On February 23 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported that Stephen S. Yoder, President and Chief Executive Officer of Pieris, is scheduled to participate in a GI Oncology and Pancreatic Cancer panel discussion at the Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021 at 9:50 AM EST (Press release, Pieris Pharmaceuticals, FEB 23, 2021, View Source [SID1234575439]).

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On January 23, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, FEB 23, 2021, View Source [SID1234575459]).

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"The fourth quarter capped an extraordinary year for Halozyme during which we transitioned to a profitable, high-growth company with strong prospects for continued growth over the long-term," said Dr. Helen Torley, president and chief executive officer. "Our strong growth prospects are fueled by recent product approvals for subcutaneous DARZALEX (daratumumab) and Phesgo (pertuzumab, trastuzumab and hyaluronidase) utilizing our ENHANZE technology. Building on our portfolio of 5 commercialized partner products, we project the expansion of our development pipeline, including 4 products being evaluated in 7 phase 3 studies utilizing our ENHANZE technology. We believe this advancing pipeline of products utilizing our ENHANZE technology is setting the potential for multiple waves of future product launches that will deliver long-term growth in revenues, profitability and cash flow."

Fourth Quarter 2020 and Recent Highlights Include:

In February 2021, argenx announced a "go" decision for its ADHERE trial evaluating subcutaneous (SC) efgartigimod with ENHANZE technology in chronic inflammatory demyelinating polyneuropathy (CIDP). argenx plans to continue enrollment to include approximately 130 patients to support potential registration of SC efgartigimod for the treatment of CIDP.
In January 2021, ENHANZE partner Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) accelerated approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. AL amyloidosis is a rare and potentially fatal disease that develops when plasma cells in the bone marrow generate abnormal light chains, which form amyloid deposits in vital organs and lead to organ deterioration. There were previously no approved therapies for the disease.
In January 2021, argenx initiated a Phase 3 study of ARGX-113 with ENHANZE technology in pemphigus vulgaris and pemphigus foliaceus, rare autoimmune diseases that cause painful blisters on the skin and mucous membranes.
In December 2020, argenx initiated a Phase 3 study of ARGX-113 with ENHANZE technology for patients with immune thrombocytopenia (ITP), an immune disorder in which the blood does not clot normally, resulting in a $15 million payment to Halozyme.
In December 2020, Roche initiated a Phase 3 study in patients with non-small cell lung cancer for Tecentriq (atezolizumab) with ENHANZE technology, resulting in a $17 million payment to Halozyme.
In December 2020, the Company announced that the European Commission approved Roche’s Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with ENHANZE technology, administered by SC injection for the treatment of patients with early and metastatic HER2-positive breast cancer. This was the first time the European Commission approved a product combining two monoclonal antibodies that can be administered by a single SC injection utilizing ENHANZE technology.
In November 2020, the Company announced a global collaboration and license agreement that provides Horizon Therapeutics plc exclusive access to ENHANZE technology for SC formulation of medicines targeting IGF-1R for which the Company received an upfront payment of $30 million. Horizon intends to use ENHANZE technology to develop a SC formulation of TEPEZZA (teprotumumab-trbw), indicated for the treatment of Thyroid Eye Disease, a serious, progressive and vision-threatening rare autoimmune disease, potentially shortening drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.
In November 2020, Janssen initiated a Phase 1 study of amivantamab utilizing ENHANZE technology in advanced solid tumors.
In November 2020, the Company announced that Janssen submitted regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of DARZALEX FASPRO in the U.S. and as DARZALEX SC in the European Union (EU) utilizing ENHANZE technology in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
In November 2020, Janssen submitted a Type II variation application to the EMA seeking European approval for DARZALEX SC utilizing ENHANZE technology to be used in the treatment of patients with AL amyloidosis.
In October 2020, the Company announced that argenx expanded its existing global collaboration and license agreement that was signed in February 2019. Under the expansion, argenx gained the ability to exclusively access Halozyme’s ENHANZE drug delivery technology for three additional targets upon nomination for a total of up to six targets. To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn, which is blocked by efgartigimod, and complement component C2.
During the fourth quarter, the Company repurchased approximately 1.1 million shares of common stock for $37.6 million at an average price per share of $34.36, bringing the total 2020 repurchases to $150.0 million at an average price of $23.05.
Fourth Quarter and Full Year 2020 Financial Highlights

