On November 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 September 30, 2021 and provides a corporate update (Press release, BioLineRx, NOV 18, 2021, View Source [SID1234595792]).

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

Announced statistically significant positive results from a pharmacoeconomic cost effectiveness study supporting Motixafortide’s use as the new standard-of-care and primary mobilization agent (in combination with G-CSF) in stem cell mobilization (SCM). The study demonstrated substantial clinical benefits and cost savings in favor of Motixafortide from a significantly higher number of mobilized cells, reduced numbers of apheresis sessions and reduced doses of G-CSF;
Announced acceptance of an oral presentation, as well as three poster presentations, at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which is taking place December 11-14. The presentations, which include an oral presentation describing the highly significant and clinically meaningful results from the Company’s GENESIS Phase 3 clinical trial in stem cell mobilization (SCM), reflect the versatility of Motixafortide as the backbone of promising new treatments for both hematological and solid tumor cancers;
Finalized preparations for a pre-NDA meeting with FDA, which is set for mid-December;
Proceeded with activities in support of a New Drug Application (NDA) submission in stem cell mobilization planned for the first half of 2022;
Ended the third quarter on a solid financial footing, with cash and cash equivalents of $62.2 million.
"The key highlight since our last quarterly update was the statistically significant positive results from a pharmacoeconomic study of Motixafortide in stem cell mobilization for multiple myeloma patients," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The study demonstrated that use of Motixafortide on top of G-CSF resulted in a net cost savings of $17,000 per patient, not including the cost of Motixafortide, driven by fewer doses of G-CSF and a reduction in the number of apheresis sessions and related costs, versus G-CSF alone. These cost savings should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter, if approved.

"These results, together with the overwhelmingly positive results from our GENESIS Phase 3 study, which showed that almost 90% of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one apheresis session, strongly support our view that Motixafortide, in combination with G-CSF, can become the new standard of care in SCM as an upfront, or primary, therapy for all multiple myeloma patients. If approved, this represents a significant advancement in SCM to the benefit of patients and payers alike and, to that end, we plan to submit an NDA to the FDA in the first half of next year.

"Our significant progress in SCM, together with the encouraging results we have seen in trials to date in metastatic pancreatic cancer, reflect the versatility of Motixafortide in both hematological and solid tumor cancers, which we have an opportunity to highlight at this year’s ASH (Free ASH Whitepaper) meeting next month. Our notable presence at such an important medical conference reflects the excellent progress that we have made to date across these core programs and underscores the momentum that we have entering 2022.

"With over $62 million in cash, we believe we are well financed to achieve our upcoming important and potentially value creating milestones," Mr. Serlin concluded.

Upcoming Expected Milestones:

Complete pre-NDA meeting with the FDA for SCM, scheduled for mid-December 2021;
Complete recruitment of part 2 of ongoing Phase 1/2a trial of AGI-134 in solid tumors by end of 2021;
Announce initial results for Part 2 of Phase 1/2a trial of AGI-134 in solid tumors in first half of 2022;
Submit NDA for Motixafortide in SCM in first half of 2022.
Financial Results for the Quarter Ended September 30, 2021

Research and development expenses for the three months ended September 30, 2021 were $4.9 million, an increase of $1.4 million, or 41.3%, compared to $3.5 million for the three months ended September 30, 2020. The increase resulted primarily from an increase in expenses associated with the AGI-134 study and a timing difference related to a tax credit received in respect of AGI-134, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period. Research and development expenses for the nine months ended September 30, 2021 were $14.3 million, an increase of $0.8 million, or 5.9%, compared to $13.5 million for the nine months ended September 30, 2020. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, as well as an increase in payroll and related-expenses due to a company-wide salary reduction related to the COVID-19 pandemic in the comparable 2020 period, offset by lower expenses associated with the completed Motixafortide GENESIS and COMBAT clinical trials.

Sales and marketing expenses for the three months ended September 30, 2021 were $0.2 million, a decrease of $0.1 million, or 20.1%, compared to $0.3 million for the three months ended September 30, 2020. The decrease resulted primarily from lower consultancy services related to Motixafortide. Sales and marketing expenses for the nine months ended September 30, 2021 were $0.7 million, similar to the comparable period in 2020.

