ITEM 7. MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis
of our financial condition and results of operations together with our consolidated financial statements and the related notes included
in Part II, Item 8 of this Annual Report on Form 10-K. This discussion and analysis and other parts of this Annual Report on Form
10-K contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial
performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives, expectations,
forecasts and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these
forward-looking statements as a result of several factors, including those set forth under Part I, Item 1A, “Risk Factors”
and elsewhere in this Annual Report on Form 10-K.
Overview
We are a clinical-stage biotechnology company dedicated
to enabling cures through therapeutics targeting mast and hemopoietic stem cells. We are focused on the development and commercialization
of safer and more effective therapeutic agents for diseases such as Chronic Spontaneous Urticaria (“CSU”), Lower to Intermediate
Risk Myelodysplastic Syndrome (“LR-MDS”) and novel conditioning regimens for stem cell transplantation and ex-vivo gene therapy,
a technique in which genetic manipulation of cells is performed outside of the body prior to transplantation.
Our drug development pipeline includes
multiple product candidates designed to target mast and/or hematopoietic stem cells. Our lead product candidate, briquilimab
(formerly known as JSP191), is in clinical development as a novel therapeutic antibody that targets mast and stem cells in various
diseases and as a conditioning agent to clear hematopoietic stem cells from bone marrow in patients prior to undergoing allogeneic
stem cell therapy or stem cell gene therapy. We are also developing engineered hematopoietic stem cells product candidates
reprogrammed using mRNA delivery (“mRNA stem cell platform”) and gene editing that have a competitive advantage over
endogenous hematopoietic stem cells (“HSCs”) because they may permit higher levels of engraftment without the need for
toxic conditioning. We also plan to continue to expand our pipeline to include other novel mast and stem cell therapies based on
immune modulation, graft engineering or cell and gene therapies. Our goal is to expand the use of therapeutic agents targeting mast
and stem cells as well as to expand curative stem cell transplants and gene therapies for all patients, including children and the
elderly.
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Our lead product candidate, briquilimab, is a monoclonal
antibody designed to block stem cell factor (“SCF”) from binding to and signaling through the CD117 receptor on mast and stem
cells. The SCF/CD117 pathway is a survival signal for mast and stem cells and we believe that blocking this pathway may lead to depletion
of these cells from skin and bone marrow environments. Currently, we are developing briquilimab as chronic therapy for CSU and LR-MDS.
We are also developing briquilimab as a one-time conditioning therapy in various stem cell transplant settings such as severe combined
immunodeficiency (“SCID”) for which we are currently conducting a Phase 1/2 clinical trial in patients who have failed a previous
stem cell transplant. Briquilimab is also being studied by our academic and institutional partners, Stanford University and National Institutes
of Health, in other transplant settings, including Fanconi Anemia, sickle cell disease (“SCD”), chronic granulomatous disease
and GATA-2 Type myelodysplastic syndromes (“MDS”).
We intend to become a fully integrated discovery,
development and commercial company in the field of mast and stem cell therapeutics. We are developing our product candidates to be used
individually or, in some cases, in combination with one another. For example, we believe our pipeline could be tailored to the patient-specific disease
so that a patient may receive more than one of our therapies as part of his or her individual allogeneic or gene-edited stem cell
therapy. Our goal is to advance our product candidates through regulatory approval and bring them to the commercial market based on the
data from our clinical trials and communications with regulatory agencies and payor communities. We expect to continue to advance our
pipeline and innovate through our research platform.
We have an exclusive license agreement with Amgen
Inc. (“Amgen”) for the development and commercialization of the briquilimab monoclonal antibody in all indications and territories
worldwide. We also have an exclusive license agreement with Stanford for the right to use briquilimab in the clearance of stem cells prior
to the transplantation of HSCs. We also entirely own the intellectual property for our mRNA stem cell platform, which has been internally
developed.
AMHC was incorporated in the State of Delaware in
August 2019. Old Jasper was incorporated in the State of Delaware in March 2018 and did not have any significant operations or research
and development activities until November 2019, when it entered into a license agreement with Amgen for a license to certain patents
and know-how related to Amgen’s proprietary monoclonal antibody known as AMG-191, which we later renamed as JSP191 and then briquilimab.
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On September 24, 2021 (the “Closing Date”),
we consummated the previously announced Business Combination pursuant to the terms of the Business Combination Agreement, dated as of
May 5, 2021 (the “BCA”), by and among AMHC, Merger Sub, and Old Jasper. Pursuant to the terms of the BCA, on the Closing
Date, (i) Merger Sub merged with and into Old Jasper (the “Merger”), with Old Jasper as the surviving company in the Merger,
and, after giving effect to the Merger, Old Jasper became a wholly-owned subsidiary of AMHC and changed its name to “Jasper Tx
Corp.”, and (ii) AMHC changed its name to “Jasper Therapeutics, Inc.”.
