On February 21, 2023 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition" or the "Company"), a multi-national epigenetics company, reported that it has commenced an underwritten public offering of shares of its common stock. In addition, Volition intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions (Press release, VolitionRX, FEB 21, 2023, View Source [SID1234627469]). All of the shares of common stock in the offering are being offered by Volition. The final terms of the proposed offering will depend on market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Volition intends to use the net proceeds from the offering for research and continued product development, clinical studies, product commercialization, working capital and other general corporate purposes, including potential strategic acquisitions.
Newbridge Securities Corporation is acting as the sole book-running manager of the offering.

The securities are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-259783) previously filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021, as amended on November 4, 2021, and declared effective by the SEC on November 8, 2021. The offering is being made only by means of a prospectus supplement and an accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. A preliminary prospectus supplement and an accompanying base prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the offering will be filed with the SEC and will also be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, the final prospectus supplement and the accompanying base prospectus relating to the offering can also be obtained, when available, from Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected], or by telephone at (877) 447-9625.

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 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.

On February 21, 2023 Propanc Biopharma, Inc. (the "Company"), reported that it has entered into a securities purchase agreement (the "Purchase Agreement") with ONE44 Capital LLC ("ONE44"), pursuant to which ONE44 purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $111,111, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of ONE44 (Filing, 8-K, Propanc, FEB 21, 2023, View Source [SID1234627467]). The transaction contemplated by the Purchase Agreement closed on February 16, 2023. The Company intends to use the net proceeds ($100,000) from the Note for general working capital purposes. The Note contains an original issue discount amount of $11,111.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The maturity date of the Note is February 14, 2024 (the "Maturity Date"). The Note bears interest at a rate of 10% per annum. Interest is payable only in shares of Company’s common stock (the "Common Stock") and is due and payable only contemporaneously with a payment of principal, whether at the Maturity Date or upon acceleration or by prepayment, as described below. ONE44 is entitled, at its option, at any time after the six-month anniversary of the Note, to convert all or any amount of the principal face amount of this Note then outstanding into shares of Common Stock at a per-share price equal to 60% of the lowest trading price of the Common Stock, as reported by the OTC Markets Group (if the shares of the Common Stock are then quoted thereon) or by any securities exchange upon which the Common Stock is then listed, for the ten prior trading days including the day upon which a Notice of Conversion is received by the Company. In the event the Company experiences a DTC "Chill" on its shares, the conversion price shall then be decreased to 50% instead of 60% while that "Chill" is in effect. Notwithstanding the foregoing, ONE44 shall be restricted from effecting a conversion if such conversion, along with other shares of Common Stock then beneficially owned by ONE44 and its affiliates, exceeds 4.99% of the outstanding shares of Common Stock (which may be increased up to 9.9% of the outstanding shares of Common Stock upon 60 days’ prior written notice by ONE44 to the Company).

The Company may prepay the principal of the Note and accrued interest until 180 days from the issuance date (August 13, 2023). If the Note is prepaid within 60 days of the issuance date (April 15, 2023), then the prepayment premium shall be 120% of the face amount plus any accrued interest. If the Note is prepaid after 60 days from the issuance date, but less than 120 days from the issuance date (June 14, 2023), then the prepayment premium shall be 130% of the face amount plus any accrued interest. If the Note is prepaid after 120 days from the issuance date, up to 180 days from the issuance date (August 13, 2023), then the prepayment premium shall be 135% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from ONE44, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Other than as described above, the Note contains certain events of default, including failure to issue shares timely upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations, or warranties, insolvency, bankruptcy, liquidation, and failure by the Company to pay the principal and interest due under the Note. Upon the occurrence and during the continuation of certain events of default, the Note will accrue an annual interest rate of 24% or, if such rate is usurious or not permitted by current law, then at the highest rate of interest permitted by law.

