Strong organizational foundation laid in 2020;
continued pipeline execution amid COVID-19 and raised gross capital
of $595.1 million
Key 2020 pipeline achievements include proof of
concept for FT-4202 in sickle cell disease; successful interim
analysis of registrational Phase 2 trial of olutasidenib in R/R AML
with IDH1m; and commencement of Phase 1 trial for FT-7051 in
mCRPC
2021 milestones already achieved; top-line
results from 600mg dose cohort of Phase 1 FT-4202 trial, enrolling
patients in Phase 2/3 FT-4202 trial, and first patient dosed in
Phase 1 FT-7051 trial in mCRPC
Anticipated 2021 milestones include initial
results from FT-4202 open label extension in second quarter and
initial FT-7051 Phase 1 results in the second half of the year
Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a
clinical-stage biopharmaceutical company focused on rare
hematologic diseases and cancers, today reported financial results
for the fourth quarter and full year ended December 31, 2020. The
company also highlighted recent progress and upcoming milestones
for its pipeline programs.
“2020 was a very productive year for Forma, starting with our
initial public offering in June and including positive clinical
data and progress on our key development programs targeting sickle
cell disease, AML and glioma, as well as prostate cancer,” said
Frank Lee, president and chief executive officer of Forma. “With
important events in 2021 for our compounds in development, we look
forward to furthering our mission to bring breakthrough therapies
to people living with rare hematologic diseases and cancers.”
Key Business and Clinical
Highlights
PKR Program in Sickle Cell Disease (SCD):
- Positive Phase 1 results of FT-4202 presented at scientific
conferences. At the European Hematology Association Annual
Congress in June 2020, results from a single ascending dose trial
demonstrated a favorable tolerability profile and
pharmacokinetic/pharmacodynamic (PK/PD) effects in patients with
SCD who were administered a 700mg dose of FT-4202. Subsequently, at
the American Society of Hematology (ASH) Annual Meeting and
Exposition in December 2020, data were presented from the ongoing
randomized, placebo-controlled Phase 1 multiple ascending dose
(MAD) trial. Results from the 300mg MAD1 dose cohort following 14
days of treatment showed an increase in hemoglobin of 1g/dL or
greater in 6 of 7 (86%) patients vs. 0% of patients receiving
placebo. In addition, markers of hemolysis such as indirect
bilirubin, reticulocytes and lactate dehydrogenasewere improved,
and measures of oxygen affinity and deformability suggested
improvement in RBC health. FT-4202 was generally well-tolerated
with no serious adverse events attributed to treatment with the
compound.
- Positive FT-4202 600 mg multiple ascending dose cohort data
support doses being evaluated in Phase 2/3 registrational trial,
called the Hibiscus Study. Doubling the dose of FT-4202 to 600
mg daily for 14 days compared to the previous 300 mg cohort was
well-tolerated with no dose-limiting toxicities or
treatment-related adverse events observed. Improvements in
hematologic (hemoglobin and reticulocytes) and hemolytic (bilirubin
and LDH) parameters were comparable to that observed with 300 mg
dose, with best response typically at the end of the 14-day
treatment period. Across 300 mg and 600 mg cohorts, 10 of 14 (71%)
patients on FT-4202 for 14 days achieved a hemoglobin increase ≥ 1
g/dL from baseline. The phase 2/3 Hibiscus Study is currently
enrolling people living with sickle cell disease (SCD). This
adaptive, randomized, placebo-controlled, double-blind,
multi-center trial is expected to enroll approximately 344 adults
and adolescents with SCD. FT-4202 doses of 200mg and 400mg
administered once-daily are being evaluated in the Phase 2 portion
of the trial. Primary endpoints in the Phase 3 portion of the trial
are hemoglobin response rate at week 24 (increase of > 1 g/dL
from baseline), and annualized vaso-occlusive crisis rate during
the 52-week blinded treatment period.
