Calyxt, Inc., Cellectis’ Majority-Owned Subsidiary, Reports Its
First Quarter 2022 Financial Results
Cellectis S.A. (Euronext Growth: ALCLS - NASDAQ: CLLS), a
clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies, announced today that Calyxt, Inc. (Nasdaq: CLXT), a
plant-based synthetic biology company and a majority-owned
subsidiary of Cellectis, released today financial results for
Calyxt’s first quarter ended March 31, 2022. The contents of
Calyxt’s announcement are included below.
“The first quarter of 2022 marked a period of
instrumental advancement across several critical areas for Calyxt.
As a result of our expanded customer engagement, the breadth and
depth of our business development discussions have grown,
demonstrated by the 28 molecules identified by potential customers
that we have evaluated for development with our PlantSpring
platform for production in our BioFactory. That amount does not
include another 58 such molecules that did not meet our criteria
and were not evaluated further. Impressively, some of these 28
molecules were identified by the potential customers as having been
unsuccessfully attempted by others in the industry. Simultaneously,
we have made significant technical advancements for our PlantSpring
and BioFactory platforms. These include the incorporation of AIML
into our bioreactor’s lab scale production process and the
completion of the development of a compound identified by a
potential customer for evaluation. As this compound’s production
scales in the BioFactory, it is expected to lead to future
development and manufacturing contracts from customers. We have
also aggressively pursued the expansion of our intellectual
property portfolio with multiple patents issued and new patent
applications filed during the quarter. This enables us to carve out
space for Calyxt's proprietary technology including our Plant Cell
Matrix™ (PCM™) and multi-cellular approach that is
foundational for the success of our Company. Finally, in the first
quarter we completed an underwritten offering of common stock and
warrants that generated approximately $10 million in net proceeds.
This strengthened our balance sheet and provides us with the runway
to continuing scaling our technology to potentially secure new
business arrangements,” said Michael A. Carr, President and Chief
Executive Officer at Calyxt.
Mr. Carr added: “We have strengthened our
position to harness the incredible diversity of plants and the
world’s demand for sustainable products. By leveraging our
proprietary PlantSpring technology platform with our BioFactory
production system to develop and sell high value plant-based
chemistries to potential customers in our large and innovative
target end markets, including cosmeceuticals, nutraceuticals, and
pharmaceuticals, we continue our focused drive to realize value for
our stakeholders.”
Key accomplishments in the first quarter of
2022, and through the date of this press release, include the
following:
Achievement of Technical PlantSpring™ and
BioFactory™ Milestones
- In January 2022, Calyxt announced
that its initial pilot BioFactory™ production system became
operational at its headquarters in Minnesota. This development
occurred on schedule and marked an important first step toward
achieving at-scale commercial production. Calyxt has completed
multiple runs in its pilot BioFactory, focusing on ensuring the
system is operating as planned, its PCM structures perform as
expected, and that data is being captured properly as it is a
driver of future artificial intelligence and machine learning
capability (AIML) capability. The pilot facility is modular and
designed to be able to continuously produce plant-based chemistries
while also producing multiple compounds at once. These capabilities
are expected to provide Calyxt with flexibility when producing
chemistries for multiple customers at the same time. Calyxt intends
to scale this pilot production to enable full production runs of
compounds similar to those demanded for commercial production.
- Calyxt has also begun to deploy
additional AIML capabilities to both PlantSpring and the pilot
Biofactory. Calyxt currently uses AIML to assist in the
identification of gene targets in the PlantSpring development
process. During the past quarter it integrated AIML capabilities
into its lab-scale reactors, enabling the continual capture and
analysis of data, leading to optimization of performance. Calyxt
intends to advance these lab-scale AIML capabilities into its
pilot-scale reactor later this year. This deployment drives future
decisions and improves test cycles with the goal of shortening
development timelines.
- Late last year, Calyxt reported
considerable progress in discovery and development of sustainable
plant-based molecules in its BioFactory. Results from its
metabolomics analyses indicated more than 15,000 chemical
signatures, including both known and as-yet-uncharacterized
molecules and building block precursors. These signatures are
chemical compounds involved in chemical reactions that produce
other compounds. The chemical signatures that have been identified
form a baseline library that enables Calyxt to quickly identify and
assess customers’ targets with the potential to drive accelerated
development timelines. From this library, Calyxt has, based on
interest expressed by potential customers, produced rosemarinic
acid, a compound with antioxidant, anti-inflammatory, and
antimicrobial properties and that is used broadly in cosmeceuticals
and nutraceuticals. Calyxt has also used this baseline library to
identify six additional compounds of interest for prospective
customers. Calyxt intends to move the PCM producing rosemarinic
acid into the pilot BioFactory to further advance the BioFactory’s
capabilities and scale.
