— Declared development candidate in first targeted conditioning
program —
— Phase 1 study for first-line stem cell mobilization program to
begin 1H19 —
— Presented updated clinical data for MGTA-456 cell therapy showing
signs of early benefit in patients with inherited metabolic disorders
(IMDs) —
— Ended 2018 with $142.6M in cash, cash equivalents and marketable
securities —
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Magenta
Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company
developing novel medicines to bring the curative power of stem cell
transplant to more patients, today reported financial results and
business highlights for the fourth quarter and full year ended December
31, 2018.
“2018 was a transformative year for Magenta, as we progressed our
first-in-class programs and achieved multiple clinical and preclinical
milestones,” said Jason Gardner, D.Phil., Chief Executive Officer and
President, Magenta Therapeutics. “As we begin 2019, Magenta is the only
company addressing the major barriers to stem cell transplant and gene
therapy, with the goal of changing the lives of patients with autoimmune
diseases, blood cancers and genetic diseases through curative therapies.
We are looking forward to building on this progress as we advance our
conditioning, mobilization and cell therapy programs.”
Upcoming Anticipated Milestones:
The
Company plans to achieve the following key milestones in 2019:
-
Present preclinical data on C100 anti-CD45 targeted conditioning
program in autoimmune diseases and declare development candidate -
Present preclinical data on C200 anti-CD117 targeted conditioning in
gene therapy, and advance development candidate -
Begin Phase 1 study of MGTA-145 first-line mobilization agent in
healthy volunteers in the first half of 2019, and present clinical
data in the second half of 2019 -
Present additional clinical data from the Phase 2 study of MGTA-456 in
IMDs
Recent Business Highlights:
Updated
preclinical data for C100 conditioning program showed potent depletion
of hematopoietic stem cells and immune cells: At the Transplant and
Cellular Therapy (TCT) meeting in February 2019, Magenta presented data
from its C100 targeted conditioning program, showing potent stem and
immune cell depletion with an anti-CD45 amanitin antibody-drug conjugate
(ADC) that was well tolerated at efficacious doses in non-human
primates. The Company expects to declare a development candidate for
this program in 2019 and intends to develop C100 in both autoimmune
diseases and blood cancers.
Declared development candidate in C200 targeted conditioning program
and presented preclinical data: At the end of 2018, Magenta declared
a development candidate in its C200 targeted conditioning program, which
is designed to deplete stem cells in the bone marrow. The Company
presented data at the TCT meeting in February 2019 on the development
candidate, an anti-CD117 amanitin ADC, showing that it potently and
selectively depleted hematopoietic stem cells in non-human primates
while preserving the immune system. The ADC was well tolerated at the
efficacious doses. Magenta has begun investigational new drug
(IND)-enabling studies with this ADC and plans to develop it as a
conditioning agent for stem cell gene therapy, in patients with genetic
disorders such as sickle cell disease, where current conditioning
regimens are toxic.
Updated preclinical data for MGTA-145 first-line mobilization therapy
showed differentiated efficacy from standard of care: In data
presented at the TCT meeting in February 2019, Magenta showed that a
single dose of MGTA-145 plus plerixafor mobilized two to three times
more stem cells in non-human primates than a multi-day regimen of
current standard of care, G-CSF. The cells mobilized with MGTA-145 plus
plerixafor rapidly engrafted in non-human primates following autologous
transplant. A subset of the MGTA-145-mobilized cells from non-human
primates was also shown to suppress graft-vs.-host-disease and extend
survival in preclinical models. The company expects to initiate a Phase
1 study of MGTA-145 in the first half of 2019 and share clinical results
in the second half of 2019.
Updated clinical data for MGTA-456 cell therapy showed early signs of
clinical benefit in IMDs: Magenta presented updated data from the
Phase 2 clinical study of MGTA-456 in patients with IMDs at the TCT
meeting in February 2019. Patients with cerebral adrenoleukodystrophy
(cALD) treated with MGTA-456 in the study showed persistent resolution
of brain inflammation and stable disease scores. Patients with Hurler
syndrome treated with MGTA-456 showed correction of enzyme deficiency
and decrease in toxic metabolites. These early clinical benefits are
associated with improved long-term disease outcomes in patients
undergoing stem cell transplant for IMDs. The Company will next present
data from this study at the American Academy of Neurology (AAN) annual
meeting in May. A Phase 2 investigator-initiated study of MGTA-456 in
blood cancers began in December 2018. After careful review of
comprehensive transplant outcomes data in sickle cell disease, the
Company will evaluate development of MGTA-456 in sickle cell disease as
less toxic conditioning becomes available.
Fourth Quarter Financial Results:
Cash
Position: Cash, cash equivalents and marketable securities as of
December 31, 2018, were $142.6 million compared to $51.4 million on
December 31, 2017. The increase is primarily driven by net proceeds from
the $52.2 million Series C preferred stock financing completed in April
2018, and net proceeds of $89.9 million from Magenta’s IPO completed in
June 2018, offset by $57.6 million in net loss during 2018. Magenta
anticipates that its cash, cash equivalents and marketable securities
will be sufficient to fund operations and capital expenditures through
2020 on the Company’s current business plan.
