- Initial data from ongoing Phase 2a study in geographic atrophy
demonstrated ability of GEM103 to durably regulate complement and
showed a differentiated safety profile with no increased risk of
CNV
- Completed enrollment in Phase 2a study of GEM103 in wet AMD
with six-month data to be shared by year-end
- A randomized, sham-controlled clinical trial to evaluate
GEM103’s ability to limit geographic atrophy is planned to initiate
in 1H 2022
Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage
precision medicine company developing innovative treatments for
genetically-defined age-related macular degeneration (AMD), today
reported its financial results for the second quarter ended June
30, 2021 and provided a business update.
“The initial results shared in June from the ongoing Phase 2a
ReGAtta study in patients with geographic atrophy showed biomarker
results that support the biological activity of GEM103 and its
ability to regulate complement in a dose-dependent and durable
manner as early as after just three months of GEM103
administration,” said Jason Meyenburg, Chief Executive Officer of
Gemini Therapeutics, Inc. “These compelling results, in an
open-label, single arm study designed primarily to demonstrate the
safety and tolerability of GEM103, met its key endpoint and
provides us the confidence to advance to a sham-controlled study
designed to assess the efficacy of GEM103 as a potential treatment
for geographic atrophy.”
Recent Business and Clinical Highlights
- Announced initial data from ongoing Phase 2a study of GEM103
in patients with geographic atrophy (GA) secondary to dry AMD.
In June 2021, Gemini shared initial data from its ongoing ReGAtta
study, an open-label Phase 2a trial of its lead product candidate,
GEM103, in patients with GA secondary to dry AMD. The single-arm,
multiple-dose escalation study design is the first repeat dose
experience with GEM103. Initial study data highlighted GEM103’s
generally favorable safety and tolerability profile, the primary
goal of the study, while also providing evidence of the candidate’s
biological activity in patients with dry AMD, achieving another key
study goal. Key initial findings include the following:
- Results indicated GEM103’s ability to regulate complement in a
dose-dependent and durable manner by reducing complement biomarkers
Ba and C3a by ~40% and ~20%, respectively. Reductions in the
biomarker C3a is indicative of a potential reduction in the
proinflammatory state of the retina in patients with GA.
- GEM103 continues to be generally well-tolerated and initial
data supports a differentiated safety profile with minimal
drug-related inflammation. Observed inflammation was attributed
either to injection procedures or was seen in patients with
autoimmune co-morbidities. Additionally, no increased risk of
choroidal neovascularization (CNV) was observed to date.
- Completed enrollment in Phase 2a study of GEM103 as
potential add-on to anti-vascular endothelial growth factor
(anti-VEGF) therapy for patients suffering from wet AMD. In May
2021, the Company completed enrollment in the Phase 2a safety and
tolerability study. The Company expects to release six-month dosing
data related to safety, tolerability, effect on intraocular
complement factor H (CFH) levels and disease-related biomarkers, in
late 2021.
- Presented preclinical data on GEM103 at the 2021 Association
for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
In May 2021, the Company presented a poster at ARVO that
demonstrated GEM103 does not pose an increased risk of CNV
following intravitreal administration in a laser induced mouse
model of disease.
Financial Results
Research and development expenses totaled $10.8 million for the
three months ended June 30, 2021, compared to $5.5 million for the
same period in 2020. The increase was primarily due to increased
expenses related to clinical studies and headcount costs.
General and administrative expenses were $5.5 million for the
three months ended June 30, 2021, compared to $1.1 million for the
same period in 2020. The increase was primarily due to increased
expenses related to professional fees associated with being a
public company, as well as headcount costs.
For the three months ended June 30, 2021, Gemini reported a net
loss of $16.4 million, or $0.38 per share, compared to a net loss
of $6.8 million, or $0.44 per share, in the corresponding period in
2020. The increase in net loss for the three months ended June 30,
2021 was primarily due to an increase in operating expenses.
At June 30, 2021, Gemini held $167.5 million in cash, $7.9
million of principal outstanding debt and 43.1 million shares
outstanding.
About the Phase 2a ReGAtta Study
The ongoing Phase 2a, multi-center, open-label, multiple
ascending dose study of GEM103 in genetically-defined patients with
GA secondary to dry AMD is designed to investigate safety and
tolerability, pharmacokinetics (PK), exploratory ocular biomarkers,
and measures of retinal anatomy and function. This study is not
designed to assess the efficacy of GEM103. GEM103 is delivered
monthly by an intravitreal injection, and PK and biomarkers of
complement regulation are determined from aqueous humor sampling.
