ctic-20201110
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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): November 10, 2020
 
CTI BIOPHARMA CORP.
(Exact name of registrant as specified in its charter)
 
Delaware000-2838691-1533912
(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: (206282-7100
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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001CTICNasdaq 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 November 10, 2020, CTI BioPharma Corp. issued a press release announcing its financial results for the quarter ended September 30, 2020 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.
DescriptionLocation
99.1Furnished herewith.
104Cover Page Interactive Data File (embedded within the Inline XBRL document)






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: November 10, 2020

By:

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




Document

Exhibit 99.1
https://cdn.kscope.io/b59f867c41b068e52324b3f58bfc1a8c-imagea151a.jpg
CTI BioPharma Reports Third Quarter 2020 Financial Results

– Rolling NDA Submission for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Initiated in October –

– Completion of Submission Expected in First Quarter 2021 –

– Management to Host Conference Call Today at 4:30 PM ET –


SEATTLE, Nov. 10, 2020 - CTI BioPharma Corp. (Nasdaq: CTIC) today reported its financial results for the third quarter and nine months ended September 30, 2020.

“This past quarter we made significant progress in our pacritinib development program. We recently announced the initiation of our rolling New Drug Application (NDA) submission for pacritinib in myelofibrosis patients with severe thrombocytopenia, following a productive Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) on how pacritinib could address the unmet need of this population, which includes both front-line treatment-naïve patients and patients with prior exposure to JAK2 inhibitors,” said Adam R. Craig, M.D., Ph.D. “The NDA submission package will be based on available data from the completed Phase 3 PERSIST-1 and PERSIST-2, and the Phase 2 PAC203 trials, and we expect to complete the submission in the first quarter of 2021. Additionally, we have started pre-commercial activities in preparation for a commercial launch in 2021, subject to priority review.”

Expected Milestones
Oral presentation of preclinical and Phase 1 trial data of pacritinib in acute graft-versus-host disease (GVHD) at American Society of Hematology (ASH) 2020 – December 6, 2020
Expected completion of rolling NDA submission for pacritinib in myelofibrosis patients with severe thrombocytopenia – Q1 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 – First half of 2021

Third Quarter Financial Results
Operating loss was $11.0 million and $33.0 million for the three and nine months ended September 30, 2020, respectively, compared to an operating loss of $9.7 million and $31.2 million for the respective periods in 2019. Operating loss for the three months ended September 30, 2020 as compared to the comparable period in 2019 resulted primarily from a decrease in license and contract revenues. The increase in operating loss for the nine



months ended September 30, 2020 as compared to the comparable period in 2019 resulted primarily from the recording of a full allowance against certain VAT receivables due to a reduced certainty of collectability.

No revenues were recognized for the three and nine months ended September 30, 2020, while revenues of $2.3 million and $3.3 million, respectively, were recognized for the comparable periods in 2019. License and contract revenues in 2019 resulted from royalty and other revenues recognized from Les Laboratoires Servier and Institut de Recherches Internationales Servier (“Servier”) and related to the asset purchase agreement and transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.

Net loss for the three months ended September 30, 2020 was $11.3 million, or $0.15 for basic and diluted loss per share, compared to net loss of $10.0 million, or $0.17 for basic and diluted loss per share, for the same period in 2019. Net loss for the nine months ended September 30, 2020 was $37.4 million, or $0.54 for basic and diluted loss per share, compared to net loss of $31.8 million, or $0.55 for basic and diluted loss per share, for the same period in 2019.

As of September 30, 2020, cash, cash equivalents and short-term investments totaled $57.4 million, compared to $33.7 million as of December 31, 2019. We expect current cash, cash equivalents and short-term investments will enable us to fund our operations into the fourth quarter of 2021.

Conference Call and Webcast
CTI will host a conference call and webcast to review its third quarter 2020 financial results and provide an update on business activities today, November 10 at 4:30 PM ET. To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 5504037. A live audio webcast of the event may also be accessed through the "Investors" section of CTI's website at www.ctibiopharma.com. A replay of the webcast will be available for 30 days following the event.

About CTI BioPharma Corp.
We are 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. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

Forward-Looking Statements



Statements included in this press release that are not historical in nature are 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 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 include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of our PACIFICA Phase 3 trial and our PRE-VENT Phase 3 trial; the risk that 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; the risk that the FDA may determine that the benefit/risk profile of pacritinib in the PRE-VENT Phase 3 trial does not support approval or requires additional clinical data for approval; the risk that pacritinib may fail in its development through our PACIFICA and PRE-VENT trial; our ability to submit a rolling NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; the accuracy of our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations; risks and uncertainties related to the COVID-19 pandemic as it relates to our operations and ongoing clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. 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

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CTI BioPharma Corp.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
 2020201920202019
License and contract revenues$— $2,289 $— $3,345 
Operating costs and expenses:   
Research and development6,994 7,598 16,457 19,126 
General and administrative4,052 4,403 12,316 14,662 
Restructuring expenses— — — 794 
Other operating expenses— — 4,200 — 
Total operating costs and expenses11,046 12,001 32,973 34,582 
Loss from operations(11,046)(9,712)(32,973)(31,237)
Non-operating income (expense):   
Interest income25 276 187 1,003 
Interest expense(115)(240)(419)(803)
Amortization of debt discount and issuance costs(131)(131)(391)(391)
Foreign exchange gain (loss)(240)(79)(409)
Loss on dissolution of majority-owned subsidiary— — (3,774)— 
Total non-operating expense, net(217)(335)(4,476)(600)
Net loss before noncontrolling interest(11,263)(10,047)(37,449)(31,837)
Noncontrolling interest— — — 
Net loss$(11,263)$(10,047)$(37,449)$(31,832)
Basic and diluted net loss per common share $(0.15)$(0.17)$(0.54)$(0.55)
Shares used in calculation of basic and diluted net loss per common share:73,712 57,974 69,966 57,973 

Balance Sheet Data (unaudited):(amounts in thousands)
September 30,December 31,
20202019
Cash and cash equivalents $45,301 $31,144 
Short-term investments12,111 2,522 
Working capital44,169 17,092 
Total assets63,091 46,280 
Current portion of long-term debt5,658 4,812 
Long-term debt, less current portion— 4,455 
Total stockholders' equity46,819 17,930