TIDMMXCT TIDMMXCR
RNS Number : 6299B
MaxCyte, Inc.
24 September 2018
MaxCyte, Inc.
("MaxCyte" or the "Company")
Results for the Six Months ended 30 June 2018
Gaithersburg, Maryland - 24 September 2018 - MaxCyte (LSE: MXCT, MXCR),
the global cell-based medicines and life sciences company, announces today
its financial results as well as key commercial and clinical highlights
for the six months ended 30 June 2018.
HIGHLIGHTS (including post-period end highlights)
All financial amounts are in USD unless noted otherwise.
Financial
* Revenues of $6.9 million for the six months ended 30
June 2018, an 11.6% increase over $6.2 million for
the same period of 2017, and up 14.7% before the
inclusion of commercial licence upfront fees
* Gross margins remained consistent at 89% for the six
months ended 30 June 2018, compared to 90% for the
same period of 2017
* Investment in CARMA(TM) (chimeric antigen receptor
"CAR" therapy) was $2.6 million (first half 2017:
$2.1 million) as the Company completed submissions
for its first investigational new drug ("IND")
application to the US Food and Drug Administration
("FDA")
* Operating expenses (including CARMA investment)
increased to $10.7 million for the six months ended
30 June 2018 (first half 2017: $9.5 million)
* Net loss before the CARMA investment was $2.2 million
for the six months ended 30 June 2018 (first half
2017: $2.2 million). Net loss including the CARMA
investment was $4.8 million over the period (first
half 2017: $4.3 million)
* EBITDA before CARMA investment was a loss of $1.4
million for the six months ended 30 June 2018 (first
half 2017: $1.7 million), after adjusting for
non-cash stock-based compensation of $0.4 million
(first half 2017: $0.1 million)
* Cash and cash equivalents, including short term
investments totalled $18.8 million at 30 June 2018
(31 December 2017: $25.3 million)
Operational
* Received IND clearance from the FDA to begin the
Company's first clinical study with its wholly-owned
CAR therapeutic candidate, MCY-M11, in patients with
ovarian cancer and peritoneal mesothelioma
* Expanded the Company's enabling technology business
to more than 55 cell therapy partnered programmes in
cutting-edge fields and increased the number of
licences to partners covering clinical-stage
programmes to more than 25 (an increase of
approximately 60% from the more than 15 programmes
reported at this time last year)
* Maintained ongoing collaborations with world leaders
in the CAR field in both solid cancers and
haematological malignancies, with nine academic
clinical trials supported by MaxCyte's technology
* Continued strong investment in sales and marketing
capabilities to grow the Company's customer base,
which now includes all of the top 10 global
pharmaceutical companies and 20 out of the top 25
* Presented at several industry conferences on
MaxCyte's next-generation autologous CAR therapies,
highlighting the Company's breakthrough CARMA
platform's ability to engineer transient persistence
to mitigate off-tumor toxicity and significantly
reduce the turnaround time of autologous cell therapy
to patients
* Entered into an agreement to develop treatments for
individuals with sickle cell disease ("SCD") using
next-generation CRISPR/Cas9-based single-nucleotide
correction enabled by MaxCyte's cell engineering
platform. This Cooperative Research and Development
Agreement ("CRADA") is with the U.S. National
Institutes of Health ("NIH") and its National Heart,
Lung, and Blood Institute ("NHLBI")
* Presented pre-clinical data at the annual meeting of
the American Society of Gene and Cell Therapy
("ASGCT") in Chicago highlighting the use of
MaxCyte's non-viral cell engineering technology for
CRISPR-mediated gene-correction of a mutation within
the hemoglobin gene of cells from a SCD patient
* Appointed new Chief Medical Officer, Claudio Dansky
Ullmann, MD (in April 2018), and new Board member,
Richard Douglas, PhD (in February 2018)
Commenting on MaxCyte's interim financial results, Doug Doerfler, Chief
Executive Officer, said: "We are in an excellent position across the business
as MaxCyte continues to grow and gain momentum. Revenue is continuing to
rise strongly with gross margins remaining consistent at 89% and partnered
cell therapy opportunities have accelerated significantly, providing a strong
near-term pipeline. We also recently announced the advancement of our lead
CARMA candidate, MCY-M11, to FDA clearance of the IND - an important milestone
- and we are on course to dose patients before the end of the year.
"This is a very exciting and important time for the Company, our partners
and patients as we bring a new generation of CAR-based cancer treatments
into the clinic for the first time and support the increasing number of
clinical and commercial advancements of our partners' therapeutics. In addition,
we have continued to make significant progress in bolstering our core business,
particularly with regard to expanding our sales and marketing infrastructure
and developing data that support the use of our technology and products
in a variety of applications. MaxCyte's Board therefore anticipates continued
progress for the remainder of the 2018 financial year and the Company is
trading in line with expectations. We thank the Company's investors, Board
members and collaborators who have helped the Company achieve its present
level of success, and who share the vision of a new way to engineer cells
to treat disease."
Conference call for analysts
A briefing for analysts will be held at 11.00 am BST on Monday 24 September
2018 at the offices of Panmure Gordon & Co., One New Change, London, EC4M
9AF. There will be a simultaneous live conference call with Q&A, and the
presentation will be available on MaxCyte's website at http://www.maxcyte.com/
Dial-in details:
Participant dial-in: 08003767922
International dial-in: +44 (0) 2071 928000
Participant code: 6076799
An audio replay file will be made available shortly afterwards via the Company
website:
http://www.maxcyte.com/
CHAIRMAN AND CHIEF EXECUTIVE OFFICER'S LETTER
We are pleased to report MaxCyte's financial and operational results for
the six months ended 30 June 2018, during which the Company exhibited another
period of strong growth and progress across all areas of the business in
line with its strategic objectives.
On the commercial side of the business, revenues grew to $6.9 million for
the six months ended 30 June 2018, an 11.6% increase over $6.2 million for
the same period of 2017, and gross margins remained consistent at 89% for
the six months ended 30 June 2018, compared to 90% for the same period of
2017. We now have more than 55 cell therapy partnered programmes in cutting-edge
fields including gene editing for the treatment of inherited diseases and
immuno-oncology, and we have increased the number of licences to partners
covering clinical-stage programmes to more than 25 (an increase of approximately
60% from the more than 15 programmes reported at this time last year). This
acceleration along with the growth of new customer prospects creates a strong
near-term pipeline for future deals in cell therapy. We also continued to
invest in our sales and marketing capabilities to further grow the Company's
customer base.