The study enrolled 62 patients with gene variants that have been
linked to the progression of dry AMD from early to late-stage.
About the Phase 2a Study of Repeat Intravitreal Injections of
GEM103 in Neovascular Age-related Macular Degeneration
(nAMD)
The ongoing Phase 2a, multicenter, multiple-dose study in
subjects with nAMD, with or at risk for MA, is designed to
investigate the safety and tolerability of GEM103 as an adjunct to
standard of care aflibercept therapy. The study enrolled 50
patients that are randomized 2:1 between GEM103 plus aflibercept
and sham plus aflibercept arms, with treatment administered via
intravitreal injection every other month for twelve months. This
study is not designed to assess the efficacy of GEM103. CFH levels
and disease relevant biomarkers of complement regulation are
determined from aqueous humor sampling throughout the study with
visual acuity and macular atrophy size measured at defined dosing
dates.
About GEM103
Gemini’s lead candidate, GEM103, is a pioneering precision
medicine approach, targeting trial enrichment with genetically
defined patients. GEM103 targets a genetically defined subset of
age-related macular degeneration (AMD) patients with complement
dysregulation. Of the 15 million dry AMD patients in the United
States, approximately 40% (or six million) have variants in the
complement factor H (CFH) gene. Such loss of function variants are
associated with increased dry AMD disease risk. GEM103 is believed
to be the first ever recombinant complement regulator and is a
full-length and human, recombinant complement factor H (rCFH)
protein. When delivered by intravitreal injection, we believe
GEM103 has the potential to address unmet medical need in
genetically defined AMD patients by circumventing the complement
dysfunction resulting from CFH loss of function variants and
slowing the progression of their retina disease. The U.S. Food and
Drug Administration (FDA) granted Fast Track Designation for GEM103
for the treatment of dry AMD in patients with CFH loss of function
gene variants.
About Dry Age-Related Macular Degeneration (AMD)
Age-related macular degeneration (AMD) is a progressive retinal
disease affecting millions of older adults, and the leading cause
of irreversible blindness in the western world. Symptoms, which
include blurry vision, loss of night vision and loss of central
vision, make activities of daily living such as reading, driving
and even recognizing faces progressively more difficult.
Third-party reports indicate there are approximately 16 million
patients with AMD in the United States alone. Dry AMD, which
results from an interaction of environmental and genetic risk
factors, represents about 90% of that population (or about 15
million) in the US compared to about 1.4 million with wet AMD.
Genetic risk of developing dry AMD is significant, with
approximately 70% attributable risk of advanced disease to
heritability, while aging and smoking confer the strongest
non-genetic risk. CFH risk variants occur in approximately 40% of
patients with dry AMD and these patients have a significantly
increased risk of developing the disease as well as progression
from intermediate AMD to GA. The complement system, of which CFH is
a regulator, is dysregulated in patients with these risk variants,
and results in amplification of aberrant inflammatory responses in
the eye. Over time, this dysregulation leads to damage to the
macular region of the retina.
About Gemini Therapeutics
Gemini Therapeutics is a clinical stage precision medicine
company developing novel therapeutic compounds to treat genetically
defined age-related macular degeneration (AMD). Gemini’s lead
candidate, GEM103, is a recombinant form of human complement factor
H protein (CFH) and is designed to address both complement
hyperactivity and restore retinal health in patients with AMD.
GEM103 is currently in a Phase 2a trial in dry AMD patients with a
CFH risk variant and a Phase 2a study in patients with neovascular
age-related macular degeneration with or at risk for macular
atrophy. Gemini has generated a rich pipeline including recombinant
proteins, gene therapies, and monoclonal antibodies and is working
to advance a potentiating antibody for CFH, GEM307, into clinical
development for treatment of systemic diseases.
For more information, visit www.geminitherapeutics.com.
Availability of Other Information About Gemini
Therapeutics
Investors and others should note that we communicate with our
investors and the public using our website
(www.geminitherapeutics.com), the investor relations website
(https://investors.geminitherapeutics.com/), and on social media
(Twitter and LinkedIn), including but not limited to investor
presentations and investor fact sheets, U.S. Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that Gemini posts on these
channels and websites could be deemed to be material information.
As a result, Gemini encourages investors, the media, and others
interested in Gemini to review the information that is posted on
these channels, including the investor relations website, on a
regular basis. This list of channels may be updated from time to
time on Gemini’s investor relations website and may include
additional social media channels. The contents of Gemini’s website
or these channels, or any other website that may be accessed from
its website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended.
