Document

 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 1, 2019
 

CTI BIOPHARMA CORP.
(Exact name of registrant as specified in its charter)
 

Delaware
 
000-28386
 
91-1533912
(State or other jurisdiction of
incorporation or organization)
 
(Commission
File Number)
 
(I.R.S. Employer
Identification Number)
3101 Western Avenue, Suite 800
Seattle, Washington 98121
(Address of principal executive offices)
Registrant’s telephone number, including area code: (206) 282-7100
Not applicable
(Former name or former address, if changed since last report)
 

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-2(b) 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 Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001
CTIC
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 or Rule 12b-2 of the Securities Exchange Act of 1934.

¨

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 1, 2019, CTI BioPharma Corp. issued a press release announcing its financial results for the quarter ended June 30, 2019 and certain other information. The full text of the press release is set forth in Exhibit 99.1 hereto. The information in this Current Report on Form 8-K and the attached exhibit are furnished to, but not filed with, the Securities and Exchange Commission.

Item 9.01. Financial Statements and Exhibits.
(d) Exhibits

Pursuant to the rules and regulations of the Securities and Exchange Commission, the attached exhibit is deemed to have been furnished to, but not filed with, the Securities and Exchange Commission:
Exhibit
No.
 
Description
 
Location
99.1
 
 
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.

 
 
CTI BIOPHARMA CORP.

Date: August 1, 2019
 

By:
 

/s/ David H. Kirske
 
 
 
 
David H. Kirske
 
 
 
 
Chief Financial Officer




Exhibit
Exhibit 99.1
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=13036818&doc=3
CTI BioPharma Reports Second Quarter 2019 Financial Results


SEATTLE, Aug. 1, 2019 - CTI BioPharma Corp. (Nasdaq: CTIC) today reported its financial results for the second quarter and six months ended June 30, 2019.

“We remain focused on advancing our development program for pacritinib in the U.S. for the treatment of myelofibrosis patients with severe thrombocytopenia,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. “In June, we met with the U.S. Food and Drug Administration (FDA), and following that meeting, plan to evaluate the 200 mg twice-daily dose of pacritinib in the new PACIFICA Phase 3 trial. We have submitted for FDA review an amendment to the PAC203 protocol to allow a rapid transition to the PACIFICA Phase 3 trial, which we expect to initiate in the third quarter of 2019. In addition, based on multiple requests from physicians, in May we made the decision to undertake a pacritinib Expanded Access Program (EAP) for patients in the PAC203 trial. To facilitate this, we have extended the PAC203 trial to enable the patients to continue to receive uninterrupted treatment through the start of the EAP. In light of this change, we now intend to first report results from the PAC203 Phase 2 trial at a scientific conference before the end of the year.”

Recent Updates
Following a Type B, End-of-Phase-2a meeting with the FDA in June, the Company announced that it plans to evaluate 200 mg of pacritinib administered twice daily (BID) compared to Physician’s Choice in a Phase 3 trial of 180 patients with myelofibrosis and severe thrombocytopenia (platelet counts of less than 50,000 per microliter).

In July 2019, the Company submitted an amendment to the PAC203 trial protocol to allow a transition to the new PACIFICA Phase 3 trial. The Company plans to initiate the PACIFICA Phase 3 trial in the third quarter of 2019.

Expected 2019 Milestones
Initiate PACIFICA Phase 3 trial of pacritinib in myelofibrosis patients with severe thrombocytopenia - Q3 2019
Report safety and efficacy data from the PAC203 Phase 2 trial at a scientific conference before the end of 2019





Second Quarter Financial Results
License and contract revenues for the three and six months ended June 30, 2019 were $0.4 million and $1.1 million, respectively, compared to $0.6 million and $11.5 million for the respective periods in 2018. The decrease in license and contract revenues for the three months ended June 30, 2019 compared to the comparable period in 2018 is primarily due to a decrease in development services revenue from our partners Les Laboratoires Servier and Institut de Recherches Internationales Servier. The decrease in license and contract revenues for the six months ended June 30, 2019 compared to the same period in 2018 is primarily due to the recognition of $10.0 million in milestone revenue in 2018 from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX® (arsenic trioxide) for first-line treatment of acute promyelocytic leukemia. There were no such revenues for the comparable period in 2019.

