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SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 OF

THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2019

_______________________

BioLineRx Ltd.

(Translation of Registrant’s name into English)

_______________________

2 HaMa’ayan Street

Modi’in 7177871, Israel

(Address of Principal Executive Offices)

_______________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F ☒          Form 40-F ☐

Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:

Yes ☐          No ☒

On November 11, 2019, the Registrant issued a press release announcing its financial results for the three and nine months ended September 30, 2019. The Registrant is hereby also publishing its unaudited interim consolidated financial statements, as well as its operating and financial review, as of September 30, 2019 and for the three and nine months then ended. Attached hereto are the following exhibits:

 

 

 

 

This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933.

 

 

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, thereunto duly authorized.

BioLineRx Ltd. By:  /s/ Philip Serlin           Philip Serlin Chief Executive Officer

Dated: November 12, 2019

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For Immediate Release

BioLineRx Reports Third Quarter 2019 Financial Results

and Provides Corporate Update

- On track for Phase 2 triple-combination data read-outs

in pancreatic cancer by year-end 2019 -

- Management to hold conference call today,

November 11, at 10:00 am EST -

TEL AVIV, Israel, November 11, 2019 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the quarter ended September 30, 2019 and provides a corporate update.

Highlights and achievements during the third quarter 2019 and subsequent period:

 

 

 

 

 

“We are quickly approaching a potentially transformational milestone for our Company with the anticipated release of results by the end of the year from the triple combination arm of our ongoing COMBAT/KEYNOTE-202 study of BL-8040, KEYTRUDA^® and chemotherapy in metastatic pancreatic cancer,” stated Philip Serlin, Chief Executive Officer of BioLineRx. “Recent preclinical results from the triple combination of BL-8040, an anti PD-1 and chemotherapy, together with clinical results from two separate dual combination studies of BL-8040 and KEYTRUDA^®, give us a high degree of conviction in BL-8040’s ability to modify the tumor microenvironment, thereby inducing infiltration of T-cells into the core and periphery of metastatic lesions. Based on our data to date, we believe we can potentially introduce a promising new treatment option not only for metastatic pancreatic cancer, but other difficult-to-treat solid tumor indications as well, where current standards of care are inadequate. At the same time, our trials of BL-8040 in AML and stem cell mobilization are progressing, with key data readouts expected next year.”

“Regarding our second clinical candidate, the universal anti-cancer vaccine AGI-134, we successfully completed Part 1 of the ongoing Phase 1/2a clinical trial in a range of solid tumor types, and quickly initiated dosing in Part 2. We look forward to initial results by year-end 2020,” Mr. Serlin concluded.

Upcoming Milestones

 

 

 

 

 

 

 

Financial Results for the Third Quarter Ended September 30, 2019

Research and development expenses for the three months ended September 30, 2019 were $5.6 million, an increase of $0.6 million, or 11%, compared to $5.0 million for the three months ended September 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT/KEYNOTE-202 clinical trials. Research and development expenses for the nine months ended September 30, 2019 were $15.3 million, an increase of $0.7 million, or 5%, compared to $14.6 million for the nine months ended September 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040 GENESIS and COMBAT/KEYNOTE-202 clinical trials, offset by a decrease in expenses related to BL-1230, a project which was terminated.

Sales and marketing expenses for the three months ended September 30, 2019 were $0.2 million, a decrease of $0.1 million, or 31%, compared to $0.3 million for the three months ended September 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses. Sales and marketing expenses for the nine months ended September 30, 2019 were $0.7 million, a decrease of $0.4 million, or 40%, compared to $1.1 million for the nine months ended September 30, 2018. The decrease resulted primarily from a decrease in payroll and related expenses, including a one-time compensation payment in the 2018 period.

General and administrative expenses for the three months ended September 30, 2019 were $0.9 million, similar to the comparable period in 2018. General and administrative expenses for the nine months ended September 30, 2019 were $2.8 million, similar to the comparable period in 2018.

The Company’s operating loss for the three months ended September 30, 2019 was $6.6 million, compared to $6.2 million for the three months ended September 30, 2018. The Company’s operating loss for the nine months ended September 30, 2019 was $18.7 million, compared to $18.6 million for the comparable period in 2018.

Non-operating income for the three and nine months ended September 30, 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses. Non-operating income (expense) for the three and nine months ended September 30, 2018 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, as well as a capital gain from realization of the investment in iPharma.

Net financial expenses amounted to $0.4 million for the three months ended September 30, 2019 compared to net financial income of $0.1 million for the three months ended September 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on bank deposits. Net financial expenses amounted to $0.9 million for the nine months ended September 30, 2019 compared to net financial income of $0.4 million for the nine months ended September 30, 2018. Net financial expenses for the 2019 period primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial income for the 2018 period primarily relates to investment income earned on bank deposits, offset by losses recorded on foreign currency hedging transactions.

