— 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 —
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 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 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 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 | ||||||
Contacts
Magenta Therapeutics:
Manisha Pai, Vice President, Communications &
Investor Relations
617-510-9193
mpai@magentatx.com