On July 23, 2019 LifeSpan BioSciences, Inc. (LSBio), the industry leader in molecular pathology, reported the first release of its PathPlus series of antibodies (Press release, LifeSpan BioSciences, JUL 23, 2019, View Source [SID1234537676]). These 565 antibodies were selected from among thousands tested and identified to be the best performing reagents for immunohistochemical detection of 200 high-value cancer targets in formalin-fixed paraffin-embedded human tissues.

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Antibody validation has become an industry roadblock as thousands of antibodies have become available to customers who face difficult choices in determining which antibodies are the best performers for each application, including immunohistochemistry, flow cytometry, ELISA, Western blot, or immunofluorescence. Antibodies that perform well in one assay, such as IHC, may not be the most specific reagent for another assay, such as flow cytometry.

"Identifying the optimal reagents to use in their experiments is a pain point for researchers," said LSBio CEO Heather Holemon. "There is a tremendous need to identify the best performers in every application from among the hundreds of antibodies that are currently available to each target."

LSBio has initiated a program to systematically identify the best performing antibodies in each application. Its initial focus is to identify those antibodies that are the best performers in immunohistochemistry on formalin-fixed paraffin-embedded tissues. With a tissue archive of over two million samples, and more than 20 years’ experience performing IHC for pharma and biotech customers, LSBio is uniquely qualified to determine which reagents are the best-in class.

Immunohistochemistry, which is the technique used by pathologists to classify tumors, is a powerful method of antibody validation because it can be used to visualize the binding of an antibody to individual cell types within complex tissues and to subcellular structures within cells such as nuclei or cell membranes. Comparing the specific binding characteristics of multiple antibodies to the same target allows LSBio to identify those that have the highest degree of specificity and least nonspecific staining.

LSBio uses a stringent validation protocol that involves blinded IHC testing of up to 20 different antibodies to a target protein on a tissue microarray containing 21 different human tissue types. The results for each antibody are analyzed and compared in order to rank them by performance. Those antibodies that show the highest specificity and least nonspecific staining on formalin-fixed paraffin-embedded tissues are offered under the PathPlus brand.

"We have a unique opportunity to leverage our leadership position in antibody validation to set the standard for providing high-quality IHC antibodies to the research and pharmaceutical communities," said Glenna Burmer, M.D., Ph.D., Chief Scientific Officer of LifeSpan. "We plan to offer multiple series of PathPlus validated reagents as we evaluate antibodies to the most important targets in the human genome."

On July 23, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Thursday, August 1, 2019 at 5pm ET to discuss second quarter 2019 financial results and provide a corporate update (Press release, Ultragenyx Pharmaceutical, JUL 23, 2019, http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-second-quarter-2019-financial [SID1234537661]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 6298416. The replay of the call will be available for one year.

On July 23, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell enhancing therapeutics, reported that Takeda Pharmaceutical Company Limited (Takeda), has exercised a second option under its existing, multi-target collaboration and license agreement (Press release, Crescendo Biologics, JUL 23, 2019, View Source [SID1234537677]). Takeda has taken an exclusive license to Humabodies directed to another of its oncology targets.

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This is the second license option that Takeda has exercised under the agreement with Crescendo and relates to the continued progression of an immuno-oncology programme. The license marks the successful delivery and further pre-clinical evaluation by Takeda of Humabody leads meeting its stringent criteria.

Theodora Harold, CEO of Crescendo, commented:

"This exciting news further underlines Crescendo’s ability to deliver innovative Humabody therapeutics which consistently meet the exacting specifications set by Takeda for progression towards the clinic. We are delighted that our close collaboration with Takeda continues to be so productive and we look forward to more successes in the future."

Chris Arendt, Head, Oncology Drug Discovery Unit & Immunology Unit, Takeda, commented:

"We are pleased that our partnership with Crescendo has continued to be fruitful in leading to another successful in-licensing milestone. This exciting immuno-oncology candidate Humabody that our teams have advanced through close collaboration aligns well with our ongoing efforts to pursue diverse modalities with transformative treatment potential."