- Using data it has accumulated from
its land-based activities and its lab scale bioreactors, Calyxt has
demonstrated at least a 35-fold increase in yield from land-based
production to a lab scale bioreactor. Calyxt projects a further
yield increase as it moves production to pilot scale. Taken
together with the land-based to lab results, the further
advancement to lab scale could drive an aggregate increase in yield
of as much as 130-fold over land-based production yields based on
the current scale of the pilot BioFactory. These results underpin
Calyxt’s scalability and sustainability benefits of the BioFactory
production system.
- As part of Calyxt’s ongoing
validation of its platform technology, it is on track to realize
certain upcoming technical milestone targets:
- Within PlantSpring, and building on
Calyxt’s current gene targeting capability, to establish AIML
capabilities for the identification of pathways in the Design phase
of development by mid-year 2022.
- Building on Calyxt’s lab-scale
reactor AIML rollout, to have AIML capabilities fully functioning
within the pilot BioFactory by mid-year 2022.
- By the end of 2022, to design
additional PCM structures capable of providing the foundational
precursors to developing chemistries and molecules that are of
interest to a broad range of customers within Calyxt’s target
end-markets.
- To advance current engagement with
potential infrastructure partners in order to have one engaged by
the end of 2022.
Steadfast Focus on Customer Relationships
- Calyxt’s business model for its
proprietary PlantSpring technology and the BioFactory is customer
demand-driven. During the quarter Calyxt continued to advance its
discussions with potential customers within its target end markets
including the cosmeceutical, including personal care and flavors
and fragrances, nutraceutical, and pharmaceutical industries. These
are three key large end markets with customers that have current
business needs to source finite plant-based chemistries. They are
also markets known to be fast adopters of innovation that are
actively seeking to reduce carbon footprints. For example, based on
research from MarketsandMarkets1, the cosmeceutical ingredients
market, which also includes personal care and flavors and
fragrances, was estimated to be a spend of more than $60 billion in
2020 and growing at a mid-single digit compound annual growth rate.
This market includes large multinational cosmetics brands, regional
and specialty brands, and flavor and fragrance houses who
manufacture products or provide ingredients for those brands.1
Source: (i) MarketsandMarkets, Personal Care Ingredients Market –
Global Forecast to 2025, (ii) MarketsandMarkets, Global Color
Cosmetics Market – Forecast Till 2020, (iii) MarketsandMarkets,
Fragrance Ingredients Market – Global Trends & Forecast
to 2019, and (iv) MarketsandMarkets, Flavors and Fragrance Market –
Global Forecast to 2026
- The breadth and depth of Calyxt’s
business development discussions have grown. Calyxt has evaluated
28 molecules identified by potential customers for development with
PlantSpring for production in Calyxt’s BioFactory. That amount does
not include another 58 such molecules that did not meet Calyxt’s
target product profile, or TPP, criteria and were not evaluated
further. The group of 28 molecules includes several that were
identified by the potential customers as having been unsuccessfully
attempted by others in the industry. As part of the customer
acquisition process, Calyxt is expecting to produce small
quantities of product for evaluation by the customer and as a
result, Calyxt believes the development cycle from contract signing
to commercialization may likely be shorter than 36 months.
- Calyxt is targeting two to four
customer demand-driven compounds for development by year end using
its selection criteria to determine the compounds to pursue. Calyxt
uses the term “compounds” to describe compounds, molecules, and
plant-based chemistries interchangeably.
“In our conversations with customers, it’s
exciting to see their recognition of the advantages in our
approach,” said Michael A. Carr, President and Chief Executive
Officer at Calyxt. “They understand that our innovative technology
platform and cutting-edge production system can provide sustainable
biomanufacturing solutions to meet their product and ingredient
needs.”
Calyxt’s business model for PlantSpring and
BioFactory has two customer demand-driven revenue streams, one
focused on development activity and the other on product sales.
Most important is the product revenue expected to be generated once
commercialization is achieved. Calyxt anticipates a rapid revenue
ramp following the customers’ commercial launch of a compound, and
is targeting customers’ compounds with large demand pools,
potential multi-million-dollar annual revenue opportunities per
compound, and a target gross profit margin in the mid-double digits
at scale. Calyxt also believes its prospective customers will pay
for development in some instances.