In July, we announced that we have received IND clearance from the FDA to
begin our first clinical study with MaxCyte's first wholly owned, and internally
developed, CAR therapeutic candidate, MCY-M11. We are excited to advance
MCY-M11 into the clinic at some of the world's top medical centers and we
hope that the results of this upcoming Phase I study, which we plan to start
before year end, will serve as validation of our proprietary CARMA(TM) drug
platform as a whole. We anticipate that the results of this initial study
in ovarian cancer and peritoneal mesothelioma may help support the safety
and potential effectiveness of our CAR drug candidate developed from the
CARMA platform. If successful, it may establish the CARMA platform as a
new autologous cell therapy platform for developing improved targeted cell-based
immune therapies. Reaching the clinical stage of development with our first
CARMA therapeutic is a key milestone and highlights the success of the company's
strategy to leverage our decades of experience in cell therapy to create
high-value applications through careful investments in promising uses of
our unique cell engineering platform.
In June, we entered into a CRADA with the NIH under which MaxCyte and the
NHLBI, one of the world's leading disease institutes, will work to develop
treatments for individuals with SCD using next-generation CRISPR/Cas9-based
single-nucleotide correction enabled by our cell engineering platform. We
believe that this work will further validate the use of our platform for
developing gene-editing therapies for a broad range of diseases while enabling
rapid development and commercial manufacturing of new therapies for patients
where there is a high unmet medical need. This is our second CRADA with
NIH. The first, with the NIH's National Institute of Allergy and Infectious
Diseases, was announced in June 2017, and is to develop treatments for X-linked
chronic granulomatous disease.
During the first half of the year, we continued to promote our cell engineering
platform technology and our CARMA platform. Specifically, we presented pre-clinical
data at the ASGCT annual meeting in May 2018 highlighting how MaxCyte's
non-viral cell engineering technology was used for CRISPR-mediated gene
correction of a mutation within the hemoglobin gene of cells from a SCD
patient.
We also presented data at several industry conferences related to our breakthrough
CARMA platform and its potential to engineer transient persistence to mitigate
off-tumor toxicity. The streamlined manufacturing process of the platform
significantly reduces the turnaround time of autologous cell therapy to
patients.
Finally, we made important appointments to further strengthen our corporate
leadership team. In April 2018, we appointed Dr Claudio Dansky Ullmann,
an expert with over 25 years' experience in clinical oncology and pharmaceutical
research as our Chief Medical Officer and in February 2018, Dr Richard Douglas,
who formerly served as the Senior Vice President of Corporate Development
and Corporate Officer at Genzyme Corporation, joined our Board of Directors.
We believe that the Company's progress during the first six months of 2018
provides us with a strong foundation for continued success and we are excited
to build on our progress.
Financial Review
Revenues for the period totaled $6.9 million, representing an 11.6% increase
over the same period of 2017 and up 14.7% before the inclusion of commercial
licence upfront fees. Gross margins remained stable over the period. This
growth in revenue reflects continued expansion of the Company's customer
base.
The Company's operating expenses for the period (including CARMA investment)
increased to $10.7 million compared to $9.5 million for the same period
of 2017 resulting principally from the $0.5 million increase in CARMA investments
and increased investments in sales and marketing, product development and
other non-CARMA R&D activities focused on driving and supporting MaxCyte's
growth. Investment in CARMA was $2.6 million (first half 2017: $2.1 million)
as the Company advanced efforts to obtain FDA clearance for its first IND
application.
MaxCyte's net loss before taking into consideration expenses from the CARMA
programme was $2.2 million over the period compared to net loss of $2.2
million (also before taking into consideration expenses from CARMA) for
the same period of 2017. The net loss including the CARMA investment was
$4.8 million over the period compared to $4.3 million in the same period
last year.
EBITDA before CARMA investment was a loss of $1.4 million for the current
period and $1.7 million after adjusting for non-cash stock-based compensation
of $0.4 million (first half 2017: $0.1 million).
As of 30 June 2018, MaxCyte held cash and cash equivalents, including short-term
investments, amounting to $18.8 million compared to $25.3 million as of
31 December 2017.
Outlook
MaxCyte's Board anticipates continued progress for the remainder of the
2018 financial year and the Company is trading in line with expectations.
We believe that the Company's progress during the first six months of 2018
provides us with a strong foundation for continued success and we are excited
to build on our progress. Our cell engineering platform is fundamental to
developing gene-editing therapies for a broad range of diseases while enabling
rapid development and commercial manufacturing of new therapies for patients
where there is a high unmet medical need.
The Company remains on track to commence dosing of its first wholly-owned
lead CARMA candidate, MCY-M11, in a Phase I clinical trial in H2 2018, as
an open-label study and we will keep investors informed of our progress.
The Company's pipeline of cell therapy partnered programmes is stronger
than ever. Finally, we have continued to make significant progress in bolstering
our core drug development business, particularly with regard to expanding
our sales and marketing infrastructure and developing applications data
for use in our products where we believe this will help deliver strong future
growth. We remain confident that the future for MaxCyte is very bright.
Doug Doerfler
President and Chief Executive Officer
J. Stark Thompson, Ph.D.
Non-executive Chairman
24 September 2018
About MaxCyte
MaxCyte is a global cell-based medicines and life sciences company applying
its patented cell engineering technology to help patients with high unmet
medical needs in a broad range of conditions. MaxCyte is developing novel
CARMA therapies for its own pipeline. CARMA is MaxCyte's mRNA-based proprietary
platform for autologous cell therapy. In addition, through its core business,
the Company leverages its Flow Electroporation(R) Technology to enable its
partners across the biopharmaceutical industry to advance the development
of innovative medicines, particularly in cell therapy, including gene editing
and immuno-oncology. The Company has placed its cutting-edge flow electroporation
instruments worldwide, with all of the top ten global biopharmaceutical
companies, has more than 55 partnered programme licences in cell therapy
including more than 25 licensed for clinical use. With its robust delivery
technology, MaxCyte helps its partners to unlock the full potential of their
products.
For more information, visit www.maxcyte.com.
This announcement contains inside information for the purposes of Article
7 of Regulation (EU) No 596/2014 (MAR).
