G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today provided a corporate and financial update for the
third quarter ended September 30, 2023.
“Despite the impact of the ongoing platinum-based chemotherapy
shortage, we continue to be encouraged by the mounting real-world
evidence confirming the benefit of COSELA and the support of
organizations like ASCO through their recent SCLC guideline update
recommending its use; we believe these are indicative of the
potential of COSELA,” said Jack Bailey, Chief Executive Officer of
G1 Therapeutics. “Beyond that, our focus remains on establishing
our leadership position in TNBC. As we approach OS readouts from
our ongoing trials, including most importantly the interim OS
analysis of our pivotal Phase 3 TNBC trial, there is palpable
excitement among clinicians regarding the potential for trilaciclib
to improve survival. If successful in the interim analysis, we look
forward to working closely with the U.S. Food and Drug
Administration to expand the indication of this important
drug."
Third Quarter
2023 and Recent Highlights
Financial
- Recognized $10.8 Million
in Net COSELA Revenue: G1 recognized total
revenues of $12.3 million for the third quarter of 2023. Vial
volume grew 3% over the second quarter of 2023 despite the impact
of an ongoing platinum-based chemotherapy shortage.
- Ended the Third
Quarter of 2023 with
Cash, Cash Equivalents, and Marketable Securities of
$94.4 Million. The Company’s
current financial position is now expected to be sufficient to fund
G1’s operations and capital expenditures beyond the third quarter
of 2024.
Clinical
- Confirmed Expectation of Interim OS Analysis of Pivotal
Phase 3 Clinical Trial (PRESERVE 2) in Patients with mTNBC in the
First Quarter of 2024: G1 expects the interim OS analysis
to be conducted by its data monitoring committee in the first
quarter of 2024. If the trial meets the interim analysis stopping
rule, it will be unblinded and G1 will report the top line results.
If it does not, the trial will continue to the final analysis,
expected later in 2024. If the results of the interim OS analysis
are positive, the Company intends to meet with the U.S. Food and
Drug Administration to discuss filing a supplemental new drug
application (sNDA) as soon as possible in 2024.
- Reiterated Expectation of Timing for Initial OS Results
from Phase 2 Trial of Trilaciclib in Combination with the ADC
Sacituzumab Govitecan-Hziy: The Company expects to report
these results in the first quarter of 2024.
- Phase 2 Bladder Cancer Trial (PRESERVE 3) To Be
Concluded in the Fourth Quarter of 2023; OS Trend Favoring
Trilaciclib Observed in Maintenance Phase: G1 intends to
conclude the trial this quarter following the next protocol defined
analyses of survival and report the results at a future medical
meeting. PRESERVE 3 is a signal finding study designed to assess
the potential additive contribution of trilaciclib to anti-cancer
therapy, including in combination with the immune checkpoint
inhibitor avelumab alone without chemotherapy during the
maintenance part of the study. To date, an overall survival trend
in favor of the trilaciclib plus avelumab arm in the maintenance
phase was observed, suggesting a potential additive benefit when
used in combination with a checkpoint inhibitor, which will inform
future studies in G1's core areas of focus.
Medical
- COSELA Recommended as a Myeloid Supportive Agent in the
Updated ASCO SCLC Guidelines: Multidisciplinary panels of
experts, including patient advocates, develop ASCO’s clinical
practice guidelines. The SCLC guidelines provide evidence-based
recommendations to practicing clinicians on the management of
patients with SCLC. (press release here)
- Presented Four Posters During the 2023 ASCO Quality
Care Symposium: These posters provide new real-world
evidence indicating that trilaciclib administered prior to
chemotherapy in patients with ES-SCLC lowers the rate of
hospitalization and cytopenia events and may improve survival. In
addition, multiple analyses indicate the consistent impact of
chemotherapy-induced myelosuppressive events, including severe
neutropenia, thrombocytopenia, and anemia, on patients with ES-SCLC
being treated with chemotherapy as well as the resulting impact on
healthcare resource utilization. The posters are available on the
G1 Therapeutics website. (press release here)
- Announced New Publication Highlighting the Real-World
Impact of Trilaciclib on Myelosuppressive Events in Patient with
ES-SCLC: Real-world outcomes data from published and new
unpublished studies indicate the potential of trilaciclib to reduce
single and multilineage myelosuppressive events associated with
chemotherapy, cytopenia-related healthcare utilization, and
hospitalizations. This review of real-world experience with
trilaciclib was published in Advanced Therapy. (press release
here)
Third Quarter
2023 Financial Results
As of September 30, 2023, cash and cash equivalents and
marketable securities totaled $94.4 million, compared to $145.1
million as of December 31, 2022.
