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 and phrases "designed to," "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 an immuno-oncology company focused on the discovery and development of next-generation immunotherapies with an initial focus on treatments for cancer. Our focus is to leverage well characterized biological targets to generate novel product candidates that incorporate next generation technologies or approaches. We have built a robust set of R&D capabilities and infrastructure to support the discovery and advancement of our product candidates. Our goal is to efficiently develop these product candidates by incorporating state-of-the-art biomarker approaches and mechanistic understanding into clinical trial designs targeted to well-defined patient populations.
We have developed two platforms that are designed to address resistance to immunotherapy. Our TMAb™ (Tumor Microenvironment Activated Biologics) platform generates next-generation antibodies that are designed to block key immune checkpoints selectively within the tumor microenvironment. Our ImmunoPhage™ platform is a pioneering approach to cancer therapy that utilizes and combines aspects of vaccine, gene therapy, and personalized medicine approaches. Both platforms are designed to work independently or have the potential to be combined to create powerful rational drug combinations.
Our Pipeline We currently have four investigational products in various stages of early development:
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SNS-101 is our monoclonal antibody targeting the immune checkpoint VISTA
(V-domain Ig suppressor of T cell activation) and is currently in IND-enabling
studies. In
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SNS-102 is our monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), an immune checkpoint often expressed on macrophages. We believe that VSIG4 is a key player in macrophage polarization.
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SNS-103 is our monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1), also known as CD39. ENTPDase1 is the rate-limiting enzyme in the breakdown of extracellular ATP, leading to the production of adenosine, a well-established immunosuppressive pathway.
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SNS-401-NG is our ImmunoPhage candidate being developed initially for the treatment of patients with Merkel cell carcinoma, or MCC. SNS-401-NG is designed to deliver a personalized cocktail of off-the-shelf premanufactured bacteriophage, which we refer to as ImmunoPhage, aimed at driving a patient-specific constellation of anti-tumor T cells.
SNS-101: Monoclonal Antibody Targeting VISTA
We believe that anti-VISTA antibodies have the potential to become the backbone of the next generation of cancer immunotherapy. Based on our expertise and deep understanding of this myeloid checkpoint target, our human monoclonal antibody targeting VISTA is designed to overcome the challenges of the previous generation of anti-VISTA monoclonal antibodies and we believe has the potential to become the first anti-VISTA monoclonal antibody approved as a therapeutic agent.
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Based on the unique biology of VISTA, we believe that there are three critical design parameters required to achieve optimal biologic activity of inhibitory anti-VISTA antibodies:
1.
Block the pH-dependent binding of VISTA to PSGL-1 (P-selectin glycoprotein ligand-1) on T cells at low pH;
2.
Selectively bind VISTA at low pH to avoid target-mediated drug disposition, or TMDD, and on-target/off-tumor side effects; and
3.
Utilize an Fc-competent IgG backbone to engage and activate FcgR+ myeloid cells within the tumor.
SNS-101 is a fully human monoclonal IgG1 antibody that has been designed to selectively bind active (low pH) VISTA, but not inactive VISTA in the blood. In preclinical studies, we have observed that SNS-101 binds to VISTA at low pH with a greater than 600-fold differential affinity compared to VISTA at physiological pH of 7.4. SNS-101 has shown favorable pharmacokinetic properties, demonstrating sustained higher serum drug concentrations of SNS-101 compared to anti-VISTA antibodies that bind blood elements at physiological pH. In addition, in the MC38 syngeneic mouse model, SNS-101 has shown significant activity in combination with anti-PD-1.
Based on the totality of the preclinical data to date and the promising profile
of this antibody, in 2021 we initiated both IND-enabling studies and GMP
manufacturing for SNS-101. We received pre-IND feedback from the FDA in
SNS-102: Monoclonal antibody targeting VSIG-4
VSIG-4 (V-set and Ig domain-containing 4; also known as complement receptor of the Ig superfamily, or CRIg) is a B7-related protein, which is highly expressed on macrophages, including tumor-associated macrophages. VSIG-4 has been shown to be a potent inhibitor of T cell proliferation and inhibits proinflammatory macrophage activity through metabolic reprogramming. We believe these complementary immunosuppressive features of VSIG-4 make it an interesting and high-potential myeloid immunotherapeutic target.
