GENFIT Announces Final Terms For Proposed Renegotiation of 2022 OCEANE Convertible Bonds

On November 23, 2020 GENFIT (Nasdaq and Euronext: GNFT) a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, reported the final terms of the partial buyback of its convertible bonds maturing in October 2022 ("2022 OCEANEs" or "OCEANEs") and the proposed amendment of the existing terms of the 2022 OCEANEs (Press release, Genfit, NOV 23, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-announces-final-terms-proposed-renegotiation-2022-oceane [SID1234571540]).

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Objectives for the Proposed Renegotiation of 2022 OCEANE Terms

On November 16, 2020, GENFIT announced its intention to propose a partial buyback of the 2022 OCEANEs, as well as an amendment of the existing terms, with the objective of:

Capital preservation for the Company’s operational functionality;
Reduction of the nominal amount of financial debt to be redeemed;
Deferment of the OCEANEs maturity date in line with the next milestones in the Company’s two main programs: the ELATIVE Phase 3 clinical trial evaluating elafibranor in PBC and the NIS4 technology for NASH diagnosis;
Maximization of potential value-creation for shareholders and the 2022 OCEANEs holders.
Under these new terms, the final maturity of the 2022 OCEANEs would be deferred until October 16, 2025. The initiation of the early redemption period1 would be deferred until November 3, 2023.

Finally, in line with previous guidance, the Company has appointed Natixis and Kepler Cheuvreux (the "Counsels") to assist GENFIT with this transaction.

Partial buyback price, adjustment of the conversion ratio, and additional amendments to the existing terms of the 2022 OCEANEs

The Company and its Counsels have collected feedback from the 2022 OCEANEs holders in order to set the definitive terms of the partial buyback and the amendments of terms and conditions of the residual portion (following the partial buyback) of the 2022 OCEANEs.

The Company undertakes to repurchase, at a price of €16.40 per 2022 OCEANE, a maximum of 3,048,780 2022 OCEANEs, representing an amount equivalent to 50.1% of the outstanding 2022 OCEANEs.

The Company proposes to amend the terms of the 2022 OCEANEs that will not be repurchased and cancelled, as described below:

Maturity extension until October 16, 2025;
Increase of the conversion ratio from 1:1 to 1:5.5;
Deferral of the initiation of the early redemption period provided for in the 2022 OCEANEs terms and conditions (until November 3, 2023); and
Amendment of the ratchet clause adjusting the conversion ratio in the event of a tender offer targeting GENFIT shares, in order to take into account the extension of the 2022 OCEANEs maturity date from 2022 until 2025. The adjustment would be calculated from the date of approval by the 2022 OCEANEs holders of the amended terms (i.e. the date on which the 2022 OCEANEs holders meeting would be held) until the new maturity date (i.e. October 16, 2025).
The nominal value as well as the redemption price of the OCEANEs will remain unchanged at €29.60 per OCEANE. The other terms and conditions of the OCEANEs not mentioned above will remain unchanged.

The buyback price of €16.40 takes into account accrued interest until the buyback effective date that is anticipated to occur in January 2021, subject to the conditions set out below. The exact buyback date will be communicated at a later date.

Considering the new conversion ratio, the new shares that could be issued upon conversion of the OCEANEs would represent 42.9% of the current share capital of the Company (against 15.6% with the current conversion ratio). In the event of a full conversion of the OCEANEs, the OCEANEs holders would hold 30.0% of the share capital of the Company (29.7% in the case of exercise of the outstanding stock options, share warrants (BSA), and final allocation of the outstanding free shares as of the date hereof).

Implementation

The Company will collect through its Counsels, or through the 2022 OCEANEs Bondholder Representative (Representant de la Masse, at [email protected]) for the retail holders, the buyback requests through a fixed price reverse book building process.

Should the buyback requests from the 2022 OCEANEs holders exceed the €50 million maximum repurchase amount contemplated by the Company, buyback requests will be reduced proportionally to ensure equal treatment among all the 2022 OCEANEs holders.

Upon collection of requests and potential reduction as described above, the 2022 OCEANEs holders and the Company will be invited to enter into a Bond Repurchase Agreement, a draft of which is available upon request to the Counsels and, for retail holders, from the 2022 OCEANEs Bondholder Representative.

The reverse book building period, at a fixed price, will begin on November 23, 2020, and end on November 27, 2020 (inclusive).

Should the buyback requests be significantly lower than the €50 million repurchase proposal, the Company would withdraw its partial buyback and the 2022 OCEANEs terms amendment offer.

