MINK THERAPEUTICS, INC. Overview
Our business activities include product research and development, manufacturing, regulatory and clinical development, corporate finance, and support of our collaborations. To be successful, our product candidates require clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. We are a party to an Amended and Restated Intercompany Services Agreement and an Intellectual Property Assignment and License Agreement with Agenus. Under the Amended and Restated Intercompany Services Agreement, Agenus provides us with certain general and administrative support, including, without limitation, financial, facilities management, human resources and information technology administrative support, and we and Agenus provide each other with certain research and development services and other support services, including legal and regulatory support. We are also entitled to use Agenus' business offices and laboratory space and equipment in exchange for us contributing a proportionate payment for the use of such facilities and equipment, and we will be covered by certain Agenus insurance policies, subject to certain conditions, including us paying the cost of such coverage. Under the Intellectual Property Assignment and License Agreement, Agenus exclusively assigned patent rights and know-how related to our technology to us. We also have a field-limited exclusive license under certain Agenus patents and know-how; and we retain the rights to expand a proprietary pipeline of products and technologies.
We recently announced the internalization of manufacturing and completed the
internal cGMP production of AgenT-797 with expansion capacity to treat >700,000
patients/year. Our most advanced product, AGENT-797, is an off-the-shelf,
allogeneic, native iNKT cell therapy. We have commenced a Phase 1 clinical trial
of AGENT-797 for the treatment of multiple myeloma, reported preliminary signals
of activity, and expect to report data from this trial in the fourth quarter of
2022. In addition, we announced the initiation of our Phase 1 clinical trial for
the study of solid tumor cancers with AGENT-797 as a monotherapy and in
combination with approved checkpoint inhibitors, which we intend to advance as a
priority. We currently expect to have preliminary readouts from this trial in
2022 in indications that may lead to an accelerated path to marketing approval.
We also intend to initiate a Phase 1 study of AGENT-797 in GvHD in 2022.
Finally, with the unique circumstances of the COVID-19 pandemic, we were able to
commence first-in-human studies of AGENT-797 in acute respiratory distress
("ARDS") secondary to COVID-19 and reported encouraging survival benefit
exceeding 75% presented at the
In addition, we are advancing a pipeline of next-generation allogeneic, engineered iNKT programs. Our two most advanced engineered programs are (1) a CAR-iNKT program targeting B-cell maturation antigen ("BCMA"), which we refer to as BCMA-CAR-iNKT, and (2) a tumor stromal targeting CAR-iNKT program, which we refer to as stromal target-CAR-iNKT. These programs are novel and differentiated, and both are in preclinical development. We initiated our investigational new drug application filings for these candidates in 2022.
Our research and development ("R&D") expenses for the six months ended
We expect to continue to incur operating losses and negative cash flows for the foreseeable future. Based on our current plans and projections, we believe our quarter-end cash and cash equivalents balance will be sufficient to satisfy our liquidity requirements for more than one year from when these financial statements were issued. Management continues to monitor our liquidity position and will adjust spending as needed in order to preserve liquidity. Our future liquidity needs will be determined primarily by the success of our operations with respect to the progress of our product candidates and key development and regulatory events in the future. Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) securing debt financing and/or (3) selling equity securities.
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Historical Results of Operations
Three Months Ended
Research and development expense
R&D expense includes the costs associated with our internal research and
development activities, including compensation and benefits, occupancy costs,
manufacturing costs, costs of expert consultants, and administrative costs. R&D
expense increased 64% to
General and administrative expense
General and administrative ("G&A") expense consists primarily of personnel
costs, facility expenses, and professional fees. G&A expense increased 110% to
Other income (expense), net
Other income (expense), net includes our foreign currency transactional activity
and other income or expense. Other income increased
Change in fair value of convertible affiliated note
Change in fair value of convertible affiliated note reflects the result of our
fair value measurement of our convertible affiliated note issued to Agenus (the
"Note") at the balance sheet date. In
Interest expense
Interest expense related to the Note was
Six Months Ended
Research and development expense
R&D expense includes the costs associated with our internal research and
development activities, including compensation and benefits, occupancy costs,
manufacturing costs, costs of expert consultants, and administrative costs. R&D
expense increased 67% to
General and administrative expense
G&A expense consists primarily of personnel costs, facility expenses, and
professional fees. G&A expense increased 168% to
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Change in fair value of convertible affiliated note
Change in fair value of convertible affiliated note reflects the result of our
fair value measurement of the Note at the balance sheet date. In
Other income (expense), net
Other income (expense), net includes our foreign currency transactional activity
and other income or expense. Other income increased
Interest expense
Interest expense related to the Note was
Research and Development Programs
R&D program costs include compensation and other direct costs plus an allocation of indirect costs, based on certain assumptions.
