BIO-TECHNE TO HOST CONFERENCE CALL ON MAY 4, 2022, TO ANNOUNCE THIRD QUARTER 2022 FINANCIAL RESULTS

On April 13, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Wednesday, May 4, 2022, at 8:00 a.m. CDT to review third quarter fiscal 2022 financial results (Press release, Bio-Techne, APR 13, 2022, https://investors.bio-techne.com/news/detail/299/bio-techne-to-host-conference-call-on-may-4-2022-to-announce-third-quarter-2022-financial-results [SID1234612150]).

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A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13728915.

The replay will be available from 11:00 a.m. CDT on Wednesday, May 4, 2022, until 11:00 p.m. CDT on Saturday, June 4, 2022.

CStone Announces Presentation of Preclinical data on a Multi-Specific Antibody-based Therapeutic Candidate CS2006/NM21-1480 at the American Association for Cancer Research (AACR) Annual Meeting 2022

On April 13, 2022 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the preclinical data of multi-specific antibody CS2006/NM21-1480 has been presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, CStone Pharmaceauticals, APR 13, 2022, View Source [SID1234612149]).

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Session: PO.IM02.09 – Therapeutic Antibodies 1
Date: April 12, 2022, 9:00 AM – 12:30 PM ET
Format: E-posters
Title: 2870/13-Dose selection investigations and combination strategies of NM21-1480, a PD-L1/4-1BB/HSA trispecific MATCH3 therapeutic clinical candidate
Presenter: Dr. Dan Snell

CS2006/NM21-1480 is a monovalent, tri-specific antibody-based molecule targeting PD-L1, 4-1BB, and human serum albumin (HSA). CS2006/NM21-1480 represents a leading class of broadly acting next-generation anti-PD-1/PD-L1 cancer immunotherapies and a new backbone molecule for tumor-specific combination therapies. CS2006/NM21-1480 is designed to bind to the immune co-stimulatory receptor 4-1BB and conditionally activate T cells only when engaging and blocking the checkpoint receptor ligand PD-L1 on the surface of tumor cells, potentially preventing the liver toxicities observed with previous anti-4-1BB agonistic antibodies.

Compared to other PD-L1/4-1BB bispecific antibody candidates, CS2006/NM21-1480’s unique monovalent structure and ultra-high-affinity PD-L1-binding are designed to tap the synergistic potential of tumor-localized modulation of PD-L1 and 4-1BB. Furthermore, half-life extension via the HSA-binding is designed to enable convenient dosing schedules for patients. CS2006/NM21-1480 is anticipated to be effective against tumors with a wide range of PD-L1 expression levels and may overcome primary and/or acquired resistance to anti-PD-1/PD-L1 therapies.

"The preclinical data of CS2006/NM21-1480 are encouraging and further demonstrate its potential to become a best-in-class anti-4-1BB agonist and next-generation immune checkpoint inhibitor. The bell-shape dose-response curve associated with this class of agents presents a unique challenge with dose-selection in the clinic. However, this concern seems to be alleviated by the fine affinity balance engineered in CS2006/NM21-1480 which allows optimal PD-L1 blockade and 4-1BB activation at the same time." Dr. Archie Tse, Chief Scientific Officer of CStone, said, "The first-in-human dose escalation study is ongoing in the United States, and patient enrollment has commenced in Taiwan, China. In addition, the investigational new drug application has been approved by the National Medical Products Administration of China and the clinical trial is underway. Moving forward, we will step up our efforts to drive research and development of CS2006/NM21-1480, and other pipeline assets to provide high-quality treatments for a wider range of cancer patients as soon as possible."

CS2006/NM21-1480 was discovered and engineered by Numab Therapeutics ("Numab"), CStone’s partner, using its proprietary λcap technology and MATCH platform. CStone and Numab signed an exclusive regional licensing agreement for the development and commercialization of the drug candidate. Pursuant to the terms of the licensing agreement, CStone will fund the research and development of CS2006/NM21-1480 up to completion of an initial Phase 1b clinical trial. In exchange, CStone obtains exclusive rights from Numab to develop and commercialize CS2006/NM21-1480 in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan), South Korea, and Singapore. Numab retains all CS2006/NM21-1480 rights for the rest of the world. Upon completion of CStone’s funding period, no further financial obligations will be owed by either party.

Genmab and AbbVie Announce Topline Results for Epcoritamab (DuoBody®-CD3xCD20) From Phase 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL)

On April 13, 2022 Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) reported topline results from the first cohort of the EPCORE NHL-1 phase 1/2, clinical trial evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody (Press release, Genmab, APR 13, 2022, View Source [SID1234612148]). The study cohort includes 157 patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy, including 38.9 percent who received prior treatment with chimeric antigen receptor (CAR) T-cell therapy. Based on the topline results, the companies will engage global regulatory authorities to determine next steps.

