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Biodesix to Participate in Two February Conferences

On February 12, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that management will participate in two upcoming conferences: the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference, which is being held February 17-19, 2021, and the LifeSci Partners Precision Oncology Day, which is being held February 17, 2021 (Press release, Biodesix, FEB 12, 2021, View Source [SID1234575023]).

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Event Details:
Event: BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Format: Fireside chat
Date: Wednesday, February 17
Time: 4:00pm ET

Event: LifeSci Partners Precision Oncology Day
Format: Panel discussion on diagnostic sequencing for the treatment of cancer patients
Date: Wednesday, February 17
Time: 12:00pm ET

Kintara Therapeutics Announces Fiscal Second Quarter 2021 Financial Results and Provides Corporate Update

On February 12, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported its financial results for its fiscal second quarter ended December 31, 2020 and provides a corporate update (Press release, Kintara Therapeutics, FEB 12, 2021, View Source [SID1234575022]).

Second Quarter Highlights and Recent Developments

Executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in its Glioblastoma Adaptive Global Innovative Learning Environment Study (GBM AGILE), a registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM). GBM AGILE is a patient-centered, adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Kintara will supply GCAR with the VAL-083 drug along with the funding to support the VAL-083 arm of the study. In turn, GCAR will manage all operational aspects of the study, including site activation and patient enrollment.

Initiated patient recruitment for the VAL-083 study arm of GBM AGILE.

Announced that VAL-083 is the only therapeutic agent currently being evaluated in all three GBM patient subtypes in GBM AGILE: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.

Announced positive data updates at the Society of Neuro-Oncology Annual Meeting from ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.
"The second quarter of fiscal year 2021 proved to be an important period of progress as we continued to advance to the latter stages of clinical development for VAL-083, our first-in-class small-molecule chemotherapeutic, and REM-001, our photodynamic therapy platform that is maintaining development pace in its confirmatory cutaneous metastatic breast cancer study," commented Saiid Zarrabian, Kintara’s President and Chief Executive Officer. "Certainly, receiving approval from the FDA and GCAR to participate in the GBM AGILE study was a major milestone for the Company as this is a registrational trial whereby VAL-083 is being evaluated in all three GBM patient subtypes."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 SECOND QUARTER ENDED DECEMBER 31, 2020

At December 31, 2020, the Company had cash and cash equivalents of approximately $17.2 million. The cash and cash equivalents at December 31, 2020, along with the proceeds from warrant exercises received subsequent to December 31, 2020, are expected to be sufficient to fund the Company’s planned operations into the fourth quarter of calendar year 2021.

For the three months ended December 31, 2020, the Company reported a net loss of approximately $5.4 million, or $0.22 per share, compared to a net loss of approximately $1.7 million, or $0.15 per share, for the three months ended December 31, 2019. For the six months ended December 31, 2020, the Company reported a net loss of approximately $24.9 million, or $1.34 per share, compared to a net loss of approximately $3.3 million, or $0.35 per share, for the six months ended December 31, 2019. The increased loss for the six months ended December 31, 2020 compared to the six months ended December 31, 2019 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the Adgero transaction.

Infinity Announces Pricing of $80 Million Public Offering of Common Stock

On February 12, 2021 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, reported the pricing of its previously announced underwritten public offering of 21,000,000 shares of its common stock, at a public offering price of $3.80 per share (Press release, Infinity Pharmaceuticals, FEB 12, 2021, View Source [SID1234575021]). The gross proceeds to the Company from this offering are expected to be $79.8 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company. The offering is expected to close on or about February 17, 2021, subject to satisfaction of customary closing conditions. The Company has granted the underwriters a 30-day option to purchase up to an additional 3,150,000 shares of its common stock at the public offering price.

Piper Sandler & Co. is acting as sole book-runner for the offering. Truist Securities, Inc. and JonesTrading Institutional Services LLC are serving as co-managers for the offering.

Infinity intends to use net proceeds from the offering for the continued clinical development of eganelisib, for general corporate purposes and for working capital.

The offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-230258) that became effective with the Securities and Exchange Commission (the "SEC") on April 29, 2019, the base prospectus contained therein and a prospectus supplement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering and the shares of common stock being offered has been filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Before you invest, you should read the prospectus in the registration statement, the prospectus supplement, and other documents the Company has filed with the SEC for more complete information about the Company and this offering. Copies of the registration statement, the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or, when available, by contacting: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation, or sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful.

AbbVie to Present at the 10th Annual SVB Leerink Global Healthcare Conference

On February 12, 2021 AbbVie (NYSE: ABBV) reported that it will participate in the 10th Annual SVB Leerink Global Healthcare Conference on Friday, February 26 (Press release, AbbVie, FEB 12, 2021, View Source [SID1234575020]). Michael Severino, M.D., vice chairman and president, Robert A. Michael, executive vice president and chief financial officer, and Jeffrey R. Stewart, executive vice president, commercial operations, will present virtually at 9:40 a.m. Central time.

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

Expanding CAR-T manufacturing in Australia

On February 12, 2021 Novartis reported it has received approval from the Therapeutic Goods Administration (TGA) for Cell Therapies to manufacture and supply its CAR-T therapies commercially for eligible patients in Australia (Press release, Novartis, FEB 12, 2021, View Source [SID1234575019]). The Cell Therapies manufacturing facility in the Peter MacCallum Cancer Center in Melbourne is the first and only approved commercial manufacturing site for CAR-T cell therapies in Australia.

As a pioneer in individualized medicine, Novartis is committed to reimagining cancer care in the emerging field of CAR-T therapies. We are determined to bring these transformative therapies to the maximum number of patients with difficult-to-treat cancers and limited treatment options. We are proud to have the largest geographical CAR-T manufacturing network in the world, which makes our therapies accessible to healthcare practitioners and patients across the globe. Cell Therapies, a world-leading manufacturing facility, adds their experience to our leadership in pioneering research, development and supply of cell and gene therapies. International collaborations such as these are critical in accelerating advancements in areas of great medical need.

Steffen Lang, Global Head of Novartis Technical Operations
The CAR-T manufacturing network of Novartis comprises of seven facilities across four continents. This includes commercial and clinical trial manufacturing now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for Cell Therapy and Immunology (Fraunhofer-Institut für Zelltherapie und Immunologie) facility in Leipzig, Germany, FBRI in Kobe, Japan, and now Cell Therapies in Australia. Manufacturing at Cellular Biomedicine Group in China is forthcoming. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain.

To date, more than 100 patients in Australia have now been treated with Novartis CAR-T treatment across clinical trials and commercially available therapy. Local manufacturing means patients’ cells can stay in Australia without the need to ship them overseas, generating greater efficiencies and an expectation of quicker timelines tor eligible patients.