Licensing of Technology and Traits
- In the first quarter of 2022,
Calyxt finalized its strategy for optimizing potential revenue from
the licensing of its technology and plant traits. The strategy is
two-pronged and reflects (1) a broad outreach to companies in the
plant gene-editing and biotechnology space for their licensing of
Calyxt’s intellectual property assets and (2) the monetization of
Calyxt’s historically developed agricultural traits through their
license to counterparties including seed companies, processors, and
others. Calyxt is offering licenses for the many gene editing and
breeding technologies in its patent portfolio, including its TALEN
patent estate. As it relates to the licensing of agricultural
traits strategy, active discussions are occurring on multiple
traits, including Calyxt’s soybean and wheat offerings. Calyxt is
targeting the execution of licenses in both the technology and
trait licensing categories during 2022.
- In the fourth quarter of 2021,
Calyxt contracted with a large food ingredient manufacturer to
develop a soybean intended to produce an oil that could serve as a
replacement for palm oil. The project remains on track for a first
quarter of 2024 completion. The food ingredient manufacturer is
funding Calyxt’s development costs over the term of the agreement
and holds an option for future development and
commercialization.
Investments in Key Hires
- In February 2022, Calyxt announced
that Gerry Nuovo joined Calyxt as Senior Vice President of Business
Development, bringing more than 30 years of experience in the
specialty chemicals and biotechnology industries and diverse
experience building multimillion-dollar income streams in the
cosmeceuticals end market, including personal care and home care.
Mr. Nuovo will be responsible for business development activities
in cosmeceuticals, including potential partnerships, deal
structures, valuation models, and subsequent transaction execution
and alliance management.
- In April 2022, Calyxt announced the
hires of Ms. Suellen Boot as Business Development Director and Ms.
Elizabeth Teigland as Manufacturing Director. Ms. Boot brings over
20 years of valuable business development experience to Calyxt
where she will be responsible for a number of functions, including
potential partnerships, deal structures, valuation models, and
subsequent transaction execution and alliance management. Ms.
Teigland brings over 15 years of chemistry and purification
expertise to Calyxt and will be responsible for pilot to commercial
scale production of Calyxt’s customer demand-driven compounds, and
along with an R&D leader, the Verify stage of product
development.
Other Business Updates
- In February 2022, Calyxt closed the
placement to an institutional investor in an SEC-registered
underwritten offering of 3,880,000 shares of its common stock,
pre-funded warrants to purchase up to 3,880,000 shares of its
common stock, and common warrants to purchase up to 7,760,000
shares of its common stock. The gross proceeds of the offering were
$10.9 million, before deducting underwriting fees and estimated
offering expenses. The Company plans to use the approximately
$10.0 million in net proceeds from the offering for enhancing the
capabilities of its BioFactory production system and increasing its
capacity to produce at larger scales, continuing to build out
Calyxt’s PlantSpring technology platform and AIML capabilities,
furthering customer relationships, and for working capital and
general corporate purposes. The pre-funded warrants were exercised
in full on May 4, 2022.
Financial Results for the Three Months Ended
March 31, 2022
- Cash, cash equivalents, and
restricted cash totaled $17.9 million as of March 31, 2022,
including net proceeds of $10.0 million that was raised in
mid-February from the SEC-registered offering.
- Revenue was nominal in the first
quarter of 2022 compared to $4.4 million in the first quarter of
2021. The decrease in revenue was driven by the late 2021
completion of the wind-down of Calyxt’s soybean product line. All
revenue in the first quarter of 2022 was associated with Calyxt’s
agreement with a food ingredient manufacturer to develop a palm oil
alternative.
- Total operating expenses were $6.1
million in the first quarter of 2022 compared to $7.3 million in
the first quarter of 2021. The decrease was primarily driven by the
recapture of non-cash stock compensation expense from the
forfeiture of unvested stock awards in the first quarter of 2022
and lower operating expenses.
- Net loss was $5.6 million in the
first quarter of 2022 compared to $10.0 million in the first
quarter of 2021. The improvement in net loss was driven by the
completion of the wind-down of the soybean product line which drove
an improvement in gross margin and lower operating expenses. Net
loss per share was $0.13 in the first quarter of 2022 compared to
$0.27 in the first quarter of 2021. The improvement in net loss per
share was driven by the improvement in net loss and a
year-over-year increase in weighted average shares
outstanding.
- Adjusted net loss was $6.0 million
in the first quarter of 2022 compared to $8.8 million in the first
quarter of 2021. The improvement in adjusted net loss was driven by
the completion of the wind-down of the soybean product line which
drove an improvement in gross margin and lower operating expenses.
Adjusted net loss per share was $0.14 in the first quarter of 2022
compared to $0.24 in the first quarter of 2021. The improvement in
adjusted net loss per share was driven by the improvement in
adjusted net loss and a year-over-year increase in weighted average
shares outstanding.
