On March 23, 2022 VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant and solid tumors and immune or inflammatory indications, reported financial results for the fiscal year ended December 31, 2021, and provided a corporate update (Press release, VBL Therapeutics, MAR 23, 2022, View Source [SID1234610733]).

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"2021 was a year of excellent progress for VBL as we advanced our development programs, strengthened our management team and established a direct presence in the United States," said Dror Harats, M.D., Chief Executive Officer of VBL. "The company is positioned for a potentially transformational year in 2022 as we look forward to the PFS primary endpoint top-line data readout in the Phase 3 OVAL trial in the second half of 2022. We are also expecting preliminary data on ofra-vec from the Phase 2 trials in mCRC and rGBM and plan to enter the clinic in the second half of the year with VB-601, the first candidate from our novel anti-inflammatory program targeting monocytes. We are pleased with the progress and execution at VBL and see multiple opportunities to create value in 2022."

Fourth Quarter and Recent Corporate Highlights

Development Programs

Enrollment in the Phase 3 OVAL registration-enabling trial in recurrent platinum-resistant ovarian cancer has been completed, with a total of 409 patients enrolled globally.
The Independent Data Safety Monitoring Committee for the OVAL trial conducted a pre-planned safety review of the 370 patients randomized in the trial by December 31, 2021 and unanimously recommended that the trial continue as planned.
Ofra-vec Phase 2 clinical trials in recurrent glioblastoma multiforme (rGBM) and metastatic colorectal cancer (mCRC) continue as planned, with preliminary data expected in 2022.
IND-enabling toxicology studies have been successfully completed for VB-601, a monoclonal antibody targeting monocytes for prevalent and chronic inflammatory disorders, and demonstrated an acceptable toxicology profile to proceed into clinical development. VBL expects to initiate a first-in-human clinical trial for the program in the second half of 2022.
Corporate

Strengthened the management team with the appointment of Matthew Trudeau to the newly created position of Chief Commercial Officer to further advance VBL’s strategic plan to become a commercial organization, and Sam Backenroth as Chief Financial Officer.
Established operations in the United States.
KOL Event on Ovarian Cancer, April 11

VBL plans to host an in-person Key Opinion Leader (KOL) luncheon for the investment community on Monday, April 11, in New York City. The event will feature presentations and a panel discussion with KOLs who will discuss the current treatment landscape and unmet medical need in treating patients with ovarian cancer. For more details and registration to the event refer to: View Source
Financial Results for the Full Year 2021

At December 31, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $53.5 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months from the date of the readout of top-line PFS data from the Phase 3 OVAL trial.
For the year ended December 31, 2021, VBL reported a net loss of $29.9 million, or ($0.45) per basic share, compared to a net loss of $24.2 million, or ($0.55) per basic share, in the comparable period in 2020.
Revenues for the year ended December 31, 2021, were $0.8 million, as compared to $0.9 million in the comparable period in 2020.
For the year ended December 31, 2021, total operating expenses were approximately $30.4 million, consisting of $22.7 million in research and development expenses, net, and $7.7 million in general and administrative expenses. This compares with total operating expenses of $25.1 million in the year ended December 31, 2020, which was comprised of $19.7 million in research and development expenses, net, and $5.4 million in general and administrative expenses.
Conference Call and Webcast, Wednesday, March 23, 2022 at 8:30am ET

The live webcast will be available online and may be accessed from the "Events and Presentations" page of VBL’s website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On March 23, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc Hedrick, M.D., President and Chief Executive Officer, has been invited to present at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest (Press release, Cytori Therapeutics, MAR 23, 2022, View Source [SID1234610730]).

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The conference will take place March 28-30, 2022, with pre-recorded presentations available on-demand through the conference portal at 2022 Virtual Growth Conference and available under the For Investors tab of the Plus website at www.plustherapeutics.com. This conference will be live on M-Vest. To attend, just sign up to become an M-Vest member here: Reserve Your Seat.

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.

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 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported the presentation of preclinical data demonstrating that its lymph node-targeted CpG TLR9 agonist, Amphiphile-CpG (AMP-CpG), induces potent immune and anti-tumor responses, at the STING & TLR-Targeting Therapies Summit 2022 Digital Event, being held virtually from March 22-24, 2022 (Press release, Elicio Therapeutics, MAR 23, 2022, View Source [SID1234610716]). The electronic presentation is accessible here.

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"We are excited to see the preclinical responses observed across studies with our AMP platform. These responses reinforce previous findings and continue to demonstrate how targeted delivery of AMP-CpG to the lymph nodes promotes a potent cellular immune response to the respective disease-associated antigens – validating our lymph node-targeted approach to treating cancer and infectious diseases," said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio Therapeutics. "These preclinical datasets have also informed our AMP boosting approach to enhance established T cell receptor therapies (TCR-Ts)."

The AMP platform is designed to deliver therapeutic payloads directly to the lymph nodes, the "schoolhouse" of the immune system, activating a potent, functional and durable immune response. Elicio’s AMP platform with the CpG adjuvant has been shown to enhance the accumulation of AMP-CpG bound payloads in the lymph nodes, thus educating the body’s immune cells and resulting in a more potent immune response. This has enabled Elicio to unlock the untapped potential of lymph node-targeting for the treatment of several indications. In SARS-CoV-2, for example, vaccination with AMP-CpG demonstrated potent and durable T cell responses across several variants of concern. When combined with TCR-Ts, AMP-CpG enhances TCR-T cell persistence and anti-tumor function. Elicio has also demonstrated potent responses with its AMP-CpG adjuvant across a range of other antigens including those from Epstein-Barr virus, human papillomavirus and influenza.

Presentation Details

Title: Lymph-Node Targeted TLR9 Agonists Enable Potent Cellular Immune Responses Against Cancer & Infectious Disease

Highlights from the Presentation

AMP-CpG efficiently targets the lymph nodes to promote potent and comprehensive innate immune activation resulting in enhanced T and B cell responses with improved functionality and persistence
Application of AMP-CpG enables potent anti-tumor responses in multiple settings of therapy including therapeutic vaccination and TCR-T cell therapy
Application of AMP-CpG enables potent and balanced immunity, including CD8 and CD4 T cells as well as neutralizing cross-reactive antibodies, against viral pathogens
About the Amphiphile Platform

Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the "brain center" of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability.