Strong pipeline progress amid challenging
COVID-19 environment
Oral presentation of MAD1 results at upcoming
2020 ASH Virtual Annual Meeting from the randomized,
placebo-controlled multi-center Phase 1 trial evaluating FT-4202 in
people with sickle cell disease
MAD2 cohort of the Phase 1 trial now enrolling
with 600 mg dose
Registrational Phase 2/3 trial of FT-4202 on
track to begin enrolling people living with sickle cell disease in
the first quarter of 2021
Phase 1 trial evaluating FT-7051 in metastatic
castration-resistant prostate cancer on track to begin enrolling
patients before end 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 third quarter ended September 30, 2020. The company also
highlighted recent progress and upcoming milestones for its
pipeline programs.
“We are very pleased with our strong pipeline progress during
the quarter amid such challenging times,” said Frank Lee, President
and Chief Executive Officer of Forma. “We look forward to
presenting new data from our ongoing Phase 1 trial of FT-4202 in
sickle cell disease at the ASH meeting in December, as well as
beginning enrollment of patients for our Phase 1 trial of FT-7051
in men living with metastatic castration-resistant prostate cancer.
The recent positive top-line results from the olutasidenib
registrational Phase 2 clinical trial in relapsed/refractory acute
myeloid leukemia with an IDH1 mutation further underscores our
commitment to developing transformative therapies for
patients.”
Key Business and Clinical
Highlights
PKR Program in Sickle Cell Disease (SCD):
- Both planned dose cohorts enrolling in the multiple
ascending dose (MAD) trial. The MAD1 cohort is designed to dose
9-12 SCD patients with 300 mg of FT-4202. Clinical measures being
assessed include change in hemoglobin, indirect bilirubin,
reticulocytes and lactate dehydrogenase, as well as the monitoring
of tolerability and safety during the 14-day dosing and 7-day
follow-up period. The MAD2 cohort is assessing a higher 600 mg dose
and is now enrolling patients. Patients completing the 600
mg MAD2 cohort may enter the 12-week Open Label Extension (OLE)
portion of the trial.
- FT-4202 abstract selected for oral presentation at the
virtual 62nd American Society of Hematology (ASH) Annual Meeting
and Exposition December 5-8, 2020. The FT-4202 abstract
describes blinded data from three patients receiving the 300 mg
dose, measuring changes in parameters over the 14-day treatment and
7-day follow-up period including hemoglobin and reticulocytes, as
well as tolerability and safety. Updated data will be presented at
the ASH annual meeting on December 7, 2020.
CPB/p300 Program in Prostate Cancer:
- Phase 1 clinical trial of FT-7051 for the treatment of
metastatic castration-resistant prostate cancer (mCRPC) on track to
start by year end. This trial will enroll patients who have
progressed while on standard anti-androgen therapy. Patients’
prostate cancer will be profiled for mutations in the androgen
receptor (AR)-signaling pathway that drive resistance to
AR-receptor antagonists, such as ARv7 mutations.
IDH1 Program in AML and Glioma:
- Announced positive 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 a favorable tolerability profile as a
monotherapy, and for the primary efficacy endpoint of composite
complete remission (CR+CRh, or complete remission plus complete
remission with partial hematologic recovery), achieved a 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) indicates the median
duration of CR/CRh to be 13.8 months. Safety results are consistent
with previously reported Phase 1 clinical trial results.
- Olutasidenib is also being evaluated in an exploratory Phase 1
trial for glioma as presented at the American Society of Clinical
Oncology meeting in June 2020, as well as in other IDH1m solid
tumor indications.
Corporate:
- In September 2020, Forma announced the appointment of
industry veteran Thomas G. Wiggans to Forma’s board of
directors. Mr. Wiggans has led successful biopharmaceutical
companies from start-up stage into the clinic and later global
commercialization, served on the boards of numerous public and
private companies, and was instrumental in the formation of the
Biotechnology Industry Organization, now Biotechnology Innovation
Organization (BIO).
Upcoming Milestones
- Results from the ongoing randomized placebo-controlled
multicenter Phase 1 trial evaluating FT-4202 in patients
with SCD to be presented at ASH. Clinical data on the safety
results, PK/PD and laboratory measurements in 9-12 patients from
the 300 mg MAD1 cohort will be presented during an oral
presentation at the virtual, 62nd American Society of Hematology
(ASH) Annual Meeting and Exposition December 5-8, 2020.
Subsequently, results from the MAD2 600 mg cohort are expected in
the first quarter of 2021, and 12-week OLE results are anticipated
in the second quarter of 2021.
- Initiation of registrational trial of FT-4202 for people
living with SCD: The global pivotal Phase 2/3 trial is expected
to initiate in the first quarter of 2021. This adaptive,
randomized, placebo-controlled, double-blind, multi-center study
will enroll approximately 344 adults and adolescents with SCD. The
trial will evaluate FT-4202 doses of 200 mg and 400 mg administered
once daily in the Phase 2 portion. 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.