The Note was issued, and any shares of Common Stock to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing descriptions of the Note and the Purchase Agreement do not purport to be complete and each is qualified in its entirety by reference to the full text of the Note and the Purchase Agreement, which are filed as Exhibits 4.20 and 10.41, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On February 21, 2023 PDX Pharma reported that it has been awarded a phase II SBIR grant of $1.87M for 2 years from the National Cancer Institute (NCI) focusing on the development of a new nano-immunotherapy ARAC-02 (Antigen Release Agent and Checkpoint Inhibitor) for lung cancer treatment (Press release, PDX Pharmaceuticals, FEB 21, 2023, View Source [SID1234627466]). ARAC-02 – nanoparticle co-delivering a PD-L1 antibody, a polo-like kinase 1 (PLK1) inhibitor, and an immune-stimulant CpG – provides effective antitumor immune response via CD8+ T cell activities. The original grant application of ARAC-02 had high merit and received a rare perfect score from the NIH. We met all phase I SBIR milestones on formulation optimization and initial efficacy and safety studies in cells and in mice, which leads to phase II SBIR grant awarded for ARAC-02’s evaluation in multiple lung cancer models. Many cancers including lung cancer depend on PLK1 for cell division and growth, and PLK1 inhibition by ARAC-02 will lead to cell death. After PLK1 inhibition, ARAC-02 transiently upregulates PD-L1 expression, rendering the cancer (which may originally have low PD-L1 expression and are not eligible for immune checkpoint inhibitors, ICIs) more sensitive to PD-L1 antibody serving as the ICI and cancer homing agent on ARAC-02. We also show that CpG on ARAC-02, which recruits and activates antigen-presenting cells, enhance CD8+ T cell population and activities. Our current data suggest that ARAC-02 will have broad efficacy in lung and other cancer types (e.g., breast, liver, and pancreatic cancer) regardless of mutational status. ARAC-02 is anticipated to reach clinical trials next year. Data on first gen ARAC (without CpG) was published in Nature Communications in 2022. A US patent (US11224573B2) on the ARAC technology was also issued in Jan, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 21, 2023 iBio CDMO LLC, a wholly owned subsidiary of iBio, Inc. (the "Company") and Woodforest National Bank ("Woodforest") reported that it has entered into the Second Amendment to the Credit Agreement that was entered into on November 1, 2021, as amended (the "Credit Agreement"), which amendment, among other things, added a milestone that had to be met by a specified date, the failure of which would be an event of default (Filing, 8-K, iBioPharma, FEB 21, 2023, View Source [SID1234627464]). In addition, on February 9, 2023, the Company, as guarantor, entered into the Second Amendment to the Guaranty, which was executed on November 1, 2021, as amended (the "Guaranty"), which amendment, among other things, allows the Company to account for all amounts owed to it by Fraunhofer USA Inc. ("Fraunhofer") as part of its legal settlement with them (the "Fraunhofer Settlement Funds") in determining whether the Company is in compliance with the Liquidity Covenant (as defined in the Credit Agreement, which currently is a requirement that the Company maintain $7,500,000 in unrestricted cash) until a specified period dependent upon the occurrence of a specific milestone in the Credit Agreement.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On February 20, 2023, iBio CDMO LLC entered into the Third Amendment to the Credit Agreement, which removed the added milestone specified in the Second Amendment, the failure of which would be an event of default. In addition, the Guaranty was amended to allow the Company until February 28, 2023, to account for the Fraunhofer Settlement Funds in determining whether the Company is in compliance with the Liquidity Covenant without being dependent upon a specified milestone. In addition, the Company agreed that each time it consummates an at-the-market issuance of Equity Interests (as defined within the Credit Agreement), no later than five (5) days following such issuance of Equity Interests, it will (a) pay to Woodforest in immediately available cash funds, without setoff or counterclaim of any kind, forty percent (40%) of the Net Proceeds (as defined within the Credit Agreement) received by the Company for such issuance of Equity Interests; provided, any such payment would cease upon payment obligations in full and (b) provide Woodforest with a detailed accounting of each such issuance of Equity Interests.

As a result of the payment of $2,1000,00 we received related to the Auction Sale Agreement we entered into on February 10, 2023, with Holland Industrial Group, together with Federal Equipment Company and Capital Recovery Group, LLC, we are currently in compliance with the Liquidity Covenant without including the Fraunhofer Settlement Funds in such calculation. However, based on current estimates, without additional funds, we do not anticipate being in compliance with the covenant on February 28, 2023 if we are unable to include the Fraunhofer Settlement Funds in such calculation. If the Company is unable to increase its unrestricted cash by February 28, 2023, and fails to meet the Liquidity Covenant, it would be in default of the terms of the Credit Agreement and the Guaranty and another amendment to the Credit Agreement and Guaranty may be necessary. The Company and Woodforest continue to be in discussions regarding a potential default and potential amendment to the Credit Agreement to rectify any such default.

