preferred Stock were not affected by the August 2019 Reverse Stock Split. No fractional shares were issued in connection with the August 2019 Reverse Stock Split. Any fractional shares of Common Stock that would have otherwise resulted from the August 2019 Reverse Stock Split were rounded up to the nearest whole share. Outstanding equity awards and the shares available for future grant under the Company's Amended and Restated 2004 Equity Incentive Plan, 2011 Employee Stock Purchase Plan, 2014 Amended and Restated Equity Incentive Plan and 2015 New Employee Incentive Plan were proportionately reduced (rounded down to the nearest whole share), and the exercise prices of outstanding equity awards were proportionately increased (rounded up to the nearest whole cent) to give effect to the August 2019 Reverse Stock Split. As a result of the August 2019 Reverse Stock Split, all share and per share amounts have been adjusted retroactively for all periods presented in this Exhibit.
The information included in this Exhibit is presented in connection with the reporting changes described above and does not otherwise amend or restate our audited consolidated financial statements that were included in the 2018 10-K. Unaffected items and unaffected portions of the 2018 10-K have not been repeated in, and are not amended or modified by this Exhibit. This Exhibit does not reflect events occurring after we filed the 2018 10-K and does not modify or update the disclosures therein in any way, other than to reflect the presentation of our former Cell Therapy business as a discontinued operation and to retroactively adjust all share and per share amounts to reflect the August 2019 Reverse Stock Split, as described above, and, where appropriate and as indicated, to reflect a more recent status of certain of our ongoing development programs. Therefore, this Exhibit should be read in conjunction with our other filings made with the SEC, including, and subsequent to, the date of the 2018 10-K.
Accordingly, this Exhibit revises the following portions of the 2018 10-K:
| Item 6. Selected Financial Data | ||
| Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations | ||
| Item 8. Financial Statements and Supplementary Data | ||
| Item 15 (a) (2) Financial Statement Schedules |
CAUTIONARY NOTES REGARDING FORWARD-LOOKING STATEMENTS
This Exhibit contains certain statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our 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 about our anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; the potential size of the market for our products; future development and/or expansion of our products and therapies in our markets, our ability to generate product or development revenues and the sources of such revenues; our ability to effectively manage our gross profit margins; our ability to obtain and maintain regulatory approvals; expectations as to our future performance; portions of the "Liquidity and Capital Resources" section of this Exhibit, including our potential need for additional financing and the availability thereof; our ability to continue as a going concern; our ability to remain listed on the Nasdaq Capital Market; our ability to repay or refinance some or all of our outstanding indebtedness and our ability to raise capital in the future; and the potential enhancement of our cash position through development, marketing, and licensing arrangements. Our actual results will likely differ, perhaps materially, from those anticipated in these forward-looking statements as a result of various factors, including: the early stage of our product candidates and therapies, the results of our research and development activities, including uncertainties relating to the clinical trials of our product candidates and therapies; our need and ability to raise additional cash, the outcome of our partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to us, market conditions, product performance, potential litigation, and competition within the regenerative medicine field, to name a few. The forward-looking statements included in this Exhibit are subject to a number of additional material risks and uncertainties, including but not limited to the risks described under the "Risk Factors" in Part I, Item 1A of the 2018 10-K, which we encourage you to read carefully.
We caution you not to place undue reliance on the forward-looking statements contained in this Exhibit. These statements, like all statements in this Exhibit, speak only as of the date of this Exhibit (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law. Such forward-looking statements are not guarantees of future performance.
Item 6. Selected Financial Data
The selected data presented below under the captions "Consolidated Statements of Operations and Comprehensive Loss", "Consolidated Statements of Cash Flows" and "Consolidated Balance Sheet Details" for, and as of the end of, each of the years in the two-year period ended December 31, 2018, are derived from, and should be read in conjunction with, our audited consolidated financial statements. The consolidated balance sheets as of December 31, 2018 and 2017, and the related consolidated statements of operations and comprehensive loss, stockholders' equity, and cash flows for each of the two years in the period ended December 31, 2018, which have been audited by BDO USA, LLP, an independent registered public accounting firm, and their report thereon, is included elsewhere in this Exhibit. This data has been updated to account for the cell therapy business as a discontinued operation and to retroactively reflect the August 2019 Reverse Stock Split for all periods presented.
