eFFECTOR Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update
November 08 2021 - 7:00AM
eFFECTOR Therapeutics (NASDAQ: EFTR), a leader in the development
of selective translation regulator inhibitors (STRIs) for the
treatment of cancer, today reported financial results for the third
quarter ended September 30, 2021 and provided a corporate update.
“We have achieved significant milestones this
year as we continue to advance clinical development of our novel
STRIs,” said Steve Worland, Ph.D., president, and chief executive
officer of eFFECTOR. “I am proud of the team’s accomplishments to
date and look forward to building on our earlier clinical findings
as we advance toward our goal of commercializing STRI’s for the
treatment of multiple types of cancer. For our lead program,
tomivosertib, we commenced dosing in our randomized Phase 2b
KICKSTART trial for frontline extension and frontline cohorts in
non-small cell lung cancer (NSCLC) in combination with
pembrolizumab. With our second clinical stage asset, zotatifin, we
are initiating several Phase 2a expansion cohorts in certain breast
cancer and lung cancer patients. We are also investigating
zotatifin in a DARPA-funded Phase 1b trial in COVID. We look
forward to multiple data readouts across our pipeline, including
two Phase 2b readouts with tomivosertib and multiple Phase 2a
readouts from zotatifin.”
Pipeline Highlights
Tomivosertib (eFT508):
eFFECTOR’s wholly-owned, highly selective MNK inhibitor designed to
enhance anti-tumor activity by stimulating activation, preventing
exhaustion and prolonging the memory of T cells.
- Enrollment in Phase 2b KICKSTART study
continues: In June 2021, the company dosed its first
patient in its Phase 2b KICKSTART study, a randomized,
double-blind, placebo-controlled trial enrolling 120 patients with
NSCLC to assess the safety and efficacy of tomivosertib in
combination with pembrolizumab, an FDA approved PD-1 inhibitor. The
two-pronged study evaluates tomivosertib versus placebo as a
frontline combination therapy with pembrolizumab or as an extension
of frontline therapy at the first radiographic progression on
pembrolizumab therapy alone. The company expects to report topline
data from the frontline extension and frontline cohorts in the
first and second half of 2022, respectively.
- Enrollment in SU2C Breast
Cancer Trial continues: Tomivosertib is being evaluated in
an ongoing Phase 2a clinical trial in patients with metastatic
breast cancer in combination with paclitaxel chemotherapy in a
study led by Professor Nahum Sonenberg Ph.D., Gilman Cheney Chair
in Biochemistry at McGill University. eFFECTOR is supplying
tomivosertib capsules for this trial, and all other costs are fully
funded through a grant from Stand Up to Cancer (SU2C) Canada. The
primary objectives of this trial are to assess clinical safety of
tomivosertib alone and in combination with paclitaxel in breast
cancer patients and to assess changes in pharmacodynamic biomarkers
as an indication of biological activity with tomivosertib
treatment. A secondary objective is to assess clinical activity as
measured by Overall Response Rate and Clinical Benefit Rate.
- Published Preclinical Data
Demonstrating Role of MNK and eIF4E in Regulating Tumor
Growth: In July 2021, the company reported data
highlighting the role of eukaryotic translation initiation factor
4E (“eIF4E”), and its activating kinase MNK, in the peer-reviewed
journal Cell Reports. The published research, which provides
insight into the potential of eIF4E inhibition for the treatment of
cancer, was conducted at the University of California, San
Francisco in collaboration with eFFECTOR. The data showed that
jointly inhibiting Bcl-xL while blocking activation of eIF4E using
the company’s MNK inhibitor, tomivosertib, could be a promising
approach for treating cancer.
Zotatifin (elF4Ai): a potent
and selective mRNA helicase inhibitor designed to downregulate key
oncoproteins and cell cycle proteins that drive tumor growth and
resistance.
- Selected RP2D in
conjunction with completing Phase 1 portion of Phase 1/2 clinical
trial of zotatifin in patients with certain solid tumors:
In June 2021, based on an evaluation of data from the Phase 1
dose-escalation portion of a Phase 1/2 clinical trial, the company
selected 0.07 mg/kg given on Day 1 and Day 8 of a 21-day cycle, a
dose at which no DLTs were observed, as the recommended Phase 2
dose.
- Enrollment in Phase 2a
expansion study continues: Following completion of the
Phase 1 portion of the trial, the company is currently enrolling
patients in Phase 2a indication-specific expansion cohorts. The
primary objectives of the Phase 2a cohorts are to further
characterize safety and preliminary efficacy in biomarker-specific
patient populations. The company plans to enroll up to six cohorts
as either monotherapy or combination therapy in breast cancer and
lung cancer indications, including estrogen receptor positive (ER+)
breast cancer and KRAS mutant (KRASmut) NSCLC. The company expects
to announce data from one or more cohorts in the Phase 2a expansion
study in the first half of 2022.