For further information, please contact:
MaxCyte Inc.
Doug Doerfler, Chief Executive Officer
Ron Holtz, Chief Financial Officer +1 301 944 1660
Nominated Adviser and Broker
Panmure Gordon
Emma Earl
Freddy Crossley
Ryan McCarthy
Corporate Broking
James Stearns +44 (0)20 7886 2500
Financial PR Adviser
Consilium Strategic Communications +44 (0)203 709 5700
Mary-Jane Elliott maxcyte@consilium-comms.com
Chris Welsh
Sukaina Virji
MaxCyte, Incorporated
Unaudited Condensed Financial Statements
as of 30 June 2018 and 31 December 2017
and for the six months ended
30 June 2018 and 2017
MaxCyte, Inc.
Unaudited Condensed Balance Sheets
(amounts in U.S. dollars, except share amounts)
31 December
30 June 2018 2017
------------------------- ---------------------------
Assets
Current assets:
Cash and cash equivalents $ 16,022,200 $ 25,341,700
Short-term investments,
at amortized cost 2,733,100 -
Accounts receivable 3,762,600 3,195,600
Inventory 2,038,600 1,347,000
Other current assets 1,099,700 665,800
------------------------- ---------------------------
Total current assets 25,656,200 30,550,100
Property and equipment,
net 1,116,000 847,600
Total Assets $ 26,772,200 $ 31,397,700
========================= ===========================
Liabilities and stockholders' equity
Current liabilities:
Current portion of note payable, net of discount
and deferred fees $ - $ 850,900
Current portion of capital lease obligations - 3,200
Accounts payable and accrued expenses 3,037,200 4,331,000
Deferred revenue and other 2,800,000 2,055,100
------------------------- ---------------------------
Total current liabilities 5,837,200 7,240,200
Note payable, net of discount, deferred fees and
current portion 5,046,400 4,176,300
Other liabilities 535,400 384,500
------------------------- ---------------------------
Total liabilities 11,419,000 11,801,800
Commitments and contingencies (Note 7)
Stockholders' equity:
Common stock, $0.01 par; 200,000,000 shares
authorized,
51,272,014 and 50,896,376 shares issued and
outstanding
at 30 June 2018 and 31 December 2017, respectively. 512,800 509,000
Additional paid-in capital 81,268,500 80,729,400
Accumulated deficit (66,428,100) (61,641,700)
------------------------- ---------------------------
Total stockholders' equity 15,353,200 19,596,700
-------------------------
Liabilities and stockholders' equity $ 26,772,200 $ 31,397,700
========================= ===========================
See accompanying notes to the unaudited condensed financial
statements.
MaxCyte, Inc.
Unaudited Condensed Statements of Operations
For the Six Months Ended 30 June,
(amounts in U.S. dollars,
except share amounts)
2018 2017
----------------- ----------------
Revenue $ 6,930,000 $ 6,210,100
Costs of goods sold 753,500 648,900
----------------- ----------------
Gross profit 6,176,500 5,561,200
----------------- ----------------
Operating expenses:
Research and development 4,912,700 4,192,600
Sales and marketing 3,255,500 2,948,000
General and administrative 2,493,500 2,405,900
----------------- ----------------
Total operating expenses 10,661,700 9,546,500
Operating loss (4,485,200) (3,985,300)
----------------- ----------------
Other income (expense):
Interest expense (308,800) (315,300)
Other income 7,600 -
----------------- ----------------
Total other income (expense) (301,200) (315,300)
Net loss $ (4,786,400) $ (4,300,600)
================= ================
Basic and diluted net loss per common share $ (0.09) $ (0.09)
================= ================
Weighted average common shares outstanding,
basic and diluted 51,077,283 46,401,189
================= ================
See accompanying notes to the unaudited condensed financial
statements.
MaxCyte, Inc.
Unaudited Condensed Statements of Cash Flow
For the Six Months Ended 30 June,
(amounts in U.S. dollars)
2018 2017
------------------- -----------------------
Cash flows from operating activities:
Net loss $ (4,786,400) $ (4,300,600)
Adjustments to reconcile net loss to cash
used in operating activities:
Depreciation and amortization 165,800 56,400
Net book value of consigned equipment
sold 20,900 27,000
Stock-based compensation 377,700 120,600
Amortization of discounts on investments (400) -
Non-cash interest expense 19,200 19,000
Changes in operating assets and liabilities:
(1,331
Accounts receivable (567,000) 300)
Inventory (856,200) (185,200)
Other current assets (433,900) (876,200)
Accounts payable and accrued expenses (1,293,800) 59,900
Deferred revenue 744,900 1,075,700
Other liabilities 150,900 16,900
------------------- -----------------------
Net cash used in operating activities (6,458,300) (5,317,800)
------------------- -----------------------
Cash flows from investing activities:
Purchases of short-term investments (2,732,700) -
Purchases of property and equipment (290,500) (142,900)
------------------- -----------------------
Net cash used in investing activities (3,023,200) (142,900)
------------------- -----------------------
Cash flows from financing activities:
Proceeds from exercise of stock options 165,200 4,000
Principal payments on capital leases (3,200) (7,000)
Net proceeds from issuance of common stock - 23,899,600
Net cash provided by financing activities 162,000 23,896,600
------------------- -----------------------
Net (decrease) increase in cash and cash
equivalents (9,319,500) 18,435,900
Cash and cash equivalents, beginning of
period 25,341,700 11,727,000
Cash and cash equivalents, end of period $ 16,022,200 $ 30,162,900
=================== =======================
Supplemental cash flow information:
Cash paid for interest $ 262,900 $ 268,200
See accompanying notes to the unaudited condensed financial
statements.
1. Organization and Description of Business
MaxCyte, Inc. (the "Company" or "MaxCyte") was incorporated as a
majority owned subsidiary of EntreMed, Inc. ("EntreMed") on 31 July
1998, under the laws and provisions of the state of Delaware, and
commenced operations on 01 July 1999. In November 2002, MaxCyte was
recapitalized and EntreMed was no longer deemed to control the
Company.