The information contained in this table should also be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the financial statements and related notes thereto included elsewhere in this Exhibit:
Consolidated Statements of Operations and Comprehensive Loss (in thousands)
| For the Years Ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Development revenues: | ||||||||
| Government contracts and other | $ | 2,983 | $ | 3,722 | ||||
| 2,983 | 3,722 | |||||||
| Operating expenses: | ||||||||
| Research and development | 5,523 | 5,073 | ||||||
| Sales and marketing | 643 | 1,341 | ||||||
| General and administrative | 5,579 | 6,700 | ||||||
| In process research and development acquired from Azaya | - | 1,686 | ||||||
| Total operating expenses | 11,745 | 14,800 | ||||||
| Operating loss | (8,762 | ) | (11,078 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 43 | 33 | ||||||
| Interest expense | (1,922 | ) | (2,049 | ) | ||||
| Change in fair value of warrants | 2,233 | - | ||||||
| Issuance cost of warrants | (470 | ) | - | |||||
| Total other expense | (116 | ) | (2,016 | ) | ||||
| Loss from continuing operations | (8,878 | ) | (13,094 | ) | ||||
| Loss from discontinued operations | (3,756 | ) | (9,592 | ) | ||||
| Net loss | $ | (12,634 | ) | $ | (22,686 | ) | ||
| Loss from continuing operations | (8,878 | ) | (13,094 | ) | ||||
| Beneficial conversion feature for convertible preferred stock | (2,487 | ) | (3,977 | ) | ||||
| Net loss allocable to common stockholders - continuing operations | $ | (11,365 | ) | $ | (17,071 | ) | ||
| Net loss allocable to common stockholders - discontinued operations | (3,756 | ) | (9,592 | ) | ||||
| Basic and diluted net loss per share attributable to common stockholders from continuing operations | $ | (65.37 | ) | $ | (263.53 | ) | ||
| Basic and diluted net loss per share allocable to common stockholders from discontinued operations | (21.61 | ) | $ | (148.07 | ) | |||
| Basic and diluted weighted average shares used in calculating net loss per share allocable to common stockholders | 173,851 | 64,780 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (12,634 | ) | $ | (22,686 | ) | ||
| Other comprehensive income - foreign currency translation adjustments | (169 | ) | 129 | |||||
| Comprehensive loss | $ | (12,803 | ) | $ | (22,557 | ) |
Consolidated Statements of Cash Flows (in thousands)
| For the Years Ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Net cash used in operating activities | $ | (11,975 | ) | $ | (18,128 | ) | ||
| Net cash used in investing activities | (133 | ) | (1,383 | ) | ||||
| Net cash provided by financing activities | 7,168 | 16,815 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | 16 | 11 | ||||||
| Net decrease in cash and cash equivalents | (4,924 | ) | (2,685 | ) | ||||
| Cash, cash equivalents, and restricted cash at beginning of year | 10,225 | 12,910 | ||||||
| Cash, cash equivalents, and restricted cash at end of year | $ | 5,301 | $ | 10,225 |
Consolidated Balance Sheet Details (in thousands)
| As of December 31, | ||||||||
| 2018 | 2017 | |||||||
| Cash and cash equivalents | $ | 5,261 | $ | 9,550 | ||||
| Working capital deficit | (10,608 | ) | (6,589 | ) | ||||
| Assets held for sale | 14,910 | 17,635 | ||||||
| Total assets | 23,991 | 31,615 | ||||||
| Warrant liability | 916 | - | ||||||
| Liabilities held for sale | 825 | 785 | ||||||
| Total stockholders' equity | 5,225 | 13,000 |
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read in conjunction with our financial statements and the notes to those financial statements appearing elsewhere in this Exhibit. This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many factors, such as those set forth in Part I, Item 1A. Risk Factors of the 2018 10-K, our actual results may differ materially from those anticipated in these forward-looking statements.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on the discovery, development, and manufacturing scale up of complex and innovative treatments for patients battling cancer and other life-threatening diseases.
