On March 23, 2022 Ube Industries, Ltd. (hereinafter referred to as "Ube Industries"; Headquarters: Yamaguchi Prefecture; President: Masato Izumihara) is pleased to announce that it has signed a license agreement with Kirilys Therapeutics, Inc. (hereinafter referred to as "Kirilys"; Headquarters: San Francisco, California, U.S.; Executive Chairman: BT Slingsby), a company founded by venture capital firm Catalys Pacific, to grant an exclusive worldwide license to Kirilys for the CDK7 inhibitor, KRLS-017, discovered by Ube Industries (Press release, Ube Industries, MAR 23, 2022, View Source [SID1234611012]).

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KRLS-017 is a reversible small molecule inhibitor of Cyclin Dependent Kinase 7 (CDK7). CDK7 has been implicated as a key regulator of both transcriptional addiction and cell cycle dysregulation in tumors and therefore represents an attractive target for therapeutic intervention across a broad range of solid tumors and hematologic malignancies.
In preclinical studies, KRLS-017 demonstrated best-in-class potency, selectivity, and anti-tumor efficacy along with very favorable properties for an oral drug and thus is expected to make a great contribution for the treatment of diseases with high unmet medical needs as an antitumor drug.

Under this license, Kirilys acquires the rights to the future development, manufacture, and marketing of KRLS-017.

Yoichi Funayama, Executive Officer and General Manager of the Pharmaceutical Business Division of Ube Industries, said, "We are working on drug discovery every day to provide more options for the treatment of diseases with high unmet medical needs. One of the fields with high unmet medical needs is that of antitumor drugs, and we have high hopes that KRLS-017 can contribute as one of the new treatment options in this area. We believe that the involvement of Kirilys, founded by members with a high level of expertise and abundant experience in antitumor drug development, in the development of KRLS-017 will further raise the possibility to achieve our purpose."

BT Slingsby, Executive Chairman of Kirilys and Managing Partner of Catalys Pacific said, "We founded Kirilys to promote the development of therapeutics that combine innovative science in precision oncology with excellent drug discovery from Japan. KRLS-017 holds significant potential for worldwide patients with cancers who have limited treatment options. We look forward to developing KRLS-017 with the well experienced Kirilys team together.

On March 23, 2022 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create new product candidates that address unmet medical needs, reported its intention to offer, subject to market and other conditions, US$500,000,000 aggregate principal amount of convertible senior notes due 2028 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ascendis Pharma, MAR 23, 2022, View Source [SID1234610720]). Ascendis Pharma also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional US$75,000,000 aggregate principal amount of notes.

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The notes will be senior, unsecured obligations of Ascendis Pharma, will accrue interest payable semi-annually in arrears and will mature on April 1, 2028, unless earlier redeemed or converted. At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into Ascendis Pharma’s ordinary shares represented by American Depositary Shares (the "ADSs") (each representing one of Ascendis Pharma’s ordinary shares as of the date of this release), together, if applicable, with cash in lieu of any fractional ADS, at the then-applicable conversion rate. The notes will be optionally redeemable, in whole or in part (subject to certain limitations), for cash at Ascendis Pharma’s option at any time, and from time to time, on or after April 7, 2025, but only if the last reported sale price per ADS exceeds 130% of the conversion price for a specified period of time. In addition, the notes will be optionally redeemable, in whole and not in part, at Ascendis Pharma’s option at any time in connection with certain changes in tax law. The optional redemption price will be equal to the principal amount of the notes to be optionally redeemed, plus accrued and unpaid interest, if any, to, but excluding, the optional redemption date. Noteholders whose notes are called for optional redemption may convert their notes at their option at any time before the close of business on the second business day immediately before the applicable optional redemption date, and any such notes that are so converted will not receive the optional redemption price. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Ascendis Pharma intends to use a portion of the net proceeds from the offering to repurchase up to 1.0 million ADSs concurrently with the pricing of the offering in privately negotiated transactions effected through one of the initial purchasers or its affiliate, as Ascendis Pharma’s agent. These repurchases, and any other repurchases of the ADSs or ordinary shares, may increase, or reduce the size of a decrease in, the trading price of the ADSs and ordinary shares, and repurchases executed concurrently with the pricing of the offering may affect the initial terms of the notes, including the initial conversion price. Ascendis Pharma intends to use the remaining net proceeds to support the commercialization and further development of TransCon hGH, to fund pre-commercialization activities and clinical development of TransCon PTH, clinical development of its other endocrinology rare disease programs and its oncology programs, including TransCon PTH, TransCon CNP, TransCon TLR7/8 Agonist and TransCon IL-2 β/γ, to identify and progress development of new product candidates, and for working capital and other general corporate purposes.

