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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported):
August 14, 2023
Checkpoint Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware |
|
001-38128 |
|
47-2568632 |
(State
or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS Employer Identification No.) |
95 Sawyer Road, Suite 110,
Waltham, MA 02453
(Address of Principal Executive Offices)
(781) 652-4500
(Registrant’s telephone number, including
area code)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Exchange
Act:
Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which
registered |
Common Stock, par value $0.0001 per share |
CKPT |
NASDAQ Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth
company x
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations
and Financial Condition.
On August 14, 2023,
Checkpoint Therapeutics, Inc. issued a press release to provide a corporate update and to announce its financial results for the second
quarter ended June 30, 2023. A copy of such press release is being furnished as Exhibit 99.1 to this report.
The information, including
Exhibit 99.1, in this Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Form 8-K shall not
be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall otherwise be expressly set
forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished herewith:
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
Checkpoint Therapeutics, Inc. |
|
(Registrant) |
|
|
|
|
Date: August 14, 2023 |
By |
/s/ James F. Oliviero |
|
|
James F. Oliviero |
|
|
President and Chief Executive Officer |
Exhibit 99.1
Checkpoint Therapeutics Reports Second Quarter
2023 Financial Results and Recent Corporate Highlights
Biologics License Application
for cosibelimab under review by U.S. FDA; Successful mid-cycle meeting with U.S. FDA completed; PDUFA goal date of January 3, 2024
Longer-term cosibelimab
results demonstrate substantial increases in complete response rates and continued favorable safety profile in advanced cutaneous squamous
cell carcinoma
Unique potential for
cosibelimab to address a large unmet clinical need in immunosuppressed and high risk patients
Waltham, MA – August 14, 2023 –
Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company,
today announced financial results for the second quarter ended June 30, 2023, and recent corporate highlights.
“We continue to work with the U.S. Food
and Drug Administration (“FDA”) toward the January 3, 2024 action date for our Biologics License Application (“BLA”)
for cosibelimab. Recently, our mid-cycle communication meeting with the FDA was successfully completed, and the FDA noted that no significant
review issues or safety concerns have been identified in their review to date,” said James Oliviero, President and Chief Executive
Officer of Checkpoint.
“We are also encouraged by the recently
announced longer-term data from our pivotal studies of cosibelimab in locally advanced and metastatic cutaneous squamous cell carcinoma
(“cSCC”), which demonstrate a deepening of response with cosibelimab treatment over time, resulting in substantially higher
complete response rates than previously reported. Specifically, complete response rates more than doubled from 10% to 23% in locally advanced
cSCC and nearly doubled, from 8% to 13%, in metastatic cSCC,” continued Oliviero. “We believe cosibelimab’s unique dual
mechanism of action will benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive
conditions or taking immunosuppressive medications who are in need of more effective treatment options than available today.”
“Equally important, longer-term results
continue to confirm cosibelimab's favorable safety profile, with only 2% of patients experiencing a severe immune-related adverse event
(“irAE”) and only 1% discontinuing treatment because of an irAE, substantially lower rates than observed with currently approved
immunotherapies. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of
oncologists for high-risk patients, such as those with solid organ transplants or autoimmune disease, upon its potential launch early
next year,” concluded Oliviero.
Recent Corporate Highlights:
| ● | Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023. In March 2023,
Checkpoint announced the FDA accepted the BLA filing for cosibelimab and set a Prescription Drug User Fee Act (“PDUFA”) goal
date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified,
and that an advisory committee meeting to discuss the application is not currently planned. |
| ● | In April, May and July 2023, Checkpoint completed registered
direct offerings priced at-the-market under Nasdaq rules for total gross proceeds of approximately $26.1 million. |
| ● | In June 2023, Checkpoint announced that new pharmacokinetic
modeling data on cosibelimab supporting the extension to an every-three-week dosing regimen were presented at the Population Approach
Group Europe 2023 annual meeting. Results support the comparability of cosibelimab 800 mg every-two-week and 1200 mg every-three-week
dosing regimens. |
| ● | In July 2023, Checkpoint announced new, longer-term data for
cosibelimab from its pivotal studies in locally advanced and metastatic cSCC. These results demonstrate a deepening of response with
cosibelimab treatment over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses
continue to remain durable over time with the median duration of response not yet reached in either the locally advanced or metastatic
cSCC group. |
Financial Results:
| ● | Cash Position: As of June 30, 2023, Checkpoint’s
cash and cash equivalents totaled $7.4 million, compared to $4.8 million at March 31, 2023 and $12.1 million at December 31, 2022, an
increase of $2.6 million for the quarter and a decrease of $4.7 million for the first half of 2023. Subsequent to the end of the second
quarter, Checkpoint raised approximately $10.0 million of gross proceeds in a registered direct offering completed in July 2023. |
| ● | R&D Expenses: Research and development expenses for the second quarter of 2023 were $13.9 million,
compared to $12.1 million for the second quarter of 2022, an increase of $1.8 million. Research and development expenses for the second
quarter of 2023 primarily consisted of $9.9 million related to commercial manufacturing costs and inventory build for cosibelimab to support
a potential 2024 launch. |
| ● | G&A Expenses: General and administrative expenses for the second quarter of 2023 were $2.3
million, compared to $2.1 million for the second quarter of 2022, an increase of $0.2 million. General and administrative expenses for
the second quarter of 2023 included $0.8 million of non-cash stock expenses, compared to $0.5 million for the second quarter of 2022. |
| ● | Net Loss: Net loss attributable to common stockholders for the second quarter of 2023 was $16.5
million, or $1.05 per share, compared to a net loss of $14.1 million, or $1.62 per share, in the second quarter of 2022. Net loss for
the second quarter of 2023 included $1.0 million of non-cash stock expenses, compared to $0.7 million for the second quarter of 2022. |
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”)
is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel
treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential
best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing open-label, multi-regional, multicohort
Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including cohorts in metastatic
and locally advanced cSCC intended to support one or more applications for marketing approval. Based on positive topline and interim results
in metastatic and locally advanced cSCC, respectively, Checkpoint submitted a BLA for these indications in January 2023, which application
is filed and under review with a PDUFA goal date of January 3, 2024. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer
agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential
new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was
founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited
to, statements regarding the FDA review of the BLA for the approval of cosibelimab for the treatment of patients with metastatic or locally
advanced cSCC who are not candidates for curative surgery or radiation and the commercial potential of cosibelimab if the BLA is approved,
statements relating to the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the
currently available anti-PD-1 therapies, the two-fold mechanism of action of cosibelimab translating into potential enhanced efficacy,
and our projections of publication and regulatory review timelines. Factors that could cause our actual results to differ materially include
the following: the risk that topline and interim data remains subject to audit and verification procedures that may result in the final
data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be
observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does
not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval
of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will
not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks
related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain,
perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional
funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent
and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones
we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of
those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and
in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in
its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release
should be read as applying mutatis mutandis to every other instance of such information appearing herein.
