On February 8, 2023 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Executive Officer, Dr. Adi Hoess, will present at the SVB Securities 2023 Global Biopharma Conference on Tuesday, February 14, 2023 at 2:20 p.m. EST / 20:20 CET (Press release, Affimed, FEB 8, 2023, View Source [SID1234626974]).

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A live webcast of the presentation will be accessible on Affimed’s website at View Source
A replay of the call will be archived on Affimed’s website for 30 days after the call.

For more information on the conference or to schedule a one-on-one meeting with Affimed management, please contact your conference representative or Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.

On February 8, 2023 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, aTyr Pharma, FEB 8, 2023, View Source [SID1234626973]). In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to an additional 15% of the shares sold in the public offering. All of the shares to be sold in the offering are to be sold by aTyr. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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RBC Capital Markets is acting as sole book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

aTyr intends to use the net proceeds from the offering primarily for general corporate purposes, including the ongoing development of efzofitimod and the expansion of its clinical development program to include a planned Phase 2 study of efzofitimod in patients with systemic sclerosis (SSc, or scleroderma)-associated interstitial lung disease (SSc-ILD), in 2023, based on recent clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration, and for working capital.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed by aTyr that was declared effective by the Securities and Exchange Commission ("SEC") on April 8, 2022. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained by contacting RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected]; or H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone at (212) 856-5711 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 8, 2023 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress" or "Company"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported that it has entered into definitive agreements for the issuance and sale of 16.6 million shares of its common stock in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Fortress Biotech, FEB 8, 2023, View Source [SID1234626972]). The purchase price of each share is $0.835.

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Certain directors and officers of the Company participated in the offering and purchased an aggregate amount of approximately $3.3 million of Fortress common stock at the same purchase price of $0.835 per share, which is at a premium to the consolidated closing bid price under Nasdaq rules.

In a concurrent private placement, investors in the registered direct offering will also receive a pro rata right to acquire, in the aggregate, securities exercisable into approximately 3.5% of the outstanding shares of common stock in each of the Company’s next 20 new operating subsidiaries (the "Contingent Subsidiary Securities"). The Contingent Subsidiary Securities will only be issued to the extent such a new operating subsidiary first consummates a specified corporate development transaction within the next five years, and will be exercisable immediately upon issuance, with an exercise period of 10 years, at an exercise price equal to the fair market value of one share of common stock of the subsidiary on the date of the corporate development transaction. The issuance of the rights and Contingent Subsidiary Securities are conditioned on the approval of the Company’s stockholders to the extent required by Nasdaq Listing Rule 5635.

H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

The offering is expected to close on or about February 10, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $13.9 million. Fortress expects to use the net proceeds from the offering for general corporate purposes and working capital.

The Fortress common stock is being offered in the registered direct offering by Fortress pursuant to a shelf registration statement on Form S-3 (File No. 333-258145) that was previously filed with the Securities and Exchange Commission ("SEC") on July 23, 2021, and subsequently declared effective on July 30, 2021. The Fortress common stock is being offered in the registered direct offering only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

The offer and sale of Contingent Subsidiary Securities and the securities issuable thereunder in the private placement have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state securities laws, and are being made pursuant to an exemption from registration provided under Section 4(a)(2) of the Securities Act. Accordingly, such Contingent Subsidiary Securities and the securities issuable thereunder in the private placement may not be reoffered or resold in the United States except pursuant to an effective registration statement with the Securities and Exchange Commission (the "SEC") or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

On February 8, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported its financial results for the fourth quarter and full year 2022, recent business highlights and key upcoming catalysts for 2023 (Press release, Atara Biotherapeutics, FEB 8, 2023, View Source [SID1234626971]).

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"Following the landmark approval of EbvalloTM in Europe, we had productive discussions with the FDA about their requirements for a tab-cel BLA. We welcome the opportunity to further discuss the topic of comparability that may advance our progress towards a BLA submission," said Pascal Touchon, President and Chief Executive Officer of Atara. "Meanwhile, we are on track for the results of our Phase 2 EMBOLD study this October, a key catalyst that could progress ATA188 towards becoming the first ever targeted and transformative therapy in multiple sclerosis (MS) following the landmark scientific discovery of EBV as the leading trigger of MS."

Tabelecleucel (tab-cel or EbvalloTM) for Post-Transplant Lymphoproliferative Disease (PTLD)

Atara recently held a productive meeting with FDA on clinical aspects for a potential biologics license application (BLA) submission for tab-cel

Atara and the FDA are expected to hold another meeting to further discuss chemistry, manufacturing, and controls (CMC) matters relating to a potential BLA for tab-cel, including aspects related to comparability that may support pooling clinical data from different process versions

Atara expects to provide a further update in Q2 2023

In December 2022, Atara announced that the European Commission (EC) granted marketing authorization for the first-of-its-kind, off-the-shelf, allogeneic T-cell therapy, Ebvallo (tabelecleucel) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy
In February 2023, Atara completed the transfer of the EC marketing authorization to Pierre Fabre, who is now leading all commercialization, distribution, medical, and regulatory activities in Europe, Middle East, Africa and other selected markets

Pierre Fabre is planning to launch Ebvallo in the first European countries during Q1 2023

Atara anticipates investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in 2023

