G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today provided a corporate and financial update for the
first quarter ended March 31, 2021.
“The first quarter of 2021 was a transformational period for G1
as the approval and availability of COSELA provided extensive-stage
small cell lung cancer patients undergoing chemotherapy with the
first proactive multilineage myeloprotection therapy to help
prevent myelosuppression,” said Jack Bailey, Chief Executive
Officer of G1 Therapeutics. “COSELA represents an opportunity to
shift the treatment paradigm away from reactive treatments with
multiple different single lineage therapeutic interventions. Our
commercial team has demonstrated that we can effectively launch and
deliver the drug during a very challenging time. Further, though
very early in the launch period, leading and lagging indicators
from the first four weeks of availability are encouraging and
suggest that the awareness and interest in COSELA is strong, that
it is being accepted by oncologists and oncology nurses, and that
it is being well covered by payers. Another important step during
the quarter was the inclusion of COSELA in two sets of NCCN
Guidelines, which are the standard resource for determining best
course of treatment and supportive care for people living with
cancer. We also maintained clinical momentum in our tumor-agnostic
development program for COSELA, including the initiation of
PRESERVE 2, our Phase 3 registrational trial in triple-negative
breast cancer.”
First Quarter 2021 and Recent Highlights
Commercial
- COSELA Approved by U.S. Food
and Drug Administration (FDA): On February 12, 2021, the
FDA approved COSELA for injection 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 (ES-SCLC). (Press release here)
- COSELA Now
Available in the U.S.: On March 2, 2021, G1 and its
commercial partner Boehringer Ingelheim announced that COSELA was
available through G1’s specialty distributors Amerisource Specialty
Distribution, Oncology Supply, McKesson Plasma and Biologics,
McKesson Specialty and Cardinal Specialty. (Press release
here)
Medical
- COSELA
Added to Two National Comprehensive Cancer
Network® (NCCN) Clinical Practice
Guidelines in Oncology (NCCN
Guidelines®): On March
25, 2021, G1 announced that COSELA had been added to the Treatment
Guidelines for Small Cell Lung Cancer and to the Supportive Care
Guidelines for Hematopoietic Growth Factors. These guidelines
document evidence-based, consensus-driven management to ensure that
all patients receive preventive, diagnostic, treatment, and
supportive services that are most likely to lead to optimal
outcomes. (Press release here)
- Presented
New Budget Impact Data for COSELA at the Academy of Managed Care
Pharmacy (AMCP) Meeting: These data described a model that
compared ES-SCLC treatment scenarios with and without COSELA. The
incremental cost of COSELA to a third-party payer is projected to
be entirely offset by a reduction in the costs of managing adverse
events related to myelosuppression. Therefore, the use of COSELA is
estimated to provide cost savings.
Clinical
- Initiated
Pivotal Trial of COSELA in Patients Receiving
First or Second Line Gemcitabine and Carboplatin Chemotherapy for
Locally Advanced Unresectable or Metastatic Triple-Negative Breast
Cancer (mTNBC): Patient enrollment is underway in PRESERVE
2, a randomized, double-blind, placebo-controlled Phase 3
registrational trial of COSELA in patients receiving first- or
second-line gemcitabine/carboplatin (GC) chemotherapy for locally
advanced unresectable or metastatic TNBC. (Press release here)
- Entered
Clinical Trial Collaboration for Upcoming First Line Locally
Advanced or Metastatic Bladder Cancer (mUC) Trial
of COSELA: G1 entered a clinical trial collaboration with
the alliance between Merck KGaA, Darmstadt, Germany and Pfizer
whereby the alliance will contribute clinical supply of the
checkpoint inhibitor avelumab to the G1-sponsored and funded
first-line mUC trial.
- On Track to
Initiate Two Phase 2 Trials of COSELA in First
Line Metastatic Bladder Cancer (mUC) and Second Line / Third Line
Non-Small Cell Lung Cancer (NSCLC) in the Second Quarter of
2021: The Company expects to initiate Phase 2 trials of
COSELA in first-line treatment of locally advanced or metastatic
bladder cancer (locally advanced or metastatic urothelial
carcinoma, or mUC) and second- and third-line treatment of NSCLC,
both of which are known immunogenic tumors, in the second quarter
of 2021. Both trials are designed to evaluate the anti-tumor
efficacy of COSELA.
First Quarter 2021 Financial Results
As of March 31, 2021, cash and cash equivalents totaled $279.0
million, compared to $207.3 million as of December 31, 2020. This
includes $86.4 million in net proceeds in the first quarter from
the “At the Market” offering with Cowen and Company, LLC. This ATM
offering is now closed. In addition, the Company drew the
additional $10M available in the first tranche of debt on its debt
financing facility with Hercules Capital. The Company has access to
an additional $70 million through this facility.
Total revenue for the first quarter of 2021 was $14.2 million,
including approximately $0.6 million in initial net product sales
of COSELA and license revenue of $13.6 million, primarily related
to development milestone payments from the Company’s license
agreement with Simcere and revenue from EQRx related to delivery of
clinical drug supply and manufacturing services and reimbursement
of clinical trial costs with EQRx. In addition, the Company
recognized revenue related to achievement of a development
milestone by Genor.