The partial buyback will remain contingent on and will occur after the following two events:

Approval by the Extraordinary General Meeting of the Company’s shareholders of the new conversion ratio;
Approval by the 2022 OCEANEs holders of the aforementioned amendments.

Upon receipt of the selling commitments from the 2022 OCEANEs holders through the signing of the Bond Repurchase Agreements, the Company will convene a general meeting of the shareholders and a general meeting of the 2022 OCEANEs holders, which are expected to be held in the first quarter of 2021.

Ligand Announces Clinical and Regulatory Progress by Multiple Partners with OmniAb® Antibodies

On November 23, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported clinical and regulatory progress by multiple partners utilizing antibodies from its OmniAb discovery platform (Press release, Ligand, NOV 23, 2020, View Source [SID1234571570]). Two large multinational pharmaceutical companies with a license to OmniAb have reached clinical-development milestones with their programs. The progress by these companies resulted in a total of $4.5 million in milestone payments being earned by Ligand.

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In addition, CStone Pharmaceuticals recently announced that China’s National Medical Products Administration has accepted for review CStone’s New Drug Application (NDA) for sugemalimab (CS1001), an OmniAb-derived anti-PD-L1 monoclonal antibody used in combination with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer (NSCLC). This marks the first regulatory submission by CStone for sugemalimab. Last month, CStone announced a major financial and commercial partnership with Pfizer to commercialize sugemalimab in greater China. Ligand is entitled to a 3% royalty on worldwide commercial sales of sugemalimab.

CStone also announced that positive clinical data based on a pre-planned interim analysis of the GEMSTONE-302 clinical study were disclosed in an oral presentation at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Virtual Congress 2020 on November 21, 2020 (link to full release here). The GEMSTONE-302 trial is the first randomized, double-blind, Phase 3 study of an anti-PD-L1 monoclonal antibody plus platinum-based chemotherapy as first-line treatment for stage IV squamous or non-squamous NSCLC. The results showed sugemalimab plus chemotherapy as first-line treatment for advanced NSCLC demonstrated statistically significant and clinically meaningful benefit in progression free survival (PFS) compared to chemotherapy across PD-L1 expression levels and histologies. Specifically, sugemalimab in combination with chemotherapy reduced the risk of disease progression or death by 50% and produced an objective response rate (ORR) of 61.4%. The combination therapy was well-tolerated with no new safety signals detected. CStone reported that these Phase 3 data are amongst the best of those reported by other anti-PD-L1 monoclonal antibodies.

"We are very pleased with the progress and impressive data our partners are reporting with their Ligand OmniAb-derived antibodies," said John Higgins, Chief Executive Officer of Ligand. "There are currently more OmniAb programs than ever under development, and as programs advance Ligand is now collecting more and larger milestone payments that are contributing to our strong financial performance. Next year we anticipate the first two OmniAb-derived antibodies could receive regulatory approvals, and these events could start the first OmniAb royalty revenue to Ligand. With partnership and royalty rights on programs that extend to 2040 and beyond, we believe we are in the early days of a substantial growth trajectory from our OmniAb business."

About OmniAb

OmniAb is a three-species transgenic-animal platform consisting of five different technologies used for producing mono- and bispecific human therapeutic antibodies. OmniRat animals comprise the industry’s first human monoclonal antibody technology based on rats. Because they have a complete immune system with a diverse antibody repertoire, OmniRat animals generate antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. OmniChicken animals comprise the industry’s first human monoclonal antibody technology based on chickens. The OmniClic chicken is specifically developed to facilitate the generation of bispecific antibodies and retains the ability to generate diverse, high quality affinity matured antibodies. All five types of OmniAb therapeutic human antibody platform, OmniRat, OmniFlic, OmniMouse, OmniChicken and OmniClic, use patented technology, have broad freedom to operate, produce highly diversified, fully human antibody repertoires optimized in vivo for immunogenicity, manufacturability, and therapeutic efficacy, and deliver fully

Blueprint Medicines To Present Broad Range of Data Reinforcing Commitment to Advance Patient Care in Systemic Mastocytosis at 62nd ASH Annual Meeting and Exposition

On November 23, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported plans to report data presentations highlighting the medical needs in systemic mastocytosis (SM) and the broad potential of AYVAKIT (avapritinib) across multiple SM patient populations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Blueprint Medicines, NOV 23, 2020, View Source [SID1234571589]). AYVAKIT is designed to potently and selectively target D816V mutant KIT, the primary driver of SM, and is being developed for the treatment of advanced and non-advanced forms of the disease.