Takeda’s option is part of the existing multi-target collaboration and license agreement announced in October 2016 in which Takeda received the right to develop and commercialize Humabody-based therapeutics resulting from the collaboration. Under the agreement, Crescendo is eligible to receive clinical development, regulatory and sales-based milestone payments of up to $754 million plus royalties on Humabody-based product sales by Takeda.

On July 22, 2019 Genmab A/S (CSE: GEN, Nasdaq: GMAB) reported the closing of its initial public offering of American Depositary Shares ("ADSs") in the United States (the "Offering") and the increase of its share capital by 2,850,000 ordinary shares as a consequence of the issuance of 2,850,000 ordinary shares (the "New Shares") with a nominal value of DKK 1 per share in the form of 28,500,000 ADSs in the Offering (Press release, Genmab, JUL 22, 2019, View Source [SID1234537646]). The subscription price of DKK 1,181.80 per New Share equals the public offering price of $17.75 per ADS at the U.S. dollar/DKK exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one, and the gross total proceeds from the issuance of the New Shares amounts to US$505,875,000 (DKK 3,368.1 million).

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As previously announced, on July 18, 2019, BofA Merrill Lynch, Morgan Stanley and Jefferies, as representatives of the several underwriters, notified Genmab of the underwriters’ exercise in full of their option to purchase up to an additional 4,275,000 additional ADSs, representing 427,500 ordinary shares (the "Option Shares"), to cover any over-allotments (the "Option") at the price of $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per Option Share at the U.S. dollar/DKK exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one. The Option is expected to close on July 23, 2019.

Following the registration of the New Shares today with the Danish Business Authority, Genmab’s share capital amounts to DKK 64,540,143 divided into 64,540,143 ordinary shares with a nominal value of DKK 1 each and following the registration of the Option Shares on July 23, 2019 (or early thereafter), Genmab’s share capital will amount to DKK 64,967,643 divided into 64,967,643 ordinary shares with a nominal value of DKK 1 each. The New Shares account for 4.4% of Genmab’s total share capital and after the closing of the Option, the New Shares and the Option Shares together will account for 5.0% of Genmab’s total share capital.

The New Shares and the Option Shares rank pari passu with Genmab’s existing shares and carry the same dividend and other rights. Each New Share and Option Share carries one vote at Genmab’s general meetings. Genmab only has one class of shares. The ADSs do not carry the same rights as Genmab’s ordinary shares and are not entitled to receive a dividend or vote as ordinary shares, except to the extent provided for through the depositary as record holder of the ordinary shares underlying the ADSs as set forth in the deposit agreement governing the ADSs.

Genmab’s ordinary shares are currently listed on Nasdaq Copenhagen under the symbol "GEN" and the ADSs are listed on the Nasdaq Global Select Market under the symbol "GMAB." We have requested that Nasdaq Copenhagen change the symbol for our ordinary shares from "GEN" to "GMAB" to become effective in connection with the admission to trading of the New Shares on Nasdaq Copenhagen, expected to occur on July 23, 2019. The New Shares have been issued today and are expected to be admitted to trading and official listing on Nasdaq Copenhagen on July 23, 2019 with the permanent ISIN code DK0010272202.

The amendments to Genmab’s articles of association as a consequence of the registration of the New Shares have been registered today with the Danish Business Authority and have been published on Genmab’s website.

The registration statement on Form F-1 relating to the Offering was declared effective by the U.S. Securities and Exchange Commission on July 17, 2019.

BofA Merrill Lynch, Morgan Stanley and Jefferies acted as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets acted as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen acted as co-managers for the Offering. A copy of the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the final prospectus related to the Offering are also available at www.sec.gov. No Danish prospectus was issued or offered.

