G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today provided a corporate and financial update for the
second quarter ended June 30, 2023.
“We know the impact that trilaciclib can have on the lives of
people battling cancer; we see it every day in patients with
extensive stage small cell lung cancer who receive COSELA prior to
their chemotherapy. And, we’ve made good progress in further
developing the potential of the drug in clinical trials for
additional indications,” said Jack Bailey, Chief Executive Officer
of G1 Therapeutics. “As such, our focus remains on driving depth of
COSELA usage and adoption in our top accounts, despite a national
platinum-based chemotherapy shortage. We are also preparing for
multiple important data readouts expected early next year, and
ensuring our continued financial strength."
Second Quarter 2023 and Recent Highlights
Financial
- Recognized $11.1 Million in Net COSELA
Revenue: Results represent a 6% increase in net sales over
the first quarter of 2023. G1 recognized total revenues of $42.4
million for the second quarter of 2023.
- Received Net Proceeds of $27.0 Million for Relief of
Future Royalty Payments from Simcere: An additional $18.0
million would be due to G1 upon filing and approval of COSELA in
mainland China for patients with TNBC. All other aspects of the
strategic collaboration remain in place. G1 retains the rights to
trilaciclib throughout the rest of the world, other than Greater
China.
- Ended the Second Quarter of 2023 with Cash, Cash
Equivalents, and Marketable Securities of $104.2 Million.
The Company’s current financial position is expected to be
sufficient to fund G1’s operations and capital expenditures well
beyond its clinical trial readouts in the first quarter of
2024.
- Amended Debt Facility With Hercules Capital:
In June 2023, the debt facility was mutually amended, providing G1
with additional financial flexibility. As of June 30, 2023, the
total loan amount outstanding is $50.0 million.
Clinical
- Confirmed Expected Timing for Initial Results from
Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with
mTNBC; Interim Overall Survival (OS) Analysis Expected in the First
Quarter of 2024: The primary endpoint of PRESERVE 2 is to
evaluate the effect of trilaciclib on OS compared with placebo in
patients receiving first-line gemcitabine/carboplatin. 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. If 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.
- Presented Preliminary Phase 2 Results Confirming
Benefit of Trilaciclib in Reducing Adverse Events Related to an
ADC; OS Endpoints Expected in the First Quarter of 2024:
New results presented at the 2023 European Society of Medical
Oncology (ESMO) Breast Cancer Congress showed a clinically
meaningful on-target effect of trilaciclib to reduce (>50%) the
rates of multiple adverse events compared to the previously
published sacituzumab govitecan-hziy single agent safety
profile. The Company expects to reach the OS
endpoints in the first quarter of 2024. (press release here)
- Presented Phase 2 Results Showing that Trilaciclib
Increases the Pool of Memory T Cells in the Tumor Microenvironment
that Could Contribute to Long Term Immune Surveillance and
Efficacy: New results presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting
highlight the potential for trilaciclib to increase the pool of
functional memory T cells that could contribute to long-term immune
surveillance and efficacy, as measured by longer term endpoints
like OS. (press release here)
- Provided Initial Results from Phase 2 Bladder Cancer
Trial of Trilaciclib (PRESERVE 3); OS Endpoints Expected in the
First Quarter of 2024: Data generated across multiple
preclinical and clinical studies to date show that trilaciclib has
the greatest effect on longer term endpoints including OS rather
than earlier efficacy measures such as overall response rate (ORR)
and progression free survival (PFS), consistent with other
immunotherapies. As of the data cutoff on July 5, 2023, PFS is
similar between patients receiving trilaciclib prior to
gemcitabine/platinum + avelumab and patients receiving
gemcitabine/platinum + avelumab alone (median PFS=6.0 months and
6.1 months, respectively; hazard ratio=1.07). Median PFS was also
similar across arms in both PD-L1 subsets. Median duration of
response (DOR) favored participants that received trilaciclib (7.0
months) compared to those that did not (6.0 months); median DOR
also favored the trilaciclib arms in both PD-L1 subsets. The
Company expects to reach the OS endpoints in the first quarter of
2024.
Medical
- Presented Real World Data Confirming Consistent Risk of
Myelosuppression Across Patients Receiving Chemotherapy for Small
Cell Lung Cancer (SCLC): Results presented at the
International Society for Pharmacoeconomics and Outcomes Research
(ISPOR) 2023 meeting showed that grade ≥3 myelosuppression
(neutropenia, anemia, thrombocytopenia) occurred in 61% of patients
included in the overall population of studied patients. No
significant associations between patient characteristics and
myelosuppression were identified. (press release here)
- Announced New Publication Describing the Immune-Based
Mechanism of Trilaciclib: G1's manuscript entitled,
"Investigating Potential Immune Mechanisms of Trilaciclib
Administered Prior to Chemotherapy in Patients with Metastatic
Triple-Negative Breast Cancer" has been published in the Journal of
Breast Cancer Research and Treatment. (publication here)
Corporate
- Appointed Monica Roberts Thomas as General Counsel and
Chief Compliance Officer: Mrs. Thomas brings nearly two
decades of leadership experience in securities filings and
corporate governance, global regulatory engagement, and all aspects
of legal support for commercial organizations. (press release
here)
Second Quarter 2023 Financial Results
As of June 30, 2023, cash and cash equivalents and
marketable securities totaled $104.2 million, compared to $145.1
million as of December 31, 2022. On June 6, 2023, G1 and
Hercules Capital Inc. amended their loan and security agreement.
The amended terms modified certain tranche advances, lowered the
minimum cash covenant, and removed the existing minimum revenue
covenant and replaced it with a conditional borrowing base limit,
beginning with the financial reporting for the period ending
June 30, 2023. On closing, G1 paid down the loan by $25.0
million, resulting in a total loan amount outstanding of $50.0
million as of June 30, 2023.