"The continued expansion of our AIML
capabilities has already contributed to expediting the development
process, and we believe we can now complete the Design, Engineer,
and Verify phases of our development cycle in some cases in as
little as nine months’ time and we look forward to reporting
progress against the 24-month pilot cycle in the future. In
addition, we have now secured key hires that represent our revenue
streams: business development, chemistry/purification, and
licensing,” said Bill Koschak, Chief Financial Officer at Calyxt.
“Further, the approximate $10.0 million in net proceeds from the
capital raise we recently completed in February, in spite of
volatile market conditions, allows us to scale our BioFactory
production and AIML capabilities. Our plans to utilize PlantSpring
and the BioFactory to target customers in large and innovative end
markets like cosmeceuticals, nutraceuticals, and pharmaceuticals
are resonating in conversations across industries, and we look
forward to providing updates in the coming months. Thanks to the
successful offering of our common stock and warrants and assessing
our discretionary spending, we now expect Calyxt’s cash runway to
extend into early 2023.”
First Quarter 2022 Results Conference
Call
Calyxt’s President and Chief Executive Officer,
Michael A. Carr, and Chief Financial Officer, Bill Koschak, will
host a conference call discussing Calyxt’s results for the first
quarter of 2022, followed by a question-and-answer session. The
conference call will be accompanied by a presentation, which can be
viewed during the webcast or accessed via the investor relations
section of Calyxt’s website at www.calyxt.com.
To access the call, please use the following
information:
Date: |
|
Thursday, May
5, 2022 |
Time: |
|
4:30 p.m. EST, 1:30 p.m. PST |
Toll Free dial-in number: |
|
+1-888-317-6003 |
Toll/International dial-in number: |
|
+1-412-317-6061 |
Conference ID: |
|
2452642 |
Please call the conference telephone number 5-10
minutes prior to the start time. An operator will register your
name and organization. The conference call will also be broadcast
live and available for replay via the investor relations section of
the company's website at www.calyxt.com.
A replay of the webcast will be available for 30
days following the event.
Toll Free Replay Number: |
+1-877-344-7529 |
International Replay Number: |
+1-412-317-0088 |
Replay ID: |
9265408 |
About the PlantSpring™ Technology
Platform and BioFactory™ Production System
Calyxt’s technology platform, PlantSpring, is
founded on Calyxt’s more than a decade of experience engineering
plant metabolism, and incorporates its scientific knowledge, its
proprietary systems, tools, and technologies; and an expanding set
of AIML capabilities. In PlantSpring, Calyxt identifies metabolic
pathways to produce plant-based chemistries, designs strategies to
reprogram host cells, engineers plant cell metabolism to optimally
produce targeted compounds, and produces those targeted compounds
at laboratory scale. Calyxt has implemented AIML capabilities for
the identification of targets for editing specific genetic pathways
and continues to develop AIML capabilities across the PlantSpring
platform, which will enable learning and adaptation of knowledge
gained from past activity and are expected to be combined with
predictive analytics to rapidly prototype and provide feedback,
accelerate the time to complete the development cycle and help
mitigate the risk associated with commercial scale-up. As a result,
Calyxt believes it can develop biomolecules in plants for customers
at both a greater breadth and level of complexity and at faster
speeds than its competitors in the synthetic biology industry. The
output from the PlantSpring platform integrates with Calyxt’s
BioFactory production system.
The BioFactory is a bioreactor-based production
system that is designed to be capable of continuous production of
plant-based chemistries. The bioreactor can be of any size
depending upon factors including yield and titer necessary to reach
the required commercial scale. For production, multicellular Plant
Cell Matrix™ (PCM™) structures are placed inside the bioreactor,
and growth media bathes the PCM structures to provide them with
nutrition, which differentiates Calyxt’s process from other methods
that require complete submersion of cells in growth media and/or
the application of hormones to facilitate growth. A PCM structure
is a living system of various cell types, which is designed to
emulate the intercellular metabolism of an entire plant, which
grows over time, produces, and stores, or excretes, the target
chemistries. The growth media is the feedstock of the BioFactory
production system and contains the essential inputs to support
growth of the PCM structures and necessary chemistry production.