Operating loss was $11.0 million and $21.5 million for the three and six months ended June 30, 2019, respectively, compared to operating loss of $14.0 million and $18.3 million for the respective periods in 2018. Operating loss during the three-month period ended June 30, 2019 as compared to the comparable period in 2018 resulted primarily from a decrease in research and development expenses. Operating loss for the six months ended June 30, 2019 as compared to the same period in 2018 resulted primarily from the decrease in license and contract revenues as mentioned above, as well as a decrease in research and development expenses.

Net loss attributable to common stockholders for the three months ended June 30, 2019 was $11.0 million, or $(0.19) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $11.3 million, or $(0.20) for basic and diluted loss per share, for the same period in 2018. Net loss attributable to common stockholders for the six months ended June 30, 2019 was $21.8 million, or $(0.38) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $15.4 million, or $(0.29) for basic and diluted loss per share, for the same period in 2018.

As of June 30, 2019, cash, cash equivalents and short-term investments totaled $53.7 million, compared to $67.0 million as of December 31, 2018.

About CTI BioPharma Corp.
CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

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 and the Private Securities Litigation Reform Act of




1995. These forward-looking statements include statements regarding our expectations regarding: our ability to commence the PACIFICA Phase 3 trial of pacritinib; the anticipated trial design and enrollment of the PACIFICA Phase 3 trial; the effectiveness of, and potential changes to, the PACIFICA Phase 3 trial design; the timing of, and results from, clinical trials and other development activities related to pacritinib, including the anticipated PACIFICA Phase 3 trial and its related protocol; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of pacritinib; and the anticipated timing of regulatory submissions and interactions, including FDA review of the amended PACIFICA Phase 3 protocol; our ability to successfully develop and achieve milestones in the development of pacritinib; and the anticipated benefits of pacritinib. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of pacritinib; the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval based on the results of such trial, previously identified FDA concerns regarding safety and dosing limitations or otherwise; pacritinib may fail in development, may not receive required regulatory approvals, or may be delayed to a point where it is not commercially viable; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; we may not achieve additional milestones in our pacritinib development program; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

“CTI BioPharma” and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

CTI BioPharma Investor Contacts:
Maeve Conneighton/Maghan Meyers
+212-600-1902
cti@argotpartners.com

(tables follow)






CTI BioPharma Corp.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
 
Three Months Ended
 June 30,
 
Six Months Ended
 June 30,
 
2019
 
2018
 
2019
 
2018
License and contract revenues
$
416

 
$
613

 
$
1,056

 
$
11,459

Operating costs and expenses:
 

 
 

 
 

 
 
Research and development
6,356

 
9,124

 
11,528

 
18,809

Selling, general and administrative
5,053

 
5,490

 
10,259

 
10,987

Restructuring expenses

 

 
794

 

Total operating costs and expenses
11,409

 
14,614

 
22,581

 
29,796

Loss from operations
(10,993
)
 
(14,001
)
 
(21,525
)
 
(18,337
)
Non-operating income (expense):
 

 
 

 
 

 
 
Interest income
347

 
364

 
727

 
364

Interest expense
(269
)
 
(297
)
 
(563
)
 
(585
)
Amortization of debt discount and issuance costs
(130
)
 
(130
)
 
(260
)
 
(264
)
Foreign exchange gain (loss)
69

 
(1,575
)
 
(169
)
 
(852
)
Other non-operating income

 
4,295

 

 
4,295

Total non-operating income (expense), net
17

 
2,657

 
(265
)
 
2,958

Net loss before noncontrolling interest
(10,976
)
 
(11,344
)
 
(21,790
)
 
(15,379
)
Noncontrolling interest
5

 
8

 
5

 
22

Net loss
(10,971
)
 
(11,336
)
 
(21,785
)
 
(15,357
)
     Deemed dividends on preferred stock

 

 

 
(80
)
Net loss attributable to common stockholders
$
(10,971
)
 
$
(11,336
)
 
$
(21,785
)
 
$
(15,437
)
Basic and diluted net loss per common share
$
(0.19
)
 
$
(0.20
)
 
$
(0.38
)
 
$
(0.29
)
Shares used in calculation of basic and diluted net loss per common share:
57,973

 
57,941

 
57,973

 
54,148



Balance Sheet Data (unaudited):
 
(amounts in thousands)
 
 
June 30,
 
December 31,
 
 
2019
 
2018
Cash and cash equivalents
 
$
35,364

 
$
36,439

Short-term investments
 
18,297

 
30,599

Working capital
 
38,653

 
59,437

Total assets
 
66,243

 
89,832

Current portion of long-term debt
 
4,812

 
4,812

Long-term debt, less current portion
 
6,861

 
9,267

Total stockholders' equity
 
34,985

 
52,939