Since Old Jasper’s inception in March 2018,
we have devoted substantially all of our resources to performing research and development, enabling manufacturing activities in support
of our product development efforts, hiring personnel, acquiring and developing our technology and product candidates, performing business
planning, establishing our intellectual property portfolio, raising capital and providing general and administrative support for these
activities. We do not have any products approved for sale and have not generated any revenue from product sales. We expect to continue
to incur significant and increasing expenses and substantial losses for the foreseeable future as we continue our development of and
seek regulatory approvals for our product candidates and commercialize any approved products, seek to expand our product pipeline and
invest in our organization. We expect to incur increased expenses associated with operating as a public company, including significant
legal, audit, accounting, regulatory, tax-related, director and officer insurance, investor relations and other expenses.
We have incurred significant losses and negative cash flows from operations
since our inception. During the years ended December 31, 2022 and 2021, we incurred net losses of $37.7 million and $30.6 million,
respectively. We generated negative operating cash flows of $45.9 million and $33.7 million for the years ended December 31, 2022 and
2021, respectively. As of December 31, 2022, we had an accumulated deficit of $105.1 million.
We had cash and cash equivalents of $38.3
million as of December 31, 2022. Management expects that our existing cash and cash equivalents, together with the total estimated
net proceeds of $101.4 million from our public offering in January 2023 and the sale of shares pursuant to the ATM Offering in
January 2023, will be sufficient to fund our operating plan for at least twelve months from the date of filing of this Annual Report
on Form 10-K. Therefore, based on management’s updated evaluation of our ability to continue as a going concern, management
has concluded the factors that previously raised substantial doubt about our ability to continue as a going concern no longer exist
as of the issuance date of our consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K. We
expect to continue to incur substantial losses for the foreseeable future, and our transition to profitability will depend upon
successful development, approval and commercialization of our product candidates and upon achievement of sufficient revenues to
support our cost structure. We do not expect to generate any revenue from commercial product sales unless and until we successfully
complete development and obtain regulatory approval for one or more of our product candidates. We may never achieve profitability,
and unless we do and until then, we will need to continue to raise additional capital.
Our management plans to monitor expenses and raise
additional capital through a combination of public and private equity, debt financings, strategic alliances, and licensing arrangements.
Our ability to access capital when needed is not assured and, if capital is not available to us when, and in the amounts, needed, we
may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization
of any product candidate, or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which
could materially harm our business, financial condition and results of operations.
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We expect our expenses will increase substantially
in connection with our ongoing and planned activities, as we:
● advance product candidates through preclinical studies and clinical trials;
● acquire, discover, validate, and develop additional product candidates;
● attract, hire and retain additional personnel;
● operate as a public company;
● implement operational, financial and management systems;
We do not currently own or operate any manufacturing
facility. We rely on contract manufacturing organizations (“CMOs”) to produce our drug candidates in accordance with the FDA’s
current good manufacturing practices (“cGMP”) regulations for use in our clinical studies. The manufacture of pharmaceuticals
is subject to extensive cGMP regulations, which impose various procedural and documentation requirements and govern all areas of record
keeping, production processes and controls, personnel and quality control. Under our license agreement with Amgen, we have received a
substantial amount of drug product to support initiation of our planned clinical trials of briquilimab. In November 2019, we entered
into development and manufacturing agreements with Lonza Sales AG (“Lonza”) relating to the manufacturing of briquilimab and
product quality testing. The facility of Lonza in Slough, United Kingdom is responsible for production and testing of drug substance.
The facility of Lonza in Stein, Switzerland is responsible for production and testing of drug product. Labelling, packaging and storage
of finished drug product is provided by PCI Pharma Services, in San Diego, California. Our agreement with Lonza includes certain limitations
on our ability to enter into supply arrangements with any other supplier without Lonza’s consent. In addition, Lonza has the right to
increase the prices it charges us for certain supplies depending on a number of factors, some of which are outside of our control.
We do not currently have sales and marketing infrastructure
to support commercial launch of our product candidates, if approved. We may build such capabilities in North America prior to potential
launch of briquilimab. Outside of North America, we may rely on licensing, co-sale and co-promotion agreements with strategic partners
for the commercialization of our product candidates. If we build a commercial infrastructure to support marketing in North America, such
commercial infrastructure could be expected to include a targeted sales force supported by sales management, internal sales support, an
internal marketing group and distribution support. To develop the appropriate commercial infrastructure internally, we would have to invest
financial and management resources, some of which would have to be deployed prior to any confirmation that briquilimab will be approved.
Because of the numerous risks and uncertainties associated
with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve
or maintain profitability. Even if we are able to generate revenue from the sale of our product candidates, we may not become profitable.
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.
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Business Impact of the COVID-19 Pandemic
While conditions related to the COVID-19 pandemic
improved in 2022 compared to 2021, the pandemic continues to be dynamic and near-term challenges across the economy remain. While our
operations to date have not been significantly impacted by the COVID-19 pandemic any continuing impact of the COVID-19 pandemic
and its downstream effects, such as healthcare and vendor staffing shortages and general disruption to the U.S. healthcare system, on
our financial performance will depend on future developments, including the duration and spread of the pandemic, its impact on our clinical
trial enrollment, trial sites, contract research organizations (“CROs”), CMOs, and other third parties with whom we do business,
its impact on regulatory authorities and our key scientific and management personnel, progress and effectiveness of vaccination and related
governmental advisories and restrictions. These developments and the impact of the COVID-19 pandemic and its downstream effects on
the financial markets and the overall economy are highly uncertain and cannot be predicted. If the financial markets or the overall economy
continue to be impacted by the COVID-19 pandemic and its downstream effects, our business may be materially adversely affected. We will
continue to actively monitor the effects of the COVID-19 pandemic and its downstream effects and will continue to take appropriate steps
to attempt to mitigate the impacts to our employees, business, financial condition and operations.