The growth media is expected to be reused throughout the production
cycle, which may run for an extended time period. To scale
production in the BioFactory productions system, Calyxt expects to
move the PCM structures from its current bioreactor into larger
capacity bioreactors or groups of bioreactors. Calyxt began running
lab-scale bioreactors in early 2021. Calyxt’s first pilot-scale
bioreactor became operational in December 2021 and is scalable up
to 200 liters. The pilot stage of development takes a compound
developed with the PlantSpring platform through to commercial
production. Depending on the compound to be produced, there may be
a range of vessel sizes between the initial pilot facility and the
commercial production facility. Calyxt’s current plan is to engage
third parties, referred to as infrastructure partners, for at-scale
commercial production. Infrastructure partners are likely to be
companies with processing assets that can be converted from current
production to Calyxt’s bioreactor-based approach. If an
infrastructure partner is used for production, Calyxt expects to
pay a fee for that production. Because of the expected modular
nature of the BioFactory production system and the types of high
value compounds Calyxt expects to develop for customers, it is also
possible that commercial production could also occur in a
customer’s in-house facility. Calyxt expects to expand the scope of
its pilot facilities based on customer demand, and the scope of
production could extend, subject to regulatory and other
considerations, outside the United States. Because of its
production methodology, Calyxt believes the BioFactory has the
potential to be one of the most sustainable production systems
across industries.
About Calyxt
Calyxt (Nasdaq: CLXT) is a plant-based synthetic
biology company. Calyxt leverages its proprietary PlantSpring™
technology platform to engineer plant metabolism to produce
innovative high value plant-based chemistries for use in customers’
materials and products. As plant-based solutions, Calyxt’s
synthetic biology products can be used in helping customers meet
their sustainability targets and financial goals. Calyxt's
diversified offerings are primarily delivered through its
proprietary BioFactory™ production system. For more information,
visit www.calyxt.com.
PlantSpring, BioFactory, Plant Cell Matrix™, and
the Calyxt logo are trademarks of Calyxt, Inc. Any other trademarks
belong to their respective owners.
Calyxt Contacts
Calyxt Media Contact: |
Calyxt Investor Relations Contact: |
David Rosen/ John Garabo/ Michael
BarronArgot Partners(212) 600-1902media@calyxt.com |
Kimberly Minarovich/ Cameron
WillisArgot Partners(212) 600-1902investors@calyxt.com |
Calyxt Business Development Contact: |
|
Gerry NuovoSenior Vice President
of Business Development(612) 427-7881contact@calyxt.com |
|
USE OF NON-GAAP FINANCIAL
INFORMATION
To supplement Calyxt’s financial results
prepared in accordance with GAAP, it has prepared certain non-GAAP
measures that include or exclude special items. These non-GAAP
measures are not meant to be considered in isolation or as a
substitute for financial information presented in accordance with
GAAP and should be viewed as supplemental and in addition to
Calyxt’s financial information presented in accordance with GAAP.
Investors are cautioned that there are material limitations
associated with the use of non-GAAP financial measures. In
addition, other companies may report similarly titled measures, but
calculate them differently, which reduces their usefulness as a
comparative measure. Management utilizes these non-GAAP metrics as
performance measures in evaluating and making operational decisions
regarding Calyxt’s business.
Calyxt’s 2021 non-GAAP financial measures
reflect adjustments for certain commodity derivatives entered into
in connection with its soybean product line. As a result of the
completed wind-down of this product line, Calyxt held no commodity
derivative contracts as of March 31, 2022.
Calyxt presents adjusted net loss, a non-GAAP
measure, and defines it as net loss including adjustments necessary
to present the underlying gross profit of its soybean product line,
including (i) unrealized gains and losses associated with commodity
derivatives entered into to hedge the change in value of fixed
price grain inventories and fixed price grain production agreements
that should be recognized in the future when the underlying
inventory is sold, (ii) gains and losses from commodity derivatives
realized in prior periods but associated with inventory sold in the
current period, (iii) net realizable value adjustments to
inventories occurring in the period which otherwise would have been
recognized in the future when the underlying inventory is sold, and
(iv) net realizable value adjustments recognized in prior periods
but associated with inventory sold in the current period, and
excluding cash-based Section 16 officer transition expenses, the
recapture of non-cash stock compensation associated with the
departure of Section 16 officers, and non-operating expenses.
Calyxt provides in the table below a
reconciliation of net loss, which is the most directly comparable
GAAP financial measure, to adjusted net loss. Calyxt provides
adjusted net loss because it believes that this non-GAAP financial
metric provides investors with useful supplemental information at
this stage of commercialization as the amounts being adjusted
affect the period-to-period comparability of net losses and
financial performance.