The descriptions of the Third Amendment to the Credit Agreement and the Third Amendment to the Guaranty do not purport to be complete and are qualified in their entirety by reference to the Third Amendment to the Credit Agreement and the Third Amendment to the Guaranty, copies of which are filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On February 21, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported its financial and operating results for the fourth quarter and full year ended December 31, 2022 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, FEB 21, 2023, View Source [SID1234627463]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our strong performance across the business, including the successful integration of Antares Pharma, drove another year of record revenue of $660 million, representing 49% year-over-year growth," said Dr. Helen Torley, president and chief executive officer of Halozyme. "In 2023, we continue to project record revenue of $815 to $845 million and greater than 30% growth in EBITDA to $415 to $440 million, driven by diversified revenue streams. I am excited with the opportunity for two partner regulatory approvals in 2023 for products utilizing ENHANZE, SC efgartigimod for generalized myasthenia gravis and SC atezolizumab. With the addition of Antares to the Halozyme portfolio, we are enthusiastic about our ability to expand our partnerships with ENHANZE and the auto-injector technology."

Recent Partner Highlights:
•Bristol Myers Squibb plans to initiate a Phase 3 trial in early 2023 to demonstrate the drug exposure level of nivolumab plus relatlimab fixed-dose combination with ENHANZE is not inferior to intravenous administration in participants with previously untreated metastatic or unresectable melanoma. This is in addition to two ongoing Phase 3 studies comparing nivolumab administrated intravenously to nivolumab administered subcutaneously in patients with renal cell carcinoma and melanoma.
•In December 2022, Takeda achieved a sales milestone for HYQVIA, triggering a payment of $10 million.
•In November 2022, Roche submitted a Biologics License Application to the FDA and a Marketing Authorization Application to the European Medical Agency (EMA) for SC atezolizumab with ENHANZE across all approved indications of IV Tecentriq. In January

2023, Roche announced the FDA accepted the Biologics License Application with a PDUFA date of September 15, 2023.
•In November 2022, Roche submitted an Initial Market Application for Mabthera subcutaneous (SC) to the Center for Drug Evaluation in China.
•In November 2022, argenx announced the acceptance of the Biologics License Application for SC efgartigimod for the treatment of adults with generalized myasthenia gravis. In January 2023, argenx announced that the FDA extended the PDUFA date to June 20, 2023.
•In November 2022, argenx announced the submission of a Marketing Authorization Application to the EMA for SC efgartigimod for the treatment of adults with generalized myasthenia gravis.
•In October 2022, Roche Pharmaceuticals China announced the approval of Herceptin SC (trastuzumab injection subcutaneous with ENHANZE) in China for the treatment of patients with early-stage and metastatic HER2-positive breast cancer.
•In July 2022, Takeda announced positive topline results from the pivotal phase 3 ADVANCE clinical trial evaluating HYQVIA for the maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), and the company confirmed its intention to submit regulatory applications in the United States and European Union in its fiscal year 2022.

Recent Corporate Highlights:
•In February 2023, Halozyme elected Barbara Duncan to its Board of Directors.
•In January 2023, Halozyme elected to redeem on March 17, 2023 all if its outstanding 1.25% convertible senior notes due 2024.
•In December 2022, Halozyme completed an Accelerated Share Repurchase agreement to repurchase $110 million of common stock. Halozyme received a total of 2.4 million shares at an average price per share of $45.62. During 2022, the Company repurchased a total of 4.5 million shares for $200 million at an average price per share of $44.44, and as of December 31, 2022, Halozyme has completed $350 million of its 3-year, $750 million dollar share repurchase plan, at an average price per share of $41.69.