The offer and sale of the notes, the ADSs issuable upon conversion of the notes and the ordinary shares represented by such ADSs have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes, such ADSs and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes, the ADSs issuable upon conversion of the notes or the ordinary shares represented by such ADSs, nor will there be any sale of the notes, such ADSs or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On March 23, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN), a leader in cell-free, enzymatic DNA production, reported that CEO Dr. James A. Hayward is invited to present at the 2022 Virtual Growth Conference presented by Maxim Group LLC and hosted by M-Vest, on March 28th – 30th from 9:00 a.m. – 5:00 p.m. EDT (Press release, Applied DNA Sciences, MAR 23, 2022, View Source [SID1234610755]). Dr. Hayward’s presentation will be available on-demand for the duration of the conference via the sign-up link: Sign up here to access the presentation

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During the virtual conference, investors will hear from executives from a wide range of sectors, including Biotech, Clean Energy, Electric Vehicles, Financial Services, Fintech & REITs, Gaming & Entertainment, Healthcare, Healthcare IT, Infrastructure, Shipping and Technology/Media/Telecom. The conference will feature company presentations, fireside chats, roundtable discussions, and live Q&A with CEOs moderated by Maxim Research Analysts.

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On March 23, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported that it has received MHRA and Research Ethics Committee approvals to initiate gamma-delta T cell therapy clinical trials of OmnImmune for the treatment of Acute Myeloid Leukemia (AML) (Press release, TC Biopharm, MAR 23, 2022, View Source [SID1234610771]).

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OmnImmune an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells has already received orphan drug designation for the treatment of patients suffering from the blood and bone marrow cancer. Phase 2/3 trials will begin enrollment in the first half of 2022 in the UK with expansion into the US following shortly thereafter.

"We are extremely pleased to receive MHRA and Research Ethics approvals, which marks the final step in our protocol submission and commencing through the clinical trial process of our proprietary AML therapy," said Bryan Kobel, CEO of TC BioPharm. "On the heels of announcing our Orphan Drug Dsignation from the FDA, we have now further demonstrated our ability to run parallel processes for clinical trials in both the US and UK/EU. The positive results demonstrated by OmnImmune in Phase 1b/2a clinical trials are encouraging and bolsters our belief in its potential as an effective therapy for Acute Myeloid Leukemia."

On March 23, 2022 Ligand Pharmaceuticals Incorporated (Ligand) (NASDAQ: LGND) reported the signing of a definitive merger agreement with Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA), a publicly traded special purpose acquisition company (SPAC), providing for the spin-off of OmniAb, Inc. (OmniAb), Ligand’s antibody discovery business, immediately followed by a merger with a newly formed subsidiary of APAC (Press release, Ligand, MAR 23, 2022, View Source [SID1234610727]). The combined company will be led by Ligand’s President, Matt Foehr, and will be renamed "OmniAb, Inc."

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Upon the closing of the transaction, Avista Capital Partners (Avista), APAC’s sponsor and a leading private equity firm focused on the healthcare industry, has agreed to invest up to $115 million in the combined company, and Ligand will contribute $15 million. The combined company will have an initial pre-money equity valuation of $850 million. Immediately prior to the transaction close, Ligand intends to distribute 100% of its ownership of OmniAb to Ligand shareholders in a tax-free distribution. The transaction is expected to close in the second half of 2022.

Ligand’s OmniAb antibody discovery platform provides pharmaceutical industry partners with access to diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of its proprietary transgenic animals including OmniRat, OmniChicken and OmniMouse, which have been genetically modified to generate antibodies with human sequences to facilitate the development of human therapeutic candidates. Over 55 partners currently have access to OmniAb-derived antibodies and more than 250 programs are being actively developed or commercialized. In 2021, nine antibodies derived from the OmniAb platform entered clinical testing and two royalty-bearing antibodies received regulatory approvals.

