G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today provided a corporate and financial update for the
second quarter ended June 30, 2021.
“The second quarter of 2021 was a period of solid progress
across G1, as we seek to develop COSELA for patients suffering from
a variety of cancers,” said Jack Bailey, Chief Executive Officer of
G1 Therapeutics. “In our first full quarter of sales of COSELA, the
commercial team continued to build the commercial foundation for
this important myeloprotection drug for patients with ES-SCLC
undergoing chemotherapy. We believe that COSELA is a
paradigm-changing product, allowing cancer patients to be treated
proactively to reduce the impact of the multilineage
myelosuppression side effects of chemotherapy. So far, the
enthusiasm for COSELA is encouraging. We also initiated three new
COSELA clinical trials during the second quarter, including a
registrational trial in metastatic TNBC and two Phase 2 trials, one
in NSCLC and the other in bladder cancer. With the ongoing
commercial launch, the expansion of our innovative tumor-agnostic
pipeline, and a strong financial position, we are excited about the
opportunities ahead for COSELA.”
Second Quarter 2021 and Recent Highlights
Financial
- Achieved Net COSELA
(trilaciclib) Revenue of $2.5 Million.
- Ended the
Second Quarter with Cash and Cash Equivalents of $244.0
million: The current financial position expected to be
sufficient to fund G1’s operations and capital expenditures into
2023.
Medical
- Presented
New Data Describing the Estimated Economic Impact of Treating
Myelosuppression in Patients with ES-SCLC at the International
Society for Pharmacoeconomics and Outcomes Research
(ISPOR): The first poster used a cost-benefit model to
predict an estimated economic value from a general U.S. commercial
payer perspective of using COSELA prior to chemotherapy in ES-SCLC
to project a significant payer cost savings based on assumptions
that myelosuppressive adverse events and their associated treatment
costs would be reduced. The second poster quantified the
significant health burden, economic toll, and health-related
quality-of-life effects of chemotherapy-induced myelosuppression
among Medicare patients diagnosed with SCLC. (Press release
here)
- Presented
Results of Analyses Evaluating the Immune Effects of COSELA in
Patients with ES-SCLC at the American Society of Clinical Oncology
(ASCO) annual meeting: Patients receiving COSELA prior to
chemotherapy had greater peripheral T-cell clonal expansion than
patients receiving placebo. The data suggest that, among patients
treated with COSELA plus either etoposide and carboplatin (E/C) or
E/C plus atezolizumab, increased clonal expansion is associated
with clinical response, indicating that COSELA may enhance
antitumor immunity in patients with ES-SCLC treated with
chemotherapy. (Press release here)
- Presented
Positive Data Suggesting Strong Safety Profile and Evidence of
Antitumor Activity of Rintodestrant Combined with Palbociclib in
ER+/HER- Advanced Breast Cancer at ASCO: In the 40-patient
combination arm of the Phase 1 trial, rintodestrant was very well
tolerated and did not result in additional or more severe
toxicities when added to Palbociclib. The clinical benefit rate
(CBR; percentage of patients with either confirmed complete or
partial response or stable disease lasting ≥ 24 weeks) doubled from
30 percent with rintodestrant monotherapy to 60 percent with the
combination of rintodestrant and Palbociclib; among patients with
early relapse, the CBR was 73%. (Press release here)
Clinical
- Initiated
Pivotal Trial of COSELA in Locally Advanced
Unresectable or Metastatic TNBC: 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
chemotherapy for locally advanced unresectable or metastatic TNBC.
(Press release here)
- Received
Fast Track Designation for COSELA in TNBC: The FDA granted
Fast Track designation to COSELA investigation for use in
combination with chemotherapy for the treatment of locally advanced
or metastatic TNBC. Fast track is a process designed to facilitate
the development and expedite the review of drugs to treat serious
conditions and fill unmet medical needs. (Press release here)
- Initiated
Phase 2 Trial of COSELA in Metastatic NSCLC: Patent
enrollment is underway in PRESERVE 4, a randomized double-blind
placebo-controlled Phase 2 trial of COSELA administered prior to
docetaxel in patients with NSCLC in the 2nd and 3rd line setting
who have previously been treated with a checkpoint inhibitor and
chemotherapy. The primary endpoint of the trial is to evaluate the
anti-tumor effect of COSELA on overall survival (OS) compared to
placebo. (Press release here)
- Initiated
Phase 2 Trial of COSELA in Bladder Cancer: Patent
enrollment is underway in PRESERVE 3, a randomized double-blind
placebo-controlled Phase 2 trial of COSELA administered with
first-line platinum-based chemotherapy and the immune checkpoint
inhibitor avelumab maintenance therapy in patients with untreated,
locally advanced or metastatic urothelial carcinoma. (Press release
here)
Corporate
- Announced
Andrew Perry as Chief Commercial Officer: Mr. Perry,
formerly the Vice President of US Marketing for ViiV Healthcare NA,
brings nearly 25 years of leadership experience in commercial
launch strategy, digital marketing, and co-promotion management to
G1, with extensive capabilities in launching and growing brands in
multiple areas including oncology. (Press release here)
Second Quarter 2021 Financial Results
As of June 30, 2021, cash and cash equivalents totaled $244.0
million, compared to $207.3 million as of December 31, 2020.
Total revenues for the second quarter of 2021 were $6.6 million,
including $2.5 million in net product sales of COSELA and license
revenue of $4.1 million, primarily related to a development
milestone payment from the Company’s license agreement with
Simcere, clinical trial reimbursements from EQRx, and delivery of
clinical drug supply and manufacturing services to Simcere, EQRx
and Genor. Total revenues for the six months ended June 30, 2021
were $20.8 million.