Fourth Quarter and Full Year 2022 Financial Highlights:
•Revenue for the fourth quarter was $181 million compared to $102.0 million for the fourth quarter of 2021. The 78% year-over-year increase was driven by an increase in royalty revenue primarily attributable to subcutaneous DARZALEX (daratumumab) and the addition of product sales as a result of the Antares Pharma acquisition. Revenue for the quarter included $106.0 million in royalties, an increase of 69% compared to $62.6 million in the prior year period.
Total revenue for the full year was $660.1 million, compared with $443.3 million in 2021, representing 49% year-over-year growth.
•Cost of sales for the fourth quarter was $42.1 million, compared to $21.6 million for the fourth quarter of 2021. The increase was driven by an increase in product sales as a result of the Antares Pharma acquisition.
Cost of sales for the full year was $139.3 million, compared to $81.4 million in 2021, primarily driven by an increase in sales in our proprietary and partnered products as a result of the Antares Pharma acquisition and amortization of inventory step-up associated with purchase accounting for the acquisition.
•Amortization of intangibles expense in the fourth quarter and full year was $4.6 million and $43.1 million, respectively, an increase from no expense in the fourth quarter and full year of 2021, due to the Antares Pharma acquisition, in which Halozyme acquired intangible assets that are amortized over a useful life related to the auto injector technology platform, XYOSTED and TLANDO.

•Research and development expenses for the fourth quarter and full year were $22.6 million and $66.6 million, respectively, compared to $10.1 million and $35.7 million for the fourth quarter and full year of 2021, respectively. Selling, general and administrative expenses for the fourth quarter and full year were $37.7 million and $143.5 million, respectively, compared to $13.8 million and $50.3 million for the fourth quarter and full year of 2021 respectively. The increases were primarily due to planned investments in ENHANZE, the Antares Pharma acquisition and increases in compensation expense related to the combined workforce.
•Operating income in the fourth quarter was $74.5 million, compared to operating income of $56.5 million in the fourth quarter of 2021. Operating income for the full year was $267.5 million, compared to $275.9 million in 2021.
•Net Income on a GAAP basis in the fourth quarter of 2022 was $57.7 million, compared with net income of $66.8 million in the fourth quarter of 2021 and for the full year was $202.1 million, compared to net income of $402.7 million in 2021, which includes the reversal of the valuation allowance recorded against the Company’s deferred tax assets and resulted in the recognition of a one-time non-cash income tax benefit during the prior year quarter and full year of $12 million and $154.2 million, respectively.
•Earnings per Share: On a GAAP basis in the fourth quarter of 2022, diluted earnings per share was $0.42, compared with $0.46 in the fourth quarter of 2021. On a non-GAAP basis diluted earnings per share was $0.48, compared with diluted earnings per share of $0.42 in the fourth quarter of 2021.1
GAAP diluted earnings per share for the full year was $1.44 compared with $2.74 per share in 2021. The 2021 GAAP results include a one-time recognition of a non-cash income tax benefit of $1.05 per share. Non-GAAP diluted earnings per share for the full year was $2.21 per share, compared to $2.00 per share in 2021.
•Cash, cash equivalents and marketable securities were $362.8 million on December 31, 2022, compared to $740.9 million on December 31, 2021.

Financial Outlook for 2023

The Company is reiterating its financial guidance for 2023, which was initially provided on January 10, 2023. For the full year 2023, the Company expects:

•Total revenue of $815 million to $845 million, representing growth of 23% to 28% over 2022 total revenue primarily driven by continued strength in Wave 2 products, including DARZALEX SC (daratumumab) and Phesgo (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE technology, as well as full year auto-injector royalty and product contribution. The Company expects revenue from royalties of $445 million to $455 million, representing growth of 23% to 26%.
•EBITDA of $415 million to $440 million, representing growth of >30% over 2022. EBITDA excludes the impact of amortization costs related to the Antares Pharma acquisition.1
•Non-GAAP diluted earnings per share of $2.50 to $2.65, representing growth of >10% over 20221. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Table 1. 2023 Financial Guidance

Guidance Range
Total Revenue $815 to $845 million
Royalty Revenue $445 to $455 million
EBITDA $415 to $440 million
Non-GAAP Diluted EPS $2.50 to $2.65

Webcast and Conference Call

Halozyme will host its Quarterly Update Conference Call for the fourth quarter ended December 31, 2022 today, Tuesday, February 21, 2023 at 4:30 p.m. ET/1:30 p.m. PT. The conference call may be accessed live with pre-registration via this link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the "Investors" section of www.halozyme.com.