Total revenues for the third quarter of 2023 were $12.3 million,
including $10.8 million in net product sales of COSELA and license
revenue of $1.5 million, primarily related to supply and
manufacturing services from Simcere and patent and clinical trial
costs reimbursed primarily by EQRx and Simcere, compared to $23.6
million in total revenues in the third quarter of 2022.
On August 1, 2023, the Company received formal notice from EQRx
of their intent to terminate the lerociclib license agreement as
part of their proposed acquisition by Revolution Medicines, Inc. G1
received a payment of $1.6 million during the quarter ended
September 30, 2023 for the remainder of the costs to wind down
the lerociclib study. No milestones have been achieved through
September 30, 2023, and as a result of the termination, the Company
will not receive any further milestone payments or future royalties
from EQRx.
Operating expenses for the third quarter of 2023 were $28.7
million, compared to $45.1 million for the third quarter of 2022.
GAAP operating expenses include stock-based compensation expense of
$3.7 million for the third quarter of 2023, compared to $4.8
million for the third quarter of 2022.
Cost of goods sold expense for the third quarter of 2023 was
$3.1 million, compared to $1.1 million for the third quarter of
2022, primarily due to an increase in sales volume and a one-time
inventory reserve for potential product obsolescence.
Research and development (R&D) expenses for the third
quarter of 2023 were $8.8 million, compared to $19.6 million for
the third quarter of 2022. The decrease in R&D expenses was
primarily due to a decrease in the Company's clinical program
costs.
Selling, general, and administrative (SG&A) expenses for the
third quarter of 2023 were $16.8 million, compared to $24.4 million
for the third quarter of 2022. The decrease in SG&A expenses
was primarily due to decreases in commercialization activities,
personnel costs, and medical affairs.
The net loss for the third quarter of 2023 was $18.2 million,
compared to $25.3 million for the third quarter of 2022. The basic
and diluted net loss per share for the third quarter of 2023 was
$(0.35), compared to $(0.59) for the third quarter of 2022.
2023 Financial Guidance
As a result of the ongoing shortage of platinum-based
chemotherapy, G1 today lowered its full year 2023 net revenue
guidance. The Company expects to generate between $44 million and
$47 million in COSELA net revenue in 2023. G1's product revenue
guidance is based on expectations for continued acceleration of
sales performance of COSELA in the U.S.
Webcast and Conference Call
G1 will host a webcast and conference call at 8:30 a.m. ET today
to provide a corporate and financial update for the third quarter
ended September 30, 2023.
Please note the following process to access the call via
telephone: To register and receive a dial in number and unique PIN
to access the live conference call, please follow this link to
register online. While not required, it is recommended to join 10
minutes prior to the start of the event. A live and archived
webcast will be available on the Events & Presentations page of
the Company’s website: www.g1therapeutics.com. The webcast will be
archived on the same page for 90 days following the event.
About COSELA®
(trilaciclib) for Injection
COSELA (trilaciclib) was approved by the U.S. Food and Drug
Administration on February 12, 2021.
Indication
COSELA® (trilaciclib) is indicated to decrease
the incidence of chemotherapy-induced myelosuppression in adult
patients when administered prior to a platinum/etoposide-containing
regimen or topotecan-containing regimen for extensive-stage small
cell lung cancer.
Important Safety Information
COSELA is contraindicated in patients with a history of serious
hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions
(including phlebitis and thrombophlebitis), acute drug
hypersensitivity reactions, interstitial lung disease
(pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue,
hypocalcemia, hypokalemia, hypophosphatemia, aspartate
aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for
full Prescribing Information.
https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact G1 Therapeutics
at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical
company focused on the development and commercialization of next
generation therapies that improve the lives of those affected by
cancer, including the Company’s first commercial product,
COSELA® (trilaciclib). G1 has a deep clinical
pipeline and is executing a development plan evaluating trilaciclib
in a variety of solid tumors, including breast, lung, and bladder
cancers. G1 Therapeutics is based in Research Triangle Park, N.C.
For additional information, please visit www.g1therapeutics.com and
follow us on X (formerly known as Twitter) @G1Therapeutics and
LinkedIn.