Business Impact of the Geopolitical Events
We are unable to predict the effect that geopolitical events, including
the conflict in Ukraine, global inflation and rising interest rates, may have on our operations. To the extent that geopolitical events
adversely affect our business prospects, financial condition, and results of operations, they may also have the effect of exacerbating
many of the other risks described or referenced in the section titled “Risk Factors” in this Annual Report on Form 10-K such
as those relating to the supply of materials for our product candidates, and the timing and possible disruptions of our ongoing and future
preclinical studies and clinical trials, and our access to the financial markets.
Amgen License Agreement
In November 2019, we entered into a worldwide
exclusive license agreement with Amgen for briquilimab (formerly AMG-191 and JSP191) that also includes translational science and materials
from Stanford University. We were assigned and accepted Amgen’s rights and obligations, effective November 21, 2019, for the Investigator
Sponsored Research Agreement (“ISRA”), entered into in June 2013, between Amgen and The Board of Trustees of the Leland
Stanford Junior University (“Stanford”) and Quality Agreement between Amgen and Stanford, effective as of October 7, 2015.
Under the ISRA, we received an option to negotiate a definitive license with Stanford for rights to certain Stanford intellectual property
related to the study of briquilimab in exchange for an option exercise fee of $1.0 million, payable over a two-year period (the “Option”).
We exercised the Option to Stanford docket S06-265 “Antibody-based clearance of endogenous stem cell niches prior to transplantation
of bone marrow or hematopoietic stem cells (c-kit)” granted by Stanford under the ISRA on June 2, 2020. As a result, we have worldwide
exclusive rights to develop and commercialize briquilimab. The issued U.S. patents would be expected to expire in 2027, absent any applicable
patent term extensions.
Stanford License Agreement
In March 2021, we entered into an exclusive license
agreement with respect to the use of briquilimab from the Stanford Office of Technology Licensing to license U.S. Patent Application Serial
Number 60/856,435, filed Nov. 3, 2006, and U.S. Patent Application Serial Number 12/447,634 (publication number US 2010/0226927 Al) and
know-how for the purpose of depleting endogenous blood stem cells in patients for whom hematopoietic cell transplantation is indicated.
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Collaboration and Clinical Trial Agreements
Collaboration with Stanford University
Effective September 2020, we entered into a
sponsored research agreement with Stanford, pursuant to which Stanford will execute a Phase 1/2 clinical trial utilizing
briquilimab to treat Fanconi Anemia patients in Bone Marrow Failure requiring allogeneic transplant with non-sibling donors at
Stanford Lucile Packard Children’s Hospital. As consideration for the services performed by Stanford under this agreement, we
will pay Stanford a total of $0.9 million over approximately three years upon the achievement of the first development and
clinical milestone, including FDA filings and patients’ enrollment. The first $0.3 million milestone was achieved in 2020 and
paid by us in February 2021. The second $0.3 million milestone was achieved in February 2022 and paid by us in March 2022. The third
milestone is based on the progress of the clinical trials and will be recognized when achieved.
Other Collaboration
and Clinical Trial Agreements
We have other collaboration and clinical trial
agreements, including with Graphite Bio, Inc. and AVROBIO, Inc., to study briquilimab as targeted, non-toxic conditioning for investigational
gene therapies. These collaborations are non-exclusive, and we have agreed with these collaborators to provide materials to use by the
collaborators in their products’ development studies and clinical studies. We also have a clinical trial agreement with the National
Cancer Institute (“NCI”) for the clinical development of briquilimab for the treatment of GATA2 deficiency, whereby NCI will
perform the preclinical studies and submit an IND for this indication to the FDA, and we will provide materials to use in such studies.
We have also entered into clinical trial agreements with the National
Heart, Lung, and Blood Institute (“NHLBI”) and the National Institute of Allergy and Infectious Diseases (“NIAID”),
pursuant to which NHLBI and NIAID will serve as the IND sponsors of a Phase 1/2 clinical trial to evaluate briquilimab as a targeted,
non-toxic conditioning regimen prior to allogeneic transplant for SCD and for chronic granulomatous disease, respectively. Each
party incurs its own costs under these agreements.
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Components of Results of Operations
Operating Expenses
Research and Development
The largest component of our total operating expenses
since our inception has been research and development activities, including the preclinical and clinical development of our product candidates.
Research and development expenses consist primarily of compensation and benefits for research and development employees, including stock-based compensation;
expenses incurred under agreements with CROs and investigative sites that conduct preclinical and clinical studies; the costs of acquiring
and manufacturing clinical study materials and other supplies; payments under licensing and research and development agreements; other
outside services and consulting costs; and facilities, information technology and overhead expenses. Research and development costs are
expensed as incurred.