MaxCyte is a global life sciences company utilizing its
proprietary cell engineering technology to enable development of
CARMA, MaxCyte's proprietary, mRNA-based immuno-oncology cell
therapy, as well as the programmes of its biotechnology and
pharmaceutical company customers who are engaged in cell therapy,
including gene editing and immuno-oncology, and in drug discovery
and development and biomanufacturing. The Company licenses and
sells its instruments and sells its consumables to pharmaceutical
and biotechnology companies for use in development of cell
therapies and in drug discovery and development and
biomanufacturing.
On 29 March 2016, the Company completed the initial public
offering ("IPO") of its Common Stock on the AIM sub-market of the
London Stock Exchange ("AIM IPO"). The Company issued approximately
14.3 million shares of its Common Stock at an initial price of
LIR0.70 per share (or approximately $1.01 per share), generating
gross proceeds of approximately LIR10 million (or approximately
$14.4 million). See Note 5.
In January 2016, the Board of Directors approved an amended Plan
of Recapitalization (the "Plan of Recapitalization"). The Plan of
Recapitalization provided that, immediately prior to completion of
an AIM IPO, (i) all Series A-1, B, C and D preferred stock shall be
converted automatically into Common Stock based on a formula set
out in, and otherwise in accordance with, the terms of the
Recapitalization, (ii) the Series E preferred stock shall be
converted automatically into Common Stock at a discount from the
AIM IPO placing price, and (iii) holders of the outstanding Series
D Preferred Stock Warrants shall have confirmed that such warrants
would be exchanged for Common Stock based on a formula as set out
in, and otherwise in accordance with, the terms of the warrants and
the Plan of Recapitalization. The Plan of Recapitalization was
effective on 29 March 2016 upon the Company's completion of its AIM
IPO.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been prepared in
accordance with accounting principles generally accepted in the
United States of America ("U.S. GAAP"). These unaudited interim
condensed financial statements do not include all the information
and footnotes required by U.S. GAAP for complete audited financial
statements. These unaudited interim condensed financial statements
should be read in conjunction with the audited financial statements
and accompanying notes for the year ended 31 December 2017. In the
opinion of management, the unaudited interim condensed financial
statements reflect all the adjustments (consisting of normal
recurring adjustments) necessary to state fairly the Company's
financial position as of 30 June 2018 and the results of operations
for the six months ended 30 June 2018 and 2017. The interim
condensed results of operations are not necessarily indicative of
the results that may occur for the full fiscal year. The 31
December 2017 balance sheet included herein was derived from the
audited financial statements, but does not include all disclosures
including notes required by U.S. GAAP for complete audited
financial statements.
The Company operates in a single business segment.
Use of Estimates
The preparation of financial statements in conformity with U.S.
GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amount of revenues and
expenses during the reporting period. In the accompanying financial
statements, estimates are used for, but not limited to, stock-based
compensation, allowance for doubtful accounts, allowance for
inventory obsolescence and other financial instruments, accruals
for contingent liabilities, deferred tax assets, liabilities and
valuation allowance, and the depreciable lives of fixed assets.
Actual results could differ from those estimates.
Concentration
During the six months ended 30 June 2018 and June 2017, no
single customer represented more than 10% of net revenues.
During the six months ended 30 June 2018 and 2017, the Company
purchased approximately 65% and 51%, respectively, of inventory
from two suppliers. As of 30 June 2018, amounts payable to these
suppliers totaled 23% of total accounts payable.
Foreign Currency
The Company's functional currency is the U.S. dollar;
transactions denominated in foreign currencies are transacted at
the exchange rate in effect at the date of each transaction.
Differences in exchange rates during the period between the date a
transaction denominated in foreign currency is consummated and the
date on which it is either settled or at the reporting date are
recognized in the Statements of Operations as general and
administrative expense. The foreign currency transaction gains
(losses) were $7,200 and ($40,200) for the six months ended 30 June
2018 and 2017, respectively.
Fair Value
Fair value is the price that would be received from the sale of
an asset or paid to transfer a liability assuming an orderly
transaction in the most advantageous market at the measurement
date. U.S. GAAP establishes a hierarchical disclosure framework
which prioritizes and ranks the level of observability of inputs
used in measuring fair value. These tiers include:
-- Level 1-Quoted prices (unadjusted) in active markets that are
accessible at the measurement date for identical assets or
liabilities. The fair value hierarchy gives the highest priority to
Level 1 inputs.
-- Level 2-Observable market-based inputs other than quoted
prices in active markets for identical assets or liabilities.
-- Level 3-Unobservable inputs are used when little or no market
data is available. The fair value hierarchy gives the lowest
priority to Level 3 inputs.
The Company's Balance Sheets include various financial
instruments (primarily cash and cash equivalents, accounts
receivable and accounts payable and accrued expenses) that are
carried at cost, which approximates fair value due to the
short-term nature of the instruments. Notes payable and capital
lease obligations are reflective of fair value based on market
comparable instruments with similar terms.
Short-term investments classified as held-to-maturity are
carried at amortized costs unless they are deemed to be impaired on
an other-than-temporary basis at which time they are carried at
fair market value using Level 1 quoted prices.
Financial Assets and Liabilities Measured at Fair Value on a
Recurring Basis
The Company has no financial assets or liabilities measured at
fair value on a recurring basis.
Financial Assets and Liabilities Measured at Fair Value on a
Non-Recurring Basis
Short-term investments classified as held-to-maturity are
measured at fair value on a non-recurring basis when they are
deemed to be impaired on an other-than-temporary basis. No such
fair value impairment was recognized during the six months ended 30
June 2018.
Non-Financial Assets and Liabilities Measured at Fair Value on a
Recurring Basis
The Company has no non-financial assets and liabilities that are
measured at fair value on a recurring basis.
Non-Financial Assets and Liabilities Measured at Fair Value on a
Non-Recurring Basis
The Company measures its long-lived assets, including property
and equipment, at fair value on a non-recurring basis. These assets
are recognized at fair value when they are deemed to be impaired.
No such fair value impairment was recognized during the six months
ended 30 June 2018 or 2017.
Cash, Cash Equivalents and Short-term Investments
Cash and cash equivalents consist of financial instruments
including money market funds and commercial paper with original
maturities of less than 90 days. Short-term investments consist of
commercial paper with original maturities greater than 90 days and
less than 1 year. All investments are classified as
"held-to-maturity" and are recorded at amortized cost unless they
are deemed to be impaired on an other-than-temporary basis at which
time they are recorded at fair value using Level 1 quoted
prices.