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"The breadth of our upcoming ASH (Free ASH Whitepaper) presentations highlights our commitment to fundamentally change the way systemic mastocytosis is diagnosed and treated across a broad population of patients impacted by this disease," said Andy Boral, M.D., Ph.D., Chief Medical Officer at Blueprint Medicines. "These presentations reflect our collaborative efforts with the systemic mastocytosis community to better understand the burden of disease, advance important strategies for facilitating diagnosis and establish new methods for measuring treatment response."

The accepted abstracts are listed below and available on the ASH (Free ASH Whitepaper) conference website: View Source

Oral Presentation

Presentation Title: Pure Pathologic Response Is Associated with Improved Overall Survival in Patients with Advanced Systemic Mastocytosis Receiving Avapritinib in the Phase I EXPLORER Study
Session Title: Myeloproliferative Syndromes: Clinical: Translational Science in MPN—Hitting the Mark
Session Date & Time: Sunday, December 6, 2020 at 10:15 a.m. PT (1:15 p.m. ET)
Abstract Number: 345

Poster Presentations

Presentation Title: Patient Reported Outcomes Among Systemic Mastocytosis (SM) Patients in Routine Clinical Practice: Results from the TouchStone Survey
Session Title: Outcomes Research—Non-Malignant Conditions: Poster I
Session Date & Time: Saturday, December 5, 2020 from 7:00 a.m. – 3:30 p.m. PT (10:00 a.m. – 6:30 p.m. ET)
Abstract Number: 1638

Presentation Title: Results from PIONEER: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Avapritinib in Patients with Indolent Systemic Mastocytosis
Session Title: Myeloproliferative Syndromes: Clinical: Poster I
Session Date & Time: Saturday, December 5, 2020 from 7:00 a.m. – 3:30 p.m. PT (10:00 a.m. – 6:30 p.m. ET)
Abstract Number: 1248

Presentation Title: Increased Detection of KIT D816V Mutation in Peripheral Blood Samples from Patients with Indolent Systemic Mastocytosis (ISM) in the Phase 2 PIONEER Study Using a High Sensitivity Droplet Digital (dd) PCR Assay Compared with Next Generation Sequencing (NGS)
Session Title: Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III
Session Date & Time: Monday, December 7, 2020 from 7:00 a.m. – 3:30 p.m. PT (10:00 a.m. – 6:30 p.m. ET)
Abstract Number: 3004

Presentation Title: Perceptions of Patient Disease Burden and Management Approaches of Systemic Mastocytosis By Healthcare Providers: Results from the TouchStone SM Survey
Session Title: Health Services Research—Non-Malignant Conditions: Poster III
Session Date & Time: Monday, December 7, 2020 from 7:00 a.m. – 3:30 p.m. PT (10:00 a.m. – 6:30 p.m. ET)
Abstract Number: 3403

Presentation Title: PIONEER Part 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib in Indolent Systemic Mastocytosis
Session Title: Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III
Session Date & Time: Monday, December 7, 2020 from 7:00 a.m. – 3:30 p.m. PT (10:00 a.m. – 6:30 p.m. ET)
Abstract Number: 2988

About AYVAKIT (avapritinib)

AYVAKIT (avapritinib) is a kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. For more information, visit www.AYVAKIT.com. This medicine is approved in Europe under the brand name AYVAKYT for the treatment of adults with unresectable or metastatic GIST harboring the PDGFRA D842V mutation.

AYVAKIT is not approved for the treatment of any other indication, including SM, in the U.S. by the FDA or in Europe by the European Commission, or for any indication in any other jurisdiction by any other health authority.

Blueprint Medicines is developing AYVAKIT globally for the treatment of advanced and indolent SM. The FDA granted breakthrough therapy designation to AYVAKIT for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of AYVAKIT in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for AYVAKIT in the rest of the world.

National Comprehensive Cancer Network® Adds INQOVI® (decitabine and cedazuridine) Tablets to its Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes

On November 23, 2020 Taiho Oncology, Inc. reported that the FDA approved hypomethylating agent INQOVI (decitabine and cedazuridine) 35 mg/100 mg tablets, for oral use, has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines) in Oncology for Myelodysplastic Syndromes (MDS) (Press release, Taiho, NOV 23, 2020, View Source [SID1234571612]). The NCCN Guidelines now include a category 2a recommendation that oral decitabine and cedazuridine (DEC-C) could be considered as a substitution for intravenous decitabine in the treatment of adult patients with MDS.1

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Specifically, the treatment guidelines allow the substitution of INQOVI for intravenous decitabine in appropriate patients with MDS who are experiencing clinically significant cytopenias or increased marrow blasts, significant anemia or are transplant candidates. The U.S. Food and Drug Administration (FDA) approved INQOVI on July 7, 2020 as the first oral hypomethylating agent for intermediate and high-risk MDS. In September, NCCN, an alliance of 30 leading cancer centers in the U.S., updated the NCCN Guidelines for Myelodysplastic Syndromes.

