MaxCyte Announces Public Filing of Registration Statement with SEC for a Proposed Nasdaq Dual Listing

On July 12, 2021 MaxCyte, Inc., (LSE: MXCT) (LSE: MXCN), a leading provider of platform technologies for cell engineering, reported the public filing of a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed dual listing of its shares of common stock on the Nasdaq Global Market ("Nasdaq") under the symbol "MXCT (Press release, MaxCyte, JUL 12, 2021, View Source [SID1234584773])." As part of the proposed Nasdaq dual listing, MaxCyte is planning a public offering of shares of its common stock in the United States (the "Offering"). Upon completion of the Offering, MaxCyte’s common stock will continue to be admitted to trading on the AIM market of the London Stock Exchange under the symbols "MXCT" and "MXCN."

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All shares to be sold in the Offering will be offered by MaxCyte. The number of shares to be offered and the price range for the proposed Offering have not yet been determined. The Offering is expected to commence after the SEC completes its review process, subject to market and other conditions. Stockholders and potential investors should note that there is no guarantee as to whether or when the potential Offering will proceed.

Cowen, Stifel and William Blair are acting as joint book-running managers for the Offering and as representatives of the underwriters for the proposed Offering. BTIG and Stephens Inc. will also act as co-managers of the Offering.

The proposed Offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Offering may be obtained from the offices of Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1 (415) 364-2720 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at 1-800-621-0687 or by email at [email protected].

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy these securities be accepted, prior to the time the registration statement becomes effective. 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any such state or jurisdiction.

CD47 Monoclonal Antibody (AK117) Completed Phase I Dose Escalation Trial and Obtained Approval to Initiate Clinical Trial in Combination with Azacitidine for Treatment of Acute Myeloid Leukemia

On July 12, 2021 Akeso, Inc. reported that, CD47 monoclonal antibody (AK117), a second-generation novel drug for immuno-oncology therapy independently developed by the Company, has completed phase I dose escalation trial in Australia (Press release, Akeso Biopharma, JUL 12, 2021, View Source [SID1234584790]). AK117 resulted in no dose-limiting toxicity (DLT) and no anemia of clinical significance in subjects in all dose escalation cohorts (with 0.3 mg/kg to 45 mg/kg administered once-weekly (QW)), and was well tolerated by subjects in all cohorts. Low-dose priming was not required.

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Akeso has obtained approval from the National Medical Products Administration (NMPA) of China to initiate phase Ib/II clinical trial of AK117 in combination with azacitidine for the treatment of acute myeloid leukemia (AML). AK117, a second-generation CD47 monoclonal antibody, has a significantly improved safety profile compared to the first-generation CD47 monoclonal antibody, and AK117 in combination with azacitidine is expected to perform better than similar drugs in the treatment of AML. Previous studies of AK117 in myelodysplastic syndromes (MDS) have shown its advantages of safety and the majority of MDS patients had hematologic improvement while receiving AK117 treatment. To date, clinical trials of AK117 in both solid tumors and hematologic tumors have been initiated and began patient dosing.

AML is a group of highly heterogeneous diseases with clonal proliferation abnormalities of hematopoietic stem cells and is the most common type of adult acute leukemia. CD47 is highly expressed on the surface of several tumor cells, including solid tumors and hematologic tumors, and is associated with poor prognosis. CD47 blockade stimulates phagocytosis of tumor cells by macrophages and promotes adaptive immune response. Preclinical data showed that CD47 monoclonal antibody in combination with azacitidine can further induce endogenous expression of calreticulin on the cell surface, thereby further enhancing the phagocytosis of tumors by macrophages. At the same time, there are clinical data showing that CD47 monoclonal antibody in combination with azacitidine is significantly more effective than azacitidine alone in treating AML subjects who are not suitable for chemotherapy at first treatment, and is safe and well tolerated.