CPB/p300 Program in Prostate Cancer:
- Preclinical data presented at scientific conference. At
the American Association for Cancer Research (AACR) virtual meeting
in June 2020, a poster was presented with preclinical data for
FT-6876, a potent and selective inhibitor of CBP/p300, a known
co-activator of the androgen receptor (AR) and a driver of
metastatic castration-resistant prostate cancer (mCRPC). The data
demonstrated antitumor activity of FT-6876 in AR-dependent breast
cancer cell lines and highlight the possible role of CBP/p300 in
proliferation and survival of AR-dependent tumors, such as prostate
cancer. FT-6876 is a research compound related to FT-7051, although
with differing PK/PD properties.
- FT-7051 Phase 1 clinical trial initiated for the treatment
of metastatic castration-resistant prostate cancer (mCRPC). In
January 2021, Forma announced that the first patient was dosed in
the ongoing Phase 1 trial. The trial is a multicenter, open-label
evaluation of the safety and tolerability, preliminary anti-tumor
activity (PSA and radiographic responses), and PK/PD of FT-7051 in
men with mCRPC who have progressed despite prior therapy with at
least one anti-androgen therapy. The trial will include genetic
mutation analysis to identify tumors with AR-v7 splice variants,
against which there are no approved therapies. This is an adaptive
trial design, intended to accelerate the escalation to potentially
therapeutic doses and yield important safety information, as well
as the identification of biomarkers of clinical benefit such as
prostate specific antigen (PSA).
IDH1 Program in AML and Glioma:
- Announced positive registrational data for olutasidenib in
relapsed/refractory acute myeloid leukemia (R/R AML). In
October 2020, Forma announced positive results from the planned
interim analysis (IA2) of the Phase 2 registration trial in R/R AML
patients with isocitrate dehydrogenase 1 gene mutations (IDH1m).
Olutasidenib demonstrated favorable tolerability as a monotherapy
and achieved the primary endpoint of a composite complete remission
(CR+CRh, or complete remission plus complete remission with partial
hematologic recovery) rate of 33.3% (30% CR and 3% CRh). While a
median duration of CR/CRh has not been reached, a sensitivity
analysis (with a hematopoietic stem cell transplant as the end of a
response) indicated a median duration of CR/CRh to be 13.8 months.
Safety results were consistent with previously reported Phase 1
clinical trial results. Additional data and analyses indicate that
the overall response rate (ORR), comprised CR, CRh, CRi, partial
response (PR), and morphologic leukemia-free state (MLFS), was 46%
and the median duration of ORR was 11.7 months. The median overall
survival (OS) was 10.5 months. For patients with CR/CRh, the median
OS has not yet been reached, but the estimated 18-month survival is
87%. The most frequently reported treatment emergent adverse events
(≥20%) were nausea (38%), constipation (25%), increased white blood
cell count (25%), decreased RBC count (24%), pyrexia (23%), febrile
neutropenia (22%), and fatigue (21%). Grade 3/4 adverse events
occurring in greater than 10% of patients, regardless of causality,
were febrile neutropenia (20%), decreased RBC count (19%),
decreased platelet count (16%), and decreased neutrophil count
(13%).
- An exploratory Phase 1 trial of olutasidenib for glioma
showed evidence of disease control. Data presented at the
American Society of Clinical Oncology meeting in June 2020
demonstrated the brain penetrant properties of olutasidenib and
preliminary clinical activity, which suggest potential for response
and prolonged disease control in the enhanced (grade III/IV) R/R
IDH1-mutated glioma. Among 24 evaluable patients treated (4 grade
II, 13 grade III, 7 grade IV), one patient had a partial response
and 11 patients had stable disease, as determined by investigator
response assessment in neuro-oncology, or RANO, criteria.
Twenty-two of the patients’ responses were also evaluated by
volumetric changes at a central review, where four patients had
more than 50% tumor reduction, one patient had 25% to 50% tumor
reduction, and an additional seven patients had prolonged stable
disease.
Corporate Achievements:
- Successful initial public offering in June 2020 and
follow-on equity offering in December 2020. On June 23, 2020,
the Company completed an initial public offering (IPO) in which the
Company issued and sold 15,964,704 shares of its common stock at a
public offering price of $20.00 per share. The Company raised
approximately $293.3 million in net proceeds after deducting
underwriting discounts and commissions and offering expenses. On
December 15, 2020, the Company completed an underwritten public
offering of 6,095,000 shares of its common stock at a public
offering price of $45.25 per share. The Company raised
approximately $258.6 million in net proceeds after deducting
underwriting discounts and commissions and offering expenses.