- First patient dosed in a
study evaluating zotatifin as potential host-directed anti-viral
therapy in patients with mild to moderate COVID-19: In
July 2021, the company announced that the first patient has been
dosed in a Phase 1b trial evaluating zotatifin as an anti-viral
agent in an outpatient setting for those with mild to moderate
COVID-19 disease. The cost of this study is fully supported by a
$5.0 million cooperative agreement from the Defense Advanced
Research Projects Agency (DARPA) and Defense Health Agency (DHA)
and is being conducted in collaboration with the Quantitative
Biosciences Institute (QBI) at University of California, San
Francisco (UCSF).
- Positive Data at 2021
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics: In October 2021, Baylor College of
Medicine presented preclinical data in triple-negative breast
cancer (TNBC) animal models at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics. The
anti-tumor data presented supports expansion of zotatifin
development into TNBC, a segment of breast cancer with particularly
high unmet medical need.
Business Highlights
- Debuted as publicly traded
next-generation oncology company: On August 25, 2021,
eFFECTOR completed its business combination with Locust
Walk Acquisition Corp. (NASDAQ: LWAC). The resulting
combined company was renamed “eFFECTOR Therapeutics, Inc.” and
commenced trading its shares and warrants under the symbols “EFTR”
and “EFTRW”, respectively, on the Nasdaq Capital Market.
- Appointed Barbara Klencke
to Board of Directors: In November 2021, eFFECTOR
announced the appointment of Barbara Klencke, M.D., to its Board of
Directors. Dr. Klencke brings over 28 years of experience in
oncology across strategic roles at biopharmaceutical companies and
leading academic institutions, and currently serves as Chief
Medical Officer and Chief Development Officer of Sierra
Oncology.
- Gross cash proceeds of
approximately $65.9 million resulting from the business
combination: eFFECTOR expects that the net cash following
the transaction will allow it to readout topline data from the
ongoing Phase 2b KICKSTART trial evaluating tomivosertib in
combination with pembrolizumab in patients with metastatic
non-small cell lung cancer (“NSCLC”), as well as readout initial
overall response rate (“ORR”) data from the ongoing Phase 2a
dose-expansion cohorts evaluating zotatifin in patients with
certain biomarker-positive solid tumors, including ER+ breast
cancer and KRAS-mutant NSCLC.
Third Quarter 2021 Financial
Results
- Cash Position: The
company had cash and cash equivalents of $54.8 million as of
September 30, 2021, compared to $15.2 million as of December 31,
2020.
- Revenue: Revenue
was $0.4 million for the quarter ended September 30, 2021, compared
to $0.6 million for the same quarter of 2020. Revenue in the
quarter ended September 30, 2021 consisted of grant revenue in
connection with the company’s subaward from UCSF under a grant from
DARPA to investigate new COVID-19 treatments. Revenue in the
quarter ended September 30, 2020 consisted of collaboration revenue
in connection with the company’s license agreement with
Pfizer.
- Research and Development
(R&D) Expenses: R&D expenses were $5.0
million for the quarter ended September 30, 2021, compared to $6.8
million for the same quarter of 2020. This decrease was
primarily due to lower external development expenses associated
with both the tomivosertib and zotatifin programs, partially offset
by an increase in personnel related and non-cash stock compensation
expenses. The decrease in external development expenses was
primarily attributable to certain pre-clinical activities for the
tomivosertib program and scale up of the zotatifin program, both of
which occurred in the 2020 period. R&D expenses included
approximately $0.9 million and $0.1 million of non-cash stock
compensation expense in the quarters ended September 30, 2021 and
2020, respectively.
- General and Administrative
(G&A) Expenses: G&A expenses were $4.1
million for the quarter ended September 30, 2021, compared to
$1.1 million for the same quarter of 2020. This increase was
primarily due to an increase in non-cash stock compensation
expense, public company related expenses, and personnel related
expenses. G&A expenses included approximately $1.5 million and
less than $0.1 million of non-cash stock compensation expense in
the quarters ended September 30, 2021 and 2020, respectively.
- Other Income
(Expense): Other income was $17.6 million for the
quarter ended September 30, 2021, which consisted primarily of
$17.8 million in income related to the change in fair value of the
company’s share earn-out liability. The fair value of the share
earn-out liability of $61.0 million at the closing date of the
business combination, was remeasured at $43.3 million as of
September 30, 2021. Other expense was $0.3 million for the quarter
ended September 30, 2020, which primarily consisted of interest
expense associated with the company’s term loan.