Our proprietary nanotechnology platform is currently centered around the enhanced delivery of a variety of drugs using novel liposomal encapsulation technology. Liposomal encapsulation has been extensively explored and undergone significant technical and commercial advances since it was first developed. Our 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.
We plan to exploit our nanotechnology platform and expertise using a simple multi-step model that enables us to address unmet needs or underserved conditions while managing risks and minimizing development costs through: (1) mapping of the current and anticipated market landscape to clearly understand the clinical and commercial opportunities and defining nanotechnology options, (2) redesign of known, safe and effective active pharmaceutical ingredients with new nanotechnology, (3) manufacture-to-scale of the reformulated drug along with critical non-clinical (i.e. bench, animal) analyses, (4) evaluation of early-stage clinical utility with a focus on proving safety and defining efficacy over the current standard of care, and (5) partnering the innovative treatment for late-stage clinical trials, regulatory approval, and commercial launch.
We intend to build our pipeline by in-licensing and/or acquiring drugs for niche and orphan markets, initially in oncology, that address significant unmet or substantially underserved medical needs and that represent global revenue opportunities greater than $250 million. We intend to focus our pipeline on products that maximize our in-house expertise in nanoparticle drug design and complex formulation and leverage accelerated regulatory pathways by the U.S. Food and Drug Administration (FDA).
Our lead product candidate, DocePLUS, is a protein-stabilized PEGylated liposomal formulation of docetaxel, for which the process of preparation is patented. The active pharmaceutical ingredient, docetaxel, was approved by the FDA in 1999 and commonly used for treating cancers of the breast, head, neck, stomach, prostate, and lung.
In nonclinical studies utilizing mouse tumor models (lung, prostate, pancreatic, and mesothelioma), DocePLUS exhibited anti-tumor activity and was well-tolerated.
A Phase 1 clinical trial was conducted under an approved FDA Investigational New Drug application to examine the safety, pharmacokinetics, and pharmacodynamics of DocePLUS in 29 patients with solid tumors. The completed and published trial demonstrated that DocePLUS has an acceptable tolerability, a favorable pharmacokinetic profile, as well as promising anti-tumor activity that we believe warrants further exploration in larger Phase 2 trials.
The development targets for DocePLUS are potentially broad, however our initial focus is to develop a new second-line treatment option for small cell lung cancer. Single-agent chemotherapy with IV topotecan is currently the only FDA approved drug for platinum-sensitive patients who relapse at least 60 days after initiation of first-line treatment. Intravenously administered topotecan demonstrates activity in this population, however, overall response rate (24%), response duration (3.3 months), time to progression (3.1 months), and overall survival (5.8 months) were not statistically improved over CAV (cyclophosphamide, doxorubicin, and vincristine) treatment in a randomized comparative trial of patients with recurrent or progressive small cell lung cancer. Patients receive 1.5 mg/m2 IV infusion of topotecan over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. We believe there is a clinical need for more effective and convenient treatment options for patients with small cell lung cancer with platinum-sensitive disease who relapsed.
Besides potential safety and efficacy benefits of DocePLUS, the dosing regimen for DocePLUS in small cell lung cancer patients will be only a 60 minute infusion on a single day, starting on Day 1 of a 21-day cycle. This approach will reduce the patient's number of visits to an infusion center from 5 (IV topotecan) to 1 in a given 21-day cycle. Overall, DocePLUS is intended to provide an effective, safe, and convenient therapeutic option for small cell lung cancer patients, thereby improving the quality of life for this population.
Recent key events associated with DocePLUS development include:
Our next step is to conduct a Phase 2 clinical trial in small cell lung cancer under our existing, approved Investigation New Drug application. The goal of this trial is to assess safety and investigate efficacy signals in patients with platinum-sensitive small cell lung cancer who have progressed. The trial is also intended to support the statistical powering or a pivotal trial for the same indication.
