On June 7, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported the pricing of its public offering of 8,700,000 shares of common stock (the "Offering") at a public offering price of $5.00 per share for gross proceeds of approximately $43.5 million, without giving effect to the underwriting discount and commission as well as estimated expenses payable by Akoya (Press release, Akoya Biosciences, JUN 8, 2023, View Source [SID1234632584]). Akoya has granted the underwriters a 30-day option to purchase up to an additional 1,305,000 shares of its common stock at the public offering price. The closing of the Offering is expected to occur on June 12, 2023, subject to the satisfaction of customary closing conditions.

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Akoya intends to use the net proceeds from the Offering for working capital and general corporate purposes.

Morgan Stanley and Piper Sandler are acting as joint book-running managers for the Offering.

The securities described above are being offered by Akoya pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on November 21, 2022. A preliminary prospectus supplement and the accompanying prospectus relating to the Offering was filed by Akoya with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and the accompanying prospectus relating to the Offering will be filed by Akoya with the SEC. The Offering may only be made by means of a prospectus, including a prospectus supplement, that forms part of the registration statement referred to above. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by phone at 1-866-718-1649 or by email at [email protected] and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Maill J12S03, Minneapolis, Minnesota 55402, by telephone at 1-800-747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

On June 8, 2023 Sandoz reported to host the first of two Capital Markets Days (CMDs) for investors, in New York City, to set out its plans for growth and success as a standalone company, following the proposed 100% spin-off from Novartis (Press release, Novartis, JUN 8, 2023, View Source [SID1234632568]).

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Sandoz reported sales of USD 9.1 bn in 2022, with a record of six consecutive quarters of single-digit growth. At the CMD today, the company will forecast mid-single digit net sales growth for 2023 as well as for the mid term (2024 to 2028). The core EBITDA margin is expected to expand to 24–26% in the mid term, from a forecast 18-19% in 2023, with the initial decrease from 21.2% in 2022 driven by ongoing inflation and investments required to stand up Sandoz as a separate company.

Free cash flow is expected to more than double by 2028, from a reported USD 0.8 bn in 2022. This should enable Sandoz, with a targeted investment grade credit profile and a prudent capital structure, to pay shareholders a full-year dividend of 20-30% of FY 2023 core net income, increasing to 30-40% in the mid term.

"I am honored to have the opportunity to lead Sandoz into its exciting new future and believe this company will have the Board, Executive team and key capabilities it needs to succeed as a standalone company", said Gilbert Ghostine, Chairman-designate of the proposed new company, who will open the event later today. "Sandoz is an established European champion and global leader in generics and biosimilars with an impressive scientific heritage, a powerful purpose-driven strategy and one of the strongest brands in the industry. I am confident that our new company represents a compelling opportunity for both equity and debt investors."

Sandoz CEO Richard Saynor said: "In recent years, we have reshaped our business for the future, driven by a strong leadership team with clear alignment on our vision. We are focused on sales execution, while significantly expanding our pipeline, investing in targeted build-up of capabilities and developing strategic partnerships. Looking forward, six strategic levers will drive long-term investor value: attractive market fundamentals, leadership and scale, multiple growth drivers, margin improvement, accelerated cash generation, and a compelling sustainability story. The proposed spin-off would enable us to deliver our full potential, with an attractive and sustainable financial outlook including an expected shareholder dividend."

The expanding Sandoz product pipeline is expected to contribute an additional USD 3 billion in potential net sales over the next five years, with the mix shifting increasingly towards high-value biosimilars and complex generics. The biosimilar pipeline has trebled in size over recent years, now with 24 products, on top of a core generic pipeline of more than 400 products.

Concluding, Saynor said: "We actively pioneer access for patients by shaping the global healthcare environment, strengthening healthcare systems worldwide by delivering over USD 17 billion in annual savings in Europe and the US alone, reaching 500 million patients a year in over 100 countries, and generating a total social impact estimated in the hundreds of billions of dollars".

Sandoz will host a second CMD, in London on June 12, where investors and analysts will have another opportunity to meet Sandoz leadership.

Both events will also be webcast; to register online for access, visit the Investor Relations section of the Novartis website at www.novartis.com, or click directly below:
Capital Markets Day – New York (media-server.com)
Capital Markets Day – London (media-server.com)

Additional Transaction Details

The proposed 100% spin-off of Sandoz is expected to occur in the second half of 2023. Completion of the proposed spin-off is subject to satisfaction of certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, receipt of favorable tax rulings and opinions, final endorsement by the Board of Directors of Novartis AG and shareholder approval. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed. Further details of the proposed spin-off will be provided at a later date.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On June 8, 2023 Sandoz reported to host the first of two Capital Markets Days (CMDs) for investors, in New York City, to set out its plans for growth and success as a standalone company, following the proposed 100% spin-off from Novartis (Press release, Novartis, JUN 8, 2023, View Source [SID1234632568]).

