Imago BioSciences Reports Second Quarter 2022 Financial Results and Provides Recent Business Updates
August 12 2022 - 4:05PM
Imago BioSciences, Inc. (“Imago” or the “Company”) (Nasdaq: IMGO),
a clinical-stage biopharmaceutical company discovering and
developing new medicines for the treatment of myeloproliferative
neoplasms (MPNs) and other bone marrow diseases, today reported
financial results for the second quarter ended June 30, 2022 and
provided business updates.
“We were delighted to present updated positive
data on our Phase 2 trial of bomedemstat in essential
thrombocythemia (ET) at EHA in June. In our updated dataset,
bomedemstat demonstrated hematologic and symptomatic improvement in
ET patients and, importantly, demonstrated the durability of these
hematologic responses. These data will support our ongoing
discussions with the FDA, as we target an End of Phase 2 meeting
with the FDA later this year, and move towards initiating the
pivotal trial,” said Hugh Young Rienhoff, Jr., M.D, Chief Executive
Officer of Imago. “At EHA, we also presented positive data from our
advanced myelofibrosis (MF) Phase 2 trial where bomedemstat
demonstrated improvements in total symptom scores, fibrosis grades,
spleen volumes and anemia, as well as reductions in mutant allele
frequencies. Looking ahead, we plan to evaluate bomedemstat in
combination with ruxolitinib in MF patients in a trial starting in
the Fall 2022. Lastly, in addition to our long-held plans to study
bomedemstat in other myeloproliferative neoplasms, such as
polycythemia vera, we were pleased to see initiation of the first
solid tumor clinical study of bomedemstat, an
investigator-sponsored study of bomedemstat in combination with
atezolizumab for small cell lung cancer.”
Second Quarter 2022 and Subsequent
Highlights
-
Presented Positive Data from the Ongoing Phase 2 Study of
Bomedemstat in Essential Thrombocythemia at EHA 2022. In
June 2022, Imago presented updated positive data from its ongoing
global Phase 2 clinical study evaluating bomedemstat in patients
with ET. As of the data cutoff date of 29 April 2022: bomedemstat
demonstrated normalization of platelets in the absence of new
thromboembolic events (the primary efficacy endpoint of this study)
in 94% of patients; as well as durability of hematologic response
with 81% of patients achieving normalized platelet counts for at
least 12 weeks (ELN criteria defining a durable response in ET);
58% of patients treated with bomedemstat experienced symptomatic
improvement (defined as a decrease in Total Symptom Score) at 24
weeks; and both JAK2 and CALR mutation burdens were decreased
during treatment with bomedemstat. As of the data cutoff date, the
most common adverse events (AEs) were dysgeusia, fatigue,
constipation, and arthralgia. Twelve patients reported a total of
19 serious adverse events (SAEs) with six deemed related to
bomedemstat by the investigator. There have been no dose limiting
toxicities (DLTs) or deaths related to drug. The EHA data cut
represented the last presentation before the End-of-Phase 2 meeting
with FDA expected later this year.
-
Presented Positive Data from the Ongoing Phase 2 Study of
Bomedemstat in Advanced Myelofibrosis at EHA 2022. In June
2022, the Company presented updated positive data from its ongoing
global Phase 2 clinical study evaluating bomedemstat in patients
with MF. As of the data cutoff date of 29 April 2022, in addition
to improvements in the standard metrics of spleen volume reduction
and symptom scores, long term treatment with bomedemstat showed:
52% of evaluable patients had reductions in mutant allele
frequencies, including ASXL1; 85% of evaluable patients
demonstrated improved or stable fibrosis scores; and 90% of
patients who were transfusion independent at baseline had stable or
improved hemoglobin. The most common non-hematologic AE was
dysgeusia. Of 14 drug related SAEs, 5 were Grade 2, 8 Grade 3 and 1
Grade 4 (thrombocytopenia). There have been no DLTs or deaths
related to drug. Eligible MF patients completing this Phase 2 study
have rolled into an extension study to evaluate the longer-term
safety and impact of bomedemstat on the natural history of MF.