For the six months
ended June 30, For the years ended December 31,
2022 2021 2020
Payroll and personnel costs $ 2,197,218 $ 3,346,853 $ 3,007,044
Professional fees 6,038,633 6,761,139 5,025,282
Allocated services 907,235 1,377,456 758,549
Materials and other 2,010,341 2,480,920 718,180
Total $ 11,153,427 $ 13,966,368 $ 9,509,055 Our product candidates are in various stages of development and significant additional expenditures will be required if we start new clinical trials, encounter delays in our programs, apply for regulatory approvals, continue development of our technologies, expand our operations and/or bring our product candidates to market. The total cost of any particular clinical trial is dependent on a number of factors such as trial design, length of the trial, number of clinical sites, number of patients and trial sponsorship. The process of obtaining and maintaining regulatory approvals for new products is lengthy, expensive and uncertain. Because of the current stage of our product candidates, among other factors, we are unable to reliably estimate the cost of completing our research and development programs or the timing for bringing such programs to various markets or substantial partnering or out-licensing arrangements, and, therefore, when, if ever, material cash inflows are likely to commence.
Liquidity and Capital Resources
We have incurred annual operating losses since inception in 2017, and we had an
accumulated deficit of
In
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Prior to our initial public offering, we had been reliant on Agenus to finance
our operations. From our inception through our initial public offering in
In
Our cash and cash equivalents balance as of
Management continues to monitor our liquidity position and will adjust spending as needed in order to preserve liquidity. Our future liquidity needs will be determined primarily by the success of our operations with respect to the progression of our product candidates and key development and regulatory events in the future. Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) securing debt financing and/or (3) selling equity securities.
Net cash used in operating activities for the six months ended
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements. You can identify these forward-looking statements by the fact they use words such as "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will," "potential," "opportunity," "future" and other words and terms of similar meaning. Certain forward-looking statements in this Quarterly Report on Form 10-Q can be identified by the fact that they do not relate strictly to historical or current facts. In particular, these statements relate to, among other things, our business strategy, our research and development, our ability to commercialize our product candidates, our prospects for initiating partnerships or collaborations, uncertainty regarding our future operating results and our profitability, anticipated sources of funds as well as our plans, objectives, expectations, and intentions. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. Therefore, we caution investors not to place significant reliance on forward-looking statements contained in this document; such statements need to be evaluated in light of all the information contained in this document. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements, except as required by law.
Some of the factors that could cause actual results to differ are identified
below, as well as those discussed in the Item 1A. Risk Factors section in our
Annual Report on Form 10-K for the year ended
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we face significant competition and there is a possibility that our competitors
may achieve regulatory approval before us or develop adoptive cell therapies
that are safer or more advanced or effective than ours; product candidates we
develop may be complex and difficult to manufacture; the regulatory landscape
that will govern any product candidates we may develop is complex and uncertain;
failure to comply with laws and regulations could expose us to criminal
sanctions, civil penalties, contractual damages, reputational harm and
diminished profits and future earnings; Agenus owns a majority of our common
stock and will be able to exert control over specific matters subject to
stockholder approval; certain of our directors and officers may have actual or
potential conflicts of interest; we rely on third parties, which may not perform
satisfactorily; if we are not able to establish collaborations, we may have to
alter our development and commercialization plans which may cause delays or
increase costs; we may be unable to obtain and maintain satisfactory patent and
other intellectual property protection for any product candidates we develop;
our rights to develop and commercialize our cell-based immunotherapies and
product candidates are subject, in part, to the terms and conditions of licenses
granted to us by others, including Agenus; third parties may initiate legal
proceedings alleging that we are infringing, misappropriating or otherwise
violating their intellectual property rights; we may be unable to retain our key
executives and to attract, retain and motivate qualified personnel; our internal
computer systems, or those of our third-party vendors, collaborators or other
contractors or consultants, may fail or suffer security breaches; the continuing
outbreak of COVID-19 in
JOBS Act
We qualify as an "emerging growth company" as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). As an emerging growth company, 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
emerging growth company earlier if we have more than
In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company 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 emerging growth company. Therefore, the reported results of operations contained in our consolidated financial statements may not be directly comparable to those of other public companies.
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