Completed upsized IPO in June 2020 raising
$319.3 million in gross proceeds
Advanced pipeline focused on rare hematologic
diseases and cancers, including reporting favorable single-dose
data for FT-4202 in sickle cell disease (SCD) from a randomized,
multi-center, placebo-controlled Phase 1 trial
Additional data expected the second half of
2020 for FT-4202 in SCD and olutasidenib in acute myeloid leukemia
(AML)
FT-7051 for patients with metastatic
castration-resistant prostate cancer (mCRPC) to begin Phase 1 trial
in the fourth quarter of 2020
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on rare
hematologic diseases and cancers, today reported financial results
for the second quarter ended June 30, 2020. The Company also
highlighted recent progress and upcoming milestones for its
pipeline programs.
“This year, to date, has been very productive for Forma. We
completed an upsized initial public offering, which will allow us
to advance both our core assets, FT-4202, a potentially
foundational, disease-modifying therapy for patients with sickle
cell disease, and FT-7051, in development for mCRPC with the
potential to address prostate cancer cell resistance related to
molecular alterations in androgen receptors. In addition, our board
of directors welcomed Dr. Wayne Frederick, who is not only a
distinguished doctor and president of Howard University but also
lives with sickle cell disease,” said Frank Lee, president and
chief executive officer of Forma Therapeutics. “We look forward to
continuing Forma’s momentum by providing several clinical updates
before the end of the year, including topline data from our FT-4202
multiple ascending dose study and interim data from a non-core
asset, olutasidenib, Phase 2 clinical trial in patients with
relapsed/refractory acute myeloid leukemia.”
Key Business and Clinical
Highlights
PKR Program in Sickle Cell Disease (SCD):
- Received FDA Orphan Drug Designation for FT-4202 in Sickle
Cell Disease. FT-4202 is being evaluated in a randomized,
multi-center, placebo-controlled Phase 1 trial in SCD patients ages
12 years and older and has been granted fast track, rare pediatric
and orphan drug designations. FT-4202 is a potent activator of
pyruvate kinase-R (PKR) designed to improve red blood cell (RBC)
metabolism, function and survival by decreasing 2,3 DPG and
increasing ATP, potentially resulting in both increased hemoglobin
levels and reduced vaso-occlusive crises.
- Reported Favorable Single Dose Cohort Data of Patients with
SCD at EHA: Results presented at the 25th European Hematology
Association (EHA) Annual Congress in June 2020 demonstrated a
favorable tolerability profile and biologic effects of FT-4202,
with evidence of pharmacodynamic activity translating into
increased oxygen affinity, a shift in the point of sickling to
lower oxygen tensions, improved membrane deformability of sickle
RBCs and an increased hemoglobin (on average 0.9 g/dL vs. placebo)
at 24 hours post-single dose. These initial findings supported the
initiation of the multiple ascending dose cohort in patients with
SCD and continued planning for the global Phase 2/3 trial in SCD
patients.
CPB Program in Prostate Cancer:
- Presented Data Demonstrating Antitumor Activity of a Potent
and Selective Inhibitor of CBP/p300 at AACR: Forma presented
preclinical data on FT-6876, a predecessor molecule to clinical
development candidate FT-7501, at the American Association of
Cancer Research (AACR) in June 2020 that demonstrated antitumor
activity in androgen receptor (AR)-dependent breast cancer cell
lines and highlighted the possible role of CREB-binding protein/E1A
binding protein p300 (CBP/p300) in proliferation and survival of
AR-independent tumors. Inhibition of CBP/p300 in vitro can suppress
AR and AR-v7 driven transcription of genes that drive the growth of
prostate cancer cells.
- FDA Cleared Investigational New Drug application for
FT-7051. In April 2020, the FDA cleared Forma’s investigational
new drug application for FT-7051. We expect to initiate a Phase 1
trial in mCRPC patients in the fourth quarter of 2020.
IDH1 Program in AML and Glioma:
- Announced Positive IDH1 Inhibitor Data for Olutasidenib in
Glioma at ASCO: Forma announced positive preliminary Phase 1
data for olutasidenib in refractory, predominantly enhancing glioma
at the 2020 American Society of Clinical Oncology (ASCO),
suggesting the potential for response and prolonged disease control
in both non-enhancing and enhancing phenotypes of
relapsed/refractory IDH1-mutated glioma patients. Olutasidenib is a
selective inhibitor for cancers with IDH1 mutations and is being
evaluated in a registrational Phase 2 trial for relapsed/refractory
acute myeloid leukemia (R/R AML) and an exploratory Phase 1 trial
for glioma and other IDH1m solid tumor indications.