General and administrative expenses for the three months ended September 30, 2021 were $1.1 million, an increase of $0.2 million, or 22.3%, compared to $0.9 million for the three months ended September 30, 2020. The increase resulted primarily from an increase in directors’ and officers’ insurance. General and administrative expenses for the nine months ended September 30, 2021 were $3.1 million, an increase of $0.3 million, or 9.3%, compared to $2.8 million for the nine months ended September 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 September 30, 2021 amounted to $6.2 million, compared to an operating loss of $4.6 million for the quarter ended September 30, 2020. The Company’s operating loss for the nine months ended September 30, 2021 was $18.2 million, compared to $17.1 million for the comparable period in 2020.

Non-operating income (expenses) for the three and nine months ended September 30, 2021 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet and issuance expenses of the ATM. Non-operating income (expenses) for the three and nine months ended September 30, 2020 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 ATM.

Net financial expenses for the three months ended September 30, 2021 amounted to $0.2 million compared to net financial expenses of $0.3 million for the three months ended September 30, 2020. Net financial expenses for the nine months ended September 30, 2021 amounted to $0.5 million compared to net financial expenses of $0.9 million for the nine months ended September 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 September 30, 2021 amounted to $5.7 million, compared with a net loss of $4.6 million for the comparable period in 2020. The Company’s net loss for the nine months ended September 30, 2021 amounted to $22.8 million, compared with a net loss of $18.0 million for the comparable period in 2020.

The Company held $62.2 million in cash, cash equivalents and short-term bank deposits as of September 30, 2021.

Net cash used in operating activities was $18.1 million for the nine months ended September 30, 2021, compared with net cash used in operating activities of $17.8 million for the nine months ended September 30, 2020. The $0.3 million increase in net cash used in operating activities in 2021 was primarily the result of an increase in research and development expenses.

Net cash used in investing activities was $42.2 million for the nine months ended September 30, 2021, compared to net cash provided by investing activities of $8.1 million for the nine months ended September 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 $57.6 million for the nine months ended September 30, 2021, compared to net cash provided by financing activities of $10.9 million for the nine months ended September 30, 2020. The cash flows in 2021 primarily reflect the underwritten public offering of our ADSs in January 2021, warrant exercises, and net proceeds from the ATM facility, offset by repayments of the 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, Thursday, November 18, 2021, at 10:00 a.m. EST. 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 November 21, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On November 18, 2021 Exact Therapeutics AS ("EXACT-Tx", or "the Company" Euronext Growth: EXTX), a clinical-stage precision health company evaluating Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported a number of strategic, operational and scientific developments (Press release, Exact Therapeutics, NOV 18, 2021, View Source [SID1234595791]).

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As reported in May 2021, EXACT-Tx plans to file a protocol amendment regarding its ACTIVATE phase 1 clinical trial with the UK MHRA. Following approval, the Company plans to recommence enrolment in the trial at the Royal Marsden Hospital London / Institute of Cancer Research with the recruitment of patients in the part 1 cohort planned to be completed by mid 2022. The study aims to evaluate the combination of PS101 ACT with standard of care chemotherapy for treatment of liver metastases in patients with metastatic colorectal cancer A number of valuable and encouraging insights have been gained from this first cohort of treated patients particularly with respect to the application of ultrasound.

The Company also announces that it aims to start its first clinical trial in the USA to evaluate ACT in pancreatic cancer patients. In the USA there are approximately 60,000 newly diagnosed cases of pancreatic cancer and approx. 50,000 deaths per year. The Company expects to submit IND filing to the FDA by mid 2022 which, if approved, will be followed by the start of the clinical trial towards the end of 2022. Today, the 18th of November, is Pancreatic Cancer Awareness Day, and EXACT-Tx is committed to play its role in fighting this aggressive disease.

EXACT-Tx is pleased to announce that Co-Founder Dr Andrew ("Andy") Healey has returned to the Company as Chief Scientific Officer. Andy brings over 20 years experience in the life sciences industry, primarily working with contrast agents and optical molecular imaging, physics, instrumentation, characterisation and clinical imaging systems & trials. The Company’s management team has been significantly strengthened this year with the appointments of Dr Hilary McElwaine-Johnn as Chief Medical Officer and Dominic Moreland as Chief Financial Officer and subsequently Interim Chief Executive Officer.