Gemini’s Forward-Looking Statements
Certain statements in this press release and the information
incorporated herein by reference may constitute “forward-looking
statements” for purposes of the federal securities laws. Our
forward-looking statements include, but are not limited to,
statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future,
including those relating to the success, cost and timing of our
product development activities and clinical trials, whether such
data, when final, will be consistent with interim reported data,
the timing to commence future clinical trials, the potential
attributes and benefits of our product candidates, including
GEM103, the reliability of the interim or final results of studies
relating to safety and possible adverse effects resulting from the
administration of our product candidates, our ability to obtain and
maintain regulatory approval for our product candidates, our
projected cash runway and our ability to obtain funding for our
operations when needed. Forward-looking statements include
statements relating to our management team’s expectations, hopes,
beliefs, intentions or strategies regarding the future. In
addition, any statements that refer to projections, forecasts or
other characterizations of future events or circumstances,
including any underlying assumptions, are forward-looking
statements. The words “anticipate,” “believe,” “contemplate,”
“continue,” “could,” “estimate,” “expect,” “intends,” “may,”
“might,” “plan,” “possible,” “potential,” “predict,” “project,”
“should,” “will,” “would” and similar expressions may identify
forward-looking statements, but the absence of these words does not
mean that a statement is not forward-looking. These forward-looking
statements are based on current expectations and beliefs concerning
future developments and their potential effects. There can be no
assurance that future developments affecting us will be those that
we have anticipated. These forward-looking statements involve a
number of risks, uncertainties (some of which are beyond our
control) or other assumptions that may cause actual results or
performance to be materially different from those expressed or
implied by these forward-looking statements. These risks and
uncertainties include, but are not limited to, those factors
described under the heading “Risk Factors” in the Gemini’s most
recent Annual Report on Form 10-K filed with the SEC, as well as
discussions of potential risks, uncertainties, and other important
factors included in any of our subsequent or future filings with
the SEC. Should one or more of these risks or uncertainties
materialize, or should any of our assumptions prove incorrect,
actual results may vary in material respects from those projected
in these forward-looking statements. Some of these risks and
uncertainties may in the future be amplified by the ongoing
COVID-19 pandemic and there may be additional risks that we
consider immaterial or which are unknown. It is not possible to
predict or identify all such risks. Our forward-looking statements
only speak as of the date they are made, and we do not undertake
any obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as may be required under applicable securities laws.
Gemini Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive
Loss (Unaudited) (In thousands, except share and per share
amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Operating expenses:
Research and development
$
10,842
$
5,528
$
22,628
$
13,745
General and administrative
5,478
1,138
10,182
2,552
Total operating expenses
16,320
6,666
32,810
16,297
Loss from operations
(16,320
)
(6,666
)
(32,810
)
(16,297
)
Other income (expense):
Interest expense
(121
)
(107
)
(1,969
)
(260
)
Interest income
5
-
6
36
Loss on conversion of convertible
notes
-
-
(711
)
-
Change in fair value of warrant
liability
-
-
-
2
Other expense
(11
)
-
(11
)
-
Net loss and comprehensive loss
$
(16,447
)
$
(6,773
)
$
(35,495
)
$
(16,519
)
Net loss attributable to common
stockholders
$
(16,447
)
$
(6,773
)
$
(35,495
)
$
(16,519
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.38
)
$
(0.44
)
$
(0.94
)
$
(1.11
)
Weighted average common shares
outstanding, basic and diluted
43,041,856
15,266,222
37,564,936
14,881,097
Gemini Therapeutics, Inc.Condensed Consolidated Balance
Sheets(Unaudited)(In thousands)
June 30, 2021
December 31, 2020
Assets
Cash and cash equivalents
$
167,477
$
4,503
Other current assets
3,834
562
Total current assets
171,311
5,065
Other assets
1,111
3,254
Total assets
$
172,422
$
8,319
Liabilities and stockholders' equity
(deficit)
Current liabilities
$
11,505
$
24,876
Long-term liabilities
3,235
5,304
Total liabilities
14,740
30,180
Total stockholders' equity (deficit)
157,682
(21,861
)
Total liabilities and stockholders' equity
(deficit)
$
172,422
$
8,319
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210812005178/en/
Gemini Investor Contact: Argot Partners Sherri Spear
212-600-1902 gemini@argotpartners.com
Gemini Media Contact: Argot Partners Joshua Mansbach
212-600-1902 gemini@argotpartners.com
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