Corporate:
- Completed Upsized Initial Public Offering: In June 2020,
Forma completed an upsized IPO of 15,964,704 shares of common
stock, including the full exercise of the underwriter’s
over-allotment option, resulting in gross proceeds of approximately
$319.3 million before deducting underwriting discounts and
commissions and other offering expenses.
- Strengthened Executive Team with Appointment of David N.
Cook, Ph.D., as Chief Scientific Officer
- Transitioned Board of Directors Composition: Following
Forma’s IPO, Dr. Steve Hall departed the board of directors and Dr.
Wayne A. I. Frederick joined.
Upcoming Milestones
- Updated Data to Inform Pivotal Trial in SCD: Forma plans
to announce topline data from the ongoing trial of FT-4202 in SCD
patients in the fourth quarter of 2020, including data from
multiple ascending dose cohorts. The results of this trial will
inform a global pivotal Phase 2/3 trial for people living with SCD,
which is expected to initiate in the first half of 2021.
- Initiation of Clinical Development in mCRPC: We continue
to make progress to initiate a Phase 1 trial of FT-7051 in mCRPC
patients in the fourth quarter of 2020.
- Additional Data from Non-core IDH1 Program: Forma plans
to announce topline data from a second interim analysis of the
registrational cohort of an olutasidenib trial in
relapsed/refractory AML (R/R AML) in the fourth quarter of
2020.
- Possibility of COVID-19 Impact: The COVID-19 pandemic
remains a factor in the successful completion of these milestones.
Many clinical trials across the biopharma industry have been
impacted by the COVID-19 pandemic, with clinical trial sites
implementing new policies in response to COVID-19, resulting in
potential delays to enrollment of clinical trials or changes in the
ability to access sites participating in clinical trials.
Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $414.3 million as of June 30, 2020, as compared to
$173.2 million as of December 31, 2019.
- Research and Development (R&D) Expenses: R&D
expenses were $20.5 million for the quarter ended June 30, 2020,
compared to $28.1 million for the quarter ended June 30, 2019. The
decrease was primarily due to planned reductions in spending on
FT-2101, FT-4101, FT-8225, research, as well as internal R&D
personnel-related costs, which were partially offset by increases
in FT-4202 expenses to conduct the Phase 1 trial and preparations
for our planned pivotal Phase 2/3 trial.
- General and Administrative (G&A) Expenses: G&A
expenses were $6.4 million for the quarter ended June 30, 2020,
compared to $5.7 million for the quarter ended June 30, 2019. The
increase was primarily due to increases in professional fees and
stock-based compensation, partially offset with lower
personnel-related costs.
- Net Income/Loss: Net loss was $25.4 million for the
quarter ended June 30, 2020, compared to $14.8 million for the
quarter ended June 30, 2019.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company
focused on the research, development and commercialization of novel
therapeutics to transform the lives of patients with rare
hematologic diseases and cancers. Our R&D engine combines deep
biology insight, chemistry expertise and clinical development
capabilities to create drug candidates with differentiated
mechanisms of action focused on indications with high unmet need.