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

On July 22, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that it closed its previously announced $15.0 million underwritten public offering (Press release, Xenetic Biosciences, JUL 22, 2019, View Source [SID1234537647]). In conjunction with the closing of the offering, Xenetic completed its previously announced acquisition of the novel CAR T ("Chimeric Antigen Receptor T Cell") platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, which has demonstrated proof-of-mechanism in B-cell Non-Hodgkin lymphomas. The XCART technology, developed by The Scripps Research Institute ("Scripps") in collaboration with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, is believed to have the potential to significantly enhance the safety and efficacy of cell therapy for B-cell lymphomas by generating patient- and tumor-specific CAR T cells.

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"We believe that the XCART technology platform has the capability to expand the potential of CAR T cell therapy, an area driving new breakthroughs in the treatment of cancer. We are incredibly pleased to have closed this acquisition and look forward to leveraging this innovative technology to propel Xenetic into its next phase of growth," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "The XCART platform has demonstrated proof-of-mechanism and promising preclinical evidence of target specificity. We believe this acquisition positions us to drive momentum in the innovation and development of new oncology therapeutics where there remains significant unmet need. Our R&D efforts will initially focus on leveraging the XCART platform to develop cell-based therapeutics for the treatment of B-cell Non-Hodgkin lymphomas, an initial global market opportunity estimated to exceed $5 billion per year." [1]

The XCART technology platform was designed by its originators to utilize an established screening technique to identify peptide ligands that bind specifically to the unique B-cell receptor ("BCR") on the surface of an individual patient’s malignant tumor cells. The peptide is then inserted into the antigen-binding domain of a CAR, and a subsequent transduction/transfection process is used to engineer the patient’s T cells into a CAR T format which redirects the patient’s T cells to attack the tumor. Essentially, the XCART screening platform is the inverse of a typical CAR T screening protocol wherein libraries of highly specific antibody domains are screened against a given target. In the case of XCART screening, the target is itself an antibody domain, and hence highly specific by its nature. The XCART technology creates the possibility of personalized treatment of lymphomas utilizing a CAR with an antigen-binding domain that should only recognize, and only be recognized by, the unique BCR of a particular patient’s B-cell lymphoma.

An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

Under the terms of the acquisition, Xenetic acquired all outstanding shares of Hesperix S.A., a newly-formed Swiss entity to which all XCART owners and inventors other than Scripps have assigned their rights to XCART, and exclusively licensed Scripps’ rights in the technology, in exchange for an aggregate 625,000 shares of Xenetic common stock.

Maxim Group LLC served as the strategic advisor to Xenetic and provided a fairness opinion to the special committee of the Board of Directors of Xenetic in connection with the acquisition.

About the Offering

Under the terms of the underwriting agreement, Xenetic sold 2,300,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and also issued warrants to purchase up to an aggregate of 2,300,000 shares of the Company’s common stock. Each share of common stock was sold together with one warrant to purchase one share of common stock at a combined price to the public of $6.50 per share and warrant. The gross proceeds to Xenetic from the underwritten public offering were approximately $15.0 million before deducting underwriting fees and other offering expenses.

Xenetic also has granted to the underwriter a 45-day option to purchase up to an additional 345,000 shares of common stock and/or warrants to purchase up to 345,000 shares of common stock, at the public offering price less discounts and commissions. On July 19, 2019, the underwriter exercised its overallotment option with respect to 160,000 warrants resulting in additional proceeds of $1,600.

The warrants are immediately exercisable at a price of $13.00 per share of common stock and will expire five years from the date of issuance. The warrants are expected to begin trading on the Nasdaq Capital Market on July 19, 2019 or as soon thereafter as practicable, under the symbol "XBIOW." The warrants also provide that if the weighted-average price of common stock on any trading day on or after 30 days after issuance is lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one share of common stock.

Maxim Group LLC acted as sole book-running manager in connection with the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus relating to the shares of common stock, pre-funded warrants and warrants was filed by Xenetic Biosciences, Inc. with the SEC. Copies of the prospectus relating to the underwritten offering can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.