- Net Income
(Loss): Net income was $8.9 million, or $0.53 per
basic share and $0.42 per diluted share, for the quarter ended
September 30, 2021 as compared to net loss of $7.6 million, or a
net loss of $5.29 per basic and diluted share, for the same quarter
of 2020. Net income attributable to common stockholders for the
quarter ended September 30, 2021 was adjusted by approximately $0.4
million related to a gain on the change in fair value of the
company’s private placement warrants.
About eFFECTOR Therapeutics
eFFECTOR is a clinical-stage biopharmaceutical
company focused on pioneering the development of a new class of
oncology drugs referred to as STRIs. eFFECTOR’s STRI product
candidates target the eIF4F complex and its activating kinase,
mitogen-activated protein kinase interacting kinase (MNK). The
eIF4F complex is a central node where two of the most frequently
mutated signaling pathways in cancer, the PI3K-AKT and RAS-MEK
pathways, converge to activate the translation of select mRNA into
proteins that are frequent culprits in key disease-driving
processes. Each of eFFECTOR’s product candidates is designed to act
on a single protein that drives the expression of multiple
functionally related proteins, including oncoproteins and
immunosuppressive proteins in T cells, that together control tumor
growth, survival and immune evasion. eFFECTOR’s lead product
candidate, tomivosertib, is a MNK inhibitor currently being
evaluated in KICKSTART, a randomized, double-blind,
placebo-controlled Phase 2b trial of tomivosertib in combination
with pembrolizumab in patients with metastatic non-small cell lung
cancer (NSCLC). Zotatifin, eFFECTOR’s inhibitor of eIF4A, is
currently being evaluated in Phase 2a expansion cohorts in certain
biomarker-positive solid tumors, including ER+ breast cancer and
KRAS-mutant NSCLC. eFFECTOR has a global collaboration with Pfizer
to develop inhibitors of a third target, eIF4E. In addition to the
company’s oncology focus, zotatifin is being evaluated as a
potential host-directed anti-viral therapy in patients with mild to
moderate COVID-19 in collaboration with the University of
California, San Francisco, under a $5 million grant sponsored by
the Defense Advanced Research Projects Agency.
Forward-Looking Statements
eFFECTOR cautions you that statements contained
in this press release regarding matters that are not historical
facts are forward-looking statements. The forward-looking
statements are based on our current beliefs and expectations and
include, but are not limited to: the future clinical development of
our product candidates, including expectations on enrollment and
the timing of reporting data from ongoing clinical trials; the
potential therapeutic benefits of our product candidates; and the
sufficiency of our capital resources to allow clinical trial data
readouts. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in our
business, including, without limitation: potential delays in the
commencement, enrollment and completion of clinical trials;
disruption to our operations from the COVID-19 pandemic, including
clinical trial and manufacturing delays; our dependence on third
parties in connection with product manufacturing, research and
preclinical and clinical testing; the results of preclinical
studies and early clinical trials are not necessarily predictive of
future results; the success of our clinical trials and preclinical
studies for our product candidates is uncertain; regulatory
developments in the United States and foreign countries; unexpected
adverse side effects or inadequate efficacy of our product
candidates that may limit their development, regulatory approval
and/or commercialization, or may result in recalls or product
liability claims; our ability to obtain and maintain intellectual
property protection for our product candidates; we may use its
capital resources sooner than it expects; and other risks described
in our prior filings with the Securities and Exchange Commission
(SEC), including under the heading “Risk Factors” in our most
recent quarterly report on Form 10-Q and any subsequent filings