Total revenues for the second quarter of 2023 were $42.4
million, including $11.1 million in net product sales of COSELA and
license revenue of $31.3 million, primarily related to the one-time
payment for the relief of future royalties from Simcere, supply and
manufacturing services and royalty revenue from Simcere, and
clinical trial reimbursements from EQRx and Simcere, compared to
$10.6 million in total revenues in the second quarter of 2022.
Operating expenses for the second quarter of 2023 were $30.9
million, compared to $47.5 million for the second quarter of 2022.
GAAP operating expenses include stock-based compensation expense of
$3.8 million for the second quarter of 2023, compared to $5.6
million for the second quarter of 2022.
Cost of goods sold expense for the second quarter of 2023 was
$1.4 million compared to $1.0 million for the second quarter of
2022, primarily due to an increase in product sales.
Research and development (R&D) expenses for the second
quarter of 2023 were $12.0 million, compared to $20.8 million for
the second 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
second quarter of 2023 were $17.4 million, compared to $25.7
million for the second quarter of 2022. The decrease in SG&A
expenses was primarily due to decreases in commercialization
activities, personnel costs, and medical affairs.
The net income for the second quarter of 2023 was $8.7 million,
compared to a net loss of $39.4 million for the second quarter of
2022. The basic and diluted net income per share for the second
quarter of 2023 was $0.17 and $0.14, respectively, compared to a
basic and diluted net loss per share of $(0.92) for the second
quarter of 2022.
2023 Financial Guidance
G1 today reiterated its full year 2023 net revenue guidance. The
Company expects to generate between $50 million and $60 million in
COSELA net revenue in 2023. G1's product revenue guidance was
initially provided in its fourth quarter and full year 2022
financial results and business update, and 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 second quarter
ended June 30, 2023.
Please note the new 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 that you 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 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
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 the 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, and the impact of
pandemics such as COVID-19 (coronavirus). 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
complete a successful 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) |
|
|
|
|
|
June 30, 2023 |
|
December 31, 2022 |
Cash and cash equivalents and Marketable securities |
$104,231 |
|
$145,070 |
Working Capital |
$106,524 |
|
$143,912 |
Total Assets |
$147,891 |
|
$187,965 |
Accumulated deficit |
$(750,903) |
|
$(732,018) |
Total stockholders'
equity |
$57,548 |
|
$68,747 |
|
|
|
|
|
G1 Therapeutics, Inc.Condensed Statements
of Operations (unaudited)(in thousands, except per share
data) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues |
|
|
|
|
|
|
|
Product sales, net |
$ |
11,091 |
|
|
$ |
8,718 |
|
|
$ |
21,583 |
|
|
$ |
14,198 |
|
License revenue |
|
31,301 |
|
|
|
1,855 |
|
|
|
33,755 |
|
|
|
3,277 |
|
Total revenues |
|
42,392 |
|
|
|
10,573 |
|
|
|
55,338 |
|
|
|
17,475 |
|
Operating expenses |
|
|
|
|
|
|
|
Cost of goods sold |
|
1,404 |
|
|
|
976 |
|
|
|
2,863 |
|
|
|
1,645 |
|
Research and development |
|
12,040 |
|
|
|
20,843 |
|
|
|
27,520 |
|
|
|
47,148 |
|
Selling, general and administrative |
|
17,432 |
|
|
|
25,716 |
|
|
|
39,185 |
|
|
|
52,425 |
|
Total operating expenses |
|
30,876 |
|
|
|
47,535 |
|
|
|
69,568 |
|
|
|
101,218 |
|
Income (loss) from
operations |
|
11,516 |
|
|
|
(36,962 |
) |
|
|
(14,230 |
) |
|
|
(83,743 |
) |
Other income (expense) |
|
|
|
|
|
|
|
Interest income |
|
643 |
|
|
|
50 |
|
|
|
1,359 |
|
|
|
59 |
|
Interest expense |
|
(2,710 |
) |
|
|
(2,407 |
) |
|
|
(5,799 |
) |
|
|
(4,672 |
) |
Other income (expense) |
|
569 |
|
|
|
(127 |
) |
|
|
1,093 |
|
|
|
(282 |
) |
Total other income (expense),
net |
|
(1,498 |
) |
|
|
(2,484 |
) |
|
|
(3,347 |
) |
|
|
(4,895 |
) |
Income (loss) before income
taxes |
|
10,018 |
|
|
|
(39,446 |
) |
|
|
(17,577 |
) |
|
|
(88,638 |
) |
Income tax expense |
|
1,308 |
|
|
|
— |
|
|
|
1,308 |
|
|
|
— |
|
Net income (loss) |
$ |
8,710 |
|
|
$ |
(39,446 |
) |
|
$ |
(18,885 |
) |
|
$ |
(88,638 |
) |
Earnings per share
attributable to common stockholders: |
|
|
|
|
|
|
|
Basic |
$ |
0.17 |
|
|
$ |
(0.92 |
) |
|
$ |
(0.37 |
) |
|
$ |
(2.08 |
) |
Diluted |
$ |
0.14 |
|
|
$ |
(0.92 |
) |
|
$ |
(0.37 |
) |
|
$ |
(2.08 |
) |
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
51,667,099 |
|
|
|
42,707,703 |
|
|
|
51,657,456 |
|
|
|
42,697,508 |
|
Diluted |
|
61,040,507 |
|
|
|
42,707,703 |
|
|
|
51,657,456 |
|
|
|
42,697,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
G1 Therapeutics (NASDAQ:GTHX)
過去 株価チャート
から 4 2024 まで 5 2024
G1 Therapeutics (NASDAQ:GTHX)
過去 株価チャート
から 5 2023 まで 5 2024