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The topline results from this cohort demonstrated an overall response rate (ORR) of 63.1 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response (DOR) was 12 months. The most common treatment-emergent adverse event was cytokine release syndrome (CRS) with 49.7 percent, including 2.5 percent grade 3. The data will be submitted for presentation at a future medical meeting.

Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration. The companies remain committed to evaluating epcoritamab as a monotherapy, and in combination, across lines of therapy, for a variety of hematologic malignancies, including an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (NCT: 04628494).

"Together with our partner, AbbVie, we will work with regulatory authorities to determine next steps and continue to evaluate epcoritamab in a variety of clinical trials as a potential treatment option for patients with various hematological malignancies," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to sharing the findings at a future medical meeting."

LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL) – a cancer that develops in the lymphatic system – that affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally. LBCL includes DLBCL, which is the most common type of NHL worldwide and accounts for approximately 31 percent of all NHL cases.i,ii,iii,iv

"We aim to leverage AbbVie’s strong blood cancer expertise to further develop epcoritamab, alongside Genmab, for certain blood cancer patients who have limited treatment options," said Mohamed Zaki, M.D., Ph.D., Vice President and Head, Global Oncology Development, AbbVie.

About the EPCORE NHL-1 Trial

EPCORE NHL-1 an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of two parts: a phase 1 first-in-human, dose escalation part; and a phase 2 expansion part. The trial was designed to evaluate

Graphic

Genmab and AbbVie Announce Topline Results for Epcoritamab (DuoBody-CD3xCD20) From Phase 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL)

subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-NHL, including LBCL and DLBCL. The dose escalation findings, which determined the recommended phase 2 dose RP2D, were published in The Lancet in 2021. In the phase 2 expansion part, additional patients are being treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who had limited therapeutic options.

The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, complete response (CR) rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were evaluated as secondary efficacy endpoints.

About Epcoritamab

Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of lymphoma B cells.v CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.vi,vii Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

Halozyme to Acquire Antares Pharma to Create a Specialty Product and Drug Delivery Leader

On April 13, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") and Antares Pharma, Inc. (NASDAQ: ATRS) ("Antares") reported that the companies have entered into a definitive agreement pursuant to which Halozyme will acquire Antares for $5.60 per share in cash (Press release, Halozyme, APR 13, 2022, View Source [SID1234612146]). The transaction, which values Antares at approximately $960 million, was unanimously approved by both the Halozyme and Antares Boards of Directors.

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The transaction is expected to be immediately accretive to Halozyme’s 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple growth drivers beyond 2027. The combination of Halozyme and Antares will create a leading drug delivery and specialty product company. The Antares business consists of a best-in-class, differentiated, royalty revenue generating auto injector platform business that offers broad licensing opportunity, and a commercial business, with three proprietary commercial products.

"The addition of Antares, particularly with its best-in-class auto injector platform and specialty commercial business, augments Halozyme’s strategy, further strengthens our position as a leading drug delivery company and extends our strategy to include specialty products," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The acquisition of Antares fits well with our previously discussed strategic priorities and provides substantial financial growth potential and disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme is well-positioned to leverage Antares’ value proposition, driven by a strong balance sheet, established industry relationships and business development experience. We look forward to welcoming Antares’ talented team as we embark on our next chapter of accelerating financial growth, maximizing patient benefit, and enhancing value."

Robert F. Apple, president and chief executive officer of Antares, commented, "We are pleased to have reached this agreement with Halozyme, as this transaction showcases the value of Antares’ highly complementary business, provides our shareholders with attractive and certain value, and brings together industry-leading expertise and drug delivery platforms to accelerate growth and create new opportunities. As we remain committed to continuing to serve our partners, I would like to thank our

employees for their hard work and dedication to this mission. We look forward to working with the Halozyme team to complete the transaction and deliver best-in-class therapies and drug delivery solutions."

Compelling Financial and Strategic Benefits

Immediate Revenue and Non-GAAP Earnings Accretion and Long-Term Financial Upside: The transaction is expected to be immediately accretive to Halozyme’s 2022 revenue and non-GAAP earnings, supported by Antares’ proprietary product revenues, royalty revenues and profitability. The addition of Antares is also expected to accelerate top- and bottom-line growth and enhance cash flow generation through 2027, increasing Halozyme’s flexibility to pursue further growth drivers in the forms of new product and therapy launches, and partnerships.

Business Development to Augment Long-Term Growth, Consistent with Strategic Priorities: The addition of Antares’ commercial products and existing auto injector capabilities accelerate Halozyme’s strategy to drive long-term, durable revenue growth and value creation through focused external growth. Halozyme expects to build on Antares’ core platform technology and capabilities to drive incremental, durable revenue opportunities with additional intellectual property protections for Antares technology in place beyond 2030.