Revenue for the fourth quarter was $121.7 million compared to $53.7 million for the fourth quarter of 2019. The year-over-year increase was primarily driven by a $30.0 million upfront payment from Horizon, a $15.0 million sales milestone from Janssen, an increase in royalty revenue following the strong DARZALEX FASPRO launch during the second quarter and an increase in product sales. Revenue for the quarter included $32.0 million in royalties, an increase of 86% compared to $17.2 million in the prior year period.
Total revenues for the full year were $267.6 million, compared with $196.0 million in 2019, representing growth of 37% year over year.
Research and development expenses for the fourth quarter were $7.4 million, compared to $45.1 million for the fourth quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts beginning in November 2019 and one-time restructuring charges of $17.2 million in the prior year related to the shift in strategic focus to the Company’s ENHANZE technology.
Research and development expenses for the full year were $34.2 million, compared with $140.8 million in 2019.
Selling, general and administrative expenses for the fourth quarter were $10.4 million, compared to $23.9 million for the fourth quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019 and a one-time restructuring charge of $11.2 million in the prior year.
Selling, general and administrative expenses for the full year were $45.7 million, compared with $77.3 million in 2019.
Operating income for the fourth quarter was $77.6 million, compared to an operating loss of $32.1 million in the fourth quarter of 2019.
Operating income for the full year was $144.3 million, compared to an operating loss of $67.6 million in 2019.
Net income for the fourth quarter was $73.2 million, or $0.50 per share, compared to a net loss in the fourth quarter of 2019 of $34.4 million, or loss of $0.24 per share.
Net income for the full year was $129.1 million or $0.91 per share, compared to a net loss of $72.2 million or loss of $0.50 per share in 2019.
Cash, cash equivalents and marketable securities were $368.0 million at December 31, 2020, compared to $421.3 million at December 31, 2019.
During 2020, the Company repurchased 6.5 million shares of common stock for $150 million at an average price of $23.05, bringing the total for share repurchases since the announcement of the Company’s three-year share repurchase program to $350.0 million at an average price of $19.88.
Financial Outlook for 2021

Based on the latest information from collaboration partners and planned expenditures for the year, the Company expects:

Revenues of $375 million to $395 million, representing year-over-year growth of 40%-48%, with revenues from royalties projected to approximately double versus 2020;
Operating Income of $215 million to $235 million, representing year-over-year growth of 49%-63%;
Earnings per share on a GAAP basis of $1.40 to $1.55, representing year-over-year growth of 54%-70%.
The Company plans to repurchase up to $125 million in common stock during 2021 as part of the $550 million three-year share repurchase plan authorized by Halozyme’s board of directors in 2019. The amount and timing of shares to be repurchased in 2021 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2020 today, Tuesday, February 23, 2021 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

On February 23, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported its financial results for the year ended December 31, 2020 and provides a corporate update (Press release, BioLineRx, FEB 23, 2021, View Source [SID1234575475]).

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

Announced positive results from an interim analysis of its GENESIS Phase 3 trial of motixafortide in stem-cell mobilization (SCM). The interim analysis found statistically significant evidence for the primary endpoint favoring treatment with motixafortide. Based on a recommendation from the independent Data Monitoring Committee (DMC), enrollment was ceased early at 122 patients (instead of 177 originally planned), and top-line data, including full primary and secondary efficacy endpoints, is anticipated in early second quarter of 2021. In parallel, the Company is proceeding with all activities in support of an NDA submission in this indication anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of 2021.
Reported positive final results from the triple combination arm of the Company’s COMBAT/KEYNOTE-202 study evaluating motixafortide in combination with KEYTRUDA (pembrolizumab) and chemotherapy in patients with second-line stage IV pancreatic ductal adenocarcinoma (PDAC). The results of the study showed substantial improvement as compared to historical results across all study endpoints. The Company is currently planning next development steps for this program, including discussions with potential collaboration partners and development of a protocol for a randomized controlled study.
Announced initiation of a Phase 2 investigator-initiated clinical trial evaluating motixafortide in combination with LIBTAYO and chemotherapy in first-line metastatic PDAC. The study is led by Columbia University.
Announced initiation of a Phase 1b investigator-initiated clinical trial evaluating motixafortide in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.
Completed underwritten public offering with gross proceeds of $34.5 million.
"The fourth quarter 2020 was perhaps our most significant so far, having achieved positive data milestones in two programs with significant unmet medical needs – stem-cell mobilization and PDAC," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The Phase 3 SCM interim data that we reported in October were overwhelmingly positive, and based on the DMC’s recommendation, we ceased enrollment at 122 out of the originally planned 177 patients. We now look forward to presenting full top-line results from the study, including data related to 100 days of post-transplantation follow-up, by early second quarter of this year. SCM remains our most expeditious path to registration, and we therefore view these data as potentially transformational for our company. In parallel, we are moving forward very aggressively with all activities in support of an NDA submission, which we expect in the first half of next year.