Any forward-looking statements set forth in this
press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly
any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in
events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases
are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and
is included for reference purposes only.
Company Contact:
Jaclyn Jaffe
Checkpoint Therapeutics, Inc.
(781) 652-4500
ir@checkpointtx.com
Investor Relations Contact:
Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
(617) 430-7577
arr@lifesciadvisors.com
Media Relations Contact:
Katie Kennedy
Gregory FCA
610-731-1045
Checkpoint@gregoryfca.com
CHECKPOINT THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and per share amounts)
(Unaudited)
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
7,421 |
|
|
$ |
12,068 |
|
Prepaid expenses and other current assets |
|
|
886 |
|
|
|
1,149 |
|
Other receivables - related party |
|
|
31 |
|
|
|
73 |
|
Total current assets |
|
|
8,338 |
|
|
|
13,290 |
|
Total Assets |
|
$ |
8,338 |
|
|
$ |
13,290 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
25,194 |
|
|
$ |
20,297 |
|
Accounts payable and accrued expenses - related party |
|
|
2,453 |
|
|
|
1,306 |
|
Common stock warrant liabilities |
|
|
3,961 |
|
|
|
11,170 |
|
Total current liabilities |
|
|
31,608 |
|
|
|
32,773 |
|
Total Liabilities |
|
|
31,608 |
|
|
|
32,773 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ (Deficit) Equity |
|
|
|
|
|
|
|
|
Common Stock ($0.0001 par value), 80,000,000 and 50,000,000 shares authorized as of June 30, 2023 and December 31, 2022, respectively |
|
|
|
|
|
|
|
|
Class A common shares, 700,000 shares issued and outstanding as of June 30, 2023 and December 31, 2022 |
|
|
- |
|
|
|
- |
|
Common shares, 17,238,393 and 9,586,683 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
|
|
2 |
|
|
|
1 |
|
Common stock issuable, 0 and 368,907 shares as of June 30, 2023 and December 31, 2022, respectively |
|
|
- |
|
|
|
1,885 |
|
Additional paid-in capital |
|
|
266,209 |
|
|
|
241,117 |
|
Accumulated deficit |
|
|
(289,481 |
) |
|
|
(262,486 |
) |
Total Stockholders’ (Deficit) Equity |
|
|
(23,270 |
) |
|
|
(19,483 |
) |
Total Liabilities and Stockholders’ (Deficit) Equity |
|
$ |
8,338 |
|
|
$ |
13,290 |
|
CHECKPOINT THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(Unaudited)
| |
For the three months ended June 30, | | |
For the six months ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue - related party | |
$ | 31 | | |
$ | 18 | | |
$ | 66 | | |
$ | 70 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 13,945 | | |
| 12,053 | | |
| 29,771 | | |
| 26,723 | |
General and administrative | |
| 2,281 | | |
| 2,129 | | |
| 4,573 | | |
| 4,372 | |
Total operating expenses | |
| 16,226 | | |
| 14,182 | | |
| 34,344 | | |
| 31,095 | |
Loss from operations | |
| (16,195 | ) | |
| (14,164 | ) | |
| (34,278 | ) | |
| (31,025 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 31 | | |
| 22 | | |
| 74 | | |
| 35 | |
(Loss) gain on common stock warrant liabilities | |
| (357 | ) | |
| - | | |
| 7,209 | | |
| - | |
Total other income | |
| (326 | ) | |
| 22 | | |
| 7,283 | | |
| 35 | |
Net Loss | |
$ | (16,521 | ) | |
$ | (14,142 | ) | |
$ | (26,995 | ) | |
$ | (30,990 | ) |
| |
| | | |
| | | |
| | | |
| | |
Loss per Share: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common share outstanding | |
$ | (1.05 | ) | |
$ | (1.62 | ) | |
$ | (1.97 | ) | |
$ | (3.59 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted weighted average number of common shares outstanding | |
| 15,700,324 | | |
| 8,750,982 | | |
| 13,735,646 | | |
| 8,628,665 | |
v3.23.2
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Aug. 14, 2023 |
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Checkpoint Therapeutics (NASDAQ:CKPT)
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