"The addition of INQOVI to the Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes will further inform healthcare providers of a new oral treatment option," said Karin Blakolmer, Senior Vice President and Head of Medical Affairs, Taiho Oncology, Inc. "As the first orally administered hypomethylating agent for MDS, and an important alternative to multiple monthly intravenous infusions, Taiho Oncology believes that INQOVI will help address unmet treatment needs for patients who may currently have limited access to in-office intravenous therapy. We look forward to working with healthcare professionals to bring this therapy to appropriate patients."

Taiho Oncology previously announced it has assumed commercialization responsibility from Astex Pharmaceuticals, Inc. and its parent company, Otsuka Pharmaceutical Co., Ltd., for INQOVI in the U.S.

The updated NCCN Guidelines are available at www.nccn.org.

About Myelodysplastic Syndromes (MDS)
Myelodysplastic syndromes are a heterogeneous group of hematopoietic stem cell disorders characterized by dysplastic changes in myeloid, erythroid, and megakaryocytic progenitor cells, and are associated with cytopenias affecting one or more of the three lineages. U.S. incidence of MDS is estimated to be 10,000 cases per year, although the condition is thought to be under-diagnosed.2,3 The prevalence has been estimated to be from 60,000 to 170,000 in the U.S.4 MDS may evolve into acute myeloid leukemia (AML) in approximately one-third of patients.5 The prognosis for MDS patients is poor; patients die from complications associated with cytopenias (infections and bleeding) or from transformation to AML.

BioLineRx Reports Third Quarter 2020 Financial Results and Provides Corporate Update

On November 23, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended September 30, 2020 and provides a corporate update (Press release, BioLineRx, NOV 23, 2020, View Source [SID1234571554]).

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Significant events and achievements during the third quarter 2020 and subsequent period:

Reported positive results from a pre-planned interim analysis of GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients. The Data Monitoring Committee (DMC) found statistically significant evidence favoring treatment with motixafortide in the primary endpoint, and subsequently issued a recommendation to cease patient enrollment immediately. In accordance with the DMC’s recommendation, study enrollment was completed at 122 patients (instead of 177 as originally planned). SCM is the Company’s most efficient path to registration;
Announced initiation of Phase 2 investigator-initiated study of motixafortide in combination with LIBTAYO and chemotherapy in first-line PDAC. The study is being run by Columbia University;
Announced initiation of investigator-initiated Phase 1b study, led by Wolfson Medical Center in Holon, Israel, to evaluate motixafortide in patients hospitalized with acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections;
Renewed study enrollment in Part of Phase 1/2a trial for AGI-134, which had been temporarily suspended in the second quarter of 2020 due to clinical operating risks associated with the COVID-19 pandemic;
Conducted interim analysis for Phase 2b BLAST study in consolidation AML; analysis did not demonstrate statistically significant effect in primary endpoint; DMC recommended not to continue the study.
"The past several months have been very exciting for BioLineRx, highlighted by the very positive result of the interim analysis of our Phase 3 GENESIS study in stem cell mobilization" stated Philip Serlin, Chief Executive Officer of BioLineRx. "A statistically significant benefit in the primary endpoint was observed by combining motixafortide with the standard of care, G-CSF, leading the DMC to recommend that we cease study enrollment at 122 patients, instead of the 177 originally planned. We look forward to publishing final results of the study in the first half of next year, as we continue to advance motixafortide toward registration.

"With regard to the Phase 2b BLAST study in consolidation AML, based on the results of the interim analysis, the DMC recommended not to continue the study. Although we are disappointed by this outcome, particularly following the positive results that we previously observed in our Phase 1/2a study of motixafortide with cytarabine in relapsed/refractory AML, we continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment. We will decide on next steps in AML once we’ve had a chance to review and analyze the unblinded data, including detailed biomarker and subpopulation data, from this study. I would also like to express our gratitude to the University of Halle, as study sponsor, and Dr. Carsten Müller-Tidow, as principal study investigator, as well as the other investigators and the patients who made this important trial possible.