We have also completed significant development work on DoxoPLUS, a generic version of Janssen's DOXIL /CAELYX , a PEGylated liposomal encapsulated doxorubicin for the treatment of breast and ovarian cancer, multiple myeloma, and Kaposi's sarcoma. PEGylated liposomal encapsulated doxorubicin is a heavily relied upon chemotherapeutic used globally for treating many types of cancer. We believe that data from a 38-patient European study of DoxoPLUS has met the statistical criteria for bioequivalence to CAELYX , the current reference listed drug in Europe. We believe that these bioequivalence data for DoxoPLUS can serve as a basis for a Marketing Authorization Application to be submitted to the European Medicines Agency, or EMA. The market size for PEGylated liposomal encapsulated doxorubicin in Europe is approximately $120 million. Our plan is to partner DoxoPLUS and we are currently in discussions with third parties. We do not currently plan to expend any more of our own funds to advance DoxoPLUS.
While we are continually looking at other product development candidates, we do not currently have any active product candidates other than DocePLUS.
On April 24, 2019 we completed the sale transaction of our UK subsidiary, Cytori Ltd., and our Cell Therapy assets, and on April 25, 2019 we completed the sale of our Japanese subsidiary, Cytori Therapeutics, K.K., and substantially all of our Cell Therapy assets used in Japan.
Results of Operations
Continuing operations
Development revenues
Under our government contract with BARDA, we recognized a total of $3.0 million and $3.7 million in development revenues for the years ended December 31, 2018 and 2017, respectively which included allowable fees as well as cost reimbursements. During the years ended December 31, 2018 and 2017, we incurred $2.7 million and $3.5 million in qualified expenditures, respectively. The decrease in revenues for the year ended December 31, 2018 as compared to 2017 is primarily due to decreases in research and development activities related to our contract with BARDA as we began a new clinical phase of the contract.
The future: On July 21, 2019, we received an order from BARDA to suspend all work related to the RELIEF clinical trial, except for certain activities related to orderly close out of the trial and contract. Pursuant to the order, within a period no longer than 180 days (or by January 17, 2020), the contract will be terminated by BARDA.
Research and development expenses
Research and development expenses relate to the development of oncology drug program expenses, as well as the continued development efforts related to our clinical trials.
Research and development expenses include costs associated with the design, development, testing and enhancement of our product candidates, payment of regulatory fees, laboratory supplies, pre-clinical studies and clinical studies.
The following table summarizes the components of our research and development expenses for the years ended December 31, 2018 and 2017 (in thousands):
| Years ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| General research and development | $ | 5,464 | $ | 4,939 | ||||
| Share-based compensation | 59 | 134 | ||||||
| Total research and development expenses | $ | 5,523 | $ | 5,073 |
The increase in research and development expenses for the year ended December 31, 2018 as compared to the same period in 2017 is primarily due to an increase in salaries and benefits of $0.8 million.
The future: We expect aggregate research and development expenditures remain at current levels for 2019, as we begin enrollment of our RELIEF clinical trial and our ongoing development efforts of ATI-0918 and ATI-1123.
Sales and marketing expenses
Sales and marketing expenses include costs of sales and marketing personnel, events and tradeshows, customer and sales representative education and training, primary and secondary market research, and product and service promotion. The following table summarizes the components of our sales and marketing expenses for the years ended December 31, 2018 and 2017 (in thousands):
| Years ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Sales and marketing | $ | 617 | $ | 1,281 | ||||
| Share-based compensation | 26 | 60 | ||||||
| Total sales and marketing expenses | $ | 643 | $ | 1,341 |
Sales and marketing expenses decreased by $0.7 million for the year ended December 31, 2018 as compared to the same period in 2017 primarily due to decreases of $0.5 million in salaries and benefits.
The future: We expect sales and marketing expenditures to remain at current levels for 2019, as we delay efforts on commercial readiness activities for Habeo in the U.S.