The following table summarizes the Company's investments at 30
June 2018:
Gross unrecognized Gross unrecognized
Amortized holding holding Aggregate
Description Classification cost gains losses fair value
Money market
funds Cash equivalents $ 12,590,100 $ - $ - $ 12,590,100
Commercial
Paper Cash equivalents 2,407,000 100 (100) 2,407,000
Commercial Short-term
Paper investments 2,733,100 - (1,300) 2,731,800
-------------- ------------------- ------------------- -----------------
Total Investments $ 17,730,200 $ 100 $ (1,400) $ 17,728,900
============== =================== =================== =================
The Company had no investments at 31 December 2017.
At times the Company's cash balances may exceed federally
insured limits and cash may also be deposited in foreign bank
accounts that are not covered by federal deposit insurance. The
Company does not believe that this results in any significant
credit risk.
Inventory
The Company sells or licenses products to customers. The Company
uses the average cost method of accounting for its inventory and
adjustments resulting from periodic physical inventory counts are
reflected in costs of goods sold in the period of the adjustment.
Inventory consisted of the following:
30 June 31 December
2018 2017
-------------- ------------------
Raw materials inventory $ 817,100 $ 371,100
Finished goods inventory 1,221,500 975,900
Total Inventory $ 2,038,600 $ 1,347,000
============== ==================
The Company determined no allowance for obsolescence was
necessary at 30 June 2018 or 31 December 2017.
Accounts Receivable
Accounts receivable are reduced by an allowance for doubtful
accounts, if needed. The allowance for doubtful accounts reflects
the best estimate of probable losses determined principally on the
basis of historical experience and specific allowances for known
troubled accounts. All accounts or portions thereof that are deemed
to be uncollectible or to require an excessive collection cost are
written off to the allowance for doubtful accounts. The Company
determined that no allowance was necessary at 30 June 2018 or 31
December 2017.
Property and Equipment
Property and equipment is stated at cost less accumulated
depreciation and amortization. Depreciation is computed using the
straight-line method. Office equipment (principally computers) is
depreciated over an estimated useful life of three years.
Laboratory equipment is depreciated over an estimated useful life
of five years. Furniture is depreciated over a useful life of seven
years. Leasehold improvements are amortized over the shorter of the
estimated lease term or its useful life. Consigned instruments
represent equipment held at a customer's site that is typically
leased to customers on a short-term basis and is depreciated over
an estimated useful life of five years.
Property and equipment includes capitalized costs to develop
internal-use software. Applicable costs are capitalized during the
development stage of the project and include direct internal costs,
third-party costs and allocated interest expense as
appropriate.
Property and equipment consist of the following:
30 June 31 December
2018 2017
------------- --------------------
Furniture and equipment $1,642,200 $ 1,497,000
Consigned instruments 546,100 419,700
Leasehold improvements 280,700 265,400
Capitalized project development 130,000 -
Accumulated depreciation
and amortization (1,483,000) (1,334,500)
Property and equipment,
net $1,116,000 $ 847,600
============= ====================
For the six months ended 30 June 2018 and 2017, the Company
incurred depreciation and amortization expense of $165,800 and
$56,400, respectively. Maintenance and repairs are charged to
expense as incurred.
Management reviews property and equipment for impairment
whenever events or changes in circumstances indicate that the
carrying amount of an asset may not be recoverable. Recoverability
of the long-lived asset is measured by a comparison of the carrying
amount of the asset to future undiscounted net cash flows expected
to be generated by the asset. If such assets are considered to be
impaired, the impairment to be recognized is measured by the amount
by which the carrying amount of the assets exceeds the estimated
fair value of the assets.
Revenue Recognition
On 1 January 2018, the Company adopted guidance for revenue
recognition for contracts (ASC 606), using the modified
retrospective method applied only to contracts that were not
completed at the date of adoption. The modified retrospective
method provides for recognition of the cumulative effect of
initially applying the new guidance as an adjustment to the opening
balance of retained earnings. The implementation of the guidance
had no material impact on the measurement or recognition of revenue
from customer contracts recognized in prior periods. For the
Company's revenue recognition policy prior to adopting the guidance
for revenue recognition for contracts, please refer to the
Company's financial statements in its annual report for the year
ended 31 December 2017.
The Company analyzes contracts to determine the appropriate
revenue recognition using the following steps: (i) identification
of contracts with customers, (ii) identification of distinct
performance obligations in the contract, (iii) determination of
contract transaction price, (iv) allocation of contract transaction
price to the performance obligations and (v) determination of
revenue recognition based on timing of satisfaction of the
performance obligations.
In some arrangements, product and services have been sold
together representing distinct performance obligations. In such
arrangements, the Company allocates the sale price to the various
performance obligations in the arrangement on a relative selling
price basis. Under this basis, the Company determines the estimated
selling price of each performance obligation in a manner that is
consistent with that used to determine the price to sell the
deliverable on a standalone basis.
The Company recognizes revenues upon the satisfaction of its
performance obligation (upon transfer of control of promised goods
or services to their customers) in an amount that reflects the
consideration to which it expects to be entitled in exchange for
those goods or services.
The Company defers incremental costs of obtaining a customer
contract and amortizes the deferred costs over the period that the
goods and services are transferred to the customer. The Company had
no material incremental costs to obtain customer contracts in any
period presented.
Deferred revenue results from amounts billed in advance to
customers or cash received from customers in advance of services
being provided.
Research and Development Costs
Research and development costs consist of independent
proprietary research and development costs and the costs associated
with work performed for fees from third parties. Research and
development costs are expensed as incurred. Research costs
performed for fees from customers are included in cost of goods
sold.
Stock-Based Compensation
The Company grants stock-based awards in exchange for employee,
consultants and non-employee director services. The value of the
award is recognized as expense on a straight-line basis over the
requisite service period.
The Company utilizes the Black-Scholes option pricing model for
estimating fair value of its stock options granted. Option
valuation models, including the Black-Scholes model, require the
input of highly subjective assumptions, and changes in the
assumptions used can materially affect the grant-date fair value of
an award. These assumptions include the expected volatility,
expected dividend yield, risk-free rate of interest and the
expected life of the award. A discussion of management's
methodology for developing each of the assumptions used in the
Black-Scholes model is as follows:
Expected volatility
Volatility is a measure of the amount by which a financial
variable such as a share price has fluctuated (historical
volatility) or is expected to fluctuate (expected volatility)
during a period. The Company does not currently have sufficient
history with its common stock subsequent to the AIM IPO in 2016 to
determine its actual volatility. The Company has been able to
identify several public entities of similar size, complexity and
stage of development; accordingly, historical volatility has been
calculated at 47% for the six months ended 30 June 2018 and between
47% and 48% for the six months ended 30 June 2017 using the
volatility of these companies.