- Three new board of directors appointments. In July 2020,
Wayne A. I. Frederick, M.D., was elected to serve on Forma’s board
of directors. Dr. Frederick is the President of Howard University,
as well as the Charles R. Drew Professor in Surgery at Howard
University’s College of Medicine, and a distinguished researcher
and practicing surgeon. In September 2020, Forma announced the
appointment of industry veteran Thomas G. Wiggans to its board of
directors. Mr. Wiggans has led successful biopharmaceutical
companies from start-up stage into the clinic and later global
commercialization and served on the boards of numerous public and
private companies. In January 2021, Forma announced the appointment
of Selwyn M. Vickers, M.D., to its board of directors. Dr. Vickers
is a world-renowned surgeon, pancreatic cancer researcher and
pioneer in health disparities research. He currently serves as
senior vice president of medicine and dean of the School of
Medicine at The University of Alabama at Birmingham (UAB).
Upcoming Milestones
- Phase 1 FT-4202 randomized cohorts successfully completed;
open label extension ongoing. Patients with sickle cell disease
are now directly enrolling into the 12-week open label extension
(OLE) with the 400mg daily dose, which was previously limited to
patients who completed the 600mg dose cohort. Initial results from
the ongoing 400mg 12-week open label extension are anticipated to
be announced at a scientific congress in the second quarter of
2021, and full results expected at a scientific congress in late
2021.
- Initial Phase 1 clinical results from FT-7051 in mCRPC
anticipated later this year. This adaptive trial is designed to
assess multiple doses of FT-7051 with dose escalation dependent
upon safety and tolerability. Initial results are anticipated in
the second half of 2021, which may include safety/tolerability,
PK/PD results and preliminary biomarker data.
- NDA being prepared for olutasidenib in R/R AML. Forma is
preparing a new drug application (NDA) for submission to the U.S.
Food and Drug Administration for refractory/relapsing AML patients
with an IDH1 mutation. In addition, a manuscript is being prepared
for publication of Phase 1 glioma results.
- Possibility of COVID-19 impact remains. 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 $645.6 million as of December 31, 2020, as compared
to $173.2 million as of December 31, 2019. Current cash runway is
projected through the third quarter of 2024.
- Research and Development (R&D) Expenses: R&D
expenses were $24.9 million and $93.4 million for the quarter and
year ended December 31, 2020, compared to $27.0 million and $111.3
million for the quarter and year ended December 31, 2019. The
decline was attributable to a decrease in spending on internal
research and development primarily due to restructuring in January
2019, and reductions in spending on olutasidenib and FT-8225, which
were partially offset by increases in FT-4202 expenses to conduct
the Phase 1 trial, clinical product manufacturing, and preparations
for the pivotal Phase 2/3 trial.
- General and Administrative (G&A) Expenses: G&A
expenses were $7.9 million and $30.8 million for the quarter and
year ended December 31, 2020, compared to $6.8 million and $24.4
million for the quarter and year ended December 31, 2019. The
increase in general and administrative expense was primarily
attributable to a $3.2 million increase in stock compensation
expense; $1.2 million increase in insurance related expenses; $1.2
million increase in professional fees; $0.5 million increase in
personnel-related costs due to executive and staff hiring,
recruiting and an increase in facilities; and IT related expenses
of $0.2 million.
- Net Income/Loss: Net loss was $28.6 million and $70.4
million for the quarter and year ended December 31, 2020, compared
to $24.7 million and $34.8 million for the quarter and year ended
December 31, 2019.
Forma will conduct a conference call and webcast on March 30th
at 8 a.m. Eastern Standard Time (EST) to discuss 2020 year-end
financial results and business update. The call can be accessed by
dialing (833) 301-1146 in the U.S., and (914) 987-7386
internationally, with conference ID 5893542.
The live webcast will be available in the “News & Investors”
section of Forma’s website www.formatherapeutics.com.
