SENSEI BIOTHERAPEUTICS, INC. Certain statements contained in this Quarterly Report on Form 10-Q may
constitute forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. The words "may," "might," "can," "will," "to be,"
"could," "would," "should," "expect," "intend," "plan," "objective,"
"anticipate," "believe," "estimate," "predict," "project," "potential,"
"likely," "continue," "ongoing" or similar expressions, or the negative of such
words, are intended to identify "forward-looking statements." We have based
these forward-looking statements on our current expectations and projections
about future events. Because such statements include risks and uncertainties,
actual results may differ materially from those expressed or implied by such
forward-looking statements. Factors that could cause or contribute to these
differences include those below in this Quarterly Report on Form 10-Q and those
in our Annual Report on Form 10-K, in each case under the caption "Risk
Factors," and in our other filings with the
The following discussion and analysis of our financial condition and results of
operations should be read in conjunction with our unaudited condensed
consolidated financial statements and related notes that appear in Item 1 of
this Quarterly Report on Form 10-Q and with our audited consolidated financial
statements and related notes for the year ended
Overview
We are developing a pipeline of medicines designed to fulfill the substantial potential of the immune system to defeat cancer and other diseases. Our research investment today is directed toward two immuno-oncology platforms, (i) our ImmunoPhage™ platform and Phortress™ library and (ii) our Tumor Microenvironment Antibody biologics, or TMAb platform:
ImmunoPhage platform and
Our proprietary ImmunoPhage platform is a powerful, self-adjuvanted and highly differentiated immunotherapy. We use inactivated bacteriophage virus, which is ubiquitous and has the potential to induce a robust, focused and coordinated innate and adaptive immune response. In addition, as part of this platform, we are creating an expanding library of pre-manufactured immunophages, which we refer to as our Phortress library. The versatility of our ImmunoPhage platform allows us to design product candidates in a modular, off-the-shelf fashion based on a cocktail of common and patient-specific antigens built from the Phortress library.
Our ImmunoPhage platform is designed to deliver three distinct technological advantages over existing platforms: 1) the use of bacteriophage to deliver a highly immunogenic vaccine strategy; 2) gene transfer technology for exquisite targeting of antigen presenting cells, or APCs; and 3) speed-to-treatment capabilities via the Phortress library.
ImmunoPhage product candidate: SNS-401-NG
SNS-401-NG, our multi-antigenic personalized ImmunoPhage candidate, is being
developed in collaboration with the
TMAb platform
Our TMAb platform is comprised of human monoclonal antibodies and alpaca-derived nanobodies selectively active in the tumor microenvironment. We are initially focusing our research for this platform on an immune checkpoint regulator V-set Immunoglobulin Domain Ig Suppressor of T-cell activation, or VISTA, which may play a role in both intrinsic and acquired PD-1/PD-L1 resistance, and V-Set And Immunoglobulin Domain Containing 4, or VSIG4, a potent inhibitor of T-cell activity, often overexpressed on macrophages within the tumor microenvironment. Through the targeted use of this platform, we believe we can further enhance activity of cancer therapies either as a monotherapy or synergistic with PD-1/PD-L1 inhibition.
15
--------------------------------------------------------------------------------
TMAb platform product candidates: SNS-VISTA and VSIG4 program
SNS-VISTA has been designed to selectively target pH-sensitive antibodies that bind only at the tumor site, as opposed to at the physiological site. Antibodies that bind at the physiological site in the tumor may encounter a "sink", which may prevent effective binding and lead to toxicities.
We have identified a set of fully-human, highly selective pH-dependent
anti-VISTA antibodies, which we are evaluating preclinically. In
We plan to present preclinical data from the SNS-VISTA program at a scientific conference in 2021 and to initiate IND-enabling studies by the end of 2021.
VSIG4 is a B7-family related protein and a potent inhibitor of T-cell activity, often overexpressed on macrophages within the tumor microenvironment. VSIG4 may play a role in enforcing the immunosuppressive program in macrophage-rich tumors. Inhibition of VSIG4 activity could also enhance T-cell-mediated anti-tumor immune responses. We anticipate the selection of a product candidate from this program in 2023.