Expression of VSIG-4 in normal tissues, chiefly on tissue-resident macrophage populations such as the Kupffer cells of the liver, suggest the presence of a large peripheral target sink and potential for on-target/off-tumor toxicities. Taken together, we believe these features make VSIG-4 a strong candidate for a TMAb-based approach.
We have generated antibodies and are currently screening to identify a lead monoclonal antibody for SNS-102. We expect to select a product candidate and initiate IND-enabling studies in 2023.
SNS-103: Monoclonal antibody targeting ENTPDase1 (CD39)
ENTPDase1 (also known as CD39) is the upstream, rate-limiting enzyme that leads to the breakdown of extracellular adenosine triphosphate, or ATP. Extracellular ATP represents a potent immunologic "danger signal", which drives immune activation. The ultimate downstream product of this pathway, adenosine, has potent immunosuppressive activity through binding to adenosine receptors. Upregulation of CD39 by tumors is common and leads to decreased extracellular ATP and a diminished anti-tumor immune response.
Pharmacologic inhibition of CD39 activity has shown anti-tumor activity in a variety of experimental tumor models. Several of these molecules are currently being evaluated as cancer therapeutics in early phase clinical trials. CD39, although upregulated in tumors, is also expressed in normal tissue on a variety of different cell populations. The expression of CD39 on endothelial cells is particularly problematic, as this is anticipated to result in significant on-target/off-tumor binding, leading to TMDD, a poor pharmacokinetic profile and potential toxicities.
We have initiated a TMAb antibody campaign aimed at developing an anti-CD39 inhibitory antibody with high selectivity for CD39 in the tumor microenvironment, or TME, versus normal tissue environments. We expect to select a product candidate in 2023.
ImmunoPhage product candidate: SNS-401-NG
SNS-401-NG, our multi-antigenic personalized ImmunoPhage candidate, is being
developed in collaboration with the
We intend to initially develop SNS-401-NG for the treatment of Merkel cell carcinoma or MCC, an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. If clinical proof of concept is achieved, we plan to evaluate a broader basket study in patients with head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of antigens found in our proprietary library of ImmunoPhages.
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
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aggregate of
We have incurred significant operating losses over the last several years. Our
net loss was
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prepare to submit INDs and then initiate clinical development of product candidates, including SNS-101;
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continue the research and development of our other product candidates;
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invest in our TMAb and ImmunoPhage platforms;
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seek to discover and develop additional product candidates or acquire or in-license drugs, product candidates or technologies;
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seek regulatory approvals for any product candidates that successfully complete clinical trials;
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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;
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manufacture our product candidates or otherwise secure the clinical and commercial supply of our product candidates;
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hire additional research and development and selling, general and administrative personnel;
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maintain, expand and protect our intellectual property portfolio; and
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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 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.
Impact of COVID-19
The COVID-19 pandemic continues to present a substantial public health and economic challenge around the world. The length of time and full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, subject to change and are difficult to predict. While we continue to conduct our research and development activities, the COVID-19 pandemic may cause disruptions that impact the timing of our planned and ongoing preclinical trials and affect our ability to complete preclinical studies, future clinical trials or to procure items that are essential for our research and development activities.
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, the majority of our employees, other than our laboratory staff, have adopted a "hybrid" work schedule which is intended to limit the number of people in our office at any particular time. 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.
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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:
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expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;
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the cost of manufacturing our product candidates including the potential cost of contract manufacturing organizations, or CMOs, that manufacture product for use in our preclinical studies and planned clinical trials and perform analytical testing, scale-up and other services in connection with our development activities;
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the cost of outsourced professional scientific development services;
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employee-related expenses, including salaries, benefits and stock-based compensation for employees engaged in the research and development function;
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expenses relating to regulatory activities, including filing fees paid to regulatory agencies;
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fees for maintaining licenses and other amounts due under our third party licensing agreements;
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laboratory materials and supplies used to support our research activities; and
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allocated expenses for utilities and other facility-related costs.