Information about AK117 (CD47 Monoclonal Antibody)

AK117 is a novel humanized IgG4 mAb independently developed by the Company. It can bind with CD47 expressed on tumor cells to prevent the interaction between CD47 and its receptor, SIRPα, expressed on macrophages so as to enhance phagocytosis to inhibit the growth of tumor cells. Previously published data demonstrated exceptional safety profile. AK117 resulted in no DLT and no anemia of clinical significance in subjects in all doseescalation cohort (the highest dose cohort was 45 mg/kg QW), and was well tolerated by subjects in all cohorts. The CD47 receptor occupancy rate (RO) of the peripheral blood T cells has reached and maintained at 100% in the 3 mg/kg cohort.

IDEAYA Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On July 12, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported the closing of its underwritten public offering of 5,333,333 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commissions, including the exercise in full by the underwriters of their option to purchase up to an additional 695,652 shares of common stock in the offering (Press release, Ideaya Biosciences, JUL 12, 2021, View Source [SID1234584791]). The net proceeds from the offering were approximately $86.1 million, after deducting the underwriting discount and commissions and estimated offering expenses payable by IDEAYA. All shares in the offering were offered by IDEAYA.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under IDEAYA’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities acted as joint book-running managers for the offering.

The public offering was made by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission, or the SEC. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

This press release shall not constitute an offer to sell or a 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.

Vaccibody enters into worldwide license agreement with Adaptive Biotechnologies for clinically validated SARS-CoV-2 T cell epitopes to combine in a second-generation T cell vaccine candidate to specifically address emerging SARS-CoV-2 variants of concern

On July 12, 2021 Vaccibody AS (Euronext Growth (Oslo): VACC), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that it has entered into an exclusive license agreement with Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, to use a broad selection of virus-specific T cell epitopes identified by Adaptive for Vaccibody to design and develop novel SARS-CoV-2 vaccines (Press release, Vaccibody, JUL 12, 2021, View Source [SID1234584775]).

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Vaccibody’s development strategy for its second-generation SARS-CoV-2 vaccine is designed to respond to the emerging threats of evolving variants with reduced sensitivity to first generation vaccines that were developed using the 2020 prototype spike protein. The 2-armed strategy aims to develop two candidates for the broad population. First, a vaccine candidate encoding the receptor binding domain (RBD) derived from the South African beta variant of concern. And second, a T cell based vaccine candidate, encoding multiple validated immunodominant, conserved Adaptive-identified T-cell epitopes spanning multiple antigens across the SARS-CoV-2 genome. 2

"To date, SARS-CoV-2 has resulted in the death of over 4 million people globally and we are facing a tremendous threat from emerging variants of concern. We are very excited to have access to Adaptive’s T cell epitopes for our use in developing second-generation SARS-CoV-2 vaccines to specifically address current and future variants of concern. Vaccibody has exclusively licensed validated SARS-CoV-2 T-cell epitopes for use in the design and development of our T-cell vaccine candidates, including the candidate in our previously announced clinical trial" said Agnete B. Fredriksen, Chief Innovation and Strategy Officer of Vaccibody.

Adaptive has mapped the T cell immune response using more than 6,500 samples from patients impacted by COVID-19. Adaptive used its immune medicine platform, leveraging its proprietary antigen mapping and deep sequencing capabilities, to identify naturally processed and presented T-cell epitopes to SARS-CoV-2 antigens. Adaptive’s T-cell epitopes will be used by Vaccibody in its modular vaccine technology platform to target specific SARS-CoV-2 antigens to antigen presenting cells.

Michael Engsig, Chief Executive Officer of Vaccibody continued, "Our aim is to design and develop novel second-generation COVID-19 vaccines using Vaccibody’s unique modular vaccine technology platform and Adaptive’s functionally validated, immunodominant T-cell epitopes."

"The SARS-COV-2 virus’ ability to rapidly mutate can impact the efficacy of many firstgeneration vaccines. Adaptive’s unique ability to read and access the immune system enables us to identify and validate SARS-COV-2 T-cell epitopes from convalescent COVID-19 individuals. We are excited to combine the strength of validated T-cell epitopes, identified using our immune medicine platform, with Vaccibody’s innovative vaccine technology in fighting the pandemic," added Harlan Robins, Chief Scientific Officer and co-founder of Adaptive Biotechnologies.