External research and development costs include:
● consulting fees associated with our research and development activities; and
Internal research and development costs include:
We expect our research and development expenses to
increase substantially for the foreseeable future as we advance our product candidates into and through preclinical studies and clinical
trials, pursue regulatory approval of our product candidates and expand our pipeline of product candidates. The process of conducting
the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of
success for our product candidates may be affected by a variety of factors, including the safety and efficacy of our product candidates,
early clinical data, investment in our clinical programs, competition, manufacturing capability and commercial viability. We may never
succeed in achieving regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are
unable to determine the duration and completion costs of our research and development projects or if, when and to what extent we will
generate revenue from the commercialization and sale of our product candidates, if approved.
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Our future research and development costs may vary
significantly based on factors, such as:
● per patient clinical trial costs;
● the number of trials required for approval;
● the number of sites included in our clinical trials;
● the countries in which the trials are conducted;
● the number of patients that participate in the trials;
● the number of doses that patients receive;
● patient drop-out or discontinuation rates;
● potential additional safety monitoring requested by regulatory agencies;
● the duration of patient participation in the trials and follow up;
● the cost and timing of manufacturing our product candidates;
● the phase of development of our product candidates;
● the efficacy and safety profile of our product candidates;
● significant and changing government regulation and regulatory guidance;
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General and Administrative
General and administrative expenses consist primarily of personnel
costs and expenses, including salaries, employee benefits, stock-based compensation for our executive and other administrative personnel;
legal services, including relating to intellectual property and corporate matters; accounting, auditing, consulting and tax services;
insurance; and facility and other allocated costs not otherwise included in research and development expenses. We expect our general and
administrative expenses to increase substantially for the foreseeable future as we anticipate an increase in our personnel headcount to
support expansion of research and development activities, as well as to support our operations generally. We also expect to continue to
incur significant expenses associated with being a public company, including costs related to accounting, audit, legal, regulatory, and
tax-related services associated with maintaining compliance with applicable Nasdaq and SEC requirements; additional director and
officer insurance costs; and investor and public relations costs.
Other Income (Expense), Net
Other income (expense), net includes foreign currency
transactions gains and losses, interest income, changes in the fair value of our derivative tranche liabilities, which were settled in
February 2021, changes in the fair value of common stock warrant liability and earnout liability, which were recorded at the closing
of the Business Combination. These financial instruments were classified as liabilities in our consolidated balance sheets and re-measured at
each reporting period end until they are exercised, settled or have expired.
Results of Operations
Comparison of the Years Ended December 31, 2022 and 2021
The following table summarizes our results of operations
for the years ended December 31, 2022 and 2021 (in thousands):
Year Ended December 31, Change Change
Operating expenses
Change in fair value of common stock warrant liability 7,200 500 6,700 *
Change in fair value of derivative liability — (3,501 ) 3,501 (100 )
Other income (expense), net 586 (80 ) 666 *
* not meaningful
Research and Development Expenses
The following table summarizes our research and development
expenses for the periods indicated (in thousands):
Year Ended December 31, Change Change
External costs:
Internal costs:
* not meaningful
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Research and development expenses increased by
$9.2 million, from $25.4 million for the year ended December 31, 2021 to $34.6 million for the year ended December 31, 2022.
External CRO, CMO and other third-party preclinical studies and clinical
trials expenses decreased by $1.5 million, from $15.3 million for the year ended December 31, 2021 to $13.8 million for the year ended
December 31, 2022. The decrease is primarily due to a $0.4 million decrease in CRO expenses, a $0.3 million decrease in expenses related
to pre-clinical studies, a $0.2 million decrease in Chemistry, Manufacturing and Controls expenses and a $0.6 million decrease in other
third-party research and development expenses. Expenses related to professional consulting services increased by $1.4 million, from
$3.2 million for the year ended December 31, 2021 to $4.6 million for the year ended December 31, 2022. The increase was related
to external consulting incurred to supplement our research and development personnel. Other external research and development costs increased
by $2.8 million from $0.5 million for the year ended December 31, 2021 to $3.3 million for the year ended December 31, 2022 due to increases
in purchases of laboratory materials, supplies and services and other miscellaneous costs.
Our external costs by program for the years ended
December 31, 2022 and 2021 were as follows (in thousands):
Year Ended December 31,
Personnel-related costs, including employee payroll
and related expenses increased by $3.0 million, from $5.3 million for the year ended December 31, 2021 to $8.3 million for the year ended
December 31, 2022, as a result of hiring additional employees in our research and development organization. Stock-based compensation expenses
related to awards granted to our employees and directors increased by $0.7 million, from $0.6 million for the year ended December 31,
2021 to $1.3 million for the year ended December 31, 2022. Facilities and overheads include common facilities, human resources and information
technology related expenses allocated to research and development. These costs increased by $3.4 million, from $1.1 million for the year
ended December 31, 2021 to $4.5 million for the year ended December 31, 2022 as a result of hiring additional employees in our research
and development organization and it being the first full year of allocated overhead expenses.
