On August 18, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the quarter ended June 30, 2021 and provides a corporate update (Press release, BioLineRx, AUG 18, 2021, View Source [SID1234586716]).

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Significant events and achievements during the second quarter 2021 and subsequent period:

Announced positive topline results from GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization (SCM). The data demonstrate that the study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001), including approximately 90% of patients who mobilized enough cells for transplantation with only one administration of Motixafortide and in only one apheresis session.
Based on the positive results from the GENESIS study, the Company is aggressively proceeding with activities in support of an NDA submission in stem cell mobilization anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of this year. This is consistent with prior guidance.
Continued to advance a pharmacoeconomic cost effectiveness study of Motixafortide in SCM to establish Motixafortide as the new standard-of-care mobilization agent (in combination with G-CSF). The aim of the study is to demonstrate the cost benefits related to the use of Motixafortide, due to a reduction in the number of doses of G-CSF and apheresis sessions required, a reduction in the number of rescue therapies required, higher rates of transplantation, and quality-of-life benefits in Motixafortide-treated patients; initial data on track to be announced in the second half of this year.
Ended the second quarter on a solid financial footing, with cash and cash equivalents of $66 million.
"Following the overwhelmingly positive results from our Phase 3 GENESIS trial of Motixafortide in stem-cell mobilization that we announced in May, we are working vigorously to submit an NDA in the first half of next year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "If approved, this would be transformative for BioLineRx as we would have a commercial-stage molecule in stem cell mobilization for transplantation in multiple myeloma, the standard of treatment for this disease, along with significant potential clinical utility in other cancer indications, most notably pancreatic cancer."

Mr. Serlin continued, "GENESIS has shown the ability of Motixafortide to mobilize substantially more than the target number of stem cells necessary for transplantation – in approximately 90% of cases with only one dose of Motixafortide and in one apheresis session – potentially resulting in significant clinical benefits for patients and cost savings for payers. We believe there is a compelling clinical and pharmacoeconomic case to be made for the use of Motixafortide as the new standard-of-care for all multiple myeloma patients. To that end, we are advancing a pharmacoeconomic cost effectiveness study that we believe will strongly support our case for the use of Motixafortide as the backbone of a new SCM treatment paradigm.

"In parallel with these activities, the versatility of Motixafortide demonstrated in studies to date has attracted interest from potential partners, and we continue to engage in productive discussions.

"We are very well financed with $66 million of cash, sufficient to bring Motixafortide through potential FDA approval in stem-cell mobilization, while continuing to advance our other clinical programs, including our second asset, AGI-134, a novel agent in immunotherapy currently being investigated in a Phase 1/2a study, with initial results expected by the end of this year," concluded Mr. Serlin.

Upcoming Significant Expected Milestones:

Results from pharmacoeconomic cost effectiveness study of Motixafortide in SCM in the second half of 2021;
Pre-NDA meeting with the FDA for SCM in the second 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;
NDA submission for SCM in the first half of 2022;
Presentation of additional data and analyses from Phase 3 GENESIS study at future medical meetings to be determined.
Financial Results for the Quarter Ended June 30, 2021

Research and development expenses for the three months ended June 30, 2021 were $5.1 million, an increase of $0.5 million, or 10.8%, compared to $4.6 million for the three months ended June 30, 2020. The increase resulted primarily from higher expenses related to NDA supporting activities for Motixafortide, an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period, and an increase in expenses associated with the AGI-134 study; offset by a decrease in expenses related to the GENESIS and COMBAT clinical trials for Motixafortide, and a timing difference related to a tax credit received in respect of AGI-134. Research and development expenses for the six months ended June 30, 2021 were $9.4 million, a decrease of $0.6 million, or 6.4%, compared to $10.1 million for the six months ended June 30, 2020. The decrease resulted primarily from lower expenses associated with the Motixafortide GENESIS and COMBAT clinical trials and a timing difference related to a tax credit received in respect of AGI-134; offset by higher expenses related to Motixafortide NDA supporting activities and by an increase in payroll and related-expenses due to a company-wide salary reduction in connection with the COVID-19 pandemic in the 2020 comparable period.