Expected dividend yield
The Company has never declared or paid common stock dividends
and has no plans to do so in the foreseeable future. Additionally,
the Company's long-term debt agreement restricts the payment of
cash dividends.
Risk-free interest rate
This approximates the U.S. Treasury rate for the day of each
option grant during the year, having a term that closely resembles
the expected term of the option. The risk-free interest rate was
between 2.7% and 2.9% for 2018 and 1.8% and 2.1% for 2017.
Expected term
This is the period of time that the options granted are expected
to remain unexercised. Options granted have a maximum term of ten
years. The Company estimates the expected term of the option to be
6.25 years for options with a standard four-year vesting period,
using the simplified method. Over time, management intends to track
estimates of the expected term of the option term so that estimates
will approximate actual behavior for similar options.
Forfeiture rate
The Company records forfeitures as they occur.
Income Taxes
The Company uses the asset and liability method of accounting
for income taxes. Deferred tax assets and liabilities are
determined based on differences between the financial reporting and
tax basis of assets and liabilities and are measured using the
enacted tax rates and laws that are expected to be in effect when
the differences are expected to reverse. The effect on deferred tax
assets and liabilities of a change in tax rates is recognized in
the period that such tax rate changes are enacted. The measurement
of a deferred tax asset is reduced, if necessary, by a valuation
allowance if it is more-likely-than-not that all or a portion of
the deferred tax asset will not be realized.
Management uses a recognition threshold and a measurement
attribute for the financial statement recognition and measurement
of tax positions taken or expected to be taken in a tax return, as
well as guidance on derecognition, classification, interest and
penalties and financial statement reporting disclosures. For those
benefits to be recognized, a tax position must be
more-likely-than-not to be sustained upon examination by taxing
authorities. The Company recognizes interest and penalties accrued
on any unrecognized tax exposures as a component of income tax
expense. The Company has not identified any uncertain income tax
positions that could have a material impact to the financial
statements.
The Company is subject to taxation in various jurisdictions in
the United States and abroad and remains subject to examination by
taxing jurisdictions for 2014 and all subsequent periods. The
Company had a net operating loss ("NOL") carry forward of $33.0
million as of 31 December 2017, which was generally available as a
deduction against future income for US federal corporate income tax
purposes, subject to applicable carry forward limitations. As a
result of the March 2016 AIM IPO, the Company's NOLs are limited on
an annual basis, subject to certain carryforward provisions,
pursuant to Section 382 of the Internal Revenue Code of 1986, as
amended, as a result of a greater than fifty percent change in
ownership that occurred in the three-year period ending at the time
of the March 2016 AIM IPO. The Company has calculated that for the
period ending 31 December 2023, the cumulative limitation amount
will exceed the NOLs subject to the limitation.
On 22 December 2017, the President of the United States signed
into law the Tax Cuts and Jobs Act of 2017 (the "Tax Act") which
included significant changes to the existing income tax laws for
domestic corporations. Key features of the Tax Act effective in
2018 include:
-- Reduction of the corporate tax rate from 35% to 21%;
-- Elimination of the alternative minimum tax;
-- Changes in the deductibility of certain aspects of executive compensation;
-- Changes in the deductibility of certain entertainment and recreation expenses; and
-- Changes in incentive tax breaks for U.S. production activities.
Because of the Company's existing Federal net operating loss
carryforwards and current expectations as to the recovery of its
net deferred tax assets, the Company believes that the Tax Act will
not have a significant impact on its financial results and
financial position, including on its liquidity, for the foreseeable
future.
Loss Per Share
Basic loss per share is computed by dividing net loss available
to common shareholders by the weighted average number of shares of
Common Stock outstanding during the period.
For periods of net income, and when the effects are not
anti-dilutive, diluted earnings per share is computed by dividing
net income available to common shareholders by the weighted-average
number of shares outstanding plus the impact of all potential
dilutive common shares, consisting of Common Stock options using
the treasury stock method, and convertible preferred stock using
the if-converted method.
For periods of net loss, diluted loss per share is calculated
similarly to basic loss per share because the impact of all
dilutive potential common shares is anti-dilutive. The number of
anti-dilutive shares, consisting of Common Stock options, which has
been excluded from the computation of diluted loss per share, was
7.2 million and 5.9 million for the six months ended 30 June 2018
and 2017, respectively.
Recent Accounting Pronouncements
Recently Adopted
In May 2014, the Financial Accounting Standards Board ("FASB")
issued guidance for revenue recognition for contracts (ASC 606),
superseding the previous revenue recognition requirements, along
with most existing industry-specific guidance. The guidance
requires an entity to review contracts in five steps: 1) identify
the contract, 2) identify performance obligations, 3) determine the
transaction price, 4) allocate the transaction price, and 5)
recognize revenue. The new standard will result in enhanced
disclosures regarding the nature, amount, timing, and uncertainty
of revenue arising from contracts with customers. In August 2015,
the FASB issued guidance approving a one-year deferral, making the
standard effective for reporting periods beginning after 15
December 2017, with early adoption permitted only for reporting
periods beginning after 15 December 2016. In March 2016, the FASB
issued guidance to clarify the implementation guidance on principal
versus agent considerations for reporting revenue gross rather than
net, with the same deferred effective date. In April 2016, the FASB
issued guidance to clarify the identification of performance
obligations and licensing arrangements. In May 2016, the FASB
issued guidance addressing the presentation of sales and other
similar taxes collected from customers, providing clarification of
the collectibility criterion assessment, as well as clarifying
certain transition requirements.
The Company performed a comprehensive review of its existing
revenue arrangements as of 1 January 2018 following the five-step
model. The analysis indicated that there were no significant
changes to how the amount and timing of revenue is recognized under
the new guidance as compared to existing guidance. Additionally,
the analysis indicated that there were no significant changes to
how costs to obtain and fulfill customer contracts are recognized
under the new guidance as compared to existing guidance. The
Company adopted this guidance as of 1 January 2018 using the
modified retrospective method and the impact of adoption on its
balance sheet, statement of operations, and statement of cash flows
was not material. The adoption of the new guidance impacted the way
the Company analyzes and documents revenue recognition under
customer contracts and resulted in additional disclosures in the
Company's financial statements.