Strong preclinical data on ACT were recently published in The Journal of Controlled Release 1 which demonstrated that ACT safely and temporarily increased the permeability of the Blood Brain Barrier ("BBB") in animal models as well as increased the penetration and accumulation of co-administered compounds including nanoparticles with no treatment related tissue damage observed. The BBB remains a formidable challenge to the delivery of drugs into the brain. The published preclinical data demonstrates that ACT could be a potential strategy to overcome this obstacle and promote efficient and specific crossing through BBB of therapeutically relevant agents, addressing a huge unmet medical need and further demonstrating the power of the ACT platform. "We have demonstrated that ACT has the ability to open the BBB in a pre-clinical model to deliver large molecules and nano particles with no observable damage to the brain. This approach is an exciting and evolving field that has the promise to deliver drug and to treat the central nervous system." says Professor Catharina de Lange Davies, Dept. of Physics, Norwegian University of Science and Technology (NTNU), and co-author of the paper.

Dr Masha Strømme, Executive Chair of the Board, stated: "We have significantly strengthened our team over the last few months and are well positioned to maximise the value of our innovative Acoustic Cluster Therapy (ACT) platform for ultrasound enhanced drug targeting which has the potential to significantly amplify the clinical utility of a wide range of therapeutic agents across most drug classes and improve upon standard of care. I am very pleased to welcome Andy whose technical expertise and industry know-how coupled with his longstanding commitment to EXACT-Tx is a very strong addition to the leadership team. I look forward to working with him again as we further investigate this exciting approach to ultrasound mediated therapeutic targeting."

On November 18, 2021 Cytovia Therapeutics, Inc., a biopharmaceutical company developing allogeneic "off-the-shelf" gene-edited iNK (NK cells derived from iPSC) and CAR (Chimeric Antigen Receptor) Natural Killer (NK) cells derived from induced pluripotent stem cells (iPSCs) and Flex-NK cell engager multifunctional antibodies, and Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage gene-editing company employing its core technology to develop products based on gene-editing with a portfolio of allogeneic chimeric antigen receptor (CAR-)T cells in the field of immuno-oncology and gene-edited hematopoietic stem cells in other indications, reported that they have expanded their collaboration of TALEN gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and development in China by Cytovia’s joint venture entity, CytoLynx Therapeutics (Press release, Cellectis, NOV 18, 2021, View Source [SID1234595789]).

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The amended financial terms include an equity stake totaling $20 million in Cytovia stock as well as up to $805 million of development, regulatory, and sales milestones and single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia.

"We are pleased to expand the collaboration with Cellectis to enable Cytovia to develop iNK products that will leverage the high-precision of TALEN to perform gene-editing to minimize the risk of off-target effects and unlock the full potential of NK cells as a first line of defense against cancer. Cytovia’s internal research and development, and manufacturing teams are actively developing multiple gene-edited therapeutic candidates and optimizing our technology platform towards next generation products," said Dr. Daniel Teper, Chairman & CEO of Cytovia Therapeutics.

Cellectis is developing custom TALEN, which Cytovia uses to edit iPSCs. Cytovia is responsible for the differentiation and expansion of the gene-edited iPSC master cell bank into NK cells and is conducting the pre-clinical evaluation, clinical development, and commercialization of the mutually-agreed-upon selected therapeutic candidates. Cellectis is granting Cytovia a worldwide license under the patent rights over which Cellectis has the control in this field, including in China, enabling Cytovia to modify NK cells to address multiple gene-targets for therapeutic use in several cancer indications.

"We are thrilled at the progress Cytovia has accomplished in the past year," said Dr. André Choulika, CEO of Cellectis. "Cytovia has attracted a world-class scientific team and is advancing its clinical candidates in areas of significant unmet medical need, sharing Cellectis’ mission to provide life-saving off-the-shelf allogeneic cell therapy to patients."

On November 18, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported an underwritten public offering of American Depositary Shares ("ADSs") (Press release, RedHill Biopharma, NOV 18, 2021, View Source [SID1234595788]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs to be sold in the offering will be offered by RedHill. RedHill has granted the underwriter a 30-day option to purchase up to an additional 15 percent of the number of ADSs offered in the public offering.

Cantor Fitzgerald & Co. is acting as sole bookrunner for the proposed offering.

RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

The securities described above will be offered by RedHill pursuant to a shelf registration statement on Form S-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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On November 18, 2021, Thermo Fisher Scientific (Finance I) B.V. ("Thermo Fisher International"), an indirect, wholly-owned finance subsidiary of Thermo Fisher Scientific Inc. (the "Company"), reported that issued €1,700,000,000 aggregate principal amount of Floating Rate Senior Notes due 2023 (the "Floating Rate Notes"), €550,000,000 aggregate principal amount of 0.000% Senior Notes due 2023 (the "2023 Notes") and €550,000,000 aggregate principal amount of 0.000% Senior Notes due 2025 (the "Sustainability Notes", and, together with the Floating Rate Notes and the 2023 Notes, the "Notes") in a public offering (the "Offering") pursuant to a registration statement on Form S-3 (File No. 333-229951) and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, Thermo Fisher Scientific, NOV 18, 2021, View Source [SID1234595787]). The Company has fully and unconditionally guaranteed the Notes on a senior unsecured basis (the "Guarantee" and, together with the Notes, the "Securities").

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The Securities were issued under an indenture, dated as of August 9, 2016 (the "Base Indenture"), and the Fourth Supplemental Indenture, dated as of November 18, 2021 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), among Thermo Fisher International, as issuer, the Company, as guarantor, and The Bank of New York Mellon Trust Company, N.A., as trustee.

The Floating Rate Notes will mature on November 18, 2023, the 2023 Notes will mature on November 18, 2023 and the Sustainability Notes will mature on November 18, 2025. Interest on the Floating Rate Notes will be paid quarterly in arrears on February 18, May 18, August 18 and November 18 of each year, commencing on February 18, 2022.

Prior to October 18, 2025, in the case of the Sustainability Notes, and at any time, in the case of the 2023 Notes, Thermo Fisher International may redeem such series of Notes, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the Notes being redeemed (assuming, with respect to the Sustainability Notes, that the Sustainability Notes to be redeemed matured on October 18, 2025), discounted to the date of redemption on an annual basis (ACTUAL/ACTUAL (ICMA)), using a discount rate equal to the Comparable Bond Rate (as defined in the Indenture) plus, in each case, 10 basis points, plus, in each case, accrued and unpaid interest on the Notes being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after October 18, 2025, the Company may redeem the Sustainability Notes, in whole at any time or in part from time to time, at a redemption price equal to 100% of the principal amount of the Sustainability Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the date of redemption.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings Limited, Thermo Fisher International will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus accrued and unpaid interest, if any, to, but excluding, the date of repurchase.

The Notes are general unsecured obligations of Thermo Fisher International. The Notes rank equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of Thermo Fisher International and rank senior in right of payment to any existing and future indebtedness of Thermo Fisher International that is subordinated to the Notes. The Notes are also effectively subordinated to any existing and future secured indebtedness of Thermo Fisher International to the extent of the assets securing such indebtedness, and are structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries.

The Guarantee is a general unsecured obligation of the Company. The Guarantee ranks equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of the Company and will rank senior in right of payment to any existing and future indebtedness of the Company that is subordinated to the Guarantee. The Guarantee is also effectively subordinated to any existing and future secured indebtedness of the Company to the extent of the assets securing such indebtedness, and is structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries (other than, with respect to Thermo Fisher International, the Notes).

The Indenture contains limited affirmative and negative covenants of the Company and Thermo Fisher International. The negative covenants restrict the ability of the Company and its subsidiaries to incur debt secured by liens on Principal Properties (as defined in the Indenture) or on shares of stock of the Company’s Principal Subsidiaries (as defined in the Indenture) and engage in sale and lease-back transactions with respect to any Principal Property. The Indenture also limits the ability of each of the Company and Thermo Fisher International to merge or consolidate or sell all or substantially all of their respective assets.

Upon the occurrence of an event of default under the Indenture, which includes payment defaults, defaults in the performance of affirmative and negative covenants, bankruptcy and insolvency related defaults and failure to pay certain indebtedness, the obligations of Thermo Fisher International under the Notes may be accelerated, in which case the entire principal amount of the Notes would be immediately due and payable.

Wilmer Cutler Pickering Hale and Dorr LLP, U.S. counsel to the Company and Thermo Fisher International, has issued an opinion to the Company and Thermo Fisher International, dated November 18, 2021, regarding the legality of the Securities, and Linklaters LLP, Dutch counsel to Thermo Fisher International, has issued an opinion to Thermo Fisher International, dated November 18, 2021, regarding the Notes. Copies of these opinions are filed as Exhibits 5.1 and 5.2 hereto, respectively.

The foregoing description of certain of the terms of the Indenture does not purport to be complete and is qualified in its entirety by reference to the full text of each of the Base Indenture and the Supplemental Indenture, which are filed with this report as Exhibits 4.1 and 4.2 hereto, respectively. Each of the foregoing documents is incorporated herein by reference.