Imago plans to commence an investigator-sponsored evaluation of
bomedemstat in combination with ruxolitinib in patients with MF who
have a sub-optimal response to JAK inhibition or are treatment
naïve in the Fall 2022.
-
Announced First Participant Dosed in Investigator-Sponsored
Study of Bomedemstat in Combination with Atezolizumab in Small Cell
Lung Cancer, the first clinical study of Bomedemstat in patients
with Solid Tumors. In May 2022, Imago announced that the
first participant had been treated in an investigator-sponsored
Phase 1/2 study of bomedemstat in combination with atezolizumab
(Tecentriq®) during the maintenance phase of treatment in people
newly diagnosed with extensive stage small cell lung cancer
(ES-SCLC). The Phase 1/2 open-label study will enroll approximately
30 participants diagnosed with ES-SCLC to establish the safety and
tolerability of a combination treatment with bomedemstat and
atezolizumab. The study is being conducted in Seattle and led by
Rafael Santana-Davila, M.D., associate professor at the University
of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of
Fred Hutchinson Cancer Center (“Fred Hutch”), and in collaboration
with the National Cancer Institute (NCI) funded Fred Hutch
Lung Specialized Project of Research Excellence.
-
Completed Enrollment in Phase 2 Study of Bomedemstat in
Essential Thrombocythemia. In May 2022, Imago announced
the completion of enrollment for the Phase 2 clinical study of
bomedemstat for the treatment of ET with 73 patients enrolled,
exceeding the initial target enrollment of 60 patients. This study
is designed to evaluate the safety, efficacy, pharmacokinetics and
pharmacodynamics of bomedemstat, an oral lysine-specific
demethylase 1 (LSD1) inhibitor, in patients with ET who have failed
at least one standard therapy.
- Obtained
Advice from FDA Clinical Outcomes Assessment (COA) Group with
Regard to Patient Reported Outcome (PRO) Endpoints for the
Company’s Planned Phase 3 Trial of Bomedemstat in ET
Patients. In June 2022, Imago discussed with FDA the
proposed instruments to assess patient-reported symptoms and
outcomes for key secondary endpoints.
Anticipated Upcoming
Milestones
-
End-of-Phase 2 meeting with FDA for bomedemstat in ET expected this
year
- Anticipate
initiating investigator-sponsored Phase 2 combination study of
bomedemstat with ruxolitinib in MF in the Fall 2022
- Expect data
updates for the bomedemstat Phase 2 trials in ET and MF at the
American Society of Hematology (ASH) Annual Meeting in December
2022
Second Quarter 2022 Financial
Results
- Cash,
Cash Equivalents and Short-term Investments: As of June
30, 2022, Imago had cash, cash equivalents and short-term
investments of $190.0 million, compared to $217.4 million as of
December 31, 2021. Based on current operating plans, management
believes cash runway extends into 2025.
- Research
& Development (R&D) Expenses: R&D expenses for
the quarter ended June 30, 2022 were $9.7 million (including
stock-based compensation expense of $0.7 million), compared to $7.1
million for the same period in 2021. The overall increase in
R&D expenses was primarily related to the commencement of a
Phase 2 extension study started in the second half of 2021 for the
long-term follow-up of patients from MF and ET clinical trials, and
salaries and non-cash stock-based compensation expense for R&D
employees as we ramped up our operations.
- General
and Administrative (G&A) Expenses: G&A expenses
for the quarter ended June 30, 2022 were $4.3 million (including
stock-based compensation expense of $1.0 million), compared to $1.7
million for the same period in 2021. The increase was primarily due
to increases in professional fees attributable to accounting,
legal, audit, and insurance expenses associated with public company
operations and compensation and personnel-related costs, including
stock-based compensation expense, as a result of increased
headcount.
- Net
Loss: Net loss for the quarter ended June 30, 2022 was
$13.7 million, compared to $8.8 million for the same period in
2021.