The table below presents a reconciliation of net
loss to adjusted net loss:
|
Three Months Ended March 31, |
|
In Thousands |
2022 |
|
|
2021 |
|
Net loss (GAAP measure) |
$ |
(5,619 |
) |
|
$ |
(10,028 |
) |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Commodity derivative impact, net |
|
— |
|
|
|
211 |
|
Net realizable value adjustment to inventories |
|
— |
|
|
|
787 |
|
Section 16 officer transition expenses |
|
116 |
|
|
|
2,721 |
|
Recapture of non-cash stock compensation |
|
— |
|
|
|
(2,540 |
) |
Non-operating expenses |
|
(487 |
) |
|
|
1 |
|
Adjusted net loss |
$ |
(5,990 |
) |
|
$ |
(8,848 |
) |
Calyxt presents adjusted net loss per share, a
non-GAAP measure, and defines it as net loss per share including
adjustments necessary to present the underlying gross profit of its
soybean product line, including (i) unrealized gains and losses
associated with commodity derivatives entered into to hedge the
change in value of fixed price grain inventories and fixed price
grain production agreements that should be recognized in the future
when the underlying inventory is sold, (ii) gains and losses from
commodity derivatives realized in prior periods but associated with
inventory sold in the current period, (iii) net realizable value
adjustments to inventories occurring in the period which otherwise
would have been recognized in the future when the underlying
inventory is sold, and (iv) net realizable value adjustments
recognized in prior periods but associated with inventory sold in
the current period, and excluding cash-based Section 16 officer
transition expenses, the recapture of non-cash stock compensation
associated with the departure of Section 16 officers, and
non-operating expenses.
Calyxt provides in the table below a
reconciliation of net loss per share, which is the most directly
comparable GAAP financial measure, to adjusted net loss per share.
Calyxt provides adjusted net loss per share because it believes
that this non-GAAP financial metric provides investors with useful
supplemental information at this stage of commercialization as the
amounts being adjusted affect the period-to-period comparability of
net losses per share and financial performance.
The table below presents a reconciliation of net
loss per share to adjusted net loss per share:
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
Net loss per share (GAAP measure) |
$ |
(0.13 |
) |
|
$ |
(0.27 |
) |
Non-GAAP adjustments: |
|
|
|
|
|
|
|
Commodity derivative impact, net |
|
— |
|
|
|
0.01 |
|
Net realizable value adjustment to inventories |
|
— |
|
|
|
0.02 |
|
Section 16 officer transition expenses |
|
— |
|
|
|
0.07 |
|
Recapture of non-cash stock compensation |
|
— |
|
|
|
(0.07 |
) |
Non-operating expenses |
|
(0.01 |
) |
|
|
— |
|
Adjusted net loss per share |
$ |
(0.14 |
) |
|
$ |
(0.24 |
) |
Forward-Looking Statements
This communication contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995. In some
cases, you can identify these statements by forward-looking words
such as “anticipates,” “believes,” “continue,” “estimates,”
“expects,” “intends,” “may,” “might,” “plans,” “predicts,”
“projects,” “should,” “targets,” “will,” or the negative of these
terms and other similar terminology. Forward-looking statements in
this report include statements about Calyxt's future financial
performance, including its cash runway; its product pipeline and
development; its business model and strategies for the development,
commercialization and sales of commercial products; commercial
demand for its synthetic biology solutions; the development and
deployment of its PlantSpring technology platform; its ability to
deploy and leverage its artificial intelligence and machine
learning (AIML) capabilities; the ability to scale production
capability for its BioFactory production system; potential
development agreements, partnerships, customer relationships, and
licensing arrangements and their contribution to its financial
results, cash usage, and growth strategies; the potential impact of
the COVID-19 pandemic on its business and operating results; and
anticipated trends in its business. These and other forward-looking
statements are predictions and projections about future events and
trends based on Calyxt's current expectations, objectives, and
intentions and are premised on current assumptions. Calyxt's actual
results, level of activity, performance, or achievements could be
materially different than those expressed, implied, or anticipated
by forward-looking statements due to a variety of factors,
including, but not limited to: the impact of increased competition,
including competition from a broader array of synthetic biology
companies; competition for customers, partners, and licensees and
the successful execution of development and licensing agreements;
disruptions at its key facilities, including disruptions impacting
its BioFactory production system; flaws in AIML algorithms,
insufficiency of data inputs required by such algorithms, and human
error in interacting with AIML; changes in customer preferences and
market acceptance of its products; changes in market consensus as
to what attributes are required for a product to be considered
“sustainable”; the impact of adverse events during development,
including unsuccessful pilot production of plant-based chemistries
or field trials; the impact of improper handling of its product
candidates during development; failures by third-party contractors;
inaccurate demand forecasting or milestone and royalty payment
projections; the effectiveness of commercialization efforts by
commercial partners or licensees; disruptions to supply chains,
including raw material inputs for its BioFactory; the impact of
changes or increases in oversight and regulation; disputes or
challenges regarding intellectual property; proliferation and
continuous evolution of new technologies; management changes;
dislocations in the capital markets; the severity and duration of
the evolving COVID-19 pandemic and the resulting impact on
macro-economic conditions; and other important factors discussed in
Part I, Item 1A, “Risk Factors” in Calyxt’s filings with the SEC,
included in Part I, Item 1A of its Annual Report on Form 10-K for
the year ended December 31, 2021, which was filed with the SEC
on March 3, 2022 (its Annual Report) and its subsequent
reports on Forms 10-Q and 8-K filed with the SEC as well as other
important factors discussed in Part I, Item 1A, “Risk Factors” in
Calyxt’s filings with the SEC, included in Part I, Item 3 of
Cellectis’ Annual Report on Form 20-F for the year ended
December 31, 2021, which was filed with the SEC on
March 3, 2022 (its Annual Report) and its subsequent reports
on Form 6-K. Any forward-looking statements made by management of
Calyxt are based only on currently available information and speak
only as of the date of this report. Except as otherwise required by
securities and other applicable laws, Calyxt does not assume any
obligation to publicly provide revisions or updates to any
forward-looking statements, whether as a result of new information,
future developments or otherwise, should circumstances change.