Sales and marketing expenses for the three months ended June 30, 2021 were $0.3 million, an increase of $0.1 million, or 81.3%, compared to $0.2 million for the three months ended June 30, 2020. The increase resulted primarily from consultancy services related to Motixafortide. Sales and marketing expenses for the six months ended June 30, 2021 were $0.5 million, an increase of $0.1 million, or 35.6%, compared to $0.4 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

General and administrative expenses for the three months ended June 30, 2021 were $1.0 million, an increase of $0.3 million, or 40.3%, compared to $0.7 million for the three months ended June 30, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance. General and administrative expenses for the six months ended June 30, 2021 were $2.1 million, an increase of $0.1 million, or 3.7%, compared to $2.0 million for the six months ended June 30, 2020. The reason for the increase is similar to the aforementioned increase in the three-month period.

The Company’s operating loss for the three months ended June 30, 2021 amounted to $6.5 million, compared to an operating loss of $5.6 million for the comparable period in 2020. The Company’s operating loss for the six months ended June 30, 2021 was $12.0 million, compared to $12.4 million for the comparable period in 2020.

Non-operating expenses for the three and six months ended June 30, 2021 and for the three and six months ended June 30, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.

Net financial expenses for the three months ended June 30, 2021 amounted to $0.1 million compared to net financial expenses of $0.4 million for the three months ended June 30, 2020. Net financial expenses for the six months ended June 30, 2021 amounted to $0.3 million compared to net financial expenses of $0.6 million for the six months ended June 30, 2020. Net financial expenses for all 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 June 30, 2021 amounted to $6.8 million, similar to the comparable period in 2020. The Company’s net loss for the six months ended June 30, 2021 amounted to $17.0 million, compared with a net loss of $13.4 million for the comparable period in 2020. The increase in net loss between the six-month periods results from an increase in 2021 non-operating expenses in connection with fair-value adjustments of warrant liabilities on the Company’s balance sheet.

The Company held $66 million in cash, cash equivalents and short-term bank deposits as of June 30, 2021.

Net cash used in operating activities was $13.1 million for the six months ended June 30, 2021, compared with net cash used in operating activities of $12.3 million for the six months ended June 30, 2020. The $0.8 million increase in net cash used in operating activities between the two periods was primarily the result of changes in operating asset and liability items in the two periods, i.e., a larger increase in prepaid expenses and other receivables in 2021 versus 2020, as well as a larger decrease in accounts payable and accruals in 2021 versus 2020.

Net cash used in investing activities was $42.3 million for the six months ended June 30, 2021, compared to net cash provided by investing activities of $0.6 million for the six months ended June 30, 2020. 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 $56.0 million for the six months ended June 30, 2021, compared to net cash provided by financing activities of $12.0 million for the six months ended June 30, 2020. The cash flows in 2021 primarily reflect an underwritten public offering of the Company’s ADSs in January 2021, warrant exercises, and net proceeds from an ATM facility, offset by repayments of a loan from Kreos Capital. The cash flows in 2020 primarily reflect two registered direct offerings to institutional investors, net proceeds from the ATM facility, offset by repayments of the loan from Kreos Capital.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, August 18, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-744-5399 from the US 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 August 20, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On August 18, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the company has entered into a research collaboration and license agreement with Orion Corporation, a global pharmaceutical company based in Finland, to discover and develop together new bispecific antibody cancer therapeutics (Press release, Alligator Bioscience, AUG 18, 2021, View Source [SID1234586715])

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The research collaboration will focus on the discovery of novel bispecific antibodies directed towards immuno-oncology targets selected by Orion. The agreement covers an option to develop three bispecific antibodies. Under the agreement, Alligator Bioscience will employ its proprietary phage display libraries and RUBY bispecific platform to develop immuno-oncology product candidates based on design criteria identified by Orion.

During the initial research period of the collaboration, Alligator Bioscience will receive an upfront payment and research support payments. Additionally, as part of the agreement, Alligator Bioscience is eligible for development, approval and sales milestone payments of up to 469 million euros, in addition to royalties if Orion exercises its options to continue development and commercialization of the resulting product candidates.

Outi Vaarala, Senior Vice President, R&D, Orion, said: "We are particularly pleased with this collaboration with Alligator Bioscience to develop new immuno-oncology treatments mobilizing the immune system to eliminate cancer cells. Bispecific antibodies provide as a tool many advantages for the next generation immuno-oncology treatments with improved efficacy, particularly in the cancer patients who do not respond to the present available therapeutics."