Substantial Market Expansion Opportunity in High Revenue Segments: Antares’ successful development and partnership of its technology platforms offers a widely licensable product suite that can be broadly applied across a spectrum of market segments representing multiple tens of billions of dollars1 in estimated peak sales. This includes the potential for conversion to both high-viscosity and high-volume auto injector devices, supported by Halozyme’s extensive infrastructure and commercially validated ENHANZE platform technology.

High Growth, Durable Commercial Franchise with Proven Track Record: Antares’ suite of FDA-approved, high quality commercial products and partner products utilizing the Antares auto injector technology have already demonstrated commercial success and are positioned for long-term growth. Launch of Tlando will leverage existing testosterone commercial infrastructure and capabilities in a growing therapeutic category, building on momentum created by Xyosted’s success.

Two Highly Complementary Platforms, Each with Meaningful Pipelines: Antares’ broadly applicable, differentiated auto injector platform is suitable for use with a broad range of medications. The versatility of this platform enables a highly licensable business with significant revenue upside. The combined entity will be able to leverage its deep industry expertise and existing commercial infrastructure in the U.S. to expand delivery capabilities and pursue growth opportunities within multiple small- and large-molecule products.

Transaction Terms, Financing and Time to Closing

Under the terms of the merger agreement, Halozyme will commence a cash tender offer to acquire all

of the outstanding shares of Antares for $5.60 per share in cash. The transaction is not subject to a financing condition. Halozyme intends to finance the transaction using existing cash on hand and new sources of debt. Following completion of the transaction, Halozyme expects to maintain a strong balance sheet with less than 3.5x net debt-to-EBITDA ratio at the time of transaction close. Net debt-to-EBITDA ratio is expected to decline significantly in the quarters post transaction close. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Antares’ outstanding shares of common stock, the expiration or termination of the HSR waiting period, and other customary conditions. Following the successful completion of the tender offer, Halozyme will acquire all remaining shares not tendered in the tender offer through a second-step merger at the same price. This transaction is expected to close in the first half of 2022.

BofA Securities and Wells Fargo Securities LLC are acting as financial advisors to Halozyme and Weil, Gotshal & Manges LLP is acting as legal advisor. Jefferies LLC is acting as financial advisor to Antares and Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal advisor.

Business Update

Halozyme reaffirms its 2022 guidance and its commitment to the three year $750 million share repurchase program.

Conference Call

Halozyme will host a conference call and a simultaneous webcast to discuss the transaction today, Wednesday, April 13, 2022 at 8:00 a.m. ET/5:00 a.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a webcast replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call.

Oncocyte Corporation Announces Pricing of Registered Direct Offering of 11,765 Shares of Series A Convertible Preferred Stock

On April 13, 2022 Oncocyte Corporation (Nasdaq: OCX), ("Oncocyte" or the "Company"), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient cancer care journey, reported the pricing of a registered direct offering of 11,765 shares of its Series A Convertible Preferred Stock (the "Preferred Stock") with institutional investors (Press release, Oncocyte, APR 13, 2022, View Source [SID1234612145]). The shares of Preferred Stock are convertible into a total of 7,689,542 shares of our common stock, at a conversion price of $1.53. The Preferred Stock will bear a dividend of 6% per annum and is required to be redeemed by the Company, if not converted, on April 8, 2024. Gross proceeds from the offering are expected to be approximately $10 million, before deducting offering expenses. There is no established public trading market for the Preferred Stock and we do not intend to apply for listing of the Preferred Stock on any national securities exchange or expect a market to development.

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Oncocyte intends to use the net proceeds from the offering primarily to promote commercialization of DetermaRx, including sales and marketing efforts and by conducting additional clinical studies to support clinical adoption of the test; to complete development of DetermaIO; for development of other future tests in our pipeline, including DetermaCNI, DetermaTx and DetermaMx. We expect to use net proceeds to pay for development costs associated with our activities under our Collaboration Agreement with Life Technologies Corporation, or LTC, a subsidiary of Thermo Fisher Scientific, pursuant to which we have agreed to undertake certain development efforts with LTC and to collaborate with LTC in the commercialization of Thermo Fisher Scientific’s existing Oncomine Comprehensive Assay Plus, and our DetermaIO assay for use with LTC’s Ion TorrentTM Genexus Integrated Sequencer and LTC’s Ion Torrent Genexus Purification System, in order to obtain in vitro diagnostic regulatory approval of those tests. We may also use net proceeds to make certain future milestone and other payments to former shareholders of companies that we have acquired, including Chronix Biomedical, Inc. and Insight Genetics, Inc. if the applicable milestones requiring such payments are met.

A shelf registration statement on Form S-3 (Registration No. 333-256650) relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 8, 2021. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.