General and Administrative Expenses
General and administrative expenses increased by
$5.2 million, from $11.4 million for the year ended December 31, 2021 to $16.6 million for the year ended December 31,
2022. Employee payroll and related expenses increased by $2.9 million, from $2.3 million for the year ended December 31, 2021
to $5.2 million for the year ended December 31, 2022, as a result of $1.5 million of higher stock based compensation and continued
hiring of executives and administrative employees. Expenses related to professional consulting services increased by $1.9 million, from
$6.4 million for the year ended December 31, 2021 to $8.3 million for the year ended December 31, 2022 due to increased
spending on consulting, recruiting, legal, audit, accounting and other services to support our growing operations as a public company.
Other expenses, including insurance, office supplies, subscriptions and other miscellaneous expenses, increased by $0.4 million for
the year ended December 31, 2022 as compared to expenses for the year ended December 31, 2021, as we continued expanding our operations
to support our business strategy and product development.
Other Income, Net
Total other income, net increased by $7.3 million,
from $6.2 million net income for the year ended December 31, 2021 to $13.5 million for the year ended December 31, 2022.
As of December 31, 2022, we have outstanding warrants
to purchase an aggregate of 4,999,863 shares of our common stock, which were recognized upon the closing of the Business Combination on
September 24, 2021. The warrants were concluded to be derivative financial instruments and are measured at fair value at each reporting
period end until these are exercised, have expired or are redeemed. These warrants are publicly traded, and the fair value is estimated
using the closing price of a warrant at the period end. We recognized $7.2 million and $0.5 million of other income related to the decrease
in the fair value of the common stock warrants for the years ended December 31, 2022 and 2021, respectively due to the decrease in the
closing prices of the warrants during the respective period.
Upon the closing of the Business Combination on
September 24, 2021, we recognized earnout liability related to the Sponsor Earnout Shares placed in escrow. These shares will be released
from escrow upon achieving agreed upon common stock price targets within the specified period. This liability is recorded at fair value
using Monte Carlo simulation model and is re-measured at each period end until shares are released or forfeited. The significant inputs
used in the Monte Carlo model include the expected volatility of our common stock and the expected term when shares will be released.
We recognized $5.7 million and $9.3 million of other income related to the decrease in the fair value of the earnout liability for the
year ended December 31, 2022 and 2021, respectively, primarily as a result of the decrease in our common stock price, which decreased
the estimated liability related to the earnout provision.
We recognized a loss of $3.5 million during the year
ended December 31, 2021 related to the change in fair value of our derivative tranche liability and did not have such expense in the
2022 period, as the derivative was settled in February 2021 and was no longer outstanding.
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Liquidity and Capital Resources
Prior to the closing of the Business Combination,
we funded our operations primarily from the issuance of redeemable convertible preferred stock shares and the issuance of convertible
promissory notes. We also received net cash proceeds of $95.3 million at the closing of the Business Combination. As of December 31,
2022, we had $38.3 million of cash and cash equivalents.
In order to assist in funding our future operations,
including our planned clinical trials, on October 7, 2022, we filed a universal shelf registration statement on Form S-3 with the SEC,
and which was declared effective on October 18, 2022 and will expire on October 18, 2025 (the “Shelf Registration Statement”),
which allows us to, from time to time, offer up to $150.0 million of securities, including any combination of common stock, preferred
stock, debt securities, warrants, rights, units and depositary shares. We believe that the Shelf Registration Statement will provide
us with the flexibility to raise additional capital to finance our operations as needed. From time to time, we may offer securities under
our Shelf Registration Statement in response to market conditions or other circumstances if we believe such a plan of financing is in
the best interests of our stockholders. The terms of any offering under the Shelf Registration Statement will be established at the time
of such offering and will be described in a prospectus supplement to the Shelf Registration Statement filed with the SEC prior to the
completion of any such offering.
On November 10, 2022, we entered into a Controlled
Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”),
pursuant to which we may offer and sell through or to the Agent, as sales agent or principal, shares of our voting common stock from time
to time (the “ATM Offering”). The Agent will use commercially reasonable efforts consistent with its normal sales and trading
practices to sell shares from time to time, based upon our instructions (including any price or size limits or other customary parameters
or conditions we may impose). We will pay a commission equal to 3.0% of the aggregate gross proceeds of any shares sold through the Agent
pursuant to the Sales Agreement. We are not obligated to sell any shares under the Sales Agreement unless it is terminated earlier. The
Sales Agreement will continue until all shares available under the Sales Agreement have been sold. On November 10, 2022, we filed under
the Shelf Registration Statement a prospectus supplement with the SEC in connection with the ATM Offering (the “ATM Prospectus Supplement”),
pursuant to which we may offer and sell shares of common stock having an aggregate offering price of up to $15.5 million. As of December
31, 2022, there have been no sales under the Sales Agreement and, as of December 31, 2022, the full capacity remained available for issuance.
In January 2023, we issued and sold an aggregate of 2,337,496 shares of our common stock pursuant to the ATM Prospectus Supplement for
total estimated net proceeds of $4.5 million.
In January 2023, we issued and sold 69,000,000 shares of our common
stock in an underwritten public offering (the “Public Offering”) for total estimated net proceeds of $96.9 million pursuant
to an underwriting agreement with Credit Suisse Securities (USA) LLC, William Blair & Company, L.L.C. and Oppenheimer & Co. Inc.,
as the representatives of the several underwriters named therein.