In May 2017, the FASB issued guidance clarifying when changes in
the terms or conditions of share-based payment awards should be
accounted for as modifications. This guidance is effective for
fiscal years beginning after 15 December 2017 and early adoption is
permitted. This guidance must be applied prospectively to awards
modified after the adoption date. The Company adopted this new
guidance on 1 January 2018. The adoption of this new guidance did
not have a material impact on the Company's financial
statements.
Unadopted
In February 2016, the FASB issued guidance for the accounting
for leases. The guidance requires lessees to recognize assets and
liabilities related to long-term leases on the balance sheet and
expands disclosure requirements regarding leasing arrangements. The
guidance is effective for reporting periods beginning after 15
December 2018 and early adoption is permitted. The guidance must be
adopted on a modified retrospective basis and provides for certain
practical expedients. The Company is currently evaluating the
impact, if any, that this new accounting pronouncement will have on
its financial statements.
In June 2016, the FASB issued guidance with respect to measuring
credit losses on financial instruments, including trade
receivables. The guidance eliminates the probable initial
recognition threshold that was previously required prior to
recognizing a credit loss on financial instruments. The credit loss
estimate can now reflect an entity's current estimate of all future
expected credit losses. Under the previous guidance, an entity only
considered past events and current conditions. The guidance is
effective for fiscal years beginning after 15 December 2020,
including interim periods within those fiscal years. Early adoption
is permitted for fiscal years beginning after 15 December 2018,
including interim periods within those fiscal years. The adoption
of certain amendments of this guidance must be applied on a
modified retrospective basis and the adoption of the remaining
amendments must be applied on a prospective basis. The Company is
currently evaluating the impact, if any, that this new accounting
pronouncement will have on its financial statements.
In July 2017, the FASB issued guidance addressing several issues
involving financial instruments. Part I of the guidance simplifies
the accounting for certain equity-linked financial instruments and
embedded features with down round features that reduce the exercise
price when the pricing of a future round of financing is lower
("down round protection"). Current accounting guidance provides
that instruments with down round protection be classified as
derivative liabilities with changes in fair value recorded through
earnings. The updated guidance provides that instruments with down
round protection are no longer precluded from being classified as
equity. This guidance is effective for fiscal years beginning after
15 December 2018 for public business entities and early adoption is
permitted. This guidance must be applied retrospectively. The
Company is currently evaluating the impact, if any, that this new
accounting pronouncement will have on its financial statements.
In June 2018, the FASB issued guidance simplifying the
accounting for nonemployee stock-based compensation awards. The
guidance aligns the measurement and classification for employee
stock-based compensation awards to nonemployee stock-based
compensation awards. Under the guidance, nonemployee awards will be
measured at their grant date fair value. Upon transition, the
existing nonemployee awards will be measured at fair value as of
the adoption date. The guidance is effective for reporting periods
beginning after 15 December 2018, including interim periods within
that fiscal year. Early adoption is permitted, including adoption
in an interim period. The Company is currently evaluating the
impact, if any, that the adoption of this guidance will have on its
financial statements.
The Company has evaluated all other issued and unadopted
Accounting Standards Updates and believes the adoption of these
standards will not have a material impact on its results of
operations, financial position, or cash flows.
3. Revenue
Revenue is principally from the sale or lease of instruments and
processing assemblies, as well as from extended warranties and
maintenance. In some arrangements, product and services have been
sold together representing distinct performance obligations. In
such arrangements the Company allocates the sale price to the
various performance obligations in the arrangement on a relative
selling price basis. Under this basis, the Company determines the
estimated selling price of each performance obligation in a manner
that is consistent with that used to determine the price to sell
the deliverable on a standalone basis.
Revenue is recognized at the time control is transferred to the
customer and the performance obligation is satisfied. Revenue from
the sale of instruments and processing assemblies is generally
recognized at the time of shipment to the customer, provided no
significant vendor obligations remain and collectability is
reasonably assured. Revenue from equipment leases are recognized
ratably over the contractual term of the lease agreement. Licensing
fee revenue is recognized ratably over the license period. Revenue
from fees for research services is recognized when services have
been provided.
Disaggregated revenue for the six months ended 30 June 2018 is
as follows:
ASC 606 Non- ASC
Revenue 606 Revenue Total Revenue
-------------
Product Sales $ 4,239,100 $ - $ 4,239,100
Leased Equipment - 2,361,200 2,361,200
Services/Other 118,100 211,600 329,700
Total $ 4,357,200 $ 2,572,800 $ 6,930,000
============= ============== ==============
Disaggregated revenue for the six months ended 30 June 2017 is
as follows:
Disaggregated revenue for the six months ended 30 June 2017 is
as follows:
ASC 606 Non- ASC
Revenue 606 Revenue Total Revenue
-------------------
Product Sales $ 3,653,500 $ - $ 3,653,500
Leased Equipment - 2,080,400 2,080,400
Services/Other 72,000 404,200 476,200
Total $ 3,725,500 $ 2,484,600 $ 6,210,100
=================== ============= ==============
Additional disclosures relating to Revenue from Contacts with
Customers (ASC 606)
Changes in deferred revenue for the six months ended 30 June
2018 were as follows:
Balance at 1 January 2018 $2,223,000
Revenue recognized in the current
period from
amounts included in the beginning
balance 1,655,300
Current period deferrals, net of amounts
recognized in the current period 2,493,600
Balance at 30
June 2018 $3,061,300
============
Remaining contract consideration for which revenue has not been
recognized due to unsatisfied performance obligations was
approximately $338,600 at 30 June 2018, the majority of which the
Company expects to recognize over the next three years. This amount
does not include contract consideration for contracts with a
duration of one year or less.
In the six months ended 30 June 2018, the Company did not incur,
and therefore did not defer, any material incremental costs to
obtain contracts or costs to fulfill contracts.