The Company’s net loss for the three months ended September 30, 2019 amounted to $3.9 million, compared with a net loss of $6.3 million for the comparable period in 2018. The Company’s net loss for the nine months ended September 30, 2019 amounted to $15.6 million, compared with a net loss of $17.3 million for the comparable period in 2018.

The Company held $30.1 million in cash, cash equivalents and short-term bank deposits as of September 30, 2019.

Net cash used in operating activities was $17.2 million for the nine months ended September 30, 2019, compared with net cash used in operating activities of $19.0 million for the nine months ended September 30, 2018. The $1.8 million decrease in net cash used in operating activities during the nine-month period in 2019, compared to the nine-month period in 2018, was primarily the result of changes in operating asset and liability items in the two periods., i.e., a decrease in prepaid expenses and other receivables in 2019 versus an increase in 2018, as well as an increase in accounts payable and accruals in 2019 versus a decrease in 2018.

Net cash provided by investing activities was $2.1 million for the nine months ended September 30, 2019, compared to net cash provided by investing activities of $16.0 million for the nine months ended September 30, 2018. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and the realization of the investment in iPharma in 2018.

Net cash provided by financing activities was $16.6 million for the nine months ended September 30, 2019, compared to net cash provided by financing activities of $2.8 million for the nine months ended September 30, 2018. The increase in cash flows from financing activities reflects the underwritten public offering completed in February 2019.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, November 11, 2019 at 10:00 a.m. EST. To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until November 13, 2019; please dial +1-888-782-4291 from the U.S. or +972-3-925-5904 internationally.

(Tables follow)

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on multiple oncology indications. The Company’s lead program, BL-8040, is a cancer therapy platform currently being evaluated in a Phase 2a study in pancreatic cancer in combination with KEYTRUDA^® and chemotherapy under a collaboration agreement with MSD. BL-8040 is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation. In addition, the Company has an ongoing collaboration agreement with Genentech, a member of the Roche Group, evaluating BL-8040 in combination with Genentech’s atezolizumab in two Phase 1b/2 solid tumor studies.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being evaluated in a Phase 1/2a study.

For additional information on BioLineRx, please visit the Company’s website at www.biolinerx.com, where you can review the Company’s SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.

Various statements in this release concerning BioLineRx’s future expectations constitute "forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may,” "expects,” "anticipates,” "believes,” and "intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2019. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

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Exhibit 2

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(UNAUDITED)

AS OF SEPTEMBER 30, 2019

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(UNAUDITED)

AS OF SEPTEMBER 30, 2019

TABLE OF CONTENTS

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY

(UNAUDITED)

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

BioLineRx Ltd.

CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

BioLineRx Ltd.

APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS

(UNAUDITED)

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

NOTE 1 – GENERAL INFORMATION

BioLineRx Ltd. (“BioLineRx”), headquartered in Modi’in, Israel, was incorporated and commenced operations in April 2003.

BioLineRx and its subsidiaries (collectively, the “Company”) are engaged in the development of therapeutics, primarily in clinical-stages, with a focus on the field of oncology.

In February 2007, BioLineRx listed its ordinary shares on the Tel Aviv Stock Exchange (“TASE”) and they have been traded on the TASE since that time. Since July 2011, BioLineRx’s American Depositary Shares (“ADSs”) have also been traded on the NASDAQ Capital Market.

In March 2017, the Company acquired Agalimmune Ltd. (“Agalimmune”), a privately-held company incorporated in the United Kingdom, with a focus on the field of immuno-oncology.

Although the Company has generated significant revenues from a number of out-licensing transactions in the past, the Company cannot determine with reasonable certainty when and if it will have sustainable profits.

The condensed consolidated interim financial statements of the Company as of September 30, 2019, and for the three and nine months then ended, were approved by the Board of Directors on November 7, 2019, and signed on its behalf by the Chairman of the Board, the Chief Executive Officer and the Chief Financial Officer.

On July 15, 2019, the Company implemented a change in the ratio of its ADSs to ordinary shares, from one ADS representing one ordinary share to a new ratio of one ADS representing 15 ordinary shares. All ADSs and per ADSs amounts in these financial statements have been retroactively adjusted as if the change in ratio had been effected at the earliest date of these financial statements.

NOTE 2 – BASIS OF PREPARATION

 

The Company’s condensed consolidated interim financial statements as of September 30, 2019 and for the three and nine months then ended (the “interim financial statements”) have been prepared in accordance with International Accounting Standard No. 34, “Interim Financial Reporting” (“IAS 34”). These interim financial statements, which are unaudited, do not include all disclosures necessary for a fair statement of financial position, results of operations, and cash flows in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”). The condensed consolidated interim financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2018 and for the year then ended and their accompanying notes, which have been prepared in accordance with IFRS. The results of operations for the three and nine months ended September 30, 2019 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.

NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES

 

The accounting policies and calculation methods applied in the preparation of these interim financial statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2018 and for the year then ended, except for the adoption of IFRS No. 16, “Leases”.

The Company has adopted IFRS 16 retrospectively from January 1, 2019 but has not restated comparatives for the 2018 reporting period, as permitted under the specific transitional provisions in the standard. On adoption of IFRS 16, the Company recognized lease liabilities in relation to leases which had previously been classified as “operating leases” under the principles of IAS 17, “Leases.” These liabilities were measured at the present value of the remaining lease payments, discounted using the lessee’s incremental borrowing rate as of January 1, 2019. The remeasurements to the lease liabilities were recognized as adjustments to the related right-of-use assets immediately after the date of initial application. The associated right-of-use assets for property leases were measured on a retrospective basis as if the new rules had always been applied. Other right-of use assets were measured at the amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments relating to that lease recognized in the balance sheet as of December 31, 2018. The lessee’s weighted average incremental borrowing rate applied to the lease liabilities on January 1, 2019 was 15.1%.

 

 

NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES (cont.)

 

In applying IFRS 16 for the first time, the Company has used the following practical expedients permitted by the standard:

The Company has also elected not to reassess whether a contract is, or contains, a lease at the date of initial application. Instead, for contracts entered into before the transition date, the Company relied on its assessment made applying IAS 17 and IFRIC 4, “Determining whether an Arrangement contains a Lease.”

As of September 30, 2019, the weighted average remaining lease term on the Company’s existing leases was 10.8 years for its property lease and 1.0 years for motor vehicle leases. Lease expense (substantially all of which is non-cash) for the nine months ended September 30, 2019 amounted to $0.3 million. Cash paid for amounts included in the measurement of the operating lease liabilities for the nine months ended September 30, 2019 was $0.1 million.

NOTE 4 – ISSUANCES OF SHARE CAPITAL AND WARRANTS

In October 2017, the Company entered into an at-the-market (“ATM”) sales agreement with BTIG, LLC (“BTIG”), pursuant to which the Company may, at its sole discretion, offer and sell through BTIG, acting as sales agent, ADSs having an aggregate offering price of up to $30.0 million throughout the period during which the ATM facility remains in effect. The Company will pay BTIG a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility. From the effective date of the agreement through September 30, 2019, 942,910 ADSs were sold under the program for total net proceeds of approximately $7.7 million, leaving an available balance under the facility of approximately $22.3 million as of September 30, 2019.

 

NOTE 4 – ISSUANCES OF SHARE CAPITAL AND WARRANTS (cont.)

In February 2019, the Company completed an underwritten public offering of 1,866,667 of its ADSs and warrants to purchase 1,866,667 ADSs, at a public offering price of $8.25 per ADS and accompanying warrant. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $11.25 per ADS. The offering raised a total of $15.4 million, with net proceeds of $14.1 million, after deducting fees and expenses. The amount of the offering consideration initially allocated to the warrants was $5.0 million. Total issuance costs initially allocated to the warrants were $0.4 million.

The warrants issued have been classified as a non-current financial liability due to a net settlement provision. This liability was initially recognized at its fair value on the date the contract was entered into and is subsequently accounted for at fair value at each balance sheet date. The fair value changes are charged to non-operating income and expense in the statement of comprehensive loss.

The fair value of the warrants is computed using the Black and Scholes option pricing model. The fair value of the warrants upon issuance was computed based on the then current price of an ADS, a risk-free interest rate of 2.50% and an average standard deviation of 62.8%. The fair value of the warrants as of September 30, 2019 was based on the then current price of an ADS, a risk-free interest rate of 1.55% and an average standard deviation of 62.4%. The change in fair value from the date of issuance through September 30, 2019 amounted to $4.1 million.

NOTE 5 – SHAREHOLDERS’ EQUITY

 

As of December 31, 2018 and September 30, 2019, share capital is composed of ordinary shares, as follows:

 

10

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Exhibit 3

OPERATING AND FINANCIAL REVIEW

 

You should read the following discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K, as well as in our Annual Report on Form 20-F filed on March 28, 2019 (the “Annual Report”).

 

Forward Looking Statements

 

The following discussion contains “forward-looking statements,” including statements regarding expectations, beliefs, intentions or strategies for the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions, and are subject to risks and uncertainties. You should not put undue reliance on any forward-looking statements. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those listed below as well as those discussed in the Annual Report (particularly those in “Item 3. Key Information – Risk Factors”). Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements.

