GEM103 updated safety information presented
during AAO including no increased risk for CNV observed to date in
ongoing ReGAtta Phase 2a study
Expect to provide six-month update from GEM103
ReGAtta study by year-end
Scheduled to meet with the FDA in 4Q’21 and
expect to initiate late-stage trial for GEM103 in patients with GA
in 1Q’22
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 third quarter ended
September 30, 2021 and provided a business update.
“This weekend at the American Academy of Ophthalmology (AAO)
annual meeting, Dr. Maturi provided a safety update on our ongoing
Phase 2a ReGAtta study of GEM103 which shows GEM103 is generally
well-tolerated with no increased risk of CNV in over 500
intravitreal injections of GEM103. We look forward to presenting a
six-month update for the study before year end. We are meeting with
the FDA this quarter and anticipate initiating our late-stage study
of GEM103 for geographic atrophy (GA) secondary to dry AMD in the
first quarter of 2022,” said Jason Meyenburg, Chief Executive
Officer of Gemini Therapeutics, Inc.
Recent Business and Clinical Highlights
- Presented newly available safety data from ongoing ReGAtta
Phase 2a study of GEM103 at AAO 2021. During the AAO Meeting in
November Dr. Raj Maturi, M.D., Adjunct Clinical Assistant Professor
of Ophthalmology, at Indiana University School of Medicine and an
investigator in the ReGAtta study, presented an e-poster with newly
available safety data that updated the May 2021 initial data from
the ongoing ReGAtta Phase 2a study of GEM103 in GA. The most recent
safety update from the ReGAtta study showed that across 510
intravitreal injections, GEM103 was generally well-tolerated with
no ocular serious adverse events and no interruption in GEM103
therapy. 17 patients (27.4%) experienced mild to moderate ocular
adverse events in the study eye and there continued to be no
increased risk of CNV in the study eyes treated with GEM103.
- Presented GEM103 biology and development at 2nd Annual Dry
AMD Therapeutic Development Summit. In October 2021 the Company
further discussed the previously released initial data from its
ongoing Phase 2a ReGAtta study in a presentation titled “Spotlight
on GEM103 – Restoring Physiologic Complement Activity with
Complement Factor H (CFH) for GA” at the 2nd Annual Dry AMD
Therapeutic Development Summit: Uncovering the Largest Untapped
Eyecare Market.
- Announced corporate restructuring to prioritize late-stage
clinical development of GEM103 for GA. In October 2021, Gemini
announced a corporate restructuring including several executive
officer transitions to prioritize assets and focus on initiating
and executing GEM103’s resource-intensive pivotal trial in GA.
- Presented preclinical data on GEM103 at the 13th
International Conference on Complement Therapeutics. In
September 2021 at the 13th International Conference on Complement
Therapeutics, an oral presentation and three poster presentations
highlighted the potential of GEM103 as the next class of complement
therapeutics for the treatment of AMD by regulating complement.
GEM103 rapidly biodistributed to key tissues of interest including
the retina, choroid and retinal pigment epithelium (RPE), and was
retained on the RPE cell surface for an extended duration and
remains functionally active in the eye following intravitreal
administration.
- Presented data from its ongoing Phase 2a study of GEM103 at
EURETINA 2021 Virtual. In September 2021, Dr. Maturi presented
Gemini’s previously released initial results from its ongoing Phase
2a ReGAtta study that GEM103 demonstrated the ability to regulate
complement in GA patients with treatment resulting in a reduction
of elevated complement biomarkers and a dose dependent reduction in
the overall inflammatory state.
- Presented data from its ongoing Phase 2a study of GEM103 at
Clinical Trials at the Summit. In August 2021, Gemini
participated in panel discussions at Clinical Trials at the Summit
and presented an analysis of the baseline GA lesion sizes for
patients enrolled in the ongoing Phase 2a ReGAtta study that showed
imbalances in GA baseline characteristics prevent efficacy
assessment in a non-controlled open-label study.
Financial Results
Research and development expenses totaled $13.5 million for the
three months ended September 30, 2021 compared to $6.7 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 $5.0 million for the
three months ended September 30, 2021 compared to $1.2 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 September 30, 2021 Gemini reported a
net loss of $18.6 million, or $0.43 per share compared to a net
loss of $10.0 million, or $0.65 per share, in the corresponding
period in 2020. The increase in net loss for the three months ended
September 30, 2021 was primarily due to an increase in operating
expenses.
At September 30, 2021, Gemini held $150.1 million in cash, $6.7
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
Geographic Atrophy 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 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
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 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, Gemini
believes 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 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)
AMD is a progressive retinal disease affecting millions of older
adults, and is 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 million with
wet AMD. The genetic risk of developing dry AMD is significant,
with approximately 70% of the risk of advanced disease being
attributable 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 the CFH gene 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 1/2a study in patients with
neovascular age-related macular degeneration with or at risk for
macular atrophy. Gemini is also working to advance a potentiating
antibody for CFH, GEM307, towards 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 timing of and costs associated with
our restructuring, and the benefits we expect to receive from the
restructuring, 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 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. Statements of
Operations (In Thousands)
Three Months Ended September
30,
Nine Months Ended September
30,
2021
2020
2021
2020
Operating expenses: Research and development
$
13,455
$
6,727
$
36,083
$
20,472
General and administrative
4,995
1,222
15,177
3,774
Total operating expenses
18,450
7,949
51,260
24,246
Loss from operations
(18,450
)
(7,949
)
(51,260
)
(24,246
)
Other income (expense): Interest expense
(104
)
(2,047
)
(2,073
)
(2,307
)
Interest income
5
1
11
37
Loss on conversion of convertible notes
-
-
(711
)
-
Change in fair value of warrant liability
-
(8
)
-
(6
)
Other expense
(2
)
-
(13
)
-
Net loss and comprehensive loss
$
(18,551
)
$
(10,003
)
$
(54,046
)
$
(26,522
)
Net loss per share, basic and diluted
$
(0.43
)
$
(0.65
)
$
(1.37
)
$
(1.77
)
Weighted average common shares outstanding, basic and diluted
43,091,822
15,282,987
39,427,476
15,016,038
Gemini Therapeutics, Inc. Balance Sheets (In
Thousands) September 30,2021 December
31,2020 Assets Cash and cash equivalents
$
150,069
$
4,503
Other current assets
4,731
562
Total current assets
154,800
5,065
Other assets
735
3,254
Total assets
$
155,535
$
8,319
Liabilities and stockholders' equity (deficit)
Current liabilities
$
12,661
$
24,876
Long-term liabilities
2,013
5,304
Total liabilities
14,674
30,180
Total stockholders' equity (deficit)
140,861
(21,861
)
Total liabilities and stockholders' equity (deficit)
$
155,535
$
8,319
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211115005469/en/
Investor Contact: Argot Partners Sherri Spear
212-600-1902 gemini@argotpartners.com
Media Contact: Argot Partners David Rosen 212-600-1902
gemini@argotpartners.com
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