About Imago BioSciences
Imago BioSciences is a clinical-stage
biopharmaceutical company discovering and developing novel small
molecule product candidates that target lysine-specific demethylase
1 (LSD1), an enzyme that plays a central role in the production of
blood cells in the bone marrow. Imago is focused on improving the
quality and length of life for patients with cancer and bone marrow
diseases. Bomedemstat, an orally available, small molecule
inhibitor of LSD1, is the lead product candidate discovered by
Imago for the treatment of certain myeloproliferative neoplasms
(MPNs), a family of related, chronic cancers of the bone marrow.
Imago is evaluating Bomedemstat as a potentially disease-modifying
therapy in two Phase 2 clinical trials for the treatment of
essential thrombocythemia (NCT04254978) and myelofibrosis
(NCT03136185). Bomedemstat has U.S. FDA Orphan Drug and Fast Track
Designation for the treatment of ET and MF, European Medicines
Agency (EMA) Orphan Designation for the treatment of ET and MF, and
PRIority MEdicines (PRIME) Designation by the EMA for the treatment
of MF. The company is based in South San Francisco, California. To
learn more, visit www.imagobio.com,
www.myelofibrosisclinicalstudy.com, www.etclinicalstudy.com and
follow us on Twitter
@ImagoBioRx, Facebook and LinkedIn.
Forward Looking Statements
This press release contains forward looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as “anticipates,” “may,” “will,”
“should,” “expect,” “believe” and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking
statements.
These statements may relate to, but are not
limited to, the results, conduct, progress and timing of Imago
clinical trials, timing of data presentations, the regulatory
approval path for bomedemstat, plans for future operations, and
expected cash runway, as well as assumptions relating to the
foregoing. Forward looking statements are inherently subject to
risks and uncertainties, some of which cannot be predicted or
quantified. Important factors that could affect future results and
cause those results to differ materially from those expressed in
the forward-looking statements include: our limited operating
history and lack of products for commercial sale; our significant
losses since inception and for the foreseeable future; our need for
substantial additional financing; our unpredictable operating
results, due to, for example, general economic conditions in the
United States and abroad; our business’s dependence on development,
regulatory approval and commercialization of our product
candidates; difficulties in enrolling patients and risks of
substantial delays in our clinical trials; our minimal control over
product candidates in investigator-initiated clinical trials;
uncertainties in the cost and outcomes of our clinical studies and
the acceptance for presentation at medical meetings of data from
our clinical studies; uncertainties in the regulatory review and
approval of our product candidates if our pivotal studies are
positive; potentially material changes to the interim, top-line and
preliminary data from our clinical trials; potential undesirable
effects of our product candidates and safety or supply issues, in
each case with respect to our product candidates alone or in
combination with other compounds or products; our potential
inability to obtain and maintain orphan drug designation and delays
in approvals despite Fast Track designation; risks related to
clinical trials outside of the United States; our need to
manufacture multiple batches of bomedemstat using a commercial
current Good Manufacturing Practice; risks related to COVID-19 or
other pandemics, natural disasters and wars; risks related to
competition; difficulties in expanding our organization and
managing growth, attracting and retaining senior management and key
scientific personnel and establishing sales and other
commercialization functions; risks related to information
technology system and cybersecurity; risks related to misconduct of
our employees and independent contractors; risks related to
hazardous materials and our compliance with environmental laws and
regulations; risks related to litigation and other claims; risks
related to reliance on third parties to conduct and support
preclinical studies and clinical trials, and to manufacture our
product candidates; risks related to third-party intellectual
property infringement claims and our ability to protect our own
intellectual property; risks related to governmental policies and
regulations including with respect to drug prices and
reimbursement, and changes thereof; risks related to our common
stock; risks related to our public company, “emerging growth
company” and “smaller reporting company” status; risks related to
material weaknesses and failure to maintain effective internal
control over financial reporting; and other risks and
uncertainties, including those listed in the section titled “Risk
Factors” in our Annual Report on Form 10-K for the year ended
December 31, 2021 and our subsequent quarterly reports. You should
not put undue reliance on any forward-looking statements. Forward
looking statements should not be read as a guarantee of future
performance or results and will not necessarily be accurate
indications of the times at, or by, which such performance or
results will be achieved, if at all.