Our work has generated a broad proprietary portfolio of programs
with the potential to provide profound patient benefit. For more
information, please visit www.FormaTherapeutics.com or follow us on
Twitter @FORMAInc and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, express or implied
statements regarding the company’s beliefs and expectations
regarding its: business plans and objectives; future plans for
FT-4202 and FT-7051, including expectations regarding timing and
success of the current ongoing clinical trials, therapeutic
potential and clinical benefits thereof, and upcoming milestones
for the company’s other product candidates; growth as a company and
the anticipated contribution of the members of our board of
directors to our operations and progress; uses of capital, expenses
and other 2020 financial results or in the future, and the
potential impact of COVID-19 on patient retention, strategy, future
operations, clinical trials or IND submissions. The words “may,”
“will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “target” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, those risks and
uncertainties associated with: the impact of the COVID-19 pandemic
on the company’s business, operations, strategy, goals and
anticipated milestones; the therapeutic potential of FT-4202, and
the timing associated with the initiation or continuation of any of
FT-4202 trials; the initiation of our phase I clinical trial of
FT-7051; the timing of the second interim analysis of the
registrational cohort of FT-2102 in R/R AML; Forma’s ability to
execute on its strategy; positive results from a clinical study may
not necessarily be predictive of the results of future or ongoing
clinical studies; regulatory developments in the United States and
foreign countries; Forma’s ability to fund operations; as well as
those risks and uncertainties set forth more fully under the
caption "Risk Factors" in the final prospectus dated June 22, 2020
and filed pursuant to Rule 424(b) under the Securities Act of 1933,
as amended, with the United States Securities and Exchange
Commission (SEC) and elsewhere in Forma’s filings and reports with
the SEC. Forma disclaims any obligation to publicly update or
revise any such statements to reflect any change in expectations or
in events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements.
Any forward-looking statements contained in this press release
represent Forma’s views only as of the date hereof and should not
be relied upon as representing its views as of any subsequent date.
Forma explicitly disclaims any obligation to update any
forward-looking statements.
Forma Therapeutics Holdings, Inc. Condensed Consolidated
Statements of Operations (unaudited) (in thousands except share
and per share data)
For the three months ended For the
six months ended June 30,2020 June 30,2019
June 30,2020 June 30,2019 Revenue
$
-
$
17,727
$
-
$
89,736
Operating expenses
Research and development
20,511
28,065
43,721
56,715
General and administrative
6,448
5,688
15,381
10,606
Restructuring charges
(20
)
849
63
5,075
Total operating expenses
26,939
34,602
59,165
72,396
Income (loss) from operations
(26,939
)
(16,875
)
(59,165
)
17,340
Other income (loss), net
(1,739
)
793
22,232
2,291
Income (loss) before taxes
(28,678
)
(16,082
)
(36,933
)
19,631
Income tax benefit
(3,238
)
(1,325
)
(22,723
)
(1,217
)
Net income (loss)
$
(25,440
)
$
(14,757
)
$
(14,210
)
$
20,848
Preferred return and accretion of preferred return and cumulative
dividends on preferred securities
(1,800
)
(600
)
(3,736
)
(1,788
)
Distribution to holders of preferred securities in excess of
accrued preferred return
-
-
-
(11,347
)
Undistributed earnings allocable to participating securities
-
-
-
(5,815
)
Net loss allocable to shares of common stock, basic and diluted
$
(27,240
)
$
(17,946
)
Net income (loss) allocable to shares of Common 1, basic
$
(15,357
)
$
1,898
Change in fair value attributable to warrants to purchase preferred
securities
(7
)
(317
)
Net income (loss) allocable to shares of Common 1, diluted
$
(15,364
)
$
1,581
Net loss per share of common stock, basic and diluted
$
(4.58
)
$
(4.23
)
Net income (loss) per share of Common 1: Basic
$
(6.03
)
$
0.74
Diluted
$
(6.03
)
$
0.61
Weighted-average shares of common stock outstanding, basic and
diluted
5,943,165
4,245,622
Weighted-average shares of Common 1 outstanding: Basic
2,547,924
2,547,924
Diluted
2,547,924
2,581,952
Forma Therapeutics Holdings,
Inc.
Condensed Consolidated Balance
Sheets
(unaudited)
(in thousands, except share data)
June 30,2020 December
31,2019 Assets
Cash, cash equivalents, and
marketable securities
$
414,301
$
173,180
Fixed assets
1,901
5,102
Other assets
51,310
4,753
Total assets
$
467,512
$
183,035
Liabilities and stockholders' equity
Current liabilities
$
24,818
$
24,868
Long-term liabilities
4,197
1,790
Total liabilities
29,015
26,658
Total stockholders' equity
438,497
156,377
Total liabilities and stockholders' equity
$
467,512
$
183,035
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version on businesswire.com: https://www.businesswire.com/news/home/20200813005247/en/
Media Contact: Kari Watson, +1 781-235-3060
MacDougall kwatson@macbiocom.com
Investor Contact: Stephanie Ascher, +1 212-362-1200 Stern
Investor Relations stephanie.ascher@sternir.com
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