"We are excited to enter into this collaborative research program which combines Alligator Bioscience’s expertise in antibody discovery and immuno-oncology development with Orion’s insights into novel immuno-oncology approaches and welcomed the opportunity to work with Orion," said Søren Bregenholt, CEO of Alligator Bioscience. Bregenholt continued, "This agreement validates that Alligator Bioscience’s extensive range of phage display libraries and our RUBY bispecific platform offer a solid foundation to identify and develop high quality first-in-class therapeutic antibodies with excellent manufacturability characteristics."

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CEST on August 18, 2021.

On August 18, 2021 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its second quarter and first half year 2021 results (Press release, Targovax, AUG 18, 2021, View Source [SID1234586712]).

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Targovax’s management will give an online presentation and update on the clinical program to investors, analysts and the press at 10:00 CET today (details below).

FIRST HALF YEAR HIGHLIGHTS
Reported class-leading median overall survival in Targovax’s ONCOS-102 trial in mesothelioma at the 24-month follow-up
Received Fast-Track designation and scientific advice from the US FDA for ONCOS-102 in PD-1-refractory advanced melanoma
Received Fast-Track designation from the US FDA for ONCOS-102 in malignant pleural mesothelioma
Completed enrollment in the phase 1/2 trial with ONCOS-102 in combination with durvalumab in patients with advanced colorectal cancer with peritoneal metastases
Entered a research collaboration with Papyrus Therapeutics to develop novel ONCOS viruses with receptor tyrosine kinase inhibitor functionality
Announced Dr Lone Ottesen’s appointment as Chief Development Officer and Dr Sonia Quaratino’s election as a new member of the Board
Øystein Soug, CEO commented: "Targovax has conducted a broad early-stage clinical development program, documenting the clinical effects of ONCOS-102. We have shown promising and important benefits in patients without raising safety concerns. The main focus going forward is to take ONCOS-102 eagerly forward in clinical development in PD1-refractory melanoma. The feedback and discussions with the FDA have provided further guidance on what is the best next step, which will be a platform trial in PD1 refractory melanoma. The trial is intended to test ONCOS-102 in monotherapy and multiple combinations, including PD1 checkpoint inhibitor and potentially other novel immunotherapies to further enhance the efficacy beyond the promising response rate we saw in our previous melanoma trial. This will provide an opportunity to differentiate ONCOS-102 from other approaches and potentially open up development avenues into the commercially highly attractive front-line melanoma therapy indication."

Presentation
We invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On August 17, 2021, Fosun Kate Biotechnology Co., Ltd. reported that the National Medical Products Administration (NMPA) has officially designated the company’s CD19 target autologous CAR-T cell therapy product Akilunsai injection for new indications Included in the breakthrough treatment drug program, the proposed indication is the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma (r/r iNHL) after receiving second-line or above systemic treatment, including follicular lymphoma (FL) and Marginal zone lymphoma (MZL) (Press release, Gilead Sciences, AUG 17, 2021, View Source [SID1234633500]).

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Indolent non-Hodgkin’s lymphoma (iNHL) is a malignant tumor that has slow clinical progress but becomes more aggressive over time. Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are common subtypes. FL is also the second most common type of lymphoma in the world, accounting for approximately 22% of confirmed cases of NHL worldwide. MZL is the third most common lymphoma, accounting for approximately 8% to 12% of all B-cell NHL. Although with the progress of disease management, the long-term survival rate of FL patients has been greatly improved, but the prognosis is very different. At present, there is no standard treatment plan for the relapsed and refractory FL patients after second-line treatment and above, and the treatment options for the relapsed and refractory MZL patients are also very limited.

Akilunza injection is Fosun Kate’s introduction of Yescarta (axicabtagene ciloleucel) from Kite (a company of Gilead) in the United States in early 2017 for technology transfer in China, and is authorized to locally produce the human CD19 autologous CAR- T cell therapy products. It is used to treat adult patients with relapsed or refractory large B-cell lymphoma (including diffuse large B-cell lymphoma, unspecified type, primary mediastinal large B-cell lymphoma, high-grade New drug applications for B-cell lymphoma and diffuse large B-cell lymphoma transformed by follicular lymphoma have been approved by the NMPA for marketing in June 2021.