Except as required by law, Imago does not
undertake any obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future developments or otherwise.
Contacts:
Media Contact: Will ZasadnyCanale
Communicationswill.zasadny@canalecomm.com
Investor Contact:
Laurence Watts
Gilmartin Group, LLC.
Laurence@gilmartinir.com
IMAGO BIOSCIENCES, INC.
Condensed Consolidated Balance
Sheets(in thousands, except share and per share
data)(unaudited)
|
JUNE 30, |
|
|
DECEMBER 31, |
|
|
2022 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
22,772 |
|
|
$ |
11,226 |
|
Short-term investments |
167,238 |
|
|
206,184 |
|
Prepaid expenses and other current assets |
2,562 |
|
|
3,894 |
|
Total current assets |
192,572 |
|
|
221,304 |
|
Property and equipment, net |
3 |
|
|
2 |
|
Other long-term assets |
3,536 |
|
|
3,480 |
|
Total assets |
$ |
196,111 |
|
|
$ |
224,786 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,584 |
|
|
$ |
3,459 |
|
Accrued and other current liabilities |
6,189 |
|
|
6,633 |
|
Total current liabilities |
8,773 |
|
|
10,092 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common stock, $0.0001 par value; 300,000,000 shares authorized as
of both June 30, 2022 and December 31, 2021; 33,737,873 and
33,531,743 shares issued and outstanding as of June 30, 2022 and
December 31, 2021, respectively |
3 |
|
|
3 |
|
Additional paid-in capital |
330,951 |
|
|
327,387 |
|
Accumulated other comprehensive loss |
(828 |
) |
|
(43 |
) |
Accumulated deficit |
(142,788 |
) |
|
(112,653 |
) |
Total stockholders’ equity |
187,338 |
|
|
214,694 |
|
Total liabilities and stockholders’ equity |
$ |
196,111 |
|
|
$ |
224,786 |
|
|
|
|
|
|
|
IMAGO BIOSCIENCES, INC.
Condensed Consolidated Statements of
Operations(in thousands, except share and per share
data)(unaudited)
|
THREE MONTHS ENDED |
|
|
SIX MONTHS ENDED |
|
|
JUNE 30, |
|
|
JUNE 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
9,677 |
|
|
$ |
7,099 |
|
|
$ |
22,179 |
|
|
$ |
11,871 |
|
General and administrative |
|
4,339 |
|
|
|
1,743 |
|
|
|
8,350 |
|
|
|
4,119 |
|
Total operating expenses |
|
14,016 |
|
|
|
8,842 |
|
|
|
30,529 |
|
|
|
15,990 |
|
Loss from operations |
|
(14,016 |
) |
|
|
(8,842 |
) |
|
|
(30,529 |
) |
|
|
(15,990 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
148 |
|
|
|
82 |
|
|
|
212 |
|
|
|
169 |
|
Other income (expense), net |
|
127 |
|
|
|
(46 |
) |
|
|
182 |
|
|
|
(94 |
) |
Total other income, net |
|
275 |
|
|
|
36 |
|
|
|
394 |
|
|
|
75 |
|
Net loss |
$ |
(13,741 |
) |
|
$ |
(8,806 |
) |
|
$ |
(30,135 |
) |
|
$ |
(15,915 |
) |
Net loss per share, basic and
diluted |
$ |
(0.41 |
) |
|
$ |
(8.13 |
) |
|
$ |
(0.89 |
) |
|
$ |
(15.06 |
) |
Weighted-average shares used in
computing net loss per share, basic and diluted |
|
33,735,785 |
|
|
|
1,082,932 |
|
|
|
33,691,163 |
|
|
|
1,056,624 |
|
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