"In late 2021, Ligand’s Board of Directors decided to separate Ligand into two public companies given the growth prospects and needs of our various proprietary technology platforms, and to unlock value to Ligand’s shareholders," said John Higgins, CEO of Ligand. "We considered multiple ways to pursue a separation with the goals of ensuring a smooth transition of operations, a healthy balance sheet for both OmniAb and Ligand, and strong market sponsorship. As we were preparing for a first-half 2022 direct spin-off of OmniAb to Ligand’s shareholders, as discussed on our recent earnings call, we received an offer from Avista to merge OmniAb with their SPAC. The Avista team is comprised of high-quality healthcare operators and investors with an excellent track record. They have done extensive due diligence and see the potential and value of OmniAb, a highly competitive, leading platform with strong momentum given recent major clinical and regulatory successes. We are very pleased to partner with APAC and its shareholders to take OmniAb to the next level."

"The OmniAb business is positioned for continued growth and success as we provide partners with access to diverse antibody repertoires and cutting-edge high-throughput screening technologies that enable the discovery of next-generation therapeutics," said Mr. Foehr. "Two OmniAb-derived antibodies recently received regulatory approvals in China and a third approval is expected in the United States later this year. Our growing roster of partners and new programs illustrates the value our technology offers. We are excited to join forces with Avista to further build and expand our differentiated capabilities with applicability to a variety of modalities, and to leverage our technical strengths to become the industry’s partner of choice."

David Burgstahler, CEO of APAC, added, "OmniAb’s merger with APAC and its subsequent status as a standalone public company will help propel the company toward a new phase of growth and value creation. The merger will empower OmniAb with access to the capital markets, strong cash reserves, the agility to drive innovation and a superb leadership team. We look forward to partnering with Matt and the entire organization as they continue to differentiate OmniAb as a critical partner in advancing drug discovery and development."

Matt Foehr will lead OmniAb as CEO and will resign from his role as Ligand’s President and COO at closing. Kurt Gustafson has joined the OmniAb management team as CFO, bringing over 25 years of diverse experience in corporate finance and senior management roles in growth-oriented publicly traded biopharmaceutical companies, most recently as CFO of Spectrum Pharmaceuticals. Mr. Gustafson previously served as CFO of Halozyme Therapeutics and held senior finance roles at Amgen.

Transaction Details

The combination of OmniAb and AHPA is structured to guarantee a minimum of $130 million in gross cash to the combined company at the time of closing, and up to $266 million in the event of no redemptions by APAC shareholders. APAC’s shareholders will be eligible to participate in the transaction or to elect redemption of their shares. Avista has agreed to guarantee that Avista and AHPA will provide at least $115 million of gross cash to the combined company through a $15 million PIPE investment and a $100 million facility to backstop potential redemptions. Ligand’s $15 million contribution to OmniAb will be made irrespective of the number of redemptions or the Avista contributions.

Ligand intends to distribute 100% of the equity in OmniAb to Ligand shareholders immediately prior to the business combination with APAC. The transaction will be effected through a "Reverse Morris Trust" transaction pursuant to which OmniAb will be spun-off to Ligand’s shareholders and simultaneously merged as a subsidiary of APAC. The transaction is expected to be tax-free to Ligand and its shareholders for U.S. federal income tax purposes, except for cash received in lieu of fractional shares. Upon the closing of the transaction, Ligand shareholders are expected to own approximately 75% to 84% of the combined company, depending on redemptions, which will be listed on the Nasdaq Global Markets under the ticker symbol "OABI".

The Boards of Directors of both APAC and Ligand have unanimously approved the proposed transaction, which is subject to customary closing conditions, including receipt of required regulatory approvals and receipt of approval from APAC’s shareholders.

Credit Suisse is acting as lead capital markets and financial advisor to OmniAb, Cowen, Stifel, SVB Leerink and Truist Securities are also acting as capital markets and financial advisors to OmniAb, and CJS Securities, Craig-Hallum Capital Group LLC, H.C. Wainwright & Co. and Roth Capital Partners are acting as advisors to OmniAb. Weil, Gotshal & Manges LLP is legal advisor to APAC. Latham & Watkins LLP is legal advisor to Ligand.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by APAC with the Securities and Exchange Commission (SEC) and will be available on the SEC’s website at www.sec.gov.

Technologies

Following the completion of this transaction, OmniAb will consist of the OmniAb discovery platform featuring transgenic animals that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates, as well as the Icagen ion channel technology. Ligand Pharmaceuticals’ platform technologies will consist of the Captisol technology, a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs, and the Pelican Expression Technology, a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production.