G1 Therapeutics® and the G1 Therapeutics logo
and COSELA® and the COSELA logo are trademarks of
G1 Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend" and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Forward-looking statements in this press release include, but are
not limited to, those relating to expectations for the commercial
sales of COSELA (trilaciclib), the therapeutic potential of COSELA
(trilaciclib), our full year 2023 financial guidance, our ability
to generate data to maximize trilaciclib’s applicability to future
treatment paradigms, our ability to drive growth of COSELA among
our top accounts, our ability to obtain approvals for and
commercialize additional indications of COSELA (trilaciclib), our
ability to complete our ongoing clinical trials on time, our
ability to minimize the impact of a national platinum-based
chemotherapy shortage, and our reliance on partners to develop
licensed products. If we are not in compliance with the minimum
cash covenant with our debt facility, we may be subject to the
acceleration clauses in our loan agreement, and the lender may call
the debt, resulting in our immediate need for additional funds. In
addition, COSELA (trilaciclib) may fail to achieve the degree of
market acceptance for commercial success. Each of these
forward-looking statements is based on the company’s expectations
and assumptions as of the date of this press release and involves
risks and uncertainties. Factors that may cause the company’s
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
the company’s filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained therein
and include, but are not limited to, the company’s ability to
successfully commercialize COSELA (trilaciclib); the company’s
ability to complete clinical trials for, obtain approvals for and
commercialize additional indications of COSELA (trilaciclib); the
company’s initial success in ongoing clinical trials may not be
indicative of results obtained when these trials are completed or
in later stage trials; the inherent uncertainties associated with
developing new products or technologies and operating as a
commercial-stage company; and market conditions. Except as required
by law, the company assumes no obligation to update any
forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
G1 Therapeutics Contacts:
John W. Umstead VChief Financial
Officer919-747-8419jumstead@g1therapeutics.com
Will RobertsCommunications OfficerVice President, Investor
Relations & Corporate Communications919-907-1944
wroberts@g1therapeutics.com
G1 Therapeutics, Inc.Condensed Balance
Sheet Data (unaudited)(in thousands) |
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
Cash and cash equivalents and Marketable securities |
$94,352 |
|
$145,070 |
Working Capital |
$92,450 |
|
$143,912 |
Total Assets |
$133,097 |
|
$187,965 |
Accumulated deficit |
$(769,107) |
|
$(732,018) |
Total stockholders'
equity |
$43,022 |
|
$68,747 |
G1 Therapeutics, Inc.Condensed Statements
of Operations (unaudited)(in thousands, except per share
data) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues |
|
|
|
|
|
|
|
Product sales, net |
$ |
10,839 |
|
|
$ |
8,269 |
|
|
$ |
32,422 |
|
|
$ |
22,467 |
|
License revenue |
|
1,461 |
|
|
|
15,307 |
|
|
|
35,216 |
|
|
|
18,584 |
|
Total revenues |
|
12,300 |
|
|
|
23,576 |
|
|
|
67,638 |
|
|
|
41,051 |
|
Operating expenses |
|
|
|
|
|
|
|
Cost of goods sold |
|
3,076 |
|
|
|
1,111 |
|
|
|
5,939 |
|
|
|
2,756 |
|
Research and development |
|
8,811 |
|
|
|
19,581 |
|
|
|
36,331 |
|
|
|
66,729 |
|
Selling, general and administrative |
|
16,781 |
|
|
|
24,432 |
|
|
|
55,966 |
|
|
|
76,857 |
|
Total operating expenses |
|
28,668 |
|
|
|
45,124 |
|
|
|
98,236 |
|
|
|
146,342 |
|
Loss from operations |
|
(16,368 |
) |
|
|
(21,548 |
) |
|
|
(30,598 |
) |
|
|
(105,291 |
) |
Other income (expense) |
|
|
|
|
|
|
|
Interest income |
|
585 |
|
|
|
211 |
|
|
|
1,944 |
|
|
|
270 |
|
Interest expense |
|
(2,115 |
) |
|
|
(2,764 |
) |
|
|
(7,914 |
) |
|
|
(7,436 |
) |
Other income (expense) |
|
599 |
|
|
|
48 |
|
|
|
1,692 |
|
|
|
(234 |
) |
Total other income (expense),
net |
|
(931 |
) |
|
|
(2,505 |
) |
|
|
(4,278 |
) |
|
|
(7,400 |
) |
Loss before income taxes |
|
(17,299 |
) |
|
|
(24,053 |
) |
|
|
(34,876 |
) |
|
|
(112,691 |
) |
Income tax expense |
|
905 |
|
|
|
1,219 |
|
|
|
2,213 |
|
|
|
1,219 |
|
Net loss |
$ |
(18,204 |
) |
|
$ |
(25,272 |
) |
|
$ |
(37,089 |
) |
|
$ |
(113,910 |
) |
Net loss per share, basic and
diluted |
$ |
(0.35 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.72 |
) |
|
$ |
(2.67 |
) |
Weighted average common shares outstanding, basic and diluted |
|
51,777,731 |
|
|
|
42,799,342 |
|
|
|
51,697,989 |
|
|
|
42,731,826 |
|
G1 Therapeutics (NASDAQ:GTHX)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
G1 Therapeutics (NASDAQ:GTHX)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024