 

Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Overview

 

General

 

We are a clinical-stage biopharmaceutical development company with a strategic focus on oncology. Our current development and commercialization pipeline consists of two clinical-stage therapeutic candidates − BL-8040, a novel peptide for the treatment of solid tumors, hematological malignancies and stem cell mobilization, and AGI-134, an immuno-oncology agent in development for solid tumors. In addition, we have an off-strategy, legacy therapeutic product called BL-5010 for the treatment of skin lesions. We have generated our pipeline by systematically identifying, rigorously validating and in-licensing therapeutic candidates that we believe exhibit a high probability of therapeutic and commercial success. Our strategy includes commercializing our therapeutic candidates through out-licensing arrangements with biotechnology and pharmaceutical companies and evaluating, on a case by case basis, the commercialization of our therapeutic candidates independently.

 

Main Therapeutic Candidates

 

The following is a description of our main programs:

 

 

Solid tumors

 

 

 

 

AML

 

 

 

Stem cell mobilization

 

 

 

 

Other matters

 

 

 

 

 

Principal Partnering and Collaboration Agreements

 

Since December 2014 we have been collaborating with Novartis for the co-development of selected Israeli-sourced novel drug candidates. The collaboration agreement with Novartis will expire at the end of 2019.

 

In December 2014, we entered into an exclusive out-licensing arrangement with Perrigo Company plc, or Perrigo, for the rights to BL-5010 for over-the-counter or OTC indications in the territory of Europe, Australia and additional selected countries. We retain all OTC rights to BL-5010 in the United States and the rest of the world, as well as all non-OTC rights on a global basis. Perrigo fulfilled its obligation to launch a licensed product commercially in the Territory in 2016. In addition, Perrigo is obligated to use commercially reasonable best efforts to obtain regulatory approval in the Territory for at least one more OTC indication and to commercialize BL-5010 for that indication. Compensation by Perrigo for the exclusive license includes an agreed amount for each unit sold. We will have full access to all clinical and research and development data, as well as manufacturing data, generated during the performance of the development plan and may use these data in order to develop or license the product in other territories and fields of use where we retain the rights.

 

For information on our collaborations with Merck, Genentech and MD Anderson, see “― Main Therapeutic Candidates” above.

 

Funding

 

We have funded our operations primarily through the sale of equity securities (both in public and private offerings), funding received from a government body which previously was called the Office of the Chief Scientist of the Israeli Ministry of the Economy (OCS) (and which in 2016 was replaced by the newly-established Israel Innovation Authority, or IIA), payments received under out-licensing arrangements, and interest earned on investments. We expect to continue to fund our operations over the next several years through our existing cash resources, potential future milestone and royalty payments that we may receive from our existing out-licensing agreement, potential future upfront, milestone or royalty payments that we may receive from out-licensing transactions for our other therapeutic candidates, interest earned on our investments and additional capital to be raised through public or private equity offerings or debt financings. As of September 30, 2019, we held $30.1 million of cash, cash equivalents and short-term bank deposits.

 

Recent Company Developments

 

BL-8040 – Clinical Development

 

In November 2019, we announced that our abstract titled, “A Multi-Center Phase 2a Trial to Assess the Safety and Efficacy of BL-8040 (a CXCR4 inhibitor) in Combination with Pembrolizumab and Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma (PDAC)” (Abstract ID: 255) was accepted for an oral presentation at the ESMO Immuno-Oncology Congress 2019 to take place during December 2019 in Geneva, Switzerland.

 

In November 2019, we announced top-line results of the Phase 2b trial conducted under the clinical collaboration with MD Anderson. The data demonstrated clinical activity of the dual combination in heavily pretreated patients. The open-label study enrolled 20 metastatic pancreatic cancer patients who progressed after at least one prior line of chemotherapy. Patients were treated for two weeks with BL-8040 as a single agent (1.25 mg/kg) followed by 3-week cycles of BL-8040 in combination with pembrolizumab (at days 1, 4, 8 and 11 of each cycle). Biopsies for tumor biology were performed before treatment, after BL-8040 monotherapy (optional), and after the drug combination. Of the 20 patients enrolled, 15 were evaluable for the primary endpoint of radiologic response. Of these 15 evaluable patients, one patient showed a partial response, two patients had stable disease and 12 patients experienced disease progression, resulting in a disease control rate of 20.0%. The overall median time to progression was two months, while the median time to progression for patients showing disease control was seven months. Median overall survival was seven months, while median survival for the patients showing disease control was 12 months. The combination was generally well tolerated with injection site discomfort being the most commonly reported adverse event. Four patients experienced grade 3 toxicities and one patient had a grade 4 dyspnea. In addition to the improved survival, tumor biopsies showed greater infiltration of T cells, especially cytotoxic CD8+ T cells, into the tumor niche in the responding patients, compared with patients that experienced disease progression. MD Anderson will be presenting the results from the study in a poster at the Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, to take place during November 2019 in Baltimore.