eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the
development of selective translation regulator inhibitors (STRIs)
for the treatment of cancer, today reported financial results for
the second quarter ended June 30, 2022, and provided a corporate
update.
“We made significant progress in our clinical
programs during the second quarter, and we are thrilled to welcome
our new chief medical officer, Doug Warner, who joins at an optimal
time to advance both tomivosertib and zotatifin into late-stage
development,” said Steve Worland, Ph.D., president and chief
executive officer of eFFECTOR. “The encouraging interim
first-in-human data from our phase 1/2 zotatifin clinical trial
presented at ASCO showed that zotatifin was generally well
tolerated with early signals of clinical activity in patients with
ER+ breast cancer. In addition, pharmacodynamic markers collected
from the ongoing clinical trial showed down regulation of a select
set of oncogenic drivers, consistent with the drug’s mechanism. We
have advanced to Stage 2 of the Simon 2-stage trial design in the
cohort of patients treated with zotatifin and fulvestrant after
progressing on a CDK4/6 inhibitor and endocrine therapy, and are
opening a new cohort in patients with ER+ breast cancer with Cyclin
D1 amplification.”
Pipeline Highlights
Tomivosertib (eFT508):
eFFECTOR’s wholly-owned, highly selective MNK inhibitor designed to
enhance anti-tumor immune activity by stimulating activation,
delaying exhaustion, and prolonging the memory of T cells.
- Enrollment continues in
Phase 2b KICKSTART trial in NSCLC. KICKSTART trial
includes patients in two cohorts: (1) “PD-L1 ≥50% cohort” for
patients with PD-L1 expression ≥50% who will receive tomivosertib
or placebo in combination with pembrolizumab as their initial
therapy; and (2) “PD-L1 ≥1% cohort” for patients with PD-L1
expression ≥1% who will receive tomivosertib or placebo in
combination with pembrolizumab as maintenance therapy immediately
after completing the platinum-based chemotherapy doublet phase of
their frontline treatment without disease progression. The company
plans to enroll approximately 60 patients in each cohort. Primary
data readouts from both cohorts are anticipated in the first half
of 2023.
Zotatifin (eFT226): eFFECTOR’s
wholly-owned potent and selective inhibitor of mRNA helicase eIF4A,
designed to downregulate expression of key oncoproteins and cell
cycle proteins that drive tumor growth and resistance.
- At ASCO 2022, eFFECTOR reported
positive interim results from Phase 1/2 dose escalation and
expansion trial. eFFECTOR had previously completed the Phase 1
portion of this ongoing Phase 1/2 clinical trial in patients with
solid tumors and is currently enrolling patients in multiple Phase
2a open-label expansion cohorts in patients with solid tumors,
including ER+ breast cancer and KRAS G12C non-small cell lung
cancer (NSCLC). As of the cutoff date of March 4, 2022, interim
results showed that zotatifin was generally well tolerated,
resulted in suppression of multiple oncogenic drivers consistent
with the drug’s mechanism of action, and demonstrated initial
signals of clinical activity. Treatment emergent adverse events
(TEAEs) related to zotatifin were mostly mild, readily managed and
reversible. TEAEs included fatigue, anemia, diarrhea, vomiting, and
nausea. In the 25 patients who received the recommended Phase 2
dose, none exhibited zotatifin-related Grade 3, 4, or 5 TEAEs.
- In Part 2 of the trial, early
signals of clinical activity were observed in two patients with ER+
breast cancer. One patient, with amplified Cyclin D1 and an
estrogen receptor (ESR1) mutation who had progressed on prior
treatment with fulvestrant, experienced a confirmed partial
response when zotatifin was combined with fulvestrant. A second
partial response, which was awaiting confirmatory scan at the time
of ASCO presentation and has now been confirmed, was observed with
the combination of zotatifin, fulvestrant, and abemaciclib in a
patient with PIK3CA mutations that had failed prior treatment with
fulvestrant and a CDK4/6 inhibitor.
Expansion of Part 2 of Ongoing
Trial
- The Company also announced that
based on zotatifin’s mechanism and results observed to date,
they’ve expanded the cohort evaluating zotatifin in combination
with fulvestrant in ER+ breast cancer patients to 18 patients. A
new cohort evaluating zotatifin in combination with fulvestrant in
ER+ breast cancer patients with Cyclin D1 amplification is being
planned.