4. Debt
The Company originally entered into a credit facility with
MidCap Financial SBIC, LP ("MidCap") in March 2014. The MidCap
facility carries a variable interest rate equal to the greater of
(i) 1.50% above the London Interbank Offered Rate ("LIBOR") then in
effect, or (ii) 10.00% and is collateralized by substantially all
tangible assets of the Company. The Company amended the MidCap
facility in February 2015, June 2015 and June 2016 to, among other
things, (i) revise certain covenants, (ii) extend the maturity date
to 1 June 2021, (iii) extend the interest only period to 1 July
2018 and increase the exit fee to 6.75%, and (iv) increase the
principal amount to $5,105,400.
The Company accounted for all amendments as "modifications" to
the facility. Accordingly, the Company has deferred additional fees
incurred and paid to the lender in connection with the amendments
and expensed all fees paid to third parties. The deferred fees are
being amortized using the effective interest method over the
remaining term of the amended debt. Unamortized deferred financing
costs were approximately $54,800 and $72,500 at 30 June 2018 and 31
December 2017, respectively, and are included as reductions to the
note payable balance.
The total balance of the MidCap credit facility at both 30 June
2018 and 31 December 2017 was $5,105,400, with an interest rate of
10%; the balance of the unamortized debt discount at 30 June 2018
and 31 December 2017 was $4,200 and $5,700, respectively. Future
minimum principal payments under the MidCap credit facility are
expected to be $0 in 2018 and 2019, approximately $851,000 in 2020,
$1,702,000 in 2021 and 2022, and $851,000 in 2023.
In the six months ended 30 June 2018, the Company capitalized
approximately $3,700 of interest expense related to capitalized
software development projects.
On 15 August 2018, the Company entered into an amendment to the
MidCap facility. The amendment was entered into primarily to delay
the start of principal payments to 1 July 2020 and extend the
maturity to 1 June 2023.
5. Stockholders' Equity
Common Stock
On 21 April 2017, the Company completed an equity capital raise
issuing 7,275,000 shares of Common Stock at a price of LIR2.75 per
share (or approximately $3.51 per share). The transaction generated
gross proceeds of approximately LIR20 million (or approximately
$25.5 million). In conjunction with the transaction the Company
incurred costs of approximately $1.6 million which resulted in the
Company receiving net proceeds of approximately $23.9 million.
During the year ended 31 December 2017, the Company issued
81,849 shares of Common Stock as a result of stock option
exercises, receiving proceeds of $16,200. During the six months
ended 30 June 2018, the Company issued 375,638 shares of Common
Stock as a result of stock option exercises, receiving gross
proceeds of $165,200.
Stock Options
The Company adopted the MaxCyte, Inc. Long-Term Incentive Plan
(the "Plan") in January 2016 to amend and restate the MaxCyte 2000
Long Term Incentive Plan to provide for the awarding of (i) stock
options, (ii) restricted stock, (iii) incentive shares, and (iv)
performance awards to employees, officers, and directors of the
Company and to other individuals as determined by the Board of
Directors. Under the Plan, the maximum number of shares of Common
Stock that the Company may issue is (a) 6,264,682 shares plus (b)
ten percent (10%) of the shares that are issued and outstanding at
the time awards are made under the Plan.
On 21 February 2018, the Company's Board resolved to increase
the number of stock options that may be issued under the Plan by
2,000,000 to provide sufficient shares to allow competitive equity
compensation in its primary markets for staff and consistent with
practices of comparable companies.
The Company has not issued any restricted stock, incentive
shares, or performance awards under the Plan. Stock options granted
under the Plan may be either incentive stock options as defined by
the Internal Revenue Code or non-qualified stock options. The Board
of Directors determines who will receive options under the Plan and
determines the vesting period. The options can have a maximum term
of no more than 10 years. The exercise price of options granted
under the Plan is determined by the Board of Directors and must be
at least equal to the fair market value of the Common Stock on the
date of grant.
In the six months ended 30 June 2018, the Company granted
610,900 stock options with an average exercise price of $3.48 per
share. The weighted-average fair value of the options granted
during the six months ended 30 June 2018 and 2017 was estimated to
be $1.68 and $1.51, respectively.
At 30 June 2018, there were 7,155,577 stock options outstanding
with an average exercise price of $1.18 per share. As of 30 June
2018, total unrecognized compensation expense was $2,920,600 which
will be recognized over the next 2.8 years.
Stock-based compensation expense for the six months ended 30
June was as follows:
2018 2017
----------
General and administrative $174,200 $ 45,700
Sales and marketing 74,300 32,700
Research and development 129,200 42,200
Total $377,700 $120,600
========== ==========
6. Retirement Plan
The Company sponsors a defined-contribution 401(k) retirement
plan covering eligible employees. Participating employees may
voluntarily contribute up to limits provided by the Internal
Revenue Code. Beginning in 2017, the Company matches employee
contributions equal to 50% of the salary deferral contributions,
with a maximum Company contribution of 3% of the employees'
eligible compensation. In the six months ended 30 June 2018 and
2017, Company matching contributions amounted to $104,200 and
$79,300, respectively.
7. Commitments and Contingencies
The Company entered into a five-year non-cancelable operating
lease agreement for office and laboratory space in February 2009
with an initial expiration of 31 January 2014 which was
subsequently extended in 2013 and then further extended to January
2020. In April 2017, the Company entered into leases for additional
office and laboratory space. All the Company's office and
laboratory leases expire in January 2020 and provide for annual 3%
increases to the base rent. The current monthly base lease payment
for all leases is approximately $42,000. In addition to base rent,
the Company pays a pro-rated share of common area maintenance
("CAM") costs for the entire building, which is adjusted annually
based on actual expenses incurred.
Total rent expense, including base rent and CAM for the six
months ended 30 June 2018 and 2017, was $344,700 and $222,600,
respectively. Rent expense is recognized on a straight-line basis
in the accompanying financial statements.
8. Subsequent Events
On 15 August 2018, the Company entered into an amendment to the
MidCap facility. The amendment was entered into primarily to delay
the start of principal payments to 1 July 2020 and extend the
maturity to 1 June 2023.
In preparing these financial statements, the Company has
evaluated events and transactions for potential recognition or
disclosure through 21 September 2018 the date the financial
statements were available to be issued.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
IR PGUMPBUPRGQW
(END) Dow Jones Newswires
September 24, 2018 02:01 ET (06:01 GMT)
Maxcyte (LSE:MXCT)
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Maxcyte (LSE:MXCT)
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