Mikkel W. Pedersen, Ph.D., Chief Scientific Officer of Vaccibody continued, "We are thrilled to work with Adaptive Biotechnologies to accurately identify immunogenic and conserved T-cell epitopes. Adaptive’s epitopes have enabled us to create a multivalent SARS-CoV-2 T-cell vaccine that may provide more complete viral protection, long-term immunity and viral clearance compared to first generation vaccines. Our T-cell candidate may have both prophylactic and therapeutic potential and may also fit the profile of a universal SARS-CoV-2 vaccine booster for individuals previously vaccinated with Spike based vaccines."

Vaccibody has demonstrated that the SARS-CoV-2 vaccine candidate that incorporates Adaptive’s T-cell epitopes induces a rapid, strong and broad T-cell response after administration of a single dose in a humanized preclinical model.

Under the terms of the license agreement, Adaptive has provided certain selected T-cell epitopesfor exclusive use in Vaccibody’s next-generation SARS-CoV-2 vaccines. Vaccibody will 3 be responsible for further development of the potential T-cell SARS-CoV-2 vaccine candidates. Financial terms of this agreement will not be disclosed.

The phase 1/2 trial is currently in the planning phase. The CTA (Clinical Trial Application) is expected to be submitted in Q3 2021 and initiation is planned for Q4 2021. The clinical trial will be conducted in Norway. Please also referto Vaccibody’s announcement on June 29, 2021 about the clinical trial.

Webcast
Michael Engsig, Chief Executive Officer of Vaccibody, and other members of Vaccibody’s management team will host a webcast on July 12, 2021 at 4 p.m. CET / 10 a.m. EDT. Harlan Robins, Chief Scientific Officer of Adaptive Biotechnologies, will also join them to discuss how Adaptive identified the T cell epitopes that Vaccibody will use in its second generation COVID19 vaccine using its proprietary immune medicine platform. A presentation will be available on Vaccibody’s website, www.vaccibody.com/financial-reports-and-presentations, before the webcast.

Servier and Nymirum Announce Strategic Collaboration to Discover and Develop RNA-Targeted Small Molecule Therapeutics

On July 12, 2021 Servier, a global independent pharmaceutical Group, and Nymirum, a pioneer in RNA-targeted small molecules, reported that they have entered into a strategic collaboration to identify and develop RNA-modulatory drugs for the treatment of neurological diseases (Press release, Servier, JUL 12, 2021, View Source [SID1234584792]).

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Under the collaboration agreement, Nymirum will leverage its proprietary DART Platform (Dynamic Atomic-Resolution RNA Targeting Platform) to discover novel small molecule therapeutics for multiple neurological targets. Servier is responsible for joint preclinical development and has the right to pursue further development on the current targets as well as expand the scope of the collaboration. The collaboration provides Nymirum with an initial payment, followed by future success payments.

"We are excited to pair Nymirum’s expertise in targeting RNA with Servier’s experience in CNS (Central Nervous System) to advance transformative therapies. The ability to resolve and leverage RNA’s dynamic structure opens a new chapter for drug discovery, enabling novel programs across all therapeutic areas," said Joshua Fairbank, Chief Executive Officer and Co-Founder of Nymirum. "Thanks to its expertise in CNS and small molecule therapeutics, Servier is a valuable partner in this collaboration, and together we look forward to accelerating the search for treatments for patients with severe neurological disorders."

"This new collaboration is the opportunity to progress innovative RNA-targeted approaches towards clinical assessment in patients with very limited or absent treatment options," stated Ross Jeggo, Global Head of Neuroscience and Immuno-inflammation Therapeutic Area at Servier. "We are delighted to work in partnership with Nymirum on multiple drug discovery projects, harnessing their platform to deliver RNA-targeting small molecules for neurodegenerative diseases. The therapeutic advantage associated to a small molecule versus other DNA- or RNA-based approaches is truly innovative and very promising for potential treatments for patients suffering from disorders of the central nervous system."