As of March 1, 2023, approximately $10.9
million remains allocated and available under the ATM Prospectus Supplement and approximately $31.0 million remains available and
unallocated under the Shelf Registration Statement.
Future Funding Requirements
Our primary uses of cash are to fund our operations,
which consist primarily of research and development expenditures related to our programs and, to a lesser extent, general and administrative
expenditures. We anticipate that we will continue to incur significant expenses for the foreseeable future as we continue to advance
our product candidates, expand our corporate infrastructure, operate as a public company, further our research and development initiatives
for our product candidates, scale our laboratory and manufacturing operations, and incur marketing costs associated with potential commercialization.
We are subject to all the risks typically related to the development of new drug candidates, and we may encounter unforeseen expenses,
difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need
substantial additional funding in connection with our continuing operations.
We have incurred significant losses and negative
cash flows from operations since our inception. As of December 31, 2022, we had an accumulated deficit of $105.1 million. Based
on our current operating plan, we have concluded that our existing cash and cash equivalents will be sufficient to fund our current operating
plan for at least the twelve months from the date of filing of this Annual Report on Form 10-K. We have based these estimates on our current
assumptions, which may require future adjustments based on our ongoing business decisions.
Our future financing requirements will depend on
many factors, including:
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● any product liability or other lawsuits related to our product candidates;
● expenses incurred to attract, hire and retain skilled personnel; and
● the costs of operating as a public company.
A change in the outcome of any of these or other
variables could significantly change the costs and timing associated with the development of our product candidates. Furthermore, our
operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated
with such change.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with CROs for
clinical trials, with CMOs for clinical supplies manufacturing and with other vendors for preclinical studies, supplies and other
services and products for operating purposes. These contracts generally provide for termination on notice or may have a potential
termination fee if a purchase order is cancelled within a specified time, and therefore are cancelable contracts. We do not expect any
such contract terminations and do not have any non-cancellable obligations under these agreements as of December 31, 2022.
Leases
In August 2020 and January 2022, we leased approximately 13,400 square
feet of space for our headquarters in Redwood City, California. The lease expires in August 2026. We have an option to extend the term
for an additional five years to August 2031. In addition to base rent, we pay our share of operating expenses and taxes. As of December
31, 2022, our rent commitments under the lease agreement are $1.1 million within the next 12 months from December 31, 2022, and $3.1 million
for the remainder of the lease term.
Stanford Sponsored Research Agreement
Effective September 2020, we entered into a sponsored research agreement
with Stanford for a research program related to the treatment of Fanconi Anemia patients in Bone Marrow Failure requiring allogeneic transplant
with non-sibling donors at Stanford Lucile Packard Children’s Hospital using briquilimab. As consideration for the services performed
by Stanford under this sponsored research agreement, we will pay Stanford a total of $0.9 million over approximately 3 years upon the
achievement of development and clinical milestones, including FDA filings and patients’ enrollment. In February 2021, we paid $0.3
million related to the achievement of the first milestone under this agreement. In February 2022, the second milestone was achieved, and
we paid $0.3 million in March 2022. The third milestone is based on the progress of the clinical trials and will be recognized when
achieved.
Stanford License Agreement
In March 2021, we entered into the Stanford License Agreement, pursuant
to which we are required to pay annual license maintenance fees, beginning on the first anniversary of the effective date of the agreement
and ending upon the first commercial sale of a product, method, or service in the licensed field of use, as follows: $25,000 for each
first and second year, $35,000 for each third and fourth year, and $50,000 at each anniversary thereafter ending upon the first commercial
sale. We are also obligated to pay late-stage clinical development milestones and first commercial sales milestone payments of up to $9.0
million in total. We will also pay low single-digit royalties on net sales of licensed products. All products are in development as of
December 31, 2022, and no such royalties were due as of such date and no milestones were achieved.
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Cash Flows
The following table summarizes our sources and uses
of cash for the periods presented (in thousands):
Year ended December 31,
Net cash used in operating activities $ (45,858 ) $ (33,678 )
Net cash used in investing activities (576 ) (2,428 )
Net cash provided by financing activities 55 100,969
Cash Flows from Operating Activities
Net cash used in operating activities was $45.9 million and $33.7 million
for the years ended December 31, 2022 and 2021, respectively.
Cash used in operating activities in the year ended
December 31, 2022 was primarily due to our net loss for the period of $37.7 million, adjusted by non-cash net gain of $7.5 million and
a net change of $0.6 million in our net operating assets and liabilities. The non-cash amounts consisted of $12.9 million net gain related
to the changes in fair value of common stock warrant liability and the earnout liability, reduced by non-cash expenses, which included
$4.1 million related to stock-based compensation expense, $1.0 million related to depreciation and amortization expense and $0.3 million
non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease of $2.2 million in accounts
payable, an increase of $0.7 million in other receivables, and a decrease of $0.6 million in operating lease liability, partially offset
by an increase of $1.7 million in other non-current liabilities, an increase of $0.8 million in accrued expenses and other current liabilities
and a decrease of $0.3 million in prepaid expenses and other current assets.