Operating expenses for the first quarter of 2021 were $39.8
million, compared to $31.8 million for the first quarter of 2020.
GAAP operating expenses include stock-based compensation expense of
$5.9 million for the first quarter of 2021, compared to $4.7
million for the first quarter of 2020.
Cost of goods sold expense for the first quarter of 2021 were
$0.2 million, compared to $0 for first quarter of 2020. The
increase related to the Company’s period costs for the sales of
COSELA.
Research and development (R&D) expenses for the first
quarter of 2021 were $16.5 million, compared to $20.4 million for
the first quarter of 2020. The decrease in R&D expenses was
primarily due to a decrease in costs for manufacturing of active
pharmaceutical ingredients and drug product to support clinical
trials, as well as a decrease in external costs related to
discovery and pre-clinical development.
Selling, general and administrative (SG&A) expenses for the
first quarter of 2021 were $23.0 million, compared to $11.4 million
for the first quarter of 2020. The increase in SG&A expenses
was largely due to an increase in compensation due to increases in
headcount and increased commercialization activities.
The net loss for the first quarter of 2021 was $26.4 million,
compared to $31.0 million for the first quarter of 2020. The basic
and diluted net loss per share for the first quarter of 2021 was
$(0.65) compared to $(0.82) for the first quarter of 2020.
Financial Guidance
The Company expects its current financial position to be
sufficient to fund its operations and capital expenditures into
2023.
Webcast and Conference Call
G1 will host a webcast and conference call at 4:30 p.m. ET today
to provide a corporate and financial update for the first quarter
2021 ended March 31, 2021. The live call may be accessed by dialing
(866) 763-6020 (domestic) or (210) 874-7713 (international) and
entering the conference code: 2509548. 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.
IndicationCOSELA™ (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 InformationCOSELA 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.
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 TherapeuticsG1 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 tumor-agnostic
development plan evaluating COSELA in a variety of solid tumors,
including colorectal, 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 Twitter @G1Therapeutics.
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
launch of COSELA (trilaciclib), the therapeutic potential of COSELA
(trilaciclib), COSELA’s (trilaciclib) possibility to improve
patient outcomes across multiple indications, our reliance on
partners to develop and commercial licensed products, COSELA
(trilaciclib) may fail to achieve the degree of market acceptance
for commercial success, and the impact of pandemics such as
COVID-19 (coronavirus), are based on the company’s expectations and
assumptions as of the date of this press release. Each of these
forward-looking statements 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 complete a successful
commercial launch for COSELA (trilaciclib); the company’s ability
to complete clinical trials for, obtain approvals for and
commercialize any of its product candidates other than 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 development-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:Jen MosesChief
Financial Officer919-930-8506jmoses@g1therapeutics.com
Will RobertsVice President, Investor Relations & Corporate
Communications919-907-1944 wroberts@g1therapeutics.com
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G1 Therapeutics, Inc. |
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Balance Sheet Data |
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(in thousands) |
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March 31, |
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December 31, |
|
|
| |
2021 |
|
|
2020 |
|
|
| |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
278,968 |
|
|
$ |
207,306 |
|
|
| Working Capital |
$ |
271,408 |
|
|
$ |
192,949 |
|
|
| Total Assets |
$ |
308,558 |
|
|
$ |
228,552 |
|
|
| Accumulated deficit |
$ |
(462,549 |
) |
|
$ |
(436,107 |
) |
|
| Total stockholders'
equity |
$ |
245,443 |
|
|
$ |
177,351 |
|
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| |
|
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| G1
Therapeutics, Inc. |
| Condensed
Statements of Operations |
| (in thousands,
except per share data) |
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Three months ended March 31, |
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2021 |
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2020 |
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Revenues: |
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Product sales, net |
$ |
609 |
|
|
$ |
- |
|
|
| |
License revenue |
|
13,609 |
|
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|
- |
|
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Total revenues |
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14,218 |
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- |
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Operating expenses: |
|
|
|
|
| |
Cost of goods sold |
|
243 |
|
|
|
- |
|
|
| |
Research and development |
|
16,540 |
|
|
|
20,434 |
|
|
| |
Selling, general and administrative |
|
22,970 |
|
|
|
11,387 |
|
|
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Total operating expenses |
|
39,753 |
|
|
|
31,821 |
|
|
|
Loss from operations |
|
(25,535 |
) |
|
|
(31,821 |
) |
|
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Other income (expense): |
|
|
|
|
| |
Interest Income |
|
19 |
|
|
|
780 |
|
|
| |
Interest Expense |
|
(748 |
) |
|
|
- |
|
|
| |
Other income (expense) |
|
(40 |
) |
|
|
18 |
|
|
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Total other income (expense), net |
|
(769 |
) |
|
|
798 |
|
|
|
Loss before income taxes |
|
(26,304 |
) |
|
|
(31,023 |
) |
|
|
Income tax expense |
|
138 |
|
|
|
- |
|
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|
Net loss |
|
|
$ |
(26,442 |
) |
|
$ |
(31,023 |
) |
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| |
|
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|
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Net loss per share, basic and diluted |
$ |
(0.65 |
) |
|
$ |
(0.82 |
) |
|
|
Weighted average common shares outstanding, basic and diluted |
|
40,700,827 |
|
|
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37,659,722 |
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