- The Company anticipates reporting
topline data from current expansion cohorts by the end of 2022, as
well as initial overall response rate data from the Cyclin D1
amplified ER+ breast cancer cohort in the first half of 2023.
Business Highlights:
- UCSF Subaward
Update: The company received an extension of a subaward
from University of California San Francisco (UCSF) to evaluate
zotatifin as a potential host-directed anti-viral therapy in
patients with mild to moderate COVID-19 disease to December 2022.
The subaward also includes an amendment to the clinical protocol to
utilize a single administration of a subcutaneous formulation of
zotatifin for more convenient dosing.
- Appointment of Doug Warner,
M.D., as Chief Medical Officer: Dr. Warner’s experience
includes roles of increasing responsibility over 18 years at Amgen
where he oversaw extensive clinical development programs in
multiple indications across oncology and general medicine. In his
most recent position, Executive Medical Director, Group Product
Area Lead, Dr. Warner provided development guidance and oversight
over a broad portfolio of solid tumor immune-oncology and pathway
inhibitor development programs that ranged from phase 1 to marketed
products. Prior to this position, Dr. Warner was the Global
Development Lead for several products including Vectibix®, XGEVA®,
and Prolia®. In this role, Dr. Warner led evidence generation and
oversaw the design, execution, and analysis of studies across the
phases of development, including large global phase 3 trials, and
was the clinical development leader for major regulatory filings
worldwide. Dr. Warner is co-author on numerous peer-reviewed
articles including those in The Lancet, The Lancet Oncology, and
The Journal of Clinical Oncology. He received his B.A. from the
University of Pennsylvania, his M.D. from the Duke University
School of Medicine, and his M.B.A. from the UCLA Anderson School of
Management.
Second Quarter 2022 Financial
Results
Cash Position and Guidance: The
company had cash and cash equivalents, and short-term investments
totaling $41.0 million as of June 30, 2022, compared to $45.7
million in cash and cash equivalents as of March 31, 2022. Current
cash is anticipated to be sufficient to fund readouts of topline
data from its Phase 2b KICKSTART trial evaluating tomivosertib in
combination with pembrolizumab in patients with NSCLC in the first
half of 2023, topline data from its Phase 2a dose expansion cohorts
evaluating zotatifin in patients with certain biomarker-positive
solid tumors, including ER+ breast cancer and KRASmut NSCLC, in the
second half of 2022 and initial overall response rate data from the
Cyclin D1 amplified ER+ cohort in the first half of 2023.
Research and Development (R&D)
Expenses: R&D expenses were $6.9 million for the
quarter ended June 30, 2022, compared to $4.1 million for the same
quarter of 2021. This increase for the quarter was due to higher
external development expenses primarily associated with both
tomivosertib and zotatifin programs, along with an increase in
personnel-related and non-cash stock compensation expenses. R&D
expenses included approximately $0.7 million and $0.1 million of
non-cash stock compensation expense in the second quarter 2022 and
2021, respectively.
General and Administrative (G&A)
Expenses: G&A expenses were $3.0 million for the
quarter ended June 30, 2022, compared to $1.7 million for the same
quarter of 2021. This increase for the quarter was primarily due to
an increase in non-cash stock compensation expense, public company
related expenses, including D&O insurance, and personnel
related expenses. G&A expenses included approximately $0.6
million and $0.1 million of non-cash stock compensation expense in
the quarters ended June 30, 2022 and 2021, respectively.
Other Income (Expense): Other
income was $1.0 million for the quarter ended June 30, 2022 and
other expense for the quarter ended June 30, 2021 was $0.5 million.
Other income in the quarter ended June 30, 2022 consisted primarily
of 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 $1.4 million at March 31, 2022 was remeasured at $0.1
million as of June 30, 2022. Other expense for the quarter ended
June 30, 2021 primarily consisted of interest expense associated
with the company’s term loans.
Net Income (Loss): Net loss was
$6.9 million, or $0.17 per basic and diluted share, for the quarter
ended June 30, 2022, as compared to net loss of $5.5 million, or a
net loss of $3.83 per basic and diluted share, for the same quarter
of 2021.
About eFFECTOR
TherapeuticseFFECTOR is a clinical-stage biopharmaceutical
company 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 a network of 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
StatementseFFECTOR 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
planned expanded development of zotatifin and the timing thereof;
the potential therapeutic benefits of our product candidates; and
the sufficiency of our capital resources to allow clinical data
readouts and the expansion of our clinical development programs.