Cash used in operating activities in the year ended
December 31, 2021 was primarily due to our net loss for the period of $30.6 million adjusted by non-cash net gain charges of $4.7 million
and a net change of $1.6 million in our net operating assets and liabilities. The non-cash charges consisted of $6.3 million net gain
related to the changes in fair value of a derivative liability, common stock warrant liability and the earnout liability, reduced by non-cash
expenses, which included $1.0 million related to stock-based compensation expense, $0.4 million related to depreciation and amortization
expense and $0.2 million related to non-cash lease expense. The changes in our net operating assets and liabilities were primarily due
to an increase of $2.9 million in accounts payable due to the timing of payments to our vendors, an increase of $1.0 million in accrued
expenses and other current liabilities and a decrease of $0.6 million in other receivables, partially offset by $2.2 million increase
in prepaid expenses and other current assets, a $0.3 million increase in other non-current assets, a decrease in other non-current liabilities
of $0.2 million and a decrease in operating lease liability of $0.1 million.
Cash Flows from Investing Activities
Cash used in investing activities was $0.6 million
and $2.4 million for the years ended December 31, 2022 and 2021, respectively, which primarily consisted of purchases of the lab equipment
and leasehold improvements.
Cash Flows from Financing Activities
Cash provided by financing activities for the year
ended December 31, 2022 was $0.1 million, which primarily consisted of cash received from exercise of stock options and
the purchase of shares under our employee stock purchase plan.
Cash provided by financing activities for the year
ended December 31, 2021 was $101.0 million, which consisted of $95.3 million net cash proceeds received at the closing of the Business
Combination, which included the PIPE Financing, $10.8 million net proceeds received in February 2021 upon the issuance of Series A-1 redeemable
convertible preferred stock shares and $0.2 million of cash received from the exercise of stock options. Cash received was reduced by
$5.3 million related to expenses paid by us related to the Business Combination.
Critical Accounting Policies and Significant Judgments and Estimates
Our critical accounting policies are disclosed in Note
2 of the notes to the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K.
Our management’s discussion and analysis of our
financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance
with accounting principles generally accepted in the United States of America. The preparation of these consolidated financial statements
requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent
assets and liabilities at the date of the consolidated financial statements, as well as the reported expenses incurred during the reporting
periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these estimates under different assumptions or conditions.
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While our significant accounting policies are described
in more detail in Note 2 to our consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K,
we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our
consolidated financial statements.
Accrued Research and Development Expenses
We have entered into various agreements with outsourced
vendors, including CROs and CMOs. Research and development expenses are recognized as services are performed and as costs occur. We make
significant judgments and estimates in determining the accrual balance in each reporting period. As actual costs become known, we adjust
our accruals. Although we do not expect our estimates to be materially different than the actual amounts incurred, such estimates for
the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in
us reporting amounts that are too high or too low in any one period. Our accrual is dependent, in part, upon the receipt of timely and
accurate reporting from CROs, CMOs, and other third-party vendors. Variations in the assumptions used to estimate accruals including,
but not limited to, the number of patients enrolled, the rate of patient enrollment and the actual services performed, may vary from our
estimates, resulting in adjustments to clinical trial expenses in future periods. Payments made under these arrangements in advance of
the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered. To
date, there have been no material differences between estimates of such expenses and the amounts actually incurred.
Earnout
Liability
Upon the closing of the Business Combination, we recognized Sponsor
Earnout Shares placed in escrow as a contingent earnout liability. These contingently issuable shares are classified as a liability on
the balance sheets and are subject to re-measurement at each balance sheet date and at the settlement date. Any change in fair value is
recognized in the consolidated statements of operations and comprehensive loss.
We utilize the Monte Carlo simulation model, which
uses a distribution of potential outcomes on a monthly basis over the earnout period prioritizing the most reliable information available.
The assumptions utilized in the calculation are based on the achievement of certain stock price milestones, including our current common
stock price, expected volatility, risk-free rate and expected term. We determine expected stock volatility based on the historical volatility
of the prices of shares of common stock of publicly traded peer companies. We estimate the risk-free interest rate by reference to the
U.S. Treasury yield curve over the expected term. The expected term equals the remaining contractual term of the escrow, which ends
on September 24, 2024. Common stock fair value equals the closing price of our common stock on the Nasdaq Capital Market at the valuation
date. An increase or decrease in the common stock fair value and volatility assumptions will significantly increase or decrease the recorded
liability, respectively.
As of December 31, 2022, we estimated the fair value of the contingent
earnout liability to be less than $0.1 million. We recognized $5.7 million of other income related to the decrease in the fair value
of the earnout liability for the year ended December 31, 2022, primarily as a result of the decrease in our common stock price, which
decreased the estimated liability.
Stock-Based Compensation
We measure stock-based awards made to employees and
non-employees based on the estimated fair values of the awards as of the grant dates using the Black-Scholes option-pricing model. The
model requires management to make a number of assumptions including common stock fair value, expected volatility, expected term, risk-free
interest rate and expected dividend yield.
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Expected Volatility — Expected
volatility is estimated by studying the volatility of the prices of shares of common stock of comparable public companies for similar
terms.
