On April 9, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its first-quarter 2021 financial results on Tuesday, May 4, 2021 (Press release, Bausch Health, APR 9, 2021, View Source [SID1234577810]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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On April 9, 2021 Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) (the "Company"), a clinical-stage biotechnological company employing its core proprietary technologies to develop best-in-class products based on gene-edited allogeneic CAR T-cells in the field of immuno-oncology, reported that it has completed sales of approximately $47 million of American Depositary Shares ("ADS") pursuant to the Company’s ATM program established on March 29, 2021 (the "ATM Sales"), through Jefferies LLC ("Jefferies"), acting as sales agent. Each ADS represents one ordinary share of the Company (Press release, Cellectis, APR 9, 2021, View Source [SID1234577778]).

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In the ATM Sales, an aggregate of 2,415,630 new ADSs and the same number of underlying new ordinary shares have been issued to existing and new investors at an at-the-market price of $19.50 per new ADS.

It is anticipated that the settlement and delivery of the new ordinary shares will take place on April 12, 2021. They will be admitted to trading on the market of Euronext Growth and the issued ADSs will trade on Nasdaq.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ securities was filed with the SEC and became effective upon filing on June 2, 2020. Before purchasing ADSs in the offering, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821-7388 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities of the Company, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful. In particular, no public offering of ADSs has been made in Europe.

On April 9, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported two poster presentations at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which is being held virtually April 10 – 15 and May 17 – 21, 2021 (Press release, aTyr Pharma, APR 9, 2021, View Source [SID1234577795]). The full text of the corresponding abstracts is available on the AACR (Free AACR Whitepaper) website. The posters will be available for browsing on the AACR (Free AACR Whitepaper) website starting Saturday April 10 at 8:30 a.m. ET through Monday June 21. The posters will also be available on the aTyr website.

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The posters present findings from preclinical studies, conducted in collaboration with Dr. Arthur M. Mercurio and his lab at the University of Massachusetts Medical School, demonstrating effects of ATYR2810, aTyr’s anti-human Neuropilin-2 (NRP2) / VEGF blocking monoclonal antibody, in solid tumors. In animal models of non-small cell lung cancer, ATYR2810 administered therapeutically as a single agent significantly inhibited tumor growth. When administered in combination with chemotherapy, including either 5-FU or cisplatin, ATYR2810 inhibited tumor growth to a greater extent compared to either chemotherapeutic agent alone. In models of triple-negative breast cancer (TNBC), ATYR2810 administered in combination with widely used anti-cancer therapeutics, including the chemotherapeutic agent cisplatin or the targeted VEGF therapy bevacizumab, increased the anti-tumor effects of each agent. ATYR2810 also down-regulated epithelial-mesenchymal transition genes, which may be a mechanism that mediates its anti-tumor effects.

"The data presented in these posters affirm the therapeutic potential of ATYR2810 for aggressive cancer and provide a compelling rationale for evaluating the efficacy of ATYR2810 in patients," said Dr. Arthur M. Mercurio, Professor and Vice Chair of the Department of Molecular, Cell and Cancer Biology at the University of Massachusetts Medical School and co-author of the posters. "Notably, the ability of this antibody to promote the differentiation of TNBC cells and render them more susceptible to chemotherapy has the potential to be a significant advancement because therapy resistance, which is associated with tumor recurrence and metastasis, is a major challenge for patients with TNBC and other aggressive cancers."

"These findings build upon our preclinical work related to ATYR2810 and strengthen our understanding of blocking VEGF-mediated NRP2 signaling as a potential approach to inhibiting tumor growth," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "Whether as a monotherapy or in combination with other widely used anti-cancer treatments, including chemotherapy or a targeted therapy such as bevacizumab, these findings suggest that ATYR2810 has potential as a therapeutic agent in certain tumors where NRP2 is implicated. We look forward to continuing IND-enabling activities for ATYR2810 to support advancement to clinical trials in cancer in the future."