In the United States, Yescarta was approved by the FDA on October 18, 2017 for the treatment of adult patients with relapsed and refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) non-specific, primary Mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL transformed from follicular lymphoma are the first CAR-T cell drugs approved by the US FDA for specific non-Hodgkin lymphoma. On March 5, 2021, its application for extended indications for the treatment of adult patients with relapsed/refractory follicular lymphoma (FL) received accelerated approval from the US FDA, becoming the world’s first CAR- approved to be marketed for FL. T cell therapy products.

Fosun Kite Biotechnology Co., Ltd. is a joint venture between Shanghai Fosun Pharmaceutical Group and Kite of the United States. It is committed to the R&D, innovation, industrialization, commercialization, and standardized development of tumor cell therapy products for the benefit of Chinese patients. The company is headquartered in Shanghai Zhangjiang Hi-Tech Park, and a CAR-T industrial production base of 10,000 square meters has been established and officially opened in Zhangjiang Innovative Medicine Industrial Base. In addition, the company also has a 2000 square meter cell therapy R&D center and a team of innovative talents. Through independent innovation and international cooperation, the company focuses on CAR-T early R&D and clinical evidence-based projects to create a sustainable innovative R&D pipeline.

Mr. Huang Hai, CEO of Fosun Kate, said: "The inclusion of Akirensai injection in the breakthrough therapeutic drug program demonstrates NMPA’s support for clinical value-oriented drug innovation, and also shows that this drug is effective in treating relapsed or refractory drugs. The clinical advantages and potential of sexually inert non-Hodgkin’s lymphoma. The company will accelerate the clinical stage of the drug’s new indications, actively communicate and communicate with the drug review center, and provide more non-Hodgkin’s lymphoma in China as soon as possible. Tumor patients bring new hope and opportunities."

On August 17, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported a business and clinical progress update for the second quarter 2021 (Press release, Cue Biopharma, AUG 17, 2021, View Source [SID1234608273]).

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"During the second quarter 2021, we continued to make significant clinical progress advancing our IL-2 based CUE-100 series, represented by the Phase 1a/1b monotherapy trial of CUE-101 and combination-therapy trial with KEYTRUDA (pembrolizumab). In addition, we have continued with the development and expansion of our pipeline programs and technology platforms, and also enhanced our capital resources," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we recently reported a confirmed partial response (PR) in a patient from our ongoing Phase 1 monotherapy dose escalation trial of CUE-101 and look forward to providing further details on this patient response during the quarterly update call. Our Phase 1 monotherapy dose escalation and expansion study is now in dose expansion and our combination study with pembrolizumab continues in dose escalation. During the call, we will also highlight the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT platform."

Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We continue to be in a solid financial position and deployed our at-the-market (ATM) common stock facility during the second quarter to extend the anticipated operational runway further into the fourth quarter of 2022."

Recent News & Business Updates

Reported first patient dosed in the Part B expansion of its CUE-101 Phase 1 monotherapy clinical trial in HPV+ second line and beyond head and neck squamous cell carcinoma (HNSCC), at the recommended Phase 2 dose of 4mg/kg.
Presented preclinical data on CUE-401, the Company’s first autoimmune drug product candidate from the CUE-400 series, at the 2021 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting.
Second Quarter 2021 Financial Results
The Company reported collaboration revenue of approximately $2.7 million and $1.1 million for the three months ended June 30, 2021 and 2020, respectively. The increase in collaboration revenue of $1.6 million was primarily due to additional research and development and contract manufacturing activities in preparation of an investigational new drug (IND) filing for its second drug product candidate from the IL-2 based CUE-100 series, CUE-102, planned for the first half of 2022.

Research and development expenses were $8.8 million and $8.1 million for the three months ended June 30, 2021 and 2020, respectively. The increase in research and development expenses of $0.7 million was primarily due to an increase in laboratory and drug substance manufacturing costs and clinical expenses.

General and administrative expenses were $4.3 million and $3.9 million for the three months ended June 30, 2021 and 2020, respectively. The increase in general and administrative expense of $0.4 million was primarily due to an increase in stock-based compensation expense and legal fees incurred in the second quarter of 2021 as compared to the same period in 2020.