"Finally, in the coming weeks, we plan to announce full results, including progression free survival (PFS) and overall survival (OS) data, on all study patients from the triple combination arm of our Phase 2a COMBAT/KEYNOTE-202 study in second-line PDAC. We previously shared preliminary positive overall response rate and disease control rate data, on approximately half of the patients enrolled in this study arm, at last year’s ESMO (Free ESMO Whitepaper) IO conference, and we remain optimistic that the combination of motixafortide and KEYTRUDA, together with chemotherapy, will prove beneficial to survival as well.

"The significant and growing body of data that we are compiling on motixafortide, including the strikingly positive results of the interim analysis in the GENESIS phase 3 study reported last month, reassure us about the unique characteristics of motixafortide as the best-in-class CXCR4 antagonist, and confirm our belief that this promising compound can potentially serve as the backbone of combination therapies to treat a broad range of solid tumor and hematological cancers," Mr. Serlin concluded.

Upcoming Expected Milestones

Overall final results, including PFS and OS data, from the COMBAT/KEYNOTE-202 Phase 2a triple combination study in second-line PDAC by the end of 2020;
Final results from the Phase 3 GENESIS trial in SCM in the first half of 2021;
Preliminary results of the Phase 1b study in ARDS in the first half of 2021;
Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021;
Data from the Columbia University-initiated study of motixafortide in combination with LIBTAYO and chemotherapy in first-line PDAC in mid-2022;
Financial Results for the Quarter Ended September 30, 2020

Research and development expenses for the three months ended September 30, 2020 were $3.5 million, a decrease of $2.1 million compared to $5.6 million for the comparable period in 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019 and from lower expenses associated with the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic carried out in the second and third quarters of 2020. Research and development expenses for the nine months ended September 30, 2020 were $13.5 million, a decrease of $1.7 million, compared to $15.2 million for the nine months ended September 30, 2019. The decrease resulted primarily from lower expenses associated with the motixafortide COMBAT clinical trial and the AGI-134 study, as well as a decrease in payroll and related expenses due to a Company-wide salary reduction related to the COVID-19 pandemic mentioned above.

Sales and marketing expenses for three months ended September 30, 2020 were $0.3 million, an increase of $0.1 million compared to $0.2 million for the comparable period in 2019. The increase resulted primarily from consultancy services and market research for motixafortide offset by a decrease in payroll and related expenses related to a reduction in headcount. Sales and marketing expenses for the nine months ended September 30, 2020 were $0.7 million, similar to the comparable period in 2019.

General and administrative expenses for the three months ended September 30, 2020 were $0.9, similar to the comparable period in 2019. General and administrative expenses for the nine months ended September 30, 2020 were $2.8 million, similar to the comparable period in 2019.

The Company’s operating loss for the three months ended September 30, 2020 amounted to $4.6 million, compared to an operating loss of $6.6 million for the comparable period in 2019. The Company’s operating loss for the nine months ended September 30, 2020 was $17.1 million, compared to $18.7 million for the comparable period in 2019.

Non-operating income (expenses) for the three- and nine-month periods ended September 30, 2020 and 2019 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses and issuance expenses of the Company’s ATM program.

Net financial expenses for the three months ended September 30, 2020 amounted to $0.3 million compared to net financial expenses of $0.4 million for the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits. Net financial expenses for the nine months ended September 30, 2020 amounted to $0.9 million, similar to the comparable period in 2019. Net financial expenses for both periods primarily relate to interest paid on loans, offset by investment income earned on bank deposits.

The Company’s net loss for the three months ended September 30, 2020 amounted to $4.6 million, compared with a net loss of $3.9 million for the comparable period in 2019. The Company’s net loss for the nine months ended September 30, 2020 amounted to $18.0 million, compared with a net loss of $15.6 million for the comparable period in 2019.

The Company held $20.8 million in cash, cash equivalents and short-term bank deposits as of September 30, 2020.

Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2020, compared with net cash used in operating activities of $17.2 million for the nine months ended September 30, 2019. The $0.6 million increase in net cash used in operating activities during the nine-month period in 2020 was primarily the result of the decrease in accounts payable and accruals in the 2020 period.

Net cash provided by investing activities was $8.1 million for the nine months ended September 30, 2020, compared to net cash provided by investing activities of $2.1 million for the nine months ended September 30, 2019. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.

Net cash provided by financing activities was $10.9 million for the nine months ended September 30, 2020, compared to net cash provided by financing activities of $16.6 million for the nine months ended September 30, 2019. The cash flows in 2020 primarily reflect the May and June financings and the net proceeds from the Company’s ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of our ADSs in February 2019, as well as net proceeds from the ATM facility.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, November 23, 2020 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0664 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 25, 2020; please dial +1-877-456-0009 from the US or +972-3-925-5929 internationally.