Research and Development Expenses: Research and development (R&D)
expenses were $12.4 million in the fourth quarter of 2018, compared to
$5.6 million for the same period in 2017. The increase was primarily due
to increased costs related to drug discovery efforts in our conditioning
programs, preclinical costs, toxicology studies and manufacturing to
support our mobilization program, the advancement of the MGTA-456 Phase
2 clinical trial, continued progression of the Company’s pipeline and
increased costs associated with the growth of the Company.
General and Administrative Expenses: General and administrative
(G&A) expenses were $5.5 million for the fourth quarter of 2018,
compared to $2.6 million for the same period in 2017. The increase was
primarily due to increased G&A personnel and facility costs associated
with the growth of the Company.
Net Loss: Net loss was $16.7 million for the fourth quarter of
2018, compared to net loss of $8.0 million for the same period in 2017.
About Magenta Therapeutics
Headquartered in Cambridge,
Mass., Magenta Therapeutics is a clinical-stage biotechnology company
developing novel medicines for patients with autoimmune diseases, blood
cancers and genetic diseases. By creating a platform focused on critical
areas of unmet need, Magenta Therapeutics is pioneering an integrated
approach to allow more patients to receive one-time, curative therapies
by making the process more effective, safer and easier.
Forward-Looking Statement
This press release contains
forward-looking statements and information within the meaning of The
Private Securities Litigation Reform Act of 1995 and other federal
securities laws. The use of words such as “may,” “will,” “could”,
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,”
“continue” or the negative of such words or other similar expressions
can be used to identify forward-looking statements.
The express or implied forward-looking statements included in this press
release are only predictions and are subject to a number of risks,
uncertainties and assumptions, including, without limitation:
uncertainties inherent in clinical studies and in the availability and
timing of data from ongoing clinical studies; whether interim results
from a clinical trial will be predictive of the final results of the
trial; whether results from preclinical studies or earlier clinical
studies will be predictive of the results of future trials; the expected
timing of submissions for regulatory approval or review by governmental
authorities, including review under accelerated approval processes;
orphan drug designation eligibility; regulatory approvals to conduct
trials or to market products; whether Magenta’s cash resources will be
sufficient to fund Magenta’s foreseeable and unforeseeable operating
expenses and capital expenditure requirements; and other risks set forth
under the caption “Risk Factors” in Magenta’s Registration Statement on
Form S-1, as updated by Magenta’s most recent Quarterly Report on Form
10-Q and its other filings with the Securities and Exchange Commission.
In light of these risks, uncertainties and assumptions, the
forward-looking events and circumstances discussed in this press release
may not occur and actual results could differ materially and adversely
from those anticipated or implied in the forward-looking statements. You
should not rely upon forward-looking statements as predictions of future
events. Although Magenta believes that the expectations reflected in the
forward-looking statements are reasonable, it cannot guarantee that the
future results, levels of activity, performance or events and
circumstances reflected in the forward-looking statements will be
achieved or occur.
Moreover, except as required by law, neither Magenta nor any other
person assumes responsibility for the accuracy and completeness of the
forward-looking statements included in this press release. Any
forward-looking statement included in this press release speaks only as
of the date on which it was made. We undertake no obligation to publicly
update or revise any forward-looking statement, whether as a result of
new information, future events or otherwise, except as required by law.
| Magenta Therapeutics, Inc. | ||||||||||||||||
| STATEMENTS OF OPERATIONS | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 12,390 | 5,551 | 41,340 | 27,899 | ||||||||||||
| General and administrative | 5,540 | 2,619 | 18,623 | 7,828 | ||||||||||||
| Total operating expenses | 17,930 | 8,170 | 59,963 | 35,727 | ||||||||||||
| Loss from operations | (17,930) | (8,170) | (59,963) | (35,727) | ||||||||||||
| Interest and other income, net | 1,251 | 134 | 2,448 | 236 | ||||||||||||
| Net loss | (16,679) | (8,036) | (57,515) | (35,491) | ||||||||||||
|
Accretion of redeemable convertible preferred stock to redemption |
— | — | (88) | (213) | ||||||||||||
|
Cumulative dividends on redeemable convertible preferred stock |
— |
— |
— | (437) | ||||||||||||
|
Reversal of cumulative dividends on redeemable convertible |
— | — | — | 634 | ||||||||||||
| Net loss attributable to common stockholders | $ | (16,679) | $ | (8,036) | $ | (57,603) | $ | (35,507) | ||||||||
|
Net loss per share attributable to common stockholders, basic and |
$ | (0.50) | $ | (3.59) | $ | (3.13) | $ | (19.12) | ||||||||
| Weighted average common shares outstanding, basic and diluted | 33,204,929 | 2,240,421 | 18,389,576 | 1,856,907 | ||||||||||||
| BALANCE SHEET DATA | ||||||||
| December 31, | ||||||||
| 2018 | 2017 | |||||||
| Cash, cash equivalents and marketable securities | $ | 142,570 | $ | 51,402 | ||||
| Working capital | 134,902 | 48,361 | ||||||
| Total assets | 157,313 |
54,463 |
||||||
| Stockholders’ equity (deficit) | 145,648 | (42,118) | ||||||
Contacts
Magenta Therapeutics:
Manisha Pai, Vice President, Communications &
Investor Relations
617-510-9193
mpai@magentatx.com