- Initiation of FT-7051 Clinical Development in mCRPC:
Patient enrollment in the Phase 1 trial of FT-7051 in mCRPC
patients is expected to begin prior to the end of 2020. Safety and
tolerability data from the trial are anticipated in 2021 and
clinical activity results in 2022.
- Non-core Partnering Strategy: Following the recent
positive registrational trial results in R/R AML with an IDH1
mutation, Forma remains focused on partnership opportunities for
olutasidenib, as well as for the non-core FASN inhibitor for NASH
(FT-8225).
- 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.
Upcoming Investor Events
- Dec. 7, 2020: Forma will conduct a conference call and
webcast on Dec. 7 at 6 p.m. Eastern Standard Time (EST) to discuss
updated results from the ongoing Phase 1 trial of FT-4202 in SCD,
as well as an overview of the company’s development plans for
FT-4202. A live webcast will be available in the “News &
Investors” section of Forma’s website
www.formatherapeutics.com.
Financial Results
- Cash Position: Cash, cash equivalents and marketable
securities were $384.3 million as of September 30, 2020, as
compared to $173.2 million as of December 31, 2019.
- Research and Development (R&D) Expenses: R&D
expenses were $24.8 million for the quarter ended September 30,
2020, compared to $27.6 million for the quarter ended September 30,
2019. The decrease was primarily due to planned reductions in
spending on FT-2102, FT-4101, FT-8225, research activities, and
internal R&D personnel-related costs, 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 $7.5 million for the quarter ended September 30,
2020, compared to $7.0 million for the quarter ended September 30,
2019. The increase in general and administrative expense was
primarily attributable to a $1.3 million increase in equity-based
compensation, and a $0.6 million increase in insurance related
expense, and a $0.5 million increase in other related general and
administrative costs, partially offset by a reduction of $2.0
million related to legal, consulting and other professional fee
expenses.
- Net Income/Loss: Net loss was $27.6 million for the
quarter ended September 30, 2020, compared to $31.0 million for the
quarter ended September 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; presentation of
additional data at upcoming scientific conferences, and other
preclinical data in 2020; 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 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; 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; 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 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.
Selected Financial Information (in thousands except share
and per share data) (unaudited) Statement of
Operations Items:
Three Months EndedSeptember 30,
Nine Months EndedSeptember 30,
2020
2019
2020
2019
Revenue
$
-
$ 3,377
$
-
$ 93,113
Operating expenses Research and development
24,780
27,558
68,501
84,273
General and administrative
7,460
7,025
22,841
17,631
Restructuring charges
-
545
63
5,620
Total operating expenses
32,240
35,128
91,405
107,524
Loss from operations
(32,240)
(31,751)
(91,405)
(14,411)
Other income, net
818
766
23,050
3,057
Loss before taxes
(31,422)
(30,985)
(68,355)
(11,354)
Income tax benefit
(3,806)
-
(26,529)
(1,217)
Net loss
$
(27,616)
$
(30,985)
$
(41,826)
$
(10,137)
Preferred return and accretion of preferred return andcumulative
dividends on preferred securities
-
(607)
(3,736)
(2,395)
Distribution to holders of preferred securities in excess ofaccrued
preferred return
-
-
-
(11,347)
Tax distribution to holders of Enterprise.1 Incentive Shares
-
(60)
-
(60)
Net loss allocable to shares of common stock, basic
$
(27,616)
$
(45,562)
Change in fair value attributable to warrants to purchasecommon
stock
(8)
-
Net loss allocable to shares of common stock, diluted
$
(27,624)
$
(45,562)
Net loss allocable to shares of Common 1, basic
$
(31,652)
$
(23,939)
Change in fair value attributable to warrants to purchasepreferred
securities
(198)
(515)
Net loss allocable to shares of Common 1, diluted
$
(31,850)
$
(24,454)
Net loss per share of common stock: Basic
$
(0.67)
$
(2.74)
Diluted
$
(0.67)
$
(2.74)
Net loss per share of Common 1: Basic
$ (12.42)
$
(9.40)
Diluted
$ (12.50)
$
(9.60)
Weighted-average shares of common stock outstanding: Basic
41,088,261
16,616,143
Diluted
41,088,924
16,616,143
Weighted-average shares of Common 1 outstanding, basicand diluted
2,547,924
2,547,924
Selected Balance Sheet Items:
September 30, December 31,
2020
2019
Cash, cash equivalents, and marketable
securities
$
384,346
$
173,180
Total Assets
$
447,396
$
183,035
Accounts payable, accrued expenses, and othercurrent liabilities
$
30,215
$
23,629
Redeemable convertible and convertible preferred stock outsideof
stockholders' equity
-
$
138,131
Total stockholders' equity
$
415,602
$
18,246
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201112005167/en/
Media: Kari Watson, +1 781-235-3060 MacDougall
kwatson@macbiocom.com Investors: Mario Corso, +1
781-366-5726 Forma Therapeutics mcorso@formatherapeutics.com
Stephanie Ascher, +1 212-362-1200 Stern Investor Relations
stephanie.ascher@sternir.com
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