"We are equally excited about the final results from our Phase 2a COMBAT/KEYNOTE-202 PDAC study that we announced in December last year. The data demonstrated that the triple combination of motixafortide, KEYTRUDA and chemotherapy outperformed historical data across all endpoints, including median overall survival, median progression free survival, confirmed and overall response rates and disease control rate. In a cancer population as difficult to treat as second-line metastatic PDAC, and even more specifically those patients initially diagnosed with unresectable stage IV disease, we view these results as highly encouraging and are planning our next development steps forward in this program, likely in collaboration with a biopharmaceutical partner.

"Finally, subsequent to the end of the year, we strengthened our balance sheet through a financing that resulted in gross proceeds of $34.5 million. These funds will allow us to continue to execute on our strategy for motixafortide in both SCM and PDAC, while in parallel advancing our second clinical candidate, the anti-cancer immunotherapy AGI-134, through clinical development. In summary, we exited 2020 on a very positive note, with two data sets that demonstrate both the effectiveness and versatility of motixafortide across multiple indications, and we plan to build upon these successes this year," concluded Mr. Serlin.

Upcoming Significant Expected Milestones

Top-line results from the Phase 3 GENESIS trial in SCM in early Q2 2021.
Initial results from Part 2 of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2021.
Pre-NDA meeting with the FDA for SCM in the second half of 2021
NDA submission for SCM in the first half of 2022
Financial Results for the Year Ended December 31, 2020

Research and development expenses for the year ended December 31, 2020 were $18.2 million, a decrease of $5.2 million, or 22.5%, compared to $23.4 million for the year ended December 31, 2019. The decrease resulted primarily from termination of the BATTLE clinical study for motixafortide in 2019, from lower expenses associated with the motixafortide COMBAT clinical trial and from lower expenses associated with the AGI-134 study, as well as a decrease in share-based compensation and payroll due to a company-wide salary reduction related to the COVID-19 pandemic.

Sales and marketing expenses for the year ended December 31, 2020 were $0.8 million, similar to sales and marketing expenses for the year ended December 31, 2019.

General and administrative expenses for the year ended December 31, 2020 were $3.9 million, an increase of $0.1 million, or 2.6% compared to $3.8 million for the year ended December 31, 2019. The increase resulted primarily from an increase in D&O insurance expenses and share-based compensation, offset by small decreases in a number of G&A expenses.

The Company’s operating loss for the year ended December 31, 2020 amounted to $22.9 million, compared to an operating loss of $28.1 million for the year ended December 31, 2019.

Non-operating expenses amounted to $5.7 million for the year ended December 31, 2020, compared to non-operating income of $4.2 million for the year ended December 31, 2019. Non-operating expenses for the year ended December 31, 2020 primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet, warrant offering expenses and ATM issuance expenses. Non-operating income for the year ended December 31, 2019 primarily relates to fair-value adjustments of warrant liabilities on the Company’s balance sheet, offset by warrant offering expenses.

Net financial expenses amounted to $1.4 million for the year ended December 31, 2020, compared to net financial expenses of $1.5 million for the year ended December 31, 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 year ended December 31, 2020 amounted to $30.0 million, compared with a net loss of $25.5 million for the year ended December 31, 2019.

The Company held $22.6 million in cash, cash equivalents and short-term bank deposits as of December 31, 2020. Subsequent to year end, the Company raised gross proceeds of $34.5 million in an underwritten public offering, and received another $9.8 million in gross proceeds from the exercise of outstanding warrants.

Net cash used in operating activities for the year ended December 31, 2020 was $23.2 million, compared to $22.7 million for the year ended December 31, 2019. The $0.5 million increase in 2020 was primarily the result of a decrease in accounts payable and accruals.

Net cash provided by investing activities for the year ended December 31, 2020 was $16.7 million, compared to $5.3 million for the year ended December 31, 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 for the year ended December 31, 2020 was $17.9 million, compared to $19.2 million for the year ended December 31, 2019. The cash flows in 2020 primarily reflect the registered direct offerings of the Company’s ADSs in May and June 2020, as well as net proceeds from the ATM program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public offering of the Company’s ADSs in February 2019, as well as net proceeds from the ATM program.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Thursday, February 23, 2021 at 10:00 a.m. EST. To access the conference call, please dial +1-866-744-5399 from the US or +972-3-918-0610 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 February 25, 2021; please dial +1-888-782-4291 from the US or +972-3-925-5904 internationally.

On February 23, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its Board of Directors has authorized a quarterly cash dividend of $0.26 per common share, payable on April 16, 2021, to shareholders of record as of March 16, 2021 (Press release, Thermo Fisher Scientific, FEB 23, 2021, View Source [SID1234575491]). This reflects an 18% increase over the previous dividend payment of $0.22.

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On February 22, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that members of the management team will participate in the 10th Annual SVB Leerink Global Healthcare Conference, Thursday, February 25, at 12:00 p.m. ET (Press release, bluebird bio, FEB 22, 2021, View Source [SID1234575367]).

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the event.