CALYXT, INC. |
CONSOLIDATED BALANCE SHEETS |
(In Thousands, Except Par Value and Share
Amounts) |
|
|
March 31, 2022(unaudited) |
|
|
December 31,2021 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
17,285 |
|
|
$ |
13,823 |
|
Restricted cash |
|
499 |
|
|
|
499 |
|
Prepaid expenses and other current assets |
|
1,189 |
|
|
|
859 |
|
Total current assets |
|
18,973 |
|
|
|
15,181 |
|
Non-current restricted cash |
|
99 |
|
|
|
99 |
|
Land, buildings, and
equipment |
|
5,125 |
|
|
|
21,731 |
|
Operating lease right-of-use assets |
|
13,973 |
|
|
|
— |
|
Other non-current assets |
|
175 |
|
|
|
183 |
|
Total assets |
$ |
38,345 |
|
|
$ |
37,194 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,167 |
|
|
$ |
1,260 |
|
Accrued expenses |
|
379 |
|
|
|
339 |
|
Accrued compensation |
|
2,209 |
|
|
|
2,522 |
|
Due to related parties |
|
64 |
|
|
|
172 |
|
Current portion of financing lease obligations |
|
290 |
|
|
|
370 |
|
Common stock warrants |
|
4,976 |
|
|
|
— |
|
Other current liabilities |
|
435 |
|
|
|
191 |
|
Total current liabilities |
|
9,520 |
|
|
|
4,854 |
|
Financing lease obligations |
|
89 |
|
|
|
17,506 |
|
Operating lease obligations |
|
13,742 |
|
|
|
— |
|
Other non-current liabilities |
|
73 |
|
|
|
702 |
|
Total liabilities |
|
23,424 |
|
|
|
23,062 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
Common stock, $0.0001 par value;
275,000,000 shares authorized; 42,841,915 shares issued and
42,741,763 shares outstanding as of March 31, 2022, and 38,874,146
shares issued and 38,773,994 shares outstanding as of December 31,
2021 |
|
5 |
|
|
|
4 |
|
Additional paid-in capital |
|
216,838 |
|
|
|
211,263 |
|
Common stock in treasury, at
cost; 100,152 shares as of March 31, 2022, and December 31,
2021 |
|
(1,043 |
) |
|
|
(1,043 |
) |
Accumulated deficit |
|
(200,879 |
) |
|
|
(196,092 |
) |
Total stockholders’ equity |
|
14,921 |
|
|
|
14,132 |
|
Total liabilities and stockholders’ equity |
$ |
38,345 |
|
|
$ |
37,194 |
|
CALYXT, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
(In Thousands Except Shares and Per Share
Amounts) |
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
Revenue |
$ |
32 |
|
|
$ |
4,402 |
|
Cost of goods sold |
|
— |
|
|
|
6,745 |
|
Gross profit |
|
32 |
|
|
|
(2,343 |
) |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
2,941 |
|
|
|
3,050 |
|
Selling, general, and administrative |
|
3,180 |
|
|
|
4,258 |
|
Management fees |
|
— |
|
|
|
30 |
|
Total operating expenses |
|
6,121 |
|
|
|
7,338 |
|
Loss from operations |
|
(6,089 |
) |
|
|
(9,681 |
) |
Interest, net |
|
(17 |
) |
|
|
(346 |
) |
Non-operating expenses |
|
487 |
|
|
|
(1 |
) |
Loss before income taxes |
|
(5,619 |
) |
|
|
(10,028 |
) |
Income taxes |
|
— |
|
|
|
— |
|
Net loss |
$ |
(5,619 |
) |
|
$ |
(10,028 |
) |
Basic and diluted net loss per share |
$ |
(0.13 |
) |
|
$ |
(0.27 |
) |
Weighted average shares outstanding - basic and
diluted |
|
42,020,090 |
|
|
|
37,136,338 |
|
Anti-dilutive stock options, restricted stock units, and
performance stock units |
|
16,276,362 |
|
|
|
5,013,780 |
|
CALYXT, INC. |
CONSOLIDATED STATEMENTS OF CASH FLOWS |
(Unaudited) |
(in Thousands) |
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
2021 |
|
Operating activities |
|
|
|
|
|
|
|
Net loss |
$ |
(5,619 |
) |
|
$ |
(10,028 |
) |