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 and olutasidenib, including expectations
regarding timing and success of the current ongoing clinical
trials, therapeutic potential, and clinical benefits and safety
thereof, planned regulatory submissions, including an NDA for
olutasidenib, 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; presentation of additional data at
upcoming scientific conferences, and other preclinical data and
potential data publications in 2021; the potential commercial and
collaboration opportunities, including potential future
collaborators and parties, as well as value and market, for our
product candidates; 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 following: 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 FT-7051, and the timing associated with the initiation
or continuation of any of FT-4202 trials and success of ongoing
clinical trials of FT-4202 and FT-7051; the initiation of our phase
I clinical trial of FT-7051; Forma’s ability to execute on its
strategy; the submission and acceptance of a new drug application
for submission to the U.S. Food and Drug Administration for
olutasidenib; positive results from a clinical study may not
necessarily be predictive of the results of future or ongoing
clinical studies; any one or more of Forma’s product candidates may
not be successfully developed and commercialized; regulatory
developments in the United States and foreign countries; Forma’s
ability to protect and maintain our intellectual property position;
the impact of COVID-19 affecting countries or regions in which we
have operations or do business, including potential negative
impacts on our employees, customers, supply chain and production as
well as global economies and financial markets; Forma’s ability to
fund operations; Forma’s ability to identify satisfactory
collaboration opportunities, as well as those risks and
uncertainties set forth more fully under the caption "Risk Factors"
in the final prospectus dated December 10, 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.
Selected Financial
Information
(in thousands except share and
per share data)
(unaudited)
Statement of Operations Items:
For the Three Months Ended
December 31,
For the Year Ended December
31,
2020
2019
2020
2019
Revenue
$
—
$
7,444
$
—
$
100,557
Operating expenses Research and development
24,866
27,042
93,367
111,315
General and administrative
7,941
6,771
30,782
24,402
Restructuring charges
—
(330
)
63
5,290
Total operating expenses
32,807
33,483
124,212
141,007
Loss from operations
(32,807
)
(26,039
)
(124,212
)
(40,450
)
Other income, net
1,029
752
24,079
3,809
Loss before taxes
(31,778
)
(25,287
)
(100,133
)
(36,641
)
Income tax benefit
(3,190
)
(631
)
(29,719
)
(1,848
)
Net loss
$
(28,588
)
$
(24,656
)
$
(70,414
)
$
(34,793
)
Preferred return and accretion of preferred return and cumulative
dividends on preferred securities
—
(568
)
(3,736
)
(2,963
)
Loss on extinguishment of Series A, Series B-1 and Series B-2
convertible preferred stock
—
(3,584
)
—
(3,584
)
Distribution to holders of preferred securities in excess of
accrued preferred return
—
—
—
(11,347
)
Tax distribution to holders of Enterprise.1 Incentive Shares
—
—
—
(60
)
Net loss allocable to shares of common stock, basic
$
(28,588
)
$
(28,808
)
$
(74,150
)
$
(52,747
)
Change in fair value attributable to warrants to purchase preferred
securities
—
(447
)
—
(962
)
Net loss allocable to shares of common stock, diluted
$
(28,588
)
$
(29,255
)
$
(74,150
)
$
(53,709
)
Net loss per share of common stock: Basic
$
(0.68
)
$
(11.31
)
$
(3.22
)
$
(20.70
)
Diluted
$
(0.68
)
$
(11.48
)
$
(3.22
)
$
(21.08
)
Weighted-average shares of common stock outstanding, Basic and
diluted
42,239,451
2,547,937
23,056,975
2,547,927
Selected Balance Sheet Items: December 31,
2020 December 31, 2019 Cash, cash equivalents, and
marketable securities
$
645,588
$
173,180
Total assets
$
680,971
$
183,035
Accounts payable, accrued expenses, and other current liabilities
$
31,399
$
23,629
Redeemable convertible and convertible preferred stock outside of
stockholders' equity
$
—
$
138,131
Total stockholders’ equity
$
648,244
$
18,246
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210330005283/en/
Investor Contact: Mario Corso, +1 781-366-5726 Forma
Therapeutics mcorso@formatherapeutics.com
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