General and administrative expenses
General and administrative expenses include costs for administrative personnel, legal and other professional expenses, and general corporate expenses. The following table summarizes the general and administrative expenses for the years ended December 31, 2018 and 2017 (in thousands):
| Years ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| General and administrative | $ | 5,350 | $ | 6,245 | ||||
| Share-based compensation | 229 | 455 | ||||||
| Total general and administrative expenses | $ | 5,579 | $ | 6,700 |
General and administrative expenses decreased by $1.1 million for the year ended December 31, 2018, as compared to 2017 primarily due to decreases of $0.7 million in salary and related benefits and $0.8 million in professional services expenses consistent with our ongoing cost curtailment efforts and restructuring implemented in September 2017, offset by an increase of $0.6 million related to the termination of a Lease Agreement for office space for our corporate headquarters in San Diego, California.
The future: We expect general and administrative expenditures to remain at current levels during 2019.
Share-based compensation expenses
Share-based compensation expenses include charges related to options and restricted stock awards issued to employees, directors and non-employees. We measure stock-based compensation expense based on the grant-date fair value of any awards granted to our employees. Such expense is recognized over the requisite service period.
The following table summarizes the components of our share-based compensation expenses for continuing operations for the years ended December 31, 2018 and 2017 (in thousands):
| Years ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Research and development-related | $ | 59 | $ | 134 | ||||
| Sales and marketing-related | 26 | 60 | ||||||
| General and administrative-related | 229 | 455 | ||||||
| Total share-based compensation | $ | 314 | $ | 649 |
The decrease in share-based compensation expenses for the year ended December 31, 2018 as compared to 2017 is primarily related to a delayed annual grant to directors and officers, lower annual grant activity to remaining employees caused by reductions in headcount and due to the decline in the stock price during 2018 as compared to the same periods in 2017, and its corresponding impact on share-based compensation.
The future: We expect to continue to grant options and stock awards (which will result in an expense) to our employees, directors, and, as appropriate, to non-employee service providers. In addition, previously granted options will continue to vest in accordance with their original terms. As of December 31, 2018, the total compensation cost related to non-vested stock options and stock awards not
yet recognized for all our plans is approximately $0.2 million which is expected to be recognized as a result of vesting under service conditions over a weighted average period of 1.45 years.
In process research and development acquired from Azaya Therapeutics
In February 2017, we entered into an agreement to acquire assets, including in process research and development, or IPR&D, related to two oncology drug product candidates, from Azaya Therapeutics. In connection with this agreement, we recorded an IPR&D charge totaling $1.7 million. The acquired IPR&D is in the early stage of development and has no alternative use. Additional research, pre-clinical studies, and regulatory approvals must be successfully completed prior to commercialization of any product.
The following table summarizes interest income, interest expense, and other income and expense for the years ended December 31, 2018 and 2017 (in thousands):
| Years ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Interest income | $ | 43 | $ | 33 | ||||
| Interest expense | (1,922 | ) | (2,049 | ) | ||||
| Change in fair value of warrants | 2,233 | - | ||||||
| Issuance cost of warrants | (470 | ) | - | |||||
| Total | $ | (116 | ) | $ | (2,016 | ) |
The future: We expect interest expense in 2019 to decrease slightly in the second half of the year. In addition, regarding to the changes in fair value of warrants, there could be material fluctuations in the value of warrants in future periods because our stock price can be volatile. Future changes in the fair value of the warrant liability will be recognized in earnings until such time as the warrants are exercised or expire.
Discontinued Cell Therapy Business
All revenues, and related operating and nonoperating expenses have been classified as discontinued operations in accordance with authoritative accounting guidance.
Liquidity and Capital Resources
Short-term and long-term liquidity
The following is a summary of our key liquidity measures for continuing operations at December 31, 2018 and 2017 (in thousands):
| As of December 31, | ||||||||
| 2018 | 2017 | |||||||
| Cash and cash equivalents | $ | 5,261 | $ | 9,550 | ||||
| Current assets | $ | 6,371 | $ | 11,242 | ||||
| Current liabilities | 16,979 | 17,831 | ||||||
| Working capital deficit | $ | (10,608 | ) | $ | (6,589 | ) |
We incurred net losses of $12.6 million for the twelve months ended December 31, 2018, including loss from discontinued operations of $3.8 million. We have an accumulated deficit of $414.4 million as of December 31, 2018. Additionally, we used net cash of $12.0 million to fund our operating activities for the twelve months ended December 31, 2018. These factors raise substantial doubt about the Company's ability to continue as a going concern.