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 planned 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:
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the scope, progress, outcome and costs of our preclinical studies, our current product candidates and any other product candidates we may acquire or develop;
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manufacturing of our product candidates or making arrangements with potential third-party manufacturers for both clinical and commercial supplies of these product candidates;
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successful patient enrollment in, and the initiation, duration and completion of clinical trials;
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the cost of gaining regulatory approvals for our product candidates, subject to the successful outcome of ongoing and future clinical trials; and
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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
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achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our planned 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 planned 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
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 endedJune 30, 2022 and 2021: Three Months Ended June 30, (in thousands) 2022 2021 Change Operating expenses: Research and development $ 6,393$ 5,898 $ 495 General and administrative 4,319 3,886 433 Total operating expenses 10,712 9,784 928 Loss from operations (10,712 ) (9,784 ) (928 ) Total other income 177 13 164 Net loss$ (10,535 ) $ (9,771 ) $ (764 )
Research and Development Expenses
Research and development expenses were
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General and Administrative Expenses
General and administrative expenses were
Other Income
Other income was
Comparison of the Six Months Ended
The following sets forth our results of operations for the six months endedJune 30, 2022 and 2021: Six Months Ended June 30, (in thousands) 2022 2021 Change Operating expenses: Research and development$ 13,848 $ 9,263 $ 4,585 General and administrative 9,351 8,490 861 Total operating expenses 23,199 17,753 5,446 Loss from operations (23,199 ) (17,753 ) (5,446 ) Total other income 259 10 249 Net loss$ (22,940 ) $ (17,743 ) $ (5,197 )
Research and Development Expenses
Research and development expenses were
General and Administrative Expenses
General and administrative expenses were
Other Income
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
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As of
Cash Flows
The following table summarizes our sources and uses of cash for each of the periods below:
Six Months Ended June 30,
(in thousands) 2022 2021
Net cash used in operating activities $ (22,649 ) $ (16,814 )
Net cash provided by (used in) investing activities 25,389 (148,248 )
Net cash provided by financing activities - 164,065
Net increase (decrease) in cash and cash equivalents
Operating Activities
During the six months ended
Investing Activities
During the six months ended
Financing Activities
During the six months ended
Material Cash Requirements
Our material cash requirements will have an impact on our future liquidity. Our material cash requirements represent material expected or contractually committed future payment obligations. We believe that we will be able to fund these obligations through cash from our existing balances of cash, cash equivalents and marketable securities.
Operating Leases
We have operating lease arrangements for our corporate offices, lab facilities
and an executive residence. As part of its adoption of ASC 842, we recorded
operating right-of-use assets and operating lease liabilities for these leases
as of
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Finance Leases
We lease research equipment, furniture and a vehicle under finance leases. As
part of its adoption of ASC 842, we recorded financing right-of-use assets and
financing lease liabilities for these leases as of
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, or initiate clinical trials of, and potentially seek marketing approval for, our product candidates. In addition, we expect to continue 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:
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the initiation, progress, timing, costs and results of current and future preclinical studies and clinical trials for our current and future product candidates;
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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;
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the costs to seek regulatory approvals for any product candidates that successfully complete clinical trials;
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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;
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the need to hire additional clinical, quality assurance, quality control and other scientific personnel;
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the number and characteristics of product candidates that we develop or may in-license;
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the outcome, timing and cost of meeting and maintaining compliance with regulatory requirements;
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the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
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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;
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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
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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 quarter of 2025. 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:
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the scope, progress, results and costs of product discovery, preclinical studies and clinical trials;
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the scope, prioritization and number of our research and development programs;
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the costs, timing and outcome of regulatory review of our product candidates;
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our ability to establish and maintain collaborations on favorable terms, if at all;
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the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under collaboration agreements, if any;
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the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
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the extent to which we acquire or in-license other product candidates and technologies;
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the costs of securing manufacturing arrangements for commercial production;
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the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates; and
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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.
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 six 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.
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
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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.
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