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You should consider carefully the risks and uncertainties described below, together with all of the other information in the Company s reports filed
with the SEC. We operate in a dynamic and rapidly changing industry that involves numerous risks and uncertainties. The risks and uncertainties described below are not the only ones we face. Other risks and uncertainties, including those that we do
not currently consider material, may impair our business. If any of the risks discussed below actually occur, our business, financial condition, operating results or cash flows could be materially adversely affected. This Exhibit 99.1 may contain
forward-looking statements that reflect our current views with respect to our development programs, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with
respect to us, specifically, and our industry, in general. Such forward-looking statements include the words expect, intend, plan, believe, project, estimate, may,
should, anticipate, will and similar statements of a future or forward-looking nature identify forward-looking statements.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs,
expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking statements are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict and many of which are outside of our control. There are or will be important factors that could cause actual results to differ materially from those indicated in these statements.
These factors include, but are not limited to, sections entitled Legal Proceedings, and Management s Discussion and Analysis of Financial Condition and Results of Operations, in our annual report on Form 10-K for the
year ended December 31, 2017, which you should review carefully. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by
Risks Relating to Our Financial Position and Capital Needs
We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the
We are a clinical-stage biopharmaceutical company focused on development of novel cancer immunotherapies for a broad range of
cancer indications. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove effective, gain regulatory
approval or become commercially viable. We do not have any products approved by regulatory authorities and have not generated any revenues from collaboration and licensing agreements or product sales to date in respect of immunotherapy products, and
have incurred significant research, development and other expenses related to our ongoing operations and expect to continue to incur such expenses. As a result, we have not been profitable and have incurred significant operating losses in every
reporting period since our inception. For the years ended December 31, 2017 and 2016, we reported a net loss of $23.8 million and $17.7 million, respectively, and as of March 31, 2018, December 31, 2017 and 2016, had an
accumulated deficit of $62.2 million, $54.2 million and $30.4 million, respectively.
We do not expect to generate revenues for many years,
if at all. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate these losses to increase as we continue to research, develop and seek regulatory approvals for our product candidates and
any additional product candidates we may acquire, and potentially begin to commercialize product candidates that may achieve regulatory approval. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors
that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If any of our product candidates fail in clinical trials or do not
gain regulatory approval, or if approved, fail to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. We anticipate that our
expenses will increase in the future as we continue to invest in research and development of our existing product candidates, investigate and potentially acquire new product candidates and expand our manufacturing and commercialization activities.
There is substantial doubt about our ability to continue as a going concern.
As of March 31, 2018, we had a cash balance of approximately $3.5 million and restricted cash of $8.6 million. In addition, we had outstanding
accounts payable and accrued expenses of $15.9 million and an outstanding current portion of long-term debt of $8.5 million as of March 31, 2018, which consists of our senior secured debenture with JGB (Cayman) Newton Ltd, or JGB,
that is due November 2018. The outstanding principal amount is maintained in a restricted cash account. We expect our existing cash as of July 16, 2018, will enable us to fund our operating expenses and capital expenditure requirements through the
first half of 2019. Our management has concluded that our need for additional funding raises substantial doubt about our ability to continue as a going concern. Our consolidated financial statements do not include any adjustments that might result
from the outcome of this uncertainty. Our auditors have included an explanatory paragraph in their audit report for this uncertainty. Our auditors may require us to include this explanatory paragraph even following completion of this offering. If we
cannot continue as a viable entity, our securityholders may lose some or all of their investment in us.
We will require substantial additional
financing to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
We expect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of GPS, our WT1 peptide cancer
immunotherapy product candidate exclusively licensed from
MSK, the clinical development of our other product candidates including NeuVax, and the advancement and expansion of our preclinical research pipeline. These expenditures will include costs
associated with research and development, potentially acquiring new product candidates or technologies, conducting preclinical studies and clinical trials and potentially obtaining regulatory approvals and manufacturing products, as well as
marketing and selling products approved for sale, if any. Under the terms of our amended and restated license agreement with MSK, we are obligated to make royalty payments and payments upon the achievement of certain development and commercial
milestones in addition to paying guaranteed annual minimum royalties, sponsoring research and making other guaranteed payments to MSK. In addition, other unanticipated costs may arise. We have payment obligations under our other licensing and
collaboration agreements, and could potentially also owe other milestone or royalty payments thereunder. In the Merger Agreement, we also agreed to fund the NeuVax programs in the amount of $3.0 million. Because the design and outcome of our
planned and anticipated clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our current or future product candidates, nor the timing and
amounts we may owe under our various licensing and collaboration agreements.
Our future capital requirements depend on many factors, including:
We expect our existing cash as
of July 16, 2018, will enable the us to fund our planned operations through the first half of 2019. We do not expect our existing cash to be sufficient to complete development and obtain regulatory approval for any of our lead product candidates,
and we expect to need to raise significant additional capital in the future to help us do so. In addition, our operating plan may change as a result of many factors currently unknown to us, and we may need additional funds sooner than planned.
Further, we may seek additional capital due to favorable market conditions or strategic considerations
even if we believe we have sufficient funds for our then current or future operating plans. Additional funds may not be available when we need them on terms that are acceptable to us, or at all.
If adequate funds are not available to us on a timely basis, we may be required to delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for one or more of our product candidates or target
indications, or delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize our product candidates.
We currently have no source of revenues. We may never generate revenues or achieve profitability.