We do not have any product candidates approved for sale, have not generated any
revenue from product sales, and do not expect to generate any revenue from
product sales for at least the next several years. We have largely funded our
operations with proceeds from the sale of convertible preferred stock, common
stock and convertible debt. Through the date of this report, we have raised an
aggregate of
We have incurred significant operating losses over the last several years. Our
net loss was
•prepare to submit INDs and then initiate clinical development of product candidates, including SNS-VISTA, VSIG4 and SNS-401-NG.
•continue the research and development of our other product candidates;
•invest in our ImmunoPhage and TMAb platforms;
•seek to discover and develop additional product candidates or acquire or in-license drugs, product candidates or technologies;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•ultimately establish a sales, marketing and distribution infrastructure and scale up manufacturing capabilities to commercialize any product candidates for which we may obtain regulatory approval;
•manufacture our product candidates or otherwise secure the clinical and commercial supply of our product candidates;
•hire additional research and development and selling, general and administrative personnel;
•maintain, expand and protect our intellectual property portfolio; and
•incur additional costs associated with operating as a public company.
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses. We expect to continue to incur net losses and negative cash flows for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our product candidates, as well as hire additional personnel, pay fees to outside consultants, lawyers and accountants, and incur other
16
--------------------------------------------------------------------------------
increased costs associated with being a public company. In addition, if we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product
Recent Security Issuances
From
In
Impact of COVID-19
In
In addition, a further recurrence of COVID-19 cases could cause other widespread or more severe impacts depending on where infection rates are highest. We plan to continue to closely monitor the ongoing impact of the COVID-19 pandemic on our employees and our business operations, as we deal with the disruptions and uncertainties relating to the COVID-19 pandemic. In an effort to provide a safe work environment for our employees, we have, among other things, implemented various social distancing measures in our office and labs including replacing in-person meetings with virtual interactions, and are working remotely when possible. We expect to continue to take actions as may be required or recommended by government authorities or as we determine are in the best interests of our employees and other business partners in light of the pandemic. To date, there has not been a significant impact on our product candidate development or on the rest of our pipeline; however we cannot at this time predict the specific extent, duration, or full impact that the COVID-19 pandemic could potentially have on our ongoing business plan, financial condition and operations.
Components of Our Results of Operations
Operating Expenses
Research and Development Expense
Our research and development expense consists of expenses incurred in connection with the discovery and development of our product candidates. These expenses include:
• expenses incurred under agreements with CROs, as well as investigative sites
and consultants that conduct our preclinical studies and clinical trials;
• the cost of manufacturing our product candidates including the potential
cost of CMOs that manufacture product for use in our preclinical studies and
clinical trials and perform analytical testing, scale-up and other services
in connection with our development activities;
• the cost of outsourced professional scientific development services;
• employee-related expenses, including salaries, benefits and stock-based
compensation for employees engaged in the research and development function;
• expenses relating to regulatory activities, including filing fees paid to
regulatory agencies;
• fees for maintaining licenses and other amounts due under our third party
licensing agreements;
• laboratory materials and supplies used to support our research activities;
and
• allocated expenses for utilities and other facility-related costs.
17
--------------------------------------------------------------------------------
We expense all research and development costs in the periods in which they are incurred. Costs for certain research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers.
Our direct external research and development expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research/testing laboratories and outside consultants in connection with our preclinical development, process development, manufacturing and clinical development activities. We do not allocate these costs to specific product candidates because many of them are deployed across several of our development programs and, as such, are not separately classified. We use internal resources primarily to conduct research and manage our preclinical development, outsourced clinical trials, process development, manufacturing and clinical development activities. These employees work across multiple development programs and, therefore, we do not track their costs by program and, as such, are not separately classified. Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase significantly over the next several years as we increase personnel costs, including stock-based compensation, conduct our preclinical studies and clinical trials, and prepare regulatory filings for our product candidates.
The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from any of our other product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:
• the scope, progress, outcome and costs of our preclinical studies, our
current product candidates and any other product candidates we may acquire
or develop;
• manufacturing of our product candidates or making arrangements with
potential third-party manufacturers for both clinical and commercial
supplies of these product candidates;
• successful patient enrollment in, and the initiation, duration and
completion of clinical trials;
• the cost of gaining regulatory approvals for our product candidates, subject
to the successful outcome of ongoing and future clinical trials; and
• the extent of any required post-marketing approval commitments to applicable
regulatory authorities.
Our expenditures are subject to additional uncertainties, including the terms and timing of regulatory approvals, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights. We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Product commercialization will take several years and significant additional development costs.
