-- Dosed first subjects in Phase 1 study of
MGTA-145 first-line mobilization therapy --
-- Presented updated Phase 2 clinical data on
MGTA-456 cell therapy in patients with inherited metabolic
disorders at American Academy of Neurology annual meeting --
-- Presented preclinical data on E478 stem cell
gene therapy expansion program at American Society of Gene and Cell
Therapy annual meeting --
-- Completed public offering of common stock in
May 2019, raising gross proceeds of $64.8 million and extending the
runway into the second half of 2021 --
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 for the first quarter ended March 31,
2019 and recent business highlights.
“In 2019 we are continuing to advance our portfolio of programs
toward our vision of curing more patients with autoimmune diseases,
blood cancers and genetic diseases. This momentum was reflected in
the recent start of our Phase 1 study of MGTA-145, our first-line
therapy for stem cell mobilization and second clinical program, as
well as in the extended evidence of disease benefit we see in our
Phase 2 study of our MGTA-456 cell therapy in patients with
inherited metabolic disorders,” said Jason Gardner, D.Phil., Chief
Executive Officer and President, Magenta Therapeutics. “We are
positioned to build on this momentum through additional important
milestones across each of our programs and to deliver value for
patients and shareholders.”
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 disease and
declare a development candidate
- Present preclinical data on C200
anti-CD117 targeted conditioning program in gene therapy
- Present clinical data from the Phase 1
study of MGTA-145
- Present additional clinical data from
the Phase 2 study of MGTA-456 in inherited metabolic disorders
(IMDs)
Recent Business
Highlights:
Dosed first subjects in Phase 1 clinical trial of MGTA-145
first-line stem cell mobilization product candidate: In April
2019, Magenta announced that it had dosed the first subjects in a
Phase 1 study of MGTA-145. Magenta intends to develop MGTA-145 in
autoimmune diseases, blood cancers and genetic diseases. The Phase
1 study will investigate the safety and tolerability of MGTA-145
alone and in combination with plerixafor in healthy volunteers and
establish recommended Phase 2 doses. The study will also measure
the number of hematopoietic stem cells in the blood after dosing
with MGTA-145 alone and in combination with plerixafor. Magenta
expects to present data from the study in the second half of 2019.
Depending on the Phase 1 data, the Company plans to move MGTA-145
into a Phase 2 study in multiple myeloma and non-Hodgkin lymphoma
in 2020.
Updated clinical data for MGTA-456 cell therapy showed
continued signs of durable clinical benefit in patients with
IMDs: Magenta presented updated data from the Phase 2 clinical
study of MGTA-456 in patients with IMDs at the American Academy of
Neurology (AAN) annual meeting in May 2019. Patients with cerebral
adrenoleukodystrophy (cALD) treated with MGTA-456 in the study
showed stable neurological function scores and persistent
resolution of brain inflammation by MRI at 6 months
post-transplant, suggesting that the progression of disease has
been halted. Magenta expects to update these results in the second
half of 2019.
Preclinical data on E478 stem cell gene therapy expansion
program show significant increase in gene-modified stem cells:
At the American Society of Gene and Cell Therapy annual meeting in
May 2019, Magenta presented data showing that E478 increased the
number of human hematopoietic stem cells modified with either
CRISPR/Cas9 or lentiviral vector by 10-fold compared to standard
culture methods. Magenta is developing E478 to achieve high doses
of gene-modified stem cells for better outcomes in patients with
genetic disorders, including sickle cell disease and
beta-thalassemia, where gene editing or viral vector technologies
are used to correct stem cells. Magenta intends to develop E478 in
partnership with gene therapy companies.
Presented nine abstracts at Transplant and Cellular Therapies
Conference: Magenta presented data covering the breadth of the
Company’s integrated portfolio of programs at the Transplant and
Cellular Therapy (TCT) annual meeting in February 2019.
Financial Results:
Cash Position: Cash, cash equivalents and marketable
securities as of March 31, 2019, were $127.3 million compared to
$142.6 million on December 31, 2018. In addition, earlier this week
Magenta announced that it completed a public offering of common
stock and raised gross proceeds of $64.8 million. Magenta
anticipates that its cash, cash equivalents and marketable
securities, including the proceeds from this recent financing, will
be sufficient to fund operations and capital expenditures into the
second half of 2021.
Research and Development Expenses: Research and
development (R&D) expenses were $10.5 million in the first
quarter of 2019, compared to $7.8 million in the first quarter of
2018. The increase was driven by investments related to the IND
filing and clinical activities for MGTA-145, as well as the
on-going clinical development of MGTA-456.
General and Administrative Expenses: General and
administrative (G&A) expenses were $5.8 million for the first
quarter of 2019, compared to $3.5 million for the first quarter in
2018. The increase was primarily due to increased personnel and
facility costs associated with the growth of the Company.
Net Loss: Net loss was $14.8 million for the first
quarter of 2019, compared to net loss of $11.2 million for the
first quarter of 2018.
About Magenta TherapeuticsHeadquartered 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 StatementThis press release may contain
forward-looking statements, including express or implied statements
regarding Magenta’s future expectations, plans and prospects,
including projections regarding future revenues and financing
performance, our long-term growth, the anticipated timing of our
clinical trials and regulatory filings, the development of our
product candidates and advancement of our preclinical programs, as
well as other statements containing the words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” might,” “plan,” “potential,” “project,” “should,” target,”
“will” or “would” and similar expressions that constitute
forward-looking statements under the Private Securities Litigation
Reform Act of 1995. 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 concerning Magenta's programs and
operations are described in additional detail in its registration
statement on Form S-1, its Annual Report on Form 10-K filed on
March 19, 2019, its Quarterly Reports on Form 10-Q and its other
filings made with the Securities and Exchange Commission from time
to time. Although Magenta's forward-looking statements reflect the
good faith judgment of its management, these statements are based
only on facts and factors currently known by Magenta. As a result,
you are cautioned not to rely on these forward-looking statements.
Any forward-looking statement made in this press release speaks
only as of the date on which it is made. Magenta undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future
developments or otherwise.
Magenta Therapeutics, Inc.
STATEMENTS OF OPERATIONS (unaudited) (In
thousands, except share and per share data) Three
Months Ended March 31, 2019 2018 Revenue $
— $ — Operating expenses: Research and development 10,537 7,849
General and administrative 5,813 3,457 Total
operating expenses 16,350 11,306 Loss from operations
(16,350) (11,306) Interest and other income, net 1,516
145 Net loss attributable to common stockholders $ (14,834)
$ (11,161) Net loss per share attributable to common stockholders,
basic and diluted $ (0.44) $ (4.53) Weighted average common shares
outstanding, basic and diluted 33,422,278 2,466,353
BALANCE SHEET DATA (unaudited) (In
thousands) March 31, 2019 December 31,
2018 Cash, cash equivalents and marketable securities $ 127,307
$ 142,570 Working capital 127,157 134,902 Total assets 147,692
157,313 Stockholders' equity 134,003 145,648
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version on businesswire.com: https://www.businesswire.com/news/home/20190509005195/en/
Magenta Therapeutics:Manisha Pai, Vice President, Communications
& Investor Relations617-510-9193mpai@magentatx.com
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