Currently, we do not generate any revenues from product sales or otherwise. Even if we are able to successfully achieve regulatory approval for our product
candidates, we do not know when we will generate revenues or become profitable, if at all. Our ability to generate revenues from product sales and achieve profitability will depend on our ability to successfully commercialize products, including our
current product candidate, and other product candidates that we may develop, in-license or acquire in the future. Our ability to generate revenues and achieve profitability also depends on a number of
additional factors, including our ability to:
Our revenues for any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories
for which it gains regulatory approval, the accepted price for the product, the ability to get reimbursement at any price, and whether we own the commercial rights for that territory. If the number of our addressable disease patients is not as
significant as our estimates, the indication approved by regulatory authorities is narrower than we expect, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate
significant revenues from sales of such products, even if approved. In addition, we anticipate incurring significant costs associated with commercializing any approved product candidate. As a result, even if we generate revenues, we may not become
profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be
forced to reduce our operations.
Following the Merger, our business and management is largely that of Private SELLAS, which has a
limited operating history. This may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
Private SELLAS was formed in January 2012. Its operations prior to the Merger were limited to organizing and staffing its company, acquiring product and
technology rights and conducting product development activities for its product candidate GPS. As a combined company, we have not yet demonstrated our ability to start or successfully complete any Phase 3 clinical trials, obtain regulatory approval,
manufacture a commercial scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization for any of our product candidates. In addition, the adaptive cancer
immunotherapy technology underlying our peptide cancer immunotherapy product candidate is new and largely unproven. Any predictions about our future success, performance or viability, particularly in view of the rapidly evolving cancer immunotherapy
field, may not be as accurate as they could be if we had a longer operating history as a combined company or approved products on the market.
have expanded the management team of Private SELLAS since completion of the Merger to bring on individuals with U.S. public company experience, we may still encounter unforeseen expenses, difficulties, complications, delays and other known and
unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition. We expect our financial condition
and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, any of our interim or annual periods results are not
indicative of future operating performance.
Raising additional capital may cause dilution to you and our existing stockholders, restrict our
operations or require us to relinquish rights to our product candidates on unfavorable terms to us.
We will need to raise additional capital in
the future. We may seek this additional capital through a variety of means, including through private and public equity offerings and debt financings. To the extent that we raise additional capital through the sale of equity or convertible debt
securities, or through the issuance of shares under management or other types of contracts, or upon exercise or conversion of outstanding derivative securities, the ownership interest of our stockholders will be diluted, and the terms may include
liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments and other provisions that adversely affect your rights as a stockholder. Debt financing, if available, could include covenants limiting or restricting
our ability to take certain actions, such as incurring additional debt, making capital expenditures, entering into licensing arrangements, or declaring dividends, and, like our senior secured debenture with JGB, require us to grant security
interests in our assets, including our intellectual property and for our subsidiaries to guarantee our obligations. The terms of a number of our outstanding equity and equity linked securities, including our senior secured debenture with JGB, our
Series A Preferred and our outstanding warrants, contain provisions that could result in significant additional dilution to you in the future. If we raise additional funds from third parties, we may have to relinquish valuable rights to our
technologies or product candidates or grant licenses on terms that are not favorable to us. If we are unable to raise additional funds through equity or debt financing when needed, we may be required to delay, limit, reduce or terminate our product
development or commercialization efforts for our product candidates, or grant to others the rights to develop and market product candidates that we would otherwise prefer to develop and market.
We expect to continue to incur significant operating and non-operating expenses, which may make it difficult for
us to secure sufficient financing and may lead to uncertainty about our ability to continue as a going concern.
Substantial funds were expended to
develop our technologies and product candidates, and additional substantial funds will be required for further preclinical testing and clinical trials of our product candidates, and to
manufacture and market any products that are approved for commercial sale. Because the successful development of our products is uncertain, we are unable to precisely estimate the actual funds we
will require to develop and potentially commercialize them. In addition, we may not be able to generate enough revenue, even if we are able to commercialize any of our product candidates, to become profitable.
In the event that we are unable to obtain additional financing if needed or if we incur significant expense related to the resolution of the ongoing legal
proceedings, we may not be able to meet our obligations as they come due, that in turn may make us unable to continue as a going concern. Any such inability to continue as a going concern may result in our common stock holders losing their entire
investment. There is no guaranty that we will be able to secure additional financing if we need such financing. Our financial statements contain an explanatory paragraph relating to our ability to continue as a going concern and do not contain any
adjustments that might result if we were unable to continue as a going concern. Changes in our operating plans, our existing and anticipated working capital needs, defense costs related to our ongoing legal proceedings and any additional legal
proceedings we might become subject to in the future, the acceleration or modification of our development activities, any near-term or future expansion plans, increased expenses, potential acquisitions or other events may further affect our ability
to continue as a going concern. Future financing may be obtained through, and future development efforts may be paid for by, the issuance of debt or equity, which may have an adverse effect on our securityholders or may otherwise adversely affect
If we raise funds through the issuance of debt or equity, any debt securities or preferred stock issued will have rights, preferences and
privileges senior to those of holders of our common stock in the event of a liquidation. In such event, there is a possibility that once all senior claims are settled, there may be no assets remaining to pay out to the holders of common stock. In
addition, if we raise funds through the issuance of additional equity, whether through private placements or additional public offerings, such an issuance would dilute our securityholders and, similar to some of our past financings, may contain
terms that could result in additional further significant dilution in the future.