Further, the Loan and Security Agreement (defined below), with Oxford Finance, LCC ("Oxford"), requires the Company to maintain a minimum of $2.0 million in unrestricted cash and cash equivalents on hand to avoid an event of default under the Loan and Security Agreement and requires the Company to achieve one of the following by March 29, 2019: (i) enter into an asset sale agreement with a
minimum unrestricted net cash proceeds to the Company of $4.0 million; or (ii) enter into a binding agreement for the issuance and sale of its equity securities or unsecured convertible subordinated debt which would result in unrestricted gross cash proceeds of not less than $7.5 million; or enter into a merger agreement pursuant to which the obligations under the Loan Agreement would be paid down to a level satisfactory to Oxford. Based on our cash and cash equivalents on hand of approximately $5.3 million at December 31, 2018, the Company estimates that it will need to raise additional capital and/or obtain a waiver or restructure the Loan and Security Agreement in the near term to avoid defaulting under its $2.0 million minimum cash/cash equivalents covenant.
To date, these operating losses have been funded primarily from outside sources of invested capital including our recently completed 2018 Rights Offering (defined below), our Lincoln Park Purchase Agreement (defined below) with Lincoln Park Capital Fund, LLC ("Lincoln Park"), the Loan and Security Agreement and gross profits. We have had, and we will continue to have, an ongoing need to raise additional cash from outside sources to fund our future clinical development programs and other operations. Our inability to raise additional cash would have a material adverse impact on operations and would cause us to default on our loan.
On April 11, 2017, we entered into an underwriting agreement (the "Underwriting Agreement") with Maxim Group LLC ("Maxim") relating to the issuance and sale of 17,881 shares of our common stock. The price to the public in this offering was $550 per share. Maxim purchased the shares from us pursuant to the Underwriting Agreement at a price of $520.00 per share. The net proceeds to us from the offering were approximately $8.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us. The offering closed on April 17, 2017. In addition, under the terms of the Underwriting Agreement, we granted Maxim a 45-day option to purchase up to 1,888 additional shares of common stock. On May 31, 2017, Maxim exercised their overallotment option and purchased 1,698 shares at $550 per share. The net proceeds to us were $0.8 million, after deducting underwriting costs and offering expenses payable by us.
On September 5, 2017, we received a written notice from The Nasdaq Stock Market LLC ("Nasdaq") indicating that, based upon the closing bid price of our common stock for the prior 30 consecutive business days, we no longer met the requirement to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided a period of 180 calendar days, or until March 5, 2018, in which to regain compliance. We were granted an additional compliance period of 180 calendar days, or until September 4, 2018, in which to regain compliance after meeting the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and providing notice to Nasdaq of our intent to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. In order to regain compliance with the minimum bid price requirement, the closing bid price of our common stock must have been at least $1.00 per share for a minimum of ten consecutive business days during the second 180-day period. On June 8, 2018, we received written notice from Nasdaq that we had regained compliance with the Nasdaq Stock Market Listing Rule 5500(a)(2) concerning our minimum bid price per share of our common stock.
On November 28, 2017, we closed a rights offering originally filed under a Form S-1 registration statement in August 2017 ("2017 Rights Offering"). Pursuant to the 2017 Rights Offering, the Company sold an aggregate of 10,000 units consisting of a total of 10,000 shares of Series B Convertible Preferred Stock, immediately convertible into approximately 60,000 shares of common stock and 360,000 warrants, exercisable for an aggregate of 36,000 shares of common stock at an exercise price of $166.65 per share of common stock, resulting in total net proceeds to the Company of $8.8 million. These warrants became exercisable on May 18, 2018.
On June 1, 2018, we entered into a Sales Agreement with B. Riley FBR, Inc. ("B. Riley FBR") to sell shares of our common stock having an aggregate offering price of up to $6.5 million from time to time, through an "at the market" equity offering program (the "ATM program") under which B. Riley FBR will act as sales agent. Through December 31, 2018, we have sold a total of 79,234 shares for proceeds of approximately $1.7 million through the ATM program.