Expected Term — Expected term
represents the period that our stock-based awards are expected to be outstanding and is determined using the simplified method.
Risk-Free Interest Rate — The
risk-free interest rate is based on the U.S. Treasury zero-coupon issued in effect at the time of grant for periods corresponding
with the expected term of the option.
Expected Dividend — The Black-Scholes
valuation model calls for a single expected dividend yield as an input. To date, we have not declared or paid any dividends.
Common Stock Fair Value— We
estimate the fair value of our common stock based on the closing quoted market price of our common stock as reported on the Nasdaq Capital
Market. Prior to the closing of the Business Combination, we determined the fair value of our common stock using methodologies, approaches,
and assumptions consistent with the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of
Privately-Held-Company Equity Securities Issued as Compensation. We recognized stock-based compensation expense on a straight-line
basis over the requisite service period, which is the period in which the related services are received. We account for forfeitures as
they occur. The expense for stock-based awards with performance conditions is recognized when it is probable that a performance condition
is met during the vesting period.
We recorded stock-based compensation expense of
$4.1 million and $1.0 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, there was
$8.2 million of total unrecognized compensation expense, which we expect to recognize over a remaining weighted-average period of
2.3 years. We expect to continue to grant equity-based awards in the future, and to the extent that we do, our stock-based compensation
expense recognized in future periods will likely increase.
Recently Issued Accounting Pronouncements
See Note 2 to the consolidated financial statements
included in Part II, Item 8 of this Annual Report on Form 10-K for more information regarding recently issued accounting pronouncements.
JOBS Act
The Jumpstart Our Business Startups Act of 2012 (the
“JOBS Act”) exempts emerging growth companies from being required to comply with new or revised financial accounting standards
until private companies (that is, those that have not had a U.S. Securities Act of 1933, as amended, registration statement declared effective
or do not have a class of securities registered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”))
are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out
of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election
to opt out is irrevocable. We have opted to take advantage of the exemption for complying with new or revised accounting standards within
the same time periods as private companies, which means that when a standard is issued or revised and it has different application dates
for public or private companies, we, as an emerging growth company, can adopt the new or revised standard at the time private companies
adopt the new or revised standard. This may make comparison of our consolidated financial statements with another public company that
is neither an emerging growth company nor an emerging growth company that has opted out of using the extended transition period difficult
or impossible because of the potential differences in accounting standards used.
We will remain an emerging growth company until the
earlier of: (i) the last day of the fiscal year (a) following November 22, 2024, (b) in which we have total annual
gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market
value of our common equity that is held by non-affiliates exceeds $700 million as of the last business day of its most
recently completed second fiscal quarter; and (ii) the date on which we have issued more than $1.00 billion in non-convertible debt
securities during the prior three-year period. References herein to “emerging growth company” have the meaning associated
with it in the JOBS Act.
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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
We had cash and cash equivalents of $38.3 million as of December
31, 2022, which consisted of checking account and money market funds. Historical fluctuations in interest rates have not been significant
for us, and we believe a hypothetical 10% change in interest rates during any of the periods presented would not have had a material effect
on our consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K. We had no outstanding debt as
of December 31, 2022. To minimize risk in the future, we intend to maintain our portfolio of cash equivalents in institutional market
funds that are composed of U.S. Treasury and U.S. Treasury-backed repurchase agreements or short-term U.S. Treasury
securities.
Foreign Currency Exchange Risk
All of our employees are currently located in the United States;
however, we do utilize certain vendors outside of the United States for our manufacturing of drug substances and clinical supplies.
As such, our expenses are denominated in both U.S. dollars and foreign currencies. Therefore, our operations are and will continue
to be subject to fluctuations in foreign currency exchange rates. To date, foreign currency transaction gains and losses have not been
material to our consolidated financial statements, and we have not had a formal hedging program with respect to foreign currency. We believe
a hypothetical 10% chance in exchange rates during any of the periods presented would not have a material effect on our consolidated financial
statements included in Part II, Item 8 of this Annual Report on Form 10-K.
Effects of Inflation
Inflation generally affects us by increasing our
cost of labor and in the future our clinical trial costs. We believe that inflation has not had a material effect on our consolidated
financial statements included in Part II, Item 8 of this Annual Report on Form 10-K.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
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JASPER THERAPEUTICS, INC.
INDEX TO THE FINANCIAL STATEMENTS
Page
Audited Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID 238) F-2
Consolidated Balance Sheets F-3
Consolidated Statements of Operations and Comprehensive Loss F-4
Consolidated Statements of Cash Flows F-6
Notes to Consolidated Financial Statements F-8
F-1
Report of Independent Registered Public Accounting
Firm
To the Board of Directors and Stockholders of Jasper Therapeutics,
Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Jasper
Therapeutics, Inc. and its subsidiary (the “Company”) as of December 31, 2022 and 2021, and the related consolidated statements
of operations and comprehensive loss, of redeemable convertible preferred stock and stockholders' equity (deficit) and of cash flows for
the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In
our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as
of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended in conformity with accounting
principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based
on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and
are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules
and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements
in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance
about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not
required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we