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: interim results of a
clinical trial are not necessarily indicative of final results and
one or more of the clinical outcomes may materially change as
patient enrollment continues, following more comprehensive reviews
of the data and more patient data become available; potential
delays in the commencement, enrollment and completion of clinical
trials; additional disruptions 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; we may use our capital resources sooner than expected
and they may be insufficient to allow clinical trial readouts;
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; any
future impacts to our business resulting from the conflict between
Russia and Ukraine or other geopolitical developments outside our
control, and other risks described in our prior filings with the
Securities and Exchange Commission. 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)
|
June 30,2022 |
|
December 31,2021 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
16,353 |
|
|
$ |
49,702 |
|
Short-term investments |
|
24,685 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
1,245 |
|
|
|
3,194 |
|
Total current assets |
|
42,283 |
|
|
|
52,896 |
|
Property and equipment, net |
|
242 |
|
|
|
91 |
|
Operating lease right-of-use assets |
|
139 |
|
|
|
166 |
|
Other assets |
|
807 |
|
|
|
903 |
|
Total assets |
$ |
43,471 |
|
|
$ |
54,056 |
|
Liabilities and stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,204 |
|
|
$ |
516 |
|
Accrued expenses |
|
2,322 |
|
|
|
3,418 |
|
Current term loans, net |
|
18,911 |
|
|
|
— |
|
Accrued final payment on term loans, current |
|
1,100 |
|
|
|
— |
|
Lease liabilities, current portion |
|
48 |
|
|
|
44 |
|
Total current liabilities |
|
23,585 |
|
|
|
3,978 |
|
Earn-out liability, non-current |
|
89 |
|
|
|
12,130 |
|
Non-current term loans, net |
|
— |
|
|
|
18,760 |
|
Accrued final payment on term loans |
|
— |
|
|
|
1,100 |
|
Non-current warrant liability |
|
80 |
|
|
|
678 |
|
Non-current lease liabilities |
|
94 |
|
|
|
126 |
|
Total liabilities |
|
23,848 |
|
|
|
36,772 |
|
Stockholders' equity: |
|
|
|
Common stock |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
144,448 |
|
|
|
138,181 |
|
Accumulated other comprehensive loss |
|
(82 |
) |
|
|
— |
|
Accumulated deficit |
|
(124,747 |
) |
|
|
(120,901 |
) |
Total stockholders' equity |
|
19,623 |
|
|
|
17,284 |
|
Total liabilities and stockholders' equity |
$ |
43,471 |
|
|
$ |
54,056 |
|
|
|
|
|
eFFECTOR Therapeutics,
Inc.Condensed Statement of Operations and
Comprehensive Loss(in thousands, except share and
per share data)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Grant revenue |
$ |
2,011 |
|
|
$ |
692 |
|
|
$ |
2,011 |
|
|
$ |
692 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
6,919 |
|
|
|
4,072 |
|
|
|
10,031 |
|
|
|
8,540 |
|
General and administrative |
|
2,973 |
|
|
|
1,664 |
|
|
|
6,409 |
|
|
|
2,933 |
|
Total operating expenses |
|
9,892 |
|
|
|
5,736 |
|
|
|
16,440 |
|
|
|
11,473 |
|
Operating loss |
|
(7,881 |
) |
|
|
(5,044 |
) |
|
|
(14,429 |
) |
|
|
(10,781 |
) |
Other income (expense) |
|
966 |
|
|
|
(504 |
) |
|
|
10,583 |
|
|
|
(1,349 |
) |
Net loss |
|
(6,915 |
) |
|
|
(5,548 |
) |
|
|
(3,846 |
) |
|
|
(12,130 |
) |
Other comprehensive loss |
|
(32 |
) |
|
|
— |
|
|
|
(82 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(6,947 |
) |
|
$ |
(5,548 |
) |
|
$ |
(3,928 |
) |
|
$ |
(12,130 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.17 |
) |
|
$ |
(3.83 |
) |
|
$ |
(0.09 |
) |
|
$ |
(8.38 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
41,118,727 |
|
|
|
1,450,159 |
|
|
|
40,984,273 |
|
|
|
1,447,626 |
|
|
|
|
|
|
|
|
|
Contacts:
Investors:Stephanie CarringtonWestwicke, an ICR
Company646-277-1282Stephanie.Carrington@westwicke.com
Media:Heidi Chokeir, Ph.D.Canale
Communications619-203-5391heidi.chokeir@canalecomm.com
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