Operating expenses for the second quarter of 2021 were $44.8
million, compared to $33.0 million for the second quarter of 2020.
GAAP operating expenses include stock-based compensation expense of
$5.7 million for the second quarter of 2021, compared to $4.4
million for the second quarter of 2020. Total operating expenses
for the six months ended June 30 was $84.5 million.
Cost of goods sold expense for the second quarter of 2021 were
$0.8 million, compared to $0 for second quarter of 2020. The
increase related to the Company’s period costs for the sales of
COSELA. Cost of goods sold for the six months ended June 30 was
$1.1 million.
Research and development (R&D) expenses for the second
quarter of 2021 were $18.8 million, compared to $18.5 million for
the second quarter of 2020. The increase in R&D expenses was
primarily due to an increase in clinical trial spend, which is
offset by a decrease in costs associated with the manufacturing of
active pharmaceutical ingredients and drug product to support
clinical trials, as well as external costs related to discovery and
pre-clinical development. R&D expenses for the six months ended
June 30 were $35.3 million.
Selling, general and administrative (SG&A) expenses for the
second quarter of 2021 were $25.2 million, compared to $14.4
million for the second quarter of 2020. The increase in SG&A
expenses was largely due to an increase in commercialization
activities, an increase in compensation due to increases in
headcount, and increased spend on information technology,
professional services, and other administrative costs. SG&A
expenses for the six months ended June 30 were $48.2 million.
The net loss for the second quarter of 2021 was $39.4 million,
compared to $31.2 million for the second quarter of 2020. The basic
and diluted net loss per share for the second quarter of 2021 was
$(0.94) compared to $(0.83) for the second quarter of 2020. The net
loss for the six months ended June 30 was $65.9 million. The basic
and diluted net loss per share for the six months ended June 30 was
$(1.59).
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 second quarter
2021 ended June 30, 2021. The live call may be accessed by dialing
(866) 763-6020 (domestic) or (210) 874-7713 (international) and
entering the conference code: 3553037. 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.
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.
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 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, and our reliance on
partners to develop and commercial licensed products. In addition,
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 additional indications of COSELA and 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 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:Jen MosesChief
Financial Officer919-930-8506jmoses@g1therapeutics.com
Will RobertsVice President, Investor Relations & Corporate
Communications919-907-1944 wroberts@g1therapeutics.com
Rebecca LevineDirector, Corporate Communications and Public
Relations(919) 667-8711 rlevine@g1therapeutics.com
|
G1
Therapeutics, Inc. |
Balance
Sheet Data |
(in thousands) |
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2021 |
|
2020 |
|
|
|
|
|
Cash and cash equivalents |
$ |
244,023 |
|
|
$ |
207,306 |
|
Working
Capital |
$ |
240,059 |
|
|
$ |
192,949 |
|
Total
Assets |
$ |
276,755 |
|
|
$ |
228,552 |
|
Accumulated
deficit |
$ |
(501,971 |
) |
|
$ |
(436,107 |
) |
Total
stockholders' equity |
$ |
213,196 |
|
|
$ |
177,351 |
|
|
|
|
|
|
|
|
|
|
G1
Therapeutics, Inc. |
Condensed
Statements of Operations |
(in thousands,
except per share data) |
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
|
Product sales, net |
$ |
2,532 |
|
|
$ |
- |
|
|
$ |
3,141 |
|
|
$ |
- |
|
|
License
revenue |
|
4,072 |
|
|
|
2,140 |
|
|
|
17,681 |
|
|
|
2,140 |
|
Total revenues |
|
6,604 |
|
|
|
2,140 |
|
|
|
20,822 |
|
|
|
2,140 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of
goods sold |
|
808 |
|
|
|
- |
|
|
|
1,051 |
|
|
|
- |
|
|
Research and
development |
|
18,752 |
|
|
|
18,531 |
|
|
|
35,292 |
|
|
|
38,965 |
|
|
Selling,
general and administrative |
|
25,236 |
|
|
|
14,431 |
|
|
|
48,206 |
|
|
|
25,818 |
|
Total operating expenses |
|
44,796 |
|
|
|
32,962 |
|
|
|
84,549 |
|
|
|
64,783 |
|
Loss from operations |
|
(38,192 |
) |
|
|
(30,822 |
) |
|
|
(63,727 |
) |
|
|
(62,643 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest
Income |
|
9 |
|
|
|
91 |
|
|
|
28 |
|
|
|
872 |
|
|
Interest
Expense |
|
(927 |
) |
|
|
(265 |
) |
|
|
(1,675 |
) |
|
|
(265 |
) |
|
Other income
(expense) |
|
(92 |
) |
|
|
(214 |
) |
|
|
(132 |
) |
|
|
(197 |
) |
Total other income (expense), net |
|
(1,010 |
) |
|
|
(388 |
) |
|
|
(1,779 |
) |
|
|
410 |
|
Loss before income taxes |
|
(39,202 |
) |
|
|
(31,210 |
) |
|
|
(65,506 |
) |
|
|
(62,233 |
) |
Income tax expense |
|
220 |
|
|
|
- |
|
|
|
358 |
|
|
|
- |
|
Net loss |
$ |
(39,422 |
) |
|
$ |
(31,210 |
) |
|
$ |
(65,864 |
) |
|
$ |
(62,233 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.94 |
) |
|
$ |
(0.83 |
) |
|
$ |
(1.59 |
) |
|
$ |
(1.65 |
) |
Weighted average common shares outstanding, basic and diluted |
|
42,119,850 |
|
|
|
37,786,208 |
|
|
|
41,414,254 |
|
|
|
37,722,965 |
|
|
|
|
|
|
|
|
|
|
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