Details of posters and corresponding abstracts are as follows:

Title: The Neuropilin-2 targeting antibody ATYR2810 inhibits non-small cell lung cancer tumor growth in monotherapy and combination therapy
Authors: Alison G. Barber, Zhiwen Xu, Justin Rahman, Hira Lal Goel, Arthur M. Mercurio, Christoph Burkart, Leslie A. Nangle. aTyr Pharma, San Diego, CA, UMass Medical School, Boston, MA.
Abstract Number: 5247
Session Category: Tumor Biology
Session Title: Human-in-Mouse Models of Human Cancer
Poster Number: LB234
Permanent Abstract Number: LB234
Date and Time: April 10 at 8:30 a.m. ET

Title: A domain-specific antibody to NRP2 down-regulated epithelial-mesenchymal transition genes and enhanced efficacy of standard-of-care therapeutics for aggressive breast cancer
Authors: Zhiwen Xu, Christoph Burkart, Hira Lal Goel, Justin Rahman, Clara Polizzi, Matt Seikkula, Luke Burman, Arthur M. Mercurio, Leslie A. Nangle. aTyr Pharma, San Diego, CA, UMass Medical School, Boston, MA.
Abstract Number: 5316
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents
Poster Number: LB095
Permanent Abstract Number: LB095
Date and Time: April 10 at 8:30 a.m. ET

About ATYR2810

aTyr is developing ATYR2810 as a potential therapeutic for certain aggressive tumors where Neuropilin-2 (NRP2) is implicated. ATYR2810 is a fully humanized monoclonal antibody that is designed to specifically and functionally block the interaction between NRP2 and one of its primary ligands, VEGF. ATYR2810 is the first Investigational New Drug (IND) candidate to arise from aTyr’s in-house research program designing monoclonal antibodies to selectively target the NRP2 receptor and its associated signaling pathways. NRP2 is a cell surface receptor that is highly expressed in certain tumors, in the lymphatic system and on key immune cells implicated in cancer progression. Increased NRP2 expression is associated with worse outcomes in many cancers. Preclinical data suggest that ATYR2810 could be effective against certain types of solid tumors. ATYR2810 is currently undergoing IND-enabling studies.

On April 9, 2021 Bionomics Limited (ASX: BNO,OTCQB:BNOEF) (Bionomics) reported that it has completed its 1 for 6 pro rata non–renounceable entitlement offer that was announced on 8 March 2021 (Entitlement Offer) and concurrent placement that was announced on 17 March 2021 (Concurrent Placement) which collectively raised approximately A$22.9 million (Press release, Bionomics, APR 9, 2021, View Source [SID1234577811]).

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The Entitlement Offer closed at 5.00pm (Adelaide time) on 30 March 2021 and raised approximately A$20.4 million from the offer of approximately 140.9 million new fully paid ordinary shares in Bionomics (New Shares) at the offer price of A$0.145 per New Share.

The Entitlement Offer was well supported by eligible shareholders who applied for approximately 85.6 million shares aggregating to approximately A$12.4 million of New Shares pursuant to their entitlements (representing a take up rate of approximately 60.7%).

Eligible shareholders subscribed for a further approximately 70.3 million additional New Shares in excess of their entitlement (up to a maximum of 100% of their entitlement) aggregating to approximately A$10.2 million in excess of their entitlement through the Oversubscription Facility. Applications under the Oversubscription Facility were in excess of the approximately 55.3 million shares or A$8 million shortfall and were scaled back in accordance with the terms of the Entitlement Offer on a pro rata basis.

Commenting on the outcome, Bionomics’ Executive Chairman, Dr Errol De Souza said, "Following on from the strong support received under the Company’s oversubscribed capital raise in February 2021, the success of the Entitlement Offer and Concurrent Placement demonstrates the confidence of Bionomics’ shareholders in the direction of the Company and the opportunities presented by progressing the development programme for BNC210 for the treatment of PTSD. We remain on track to starting the Phase 2b BNC210 PTSD trial in mid-2021".

As announced on 17 March 2021, Bionomics also conducted the Concurrent Placement concurrently with the Entitlement Offer pursuant to which certain investors were entitled to apply for new shares at the same price and on the same pro rata basis as was offered to subscribers under the Entitlement Offer. The investors to whom this Concurrent Placement offer was extended were those who participated in the Bionomics placement announced on 9 February 2021 and which completed on 2 March 2021, but who were unable to participate in the Entitlement Offer due to having a registered address outside of Australia or New Zealand.