with the SEC. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof, and we undertake no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date hereof. All forward-looking statements are qualified in their
entirety by this cautionary statement, which is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
eFFECTOR Therapeutics,
Inc.Condensed Balance Sheets(in
thousands)(Unaudited)
|
September 30,2021 |
|
December 31,2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
54,768 |
|
|
$ |
15,216 |
|
Prepaid expenses and other current assets |
|
4,173 |
|
|
|
1,362 |
|
Total current assets |
|
58,941 |
|
|
|
16,578 |
|
Property and equipment, net |
|
21 |
|
|
|
34 |
|
Operating lease right-of-use assets |
|
24 |
|
|
|
92 |
|
Other assets |
|
950 |
|
|
|
— |
|
Total assets |
$ |
59,936 |
|
|
$ |
16,704 |
|
Liabilities, convertible preferred stock, and stockholders'
deficit |
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
321 |
|
|
$ |
347 |
|
Accrued expenses |
|
2,748 |
|
|
|
1,984 |
|
Warrant liability |
|
— |
|
|
|
433 |
|
Term loans, net |
|
— |
|
|
|
5,907 |
|
Earn-out liability |
|
43,250 |
|
|
|
— |
|
Lease liabilities, current portion |
|
28 |
|
|
|
108 |
|
Total current liabilities |
|
46,347 |
|
|
|
8,779 |
|
Non-current term loans, net |
|
18,663 |
|
|
|
6,946 |
|
Accrued final payment on term loans |
|
1,100 |
|
|
|
— |
|
Non-current warrant liability |
|
1,495 |
|
|
|
— |
|
Total liabilities |
|
67,605 |
|
|
|
15,725 |
|
Series A convertible preferred stock |
|
— |
|
|
|
46,567 |
|
Series B convertible preferred stock |
|
— |
|
|
|
51,084 |
|
Series C convertible preferred stock |
|
— |
|
|
|
35,573 |
|
Stockholders' deficit: |
|
|
|
|
|
|
|
Common stock |
|
4 |
|
|
|
— |
|
Additional paid-in capital |
|
132,277 |
|
|
|
4,454 |
|
Accumulated deficit |
|
(139,950 |
) |
|
|
(136,699 |
) |
Total stockholders' deficit |
|
(7,669 |
) |
|
|
(132,245 |
) |
Total liabilities, convertible preferred stock, and stockholders'
deficit |
$ |
59,936 |
|
|
$ |
16,704 |
|
|
|
|
|
eFFECTOR Therapeutics,
Inc.Condensed Statement of Operations and
Comprehensive Income (Loss)(in thousands, except
share and per share data)(Unaudited)
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Collaboration revenue |
$ |
— |
|
|
$ |
574 |
|
|
$ |
— |
|
|
$ |
41,958 |
|
Grant revenue |
|
427 |
|
|
|
— |
|
|
|
1,119 |
|
|
|
— |
|
Total revenue |
|
427 |
|
|
|
574 |
|
|
|
1,119 |
|
|
|
41,958 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
5,022 |
|
|
|
6,780 |
|
|
|
13,562 |
|
|
|
17,231 |
|
General and administrative |
|
4,119 |
|
|
|
1,063 |
|
|
|
7,052 |
|
|
|
3,289 |
|
Total operating expenses |
|
9,141 |
|
|
|
7,843 |
|
|
|
20,614 |
|
|
|
20,520 |
|
Operating (loss) income |
|
(8,714 |
) |
|
|
(7,269 |
) |
|
|
(19,495 |
) |
|
|
21,438 |
|
Other income (expense) |
|
17,593 |
|
|
|
(335 |
) |
|
|
16,244 |
|
|
|
(1,022 |
) |
Income (loss) before income taxes |
|
8,879 |
|
|
|
(7,604 |
) |
|
|
(3,251 |
) |
|
|
20,416 |
|
Income tax expense |
|
— |
|
|
|
5 |
|
|
|
— |
|
|
|
351 |
|
Net income (loss) and comprehensive income (loss) |
|
8,879 |
|
|
|
(7,609 |
) |
|
|
(3,251 |
) |
|
|
20,065 |
|
Income allocable to participating securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(19,502 |
) |
Net income (loss) attributable to common shareholders |
$ |
8,879 |
|
|
$ |
(7,609 |
) |
|
$ |
(3,251 |
) |
|
$ |
563 |
|
Net income (loss) per share attributable to common
shareholders: |
|
|
|
|
|
|
Basic |
$ |
0.53 |
|
|
$ |
(5.29 |
) |
|
$ |
(0.49 |
) |
|
$ |
0.40 |
|
Diluted |
$ |
0.42 |
|
|
$ |
(5.29 |
) |
|
$ |
(0.49 |
) |
|
$ |
0.39 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
16,701,967 |
|
|
|
1,438,584 |
|
|
|
6,588,282 |
|
|
|
1,398,954 |
|
Diluted |
|
20,067,715 |
|
|
|
1,438,584 |
|
|
|
6,588,282 |
|
|
|
2,505,240 |
|
|
|
|
|
|
|
|
|
Contacts:Investors:Stephanie
CarringtonICR
Westwicke646-277-1282Stephanie.Carrington@westwicke.com
Media:Heidi Chokeir, Ph.D.Canale
Communications619-203-5391heidi.chokeir@canalecomm.com
eFFECTOR Therapeutics (NASDAQ:EFTR)
Historical Stock Chart
From Mar 2024 to Apr 2024
eFFECTOR Therapeutics (NASDAQ:EFTR)
Historical Stock Chart
From Apr 2023 to Apr 2024