Atara is engaged in discussions with potential U.S. commercialization partners
ATA188 for Progressive Multiple Sclerosis (MS)

Following target enrollment in the Phase 2 EMBOLD study, the primary analysis data read out is on track for October 2023
ATA3219: CD19 Program for B-Cell Malignancies

IND for ATA3219 is anticipated for Q2 2023
ATA3219 is an allogeneic CD19-1XX CAR+ EBV T cell that incorporates multiple clinically-validated technologies designed for T-cell memory, robust expansion, and potent anti-tumor efficacy
Currently, the majority of eligible patients are not receiving approved autologous CD19 CAR-T treatment due to technical, operational and access challenges. Within the minority of diffuse large B-cell lymphoma (DLBCL) patients who do receive CAR T treatment, only 30-40% have durable response at 6 months, representing a significant opportunity for ATA3219 to potentially expand patient access and deliver durable, safe responses
Chief Financial Officer Transition

Utpal Koppikar, who has served as the Company’s Chief Financial Officer since 2018, will depart Atara to pursue an external career opportunity effective March 31, 2023

Effective April 1, 2023, Eric Hyllengren will assume the role of Senior Vice President, Chief Financial Officer. Mr. Hyllengren will also serve as the Company’s Principal Financial Officer and Principal Accounting Officer
Mr. Hyllengren joined Atara in 2018 as Vice President, Financial Planning and Analysis and added the role of Head of Investor Relations in April 2020. Previously, Mr. Hyllengren spent 15 years at Amgen Inc. in several finance roles with increasing responsibilities, including corporate finance and investor relations

Fourth Quarter and Full Year 2022 Financial Results

Atara sold a portion of its right to receive royalties and certain milestones in Ebvallo under the Pierre Fabre Commercialization Agreement to HCR Molag Fund L.P (HCRx) for $31.0 million, which was received in December 2022. Total royalties and milestones payable to HCRx are capped between 185% and 250% of the $31.0 million, depending upon the timing of such payments to HCRx
Cash, cash equivalents and short-term investments as of December 31, 2022 totaled $242.8 million, as compared to $371.1 million as of December 31, 2021

Atara believes that its cash and investments as of December 31, 2022, together with the $40.0 million received in January 2023 for achievement of certain milestones under the Pierre Fabre Commercialization Agreement, will be sufficient to fund the Company’s planned operations into Q2 2024
Atara reported net losses of $74.6 million, or $0.72 per share, and $228.3 million, or $2.24 per share, for the fourth quarter and fiscal year 2022, respectively, as compared to $93.3 million, or $0.96 per share, and $340.1 million, or $3.63 per share, for the same periods in 2021

Total operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $12.6 million and $59.5 million for the fourth quarter and fiscal year 2022, respectively, as compared to $16.5 million and $63.0 million for the same periods in 2021

Research and development expenses were $62.5 million and $272.5 million for the fourth quarter and fiscal year 2022, respectively, as compared to $79.1 million and $282.0 million for the same periods in 2021
Research and development expenses include $7.0 million and $31.4 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2022, respectively, as compared to $8.4 million and $32.1 million for the same periods in 2021

General and administrative expenses were $13.2 million and $71.6 million for the fourth quarter and fiscal year 2022, respectively, as compared to $21.8 million and $78.8 million for the same periods in 2021
General and administrative expenses include $4.4 million and $22.5 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2022, respectively, as compared to $5.6 million and $21.8 million for the same periods in 2021

On February 8, 2023 Celyad Oncology (Euronext & Nasdaq: CYAD) (the "Company"), a biotechnology company focused on the discovery and development of innovative technologies for chimeric antigen receptor (CAR) T-cell therapies, reported the publication of the data from the haematological arm of the THINK study which evaluated CYAD-01 in relapsed or refractory (r/r) acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) or multiple myeloma (MM) patients (Press release, Celyad, FEB 8, 2023, View Source [SID1234626970]). The findings were published in the journal The Lancet Haematology.

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CYAD-01 is the Company’s first autologous CAR T-cell candidate, based on the natural killer receptor NKG2D, assessed clinically. The completed THINK study was an open-label, dose-escalation Phase 1 study for patients with r/r AML, MDS, or MM, after at least one previous line of therapy. Patients were recruited from five hospitals in the USA and Belgium.

The Lancet Haematology publication includes data from the 16 patients treated with CYAD-01 in the dose escalation segment of the study, which evaluated three dose levels of CYAD-01 using a schedule of three infusions at two-week intervals in the absence of any preconditioning chemotherapy. Overall, CYAD-01 showed favourable safety data with signs of clinical activity with three of the 12 evaluable AML/MDS patients presenting an objective response.

Importantly, the THINK study is one of the first completed dose-escalation CAR T-cell studies in r/r AML/MDS. Unlike the majority of the studies evaluating CAR T-cell therapy candidates, the THINK study evaluated multiple infusions of CYAD-01 as a stand-alone product candidate (i.e., without prior bridging or preconditioning chemotherapy). This feature is of particular interest considering the median older age and the poorer general condition of patients with r/r AML or MDS at diagnosis. Although the need to improve the anti-tumour activity is warranted, these data in a difficult-to-treat patient population potentially provide the proof-of-concept of targeting NKG2D ligands by a CAR T-cell product candidate, and support the further development of NKG2D-based CAR T-cell therapies.