General and Administrative Expense
General and administrative expenses consist principally of salaries and related costs for personnel in executive, administrative, finance and legal functions, including stock-based compensation, travel expenses and recruiting expenses. Other general and administrative expenses include facility related costs, patent filing and prosecution costs and professional fees for legal, auditing and tax services, and insurance costs.
We anticipate that our general and administrative expenses will increase as a
result of increased payroll, expanded infrastructure and higher consulting,
legal and tax-related services associated with maintaining compliance with
Nasdaq listing and
18
--------------------------------------------------------------------------------
Alvaxa IPR&D
On
The 304,376 shares of common stock was valued at
Other Income (Expense)
Our other income (expense) consists of changes in the fair value of our derivative liability related to an embedded derivative on certain convertible debt, realized gain or loss on short-term investments, gain on debt extinguishments, accretion expense on short-term investments and interest expense.
Income Taxes
Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development tax credits earned in each year, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credit carryforwards will not be realized.
Results of Operations
Comparison of the Three Months Ended
The following sets forth our results of operations for the three months endedSeptember 30, 2021 and 2020: Three Months Ended September 30, (in thousands) 2021 2020 Change Operating expenses: Research and development $ 6,443 $ 3,576$ 2,867 General and administrative 3,873 1,788 2,085 Total operating expenses $ 10,316 $ 5,364$ 4,952 Loss from operations (10,316 ) (5,364 ) (4,952 ) Total other income (expense) 631 (3 ) 634 Net loss $ (9,685 )$ (5,367 ) $ (4,318 )
Research and Development Expenses
Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
19
--------------------------------------------------------------------------------
Other Income (Expense)
Other income was
Comparison of the Nine Months Ended
The following sets forth our results of operations for the nine months endedSeptember 30, 2021 and 2020: Nine Months Ended September 30, (in thousands) 2021 2020 Change Operating expenses: Research and development $ 15,706 $ 8,629$ 7,077 General and administrative 12,363 5,007 7,356 Alvaxa IPR&D - 738 (738 ) Total operating expenses $ 28,069 $ 14,374$ 13,695 Loss from operations (28,069 ) (14,374 ) (13,695 ) Total other income (expense) 641 (595 ) 1,236 Net loss$ (27,428 ) $ (14,969 ) $ (12,459 )
Research and Development Expenses
Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
Other Income (Expense)
Other income was
Liquidity and Capital Resources
Sources of Liquidity
We have not generated any product revenue and have incurred net losses and
negative cash flows from our operations. We have financed our operations through
sales of our common stock, convertible preferred stock and convertible debt.
Through the date of this report, we have raised an aggregate of
20
--------------------------------------------------------------------------------
As of
Cash Flows
The following table summarizes our sources and uses of cash for each of the
periods below:
Nine Months Ended September 30,
(in thousands) 2021 2020
Net cash used in operating activities $ (22,391 ) $ (15,025 )
Net cash used in investing activities (148,730 ) (1,087 )
Net cash provided by financing activities 164,058 19,594
Net (decrease) increase in cash and cash equivalents $ (7,063 ) $ 3,482
Operating Activities
During the nine months ended
Investing Activities
During the nine months ended
Financing Activities
During the nine months ended
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or initiate clinical trials of, and potentially seek marketing approval for, our product candidates. In addition, we expect to incur significant costs associated with operating as a newly public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company. The timing and amount of our operating expenditures will depend largely on:
• the initiation, progress, timing, costs and results of current and future
preclinical studies and clinical trials for SNS-401-NG and SNS-VISTA and our
other product candidates;
• the cost and timing of the manufacture of additional clinical trial material
as well as any costs related to the scale-up of manufacturing activities;
• the costs to seek regulatory approvals for any product candidates that
successfully complete clinical trials;
• the extent to which we or any third-party service providers on whom we rely
experience delays or interruptions to preclinical studies and clinical
trials, or to our supply chain due to the COVID-19 pandemic;
21
--------------------------------------------------------------------------------
• the need to hire additional clinical, quality assurance, quality control and
other scientific personnel;
• the number and characteristics of product candidates that we develop or may
in-license;
• the outcome, timing and cost of meeting and maintaining compliance with
regulatory requirements;
• the cost of filing, prosecuting, defending and enforcing our patent claims
and other intellectual property rights;
• the terms of any collaboration agreements we may choose to enter into,
including the achievement of milestones or occurrence of other developments
that trigger payments under any license or collaboration agreements we might
have at such time;
• the cost associated with the expansion of our operational, financial and
management systems and increased personnel, including personnel to support
our operations as a public company; and
• the cost of establishing sales, marketing and distribution capabilities for
any product candidates for which we may receive regulatory approval in
regions where we choose to commercialize our products, if approved, on our
own.