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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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Sandoz reported sales of USD 9.1 bn in 2022, with a record of six consecutive quarters of single-digit growth. At the CMD today, the company will forecast mid-single digit net sales growth for 2023 as well as for the mid term (2024 to 2028). The core EBITDA margin is expected to expand to 24–26% in the mid term, from a forecast 18-19% in 2023, with the initial decrease from 21.2% in 2022 driven by ongoing inflation and investments required to stand up Sandoz as a separate company.

Free cash flow is expected to more than double by 2028, from a reported USD 0.8 bn in 2022. This should enable Sandoz, with a targeted investment grade credit profile and a prudent capital structure, to pay shareholders a full-year dividend of 20-30% of FY 2023 core net income, increasing to 30-40% in the mid term.

"I am honored to have the opportunity to lead Sandoz into its exciting new future and believe this company will have the Board, Executive team and key capabilities it needs to succeed as a standalone company", said Gilbert Ghostine, Chairman-designate of the proposed new company, who will open the event later today. "Sandoz is an established European champion and global leader in generics and biosimilars with an impressive scientific heritage, a powerful purpose-driven strategy and one of the strongest brands in the industry. I am confident that our new company represents a compelling opportunity for both equity and debt investors."

Sandoz CEO Richard Saynor said: "In recent years, we have reshaped our business for the future, driven by a strong leadership team with clear alignment on our vision. We are focused on sales execution, while significantly expanding our pipeline, investing in targeted build-up of capabilities and developing strategic partnerships. Looking forward, six strategic levers will drive long-term investor value: attractive market fundamentals, leadership and scale, multiple growth drivers, margin improvement, accelerated cash generation, and a compelling sustainability story. The proposed spin-off would enable us to deliver our full potential, with an attractive and sustainable financial outlook including an expected shareholder dividend."

The expanding Sandoz product pipeline is expected to contribute an additional USD 3 billion in potential net sales over the next five years, with the mix shifting increasingly towards high-value biosimilars and complex generics. The biosimilar pipeline has trebled in size over recent years, now with 24 products, on top of a core generic pipeline of more than 400 products.

Concluding, Saynor said: "We actively pioneer access for patients by shaping the global healthcare environment, strengthening healthcare systems worldwide by delivering over USD 17 billion in annual savings in Europe and the US alone, reaching 500 million patients a year in over 100 countries, and generating a total social impact estimated in the hundreds of billions of dollars".

Sandoz will host a second CMD, in London on June 12, where investors and analysts will have another opportunity to meet Sandoz leadership.

Both events will also be webcast; to register online for access, visit the Investor Relations section of the Novartis website at www.novartis.com, or click directly below:
Capital Markets Day – New York (media-server.com)
Capital Markets Day – London (media-server.com)

Additional Transaction Details

The proposed 100% spin-off of Sandoz is expected to occur in the second half of 2023. Completion of the proposed spin-off is subject to satisfaction of certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, receipt of favorable tax rulings and opinions, final endorsement by the Board of Directors of Novartis AG and shareholder approval. There can be no assurance regarding the ultimate timing of the proposed transaction or that the transaction will be completed. Further details of the proposed spin-off will be provided at a later date.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

On June 7, 2023 Neomabs Biotechnologies reported that developing new generations of immunotherapies to treat still incurable pediatric leukemias: this is the objective of Neomabs Biotechnologies, a new Montreal biotechnology company specializing in the discovery and development of innovative therapies in oncology (Press release, Neomabs Biothechnologies, JUN 7, 2023, View Source [SID1234636476]).

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The result of a strategic and innovative partnership between key players in the life sciences ecosystem, the creation of Neomabs was made possible thanks to pre-seed financing of $2M led by Theodorus, with the participation of Eureka Investment Fund. Neomabs also counts CQDM, Immune Biosolutions and the CHU Sainte-Justine Research Center among its partners.

Neomabs is working to develop therapeutic antibodies directed against new targets – neo-antigens – against acute pediatric leukemia, of which 20% to 30% of affected children still die today. The discovery of these targets is made possible thanks to the expertise of researcher Étienne Caron, his associate Isabelle Sirois and Dr. Sonia Cellot at CHU Sainte-Justine. Indeed, Étienne Caron, also an assistant professor in the pathology department of the University of Montreal, uses high-performance methods of proteomics, immunopeptidomics and computational mass spectrometry which he pairs with a unique biobank of leukemic specimens, xenografts derived from patients and artificial human leukemia models led by Dr. Sonia Cellot , hemato-oncologist and clinician-researcher at CHU Sainte-Justine. It is this combination of expertise which is the source of the antibodies developed by Neomabs.

The company has thus concluded an exclusive worldwide licensing agreement on the neo-antigens identified at the CHU Sainte-Justine Research Center, through Axelys, partner of CHU Sainte-Justine for the management and marketing of its active ingredients. intellectual property.