On July 25, 2018, we closed a rights offering originally filed under a Form S-1 registration statement in April 2018 ("2018 Rights Offering"). Pursuant to the 2018 Rights Offering, the Company sold an aggregate of 6,723 units consisting of a total of 6,723 shares of Series C Convertible Preferred Stock, immediately convertible into approximately 168,478 shares of common stock and 7,059,150 warrants, with 50 warrants exercisable for one share of common stock at an exercise price of $39.93 per share, resulting in total net proceeds to the Company of approximately $5.7 million.
On August 28, 2018, we received a written notice from Nasdaq indicating that, based upon the closing bid price of our common stock for the prior 30 consecutive business days, we no longer meet the requirement to maintain a minimum bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided an initial period of 180 calendar days, or until February 25, 2019, in which to regain compliance. On February 26. 2019, we were granted an additional compliance period of 180 calendar days, or until August 26, 2019, in which to regain compliance after meeting the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and providing notice to Nasdaq staff of our intent to cure the deficiency during this second compliance period, by effecting a reverse stock split, if necessary. In order to regain compliance with the minimum bid price requirement, the closing bid price of our common stock must have been at least $1.00 per share for a minimum of ten consecutive business days during the 180-day period.
On September 21, 2018, Plus entered into a purchase agreement and a registration rights agreement, with Lincoln Park, pursuant to which the Company has the right to sell to Lincoln Park and Lincoln Park is obligated to purchase up to $5.0 million of shares of the Company's common stock over the 24-month period following October 15, 2018, subject to the satisfaction of certain conditions. Through December 31, 2018, the Company sold a total of 12,802 shares for proceeds of approximately $0.3 million through the Lincoln Park Purchase Agreement. See Note 10 for further discussion on the Lincoln Park Agreement.
We continue to seek additional capital through product revenues, strategic transactions, including extension opportunities under our awarded U.S. Department of Health and Human Service's Biomedical Advanced Research and Development Authority ("BARDA") contract, and from other financing alternatives. Without additional capital, current working capital and cash generated from sales will not provide adequate funding for research, sales and marketing efforts and product development activities at their current levels. If sufficient capital is not raised, we will at a minimum need to significantly reduce or curtail our research and development and other operations, and this would negatively affect our ability to achieve corporate growth goals.
Should we be unable to raise additional cash from outside sources, this would have a material adverse impact on our operations.
The accompanying consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.
Cash (used in) provided by operating, investing and financing activities for the years ended December 31, 2018 and 2017 is summarized as follows (in thousands):
| Years Ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Net cash used in operating activities | $ | (11,975 | ) | $ | (18,128 | ) | ||
| Net cash used in investing activities | (133 | ) | (1,383 | ) | ||||
| Net cash provided by financing activities | 7,168 | 16,815 | ||||||
| Effect of exchange rate changes on cash and cash equivalents | 16 | 11 | ||||||
| Net decrease in cash and cash equivalents | $ | (4,924 | ) | $ | (2,685 | ) |
Operating activities
Net cash used in operating activities for the year ended December 31, 2018 was $12.0 million. Overall, our operational cash use decreased during the year ended December 31, 2018 as compared to 2017 due primarily to a decrease in losses from operations (when adjusted for non-cash items) of $6.1 million.
Investing activities
The decrease in net cash used in investing activities for the year ended December 31, 2018, as compared to 2017, resulted primarily from cash outflows for payment for long-lived assets purchased as part of Azaya's acquisition of $1.2 million and purchase of fixed assets of $0.2 million.
Financing Activities
The net cash provided by financing activities for the year ended December 31, 2018 is primarily related to sales of common and preferred stocks of $7.2 million, net of costs from sale, through our Rights Offering, a confidentially marketed public offering, Lincoln Park Agreement and ATM program, which decreased compared to the sales of common and preferred stocks of $21.5 million, net of costs from sale, for the year ended December 31, 2017, offset by the cash used in principal payments on our debt of $4.7 million.