We expect our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements at least into the first half of 2024. We have based this estimate on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:
• the scope, progress, results and costs of product discovery, preclinical
studies and clinical trials;
• the scope, prioritization and number of our research and development
programs;
• the costs, timing and outcome of regulatory review of our product candidates;
• our ability to establish and maintain collaborations on favorable terms, if
at all;
• the extent to which we are obligated to reimburse, or entitled to
reimbursement of, clinical trial costs under collaboration agreements, if
any;
• the costs of preparing, filing and prosecuting patent applications,
maintaining and enforcing our intellectual property rights and defending
intellectual property-related claims;
• the extent to which we acquire or in-license other product candidates and
technologies;
• the costs of securing manufacturing arrangements for commercial production;
• the costs of establishing or contracting for sales and marketing
capabilities if we obtain regulatory approvals to market our product
candidates; and
• the impact of the COVID-19 pandemic and the corresponding responses of
businesses and governments.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in fixed payment obligations.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Internal Control Over Financial Reporting
During the audit of our financial statements for the year ended
22
--------------------------------------------------------------------------------
combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.
We are in the process of implementing a number of measures to address the
material weaknesses and deficiencies that have been identified including:
(i) hiring additional accounting and financial reporting personnel with
generally accepted accounting principles in
These additional resources and procedures are designed to enable us to broaden the scope and quality of our internal review of underlying information related to financial reporting and to formalize and enhance our internal control procedures. With the oversight of senior management and our audit committee, we have begun taking steps and plan to take additional measures to remediate the underlying causes of the material weaknesses.
We intend to complete the implementation of our remediation plan during the remainder of 2021. Although we believe that our remediation plan will improve our internal control over financial reporting, additional time may be required to fully implement it and to make conclusions regarding the effectiveness of our internal control over financial reporting. Our management will closely monitor and modify, as appropriate, the remediation plan to eliminate the identified material weakness.
If our remediation of the material weaknesses is not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations. Accordingly, there could continue to be a reasonable possibility that a material misstatement of our financial statements would not be prevented or detected on a timely basis. We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to remediate the material weaknesses we have identified or avoid potential future material weaknesses.
We, and our independent registered public accounting firm, were not required to
report on our evaluation of the Company's internal control over financial
reporting as of
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any
off-balance sheet arrangements, as defined in the rules and regulations of the
Critical Accounting Policies and Significant Judgements and Estimates
This Management's Discussion and Analysis of Financial Condition and Results of Operations is based on our financial statements, which are prepared in accordance with US GAAP. The preparation of our financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.
We define our critical accounting policies as those accounting principles that
require us to make subjective estimates and judgments about matters that are
uncertain and are likely to have a material impact on our financial condition
and results of operations, as well as the specific manner in which we apply
those principles. During the three months ended
Recent Accounting Pronouncements
See note 2 in our condensed consolidated financial statements included elsewhere in this Form 10-Q for a description of recent accounting pronouncements applicable to our financial statements. Other than as disclosed in our financial statements, we do not expect that any recently issued accounting standards will have a material impact on our financial statements or will otherwise apply to our operations.
23
--------------------------------------------------------------------------------
Emerging Growth Company and Smaller Reporting Company Status
We qualify as an EGC, as defined in the JOBS Act. As an EGC, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally to public companies, including reduced disclosure about our executive compensation arrangements, exemption from the requirements to hold non-binding advisory votes on executive compensation and golden parachute payments and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.
We may take advantage of these exemptions until the last day of the fiscal year
following the fifth anniversary of our initial public offering or such earlier
time that we are no longer an emerging growth company. We would cease to be an
EGC earlier if we have more than
In addition, the JOBS Act provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to "opt out" of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to "opt out" of such extended transition period or (ii) no longer qualify as an EGC. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.
We are also a "smaller reporting company," meaning that the market value of our
stock held by non-affiliates is less than
If we are a smaller reporting company at the time we cease to be an EGC, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to EGCs, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
24
--------------------------------------------------------------------------------
© Edgar Online, source