"We are delighted with the launch of this new company in Montreal. This is the culmination of a unique partnership between Theodorus and CQDM, launched in 2021, which aimed to identify innovative research programs in the development of new therapies and to accelerate their commercialization through the creation of new companies. in life sciences in Quebec, declared Patricia Escoffier , Director at Theodorus. We are proud to be able to lead this round of financing and to participate in this unique partnership which will promote the creation of a real commercial opportunity for this promising technology."

"The Eureka Fund was set up with the objective of supporting the development of new innovative technology companies at the pre-seed stage such as Neomabs. We are proud to support promising young companies operating in key sectors of our economy, such as life sciences, and which develop technologies through close collaboration with the community. », Underlines Benoit Leroux , president of the Eureka Investment Fund.

"The Eureka Fund propels young innovative technological companies like Neomabs Biotechnologies, which work to improve the well-being of the Quebec population. By supporting their creation, we enable the emergence of new therapies from public research centers which will have a real effect on people’s health," says Pierre Fitzgibbon , Minister of the Economy, Innovation and Energy. , Minister responsible for Regional Economic Development and Minister responsible for the Metropolis and the Montreal region.

"The CHU Sainte-Justine Research Center is pleased to actively contribute, through its academic and clinical excellence, to the emergence of this new partnership model dedicated to transforming the care pathway for children with cancer," says Dr. Jacques L. Michaud , director of research at CHU Sainte-Justine.

"We are proud to join this unique group of partners to support the growth of Neomabs and accelerate the development of new treatments to fight pediatric cancers," said Jesse Paterson, Senior Director of Business Development at CQDM. This is a perfect example of how CQDM contributes to the development of a solid Quebec ecosystem in the field of life sciences by bringing together the right partners and the most promising innovations.

"This strategic partnership with NeoMabs will help identify the next generation of therapeutic antibodies to treat pediatric leukemias. Thanks to our common passion and our shared resources, we are convinced that we can improve the quality of life of young patients as well as their families," underlines Luc Paquet , President and CEO of Immune Biosolutions and Chairman of the Board of Immune Biosolutions. administration of Neomabs.

"Neomabs fully illustrates the quality of the Quebec biotechnology ecosystem that Axelys wishes to support in its growth and maturation, in order to create, grow and shine leaders offering therapies for patients suffering from serious illnesses and often without a therapeutic alternative," explains Catherine Gagnon , vice-president, business development and investments at Axelys.

On June 7, 2023 ITabMed Ltd., a clinical-stage biotech company in China, reported the IND approval from China National Medical Products Administration (NMPA) for A-337, a CD3-activating bi-specific antibody targeting EpCAM. This is a "Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of A-337 in patients with advanced solid tumors" (Press release, ITabMed, JUN 7, 2023, View Source [SID1234632575]). EpCAM is one of the earliest identified tumor-associated antigens (TAA) and up-regulated and over-expressed in many solid tumors.

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A-337 is the second immune oncology product generated by the immunotherapy antibody (iTab) platform to enter clinical development in China. iTab is a T cell engager (TCE) platform for human CD3-activating bi- and tri-specific antibodies targeting tumor associated antigens (TAA). A-337 was designed with two EpCAM targeting fragments (EpCAM x EpCAM x CD3) with significantly enhanced biological properties and improved safety profile compared to the competitor’s products including EpCAM x CD3 TCE, EpCAM x CD3 bispecific antibodies. In preclinical studies, A-337 demonstrated potent anti-tumor activity, favorable pharmacokinetics, and a significantly improved safety window.

Dr. Xiao Qiang Yan, Chairman and CEO of ITabMed Ltd commented "A-337 is our second immunotherapeutic antibody entering clinical development in China. A-337 has the similar structural design as A-319 which is in phase I development to treat liquid tumors. Two phase I studies of A-319 are being conducted in patients with relapsed and refractory B cell acute lymphoblastic leukemia (r/r-B-ALL) and in patients with relapsed and refractory non-Hodgkin’s lymphoma (r/r-NHL). The preliminary results of the two phase I studies have demonstrated an excellent safety profile and promising anti-tumor responses of A-319 during dose-escalation. Likewise, we believe that A-337 has enormous potential to treat metastatic solid tumors due to its improved safety profile and its unique format design. The IND approval demonstrates our continued effort in "innovating for life" and to cure many cancer patients with our innovative medicines".

About iTab platform

ITabMed has been developing the iTAb (immunotherapy antibody) platform for more than a decade. iTAb generates bi- and tri-specific antibodies that bind to the CD3 molecule on human T cells, and simultaneously bind to TAAs or TSA on a tumor cell. The formation of a synapse between the tumor cell and the T cell linked by the antibody leads to the activation of the T cells, and the release of mediators lysing the tumor cells. These T cell engaging bi- and tri-specific antibodies can drive the expansion of T cells, rendering T cells as serial killers of tumor cells. The iTAb antibodies are very potent and are manufactured in CHO cells in serum-free conditions. The iTAb drug products are very stable in liquid formulation with extra-long stability profile.