Adjustments to reconcile net loss to net cash used by operating
activities: |
|
|
|
|
|
|
|
Depreciation and amortization |
|
370 |
|
|
|
585 |
|
Stock-based compensation |
|
531 |
|
|
|
(1,450 |
) |
Unrealized (gain) loss on mark-to-market of common stock
warrants |
|
(435 |
) |
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivable |
|
— |
|
|
|
3,533 |
|
Due to/from related parties |
|
(108 |
) |
|
|
(652 |
) |
Inventory |
|
— |
|
|
|
(3,149 |
) |
Prepaid expenses and other current assets |
|
(110 |
) |
|
|
583 |
|
Accounts payable |
|
(145 |
) |
|
|
30 |
|
Accrued expenses |
|
37 |
|
|
|
167 |
|
Accrued compensation |
|
(313 |
) |
|
|
(186 |
) |
Other |
|
(612 |
) |
|
|
1,150 |
|
Net cash used by operating activities |
|
(6,404 |
) |
|
|
(9,417 |
) |
Investing activities |
|
|
|
|
|
|
|
Sales and (purchases) of short-term investments, net |
|
— |
|
|
|
8,653 |
|
Purchases of land, buildings, and equipment |
|
(545 |
) |
|
|
(269 |
) |
Net cash (used by) provided by investing
activities |
|
(545 |
) |
|
|
8,384 |
|
Financing activities |
|
|
|
|
|
|
|
Proceeds from the issuance of common stock |
|
11,209 |
|
|
|
— |
|
Costs incurred related to the issuance of common stock |
|
(704 |
) |
|
|
— |
|
Repayments of financing lease obligations |
|
(94 |
) |
|
|
(88 |
) |
Proceeds from the exercise of stock options |
|
— |
|
|
|
208 |
|
Net cash provided by financing activities |
|
10,411 |
|
|
|
120 |
|
Net
increase (decrease) in cash, cash equivalents, and restricted
cash |
|
3,462 |
|
|
|
(913 |
) |
Cash, cash equivalents, and restricted cash - beginning of
period |
|
14,421 |
|
|
|
18,289 |
|
Cash, cash equivalents, and restricted cash – end of
period |
$ |
17,883 |
|
|
$ |
17,376 |
|
********
About CellectisCellectis is a
clinical-stage biotechnology company using its pioneering
gene-editing platform to develop life-saving cell and gene
therapies. Cellectis utilizes an allogeneic approach for CAR-T
immunotherapies in oncology, pioneering the concept of
off-the-shelf and ready-to-use gene-edited CAR T-cells to treat
cancer patients, and a platform to make therapeutic gene editing in
hemopoietic stem cells for various diseases. As a clinical-stage
biopharmaceutical company with over 22 years of expertise in gene
editing, Cellectis is developing life-changing product candidates
utilizing TALEN®, its gene editing technology, and PulseAgile, its
pioneering electroporation system to harness the power of the
immune system in order to treat diseases with unmet medical needs.
Cellectis’ headquarters are in Paris, France, with locations in New
York, New York and Raleigh, North Carolina. Cellectis is listed on
the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth
(ticker: ALCLS).
For more information, visit
www.cellectis.com. Follow Cellectis on social media:
@cellectis, LinkedIn and YouTube.
For further information on Cellectis,
please contact:
Media contacts: Pascalyne
Wilson, Director, Communications, +33 (0)7 76 99 14 33,
media@cellectis.com Margaret Gandolfo, Senior Manager,
Communications, +1 (646) 628 0300
Investor Relation contact: Arthur Stril,
Chief Business Officer, +1 (347) 809 5980,
investors@cellectis.com Ashley R. Robinson, LifeSci
Advisors, +1 617 430 7577
- 1530466945_1_CLLS PR CLXT Results Q12022
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