The Concurrent Placement which was made on substantially the same terms as the Entitlement Offer raised approximately A$2.5 million from the offer of approximately 17.2 million new fully paid ordinary shares in Bionomics (New Concurrent Shares) at the offer price of A$0.145 per New Concurrent Share. New Concurrent Shares applied for under the Concurrent Placement were scaled back on a pro rata basis in the same manner as shareholders who applied under the Entitlement Offer.

The New Concurrent Shares issued under the Concurrent Placement were allocated from Bionomics’ expanded placement capacity following the Entitlement Offer.

Allotment of New Shares and New Concurrent Shares under the Entitlement Offer and the Concurrent Placement occurred on Thursday, 8 April 2021.

New Shares and Concurrent New Shares issued under the Entitlement Offer and the Concurrent Placement rank equally in all respects with existing shares. Shareholders should confirm their holding before trading in New Shares and Concurrent New Shares.

On April 9, 2021 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported data from its T cell programs are being presented at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Sana Biotechnology, APR 9, 2021, View Source [SID1234584004]).

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Sana is investing in multiple platform technologies to engineer cells, and several of these have the potential to address unmet needs for patients with cancer. Two of these platforms are highlighted in posters to be presented at AACR (Free AACR Whitepaper). Sana’s fusogen platform has the potential to deliver genetic payloads to specific cells in vivo, or inside a patient’s body, including delivery to T cells of the gene needed to make a chimeric antigen receptor (CAR). Sana’s hypoimmune platform has the potential to enable transplants of allogeneic cells without immunosuppression, including allogeneic CAR T cells.

"We are excited to share data for the first time at AACR (Free AACR Whitepaper), as we are optimistic that Sana’s platforms can be applied to help cancer patients," said Steve Harr, MD, Sana’s President and CEO. "CAR T cells have shown enormous potential for certain cancer patients, and Sana’s goal is to make better and more accessible CAR T therapies so that more patients can benefit."

"The data presented in these abstracts highlight the potential of our fusogen and hypoimmune platforms to make high quality, functional CAR T cells without the logistical complexities of autologous CAR T cell therapies," said Terry Fry, MD, Sana’s Head of T Cell Therapeutics. "The goal of our CD8-targeted fusogen program is to deliver the CAR gene directly to the T cell in vivo, and our data highlight the potential of these genetically modified CAR T cells to kill tumors. Separately, we modify gene expression in donor T cells to create hypoimmune allogeneic CAR T cells, and data highlight the potential of these cells to evade both the innate and adaptive immune systems while retaining anti-tumor effects. These results represent important progress in validating Sana’s platforms as we continue towards the clinic."

Data from two late-breaker abstracts were made available to the AACR (Free AACR Whitepaper) community today and are outlined below. The full posters will be available to conference participants online beginning Saturday, April 10 at 8:30 a.m. Eastern Time.

In vivo CAR T therapy: targeted in vivo gene delivery of a CAR using a CD8-specific fusogen results in tumor eradication
Authors: Terry Fry, MD et al.

Key takeaways include:

A single intravenous delivery of a CD8 fusogen containing a second-generation CD19 CAR transgene resulted in the generation of CD8 CAR Ts that eradicated the CD19+ tumor xenografts;
CD8 fusogen delivery resulted in a high percentage of T cells engineered to express the CAR with specificity for the CD8+ cells; and
The fusogen was able to generate a functional CAR response regardless of prior activation status of the T cells.
Overexpression of CD47 protects hypoimmune CAR T cells from innate immune cell killing
Authors: Sonja Schrepfer, MD, PhD et al.

Key takeaways include:

Innate immune cell assays show that CD47 overexpression protects HLA-I/II deficient CAR T cells from natural killer cell and macrophage killing both in vitro and in vivo;
Hypoimmunogenic CAR T cells have shown the ability to functionally evade the innate and adaptive immune system in allogeneic recipients with cytotoxic anti-tumor capacity; and
Hypoimmune CAR T cells have the potential to provide universal CAR T cells that are able to persist without immunosuppression.