On March 29, 2022 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported 2021 annual results including its major achievements and progress (Press release, Innovent Biologics, MAR 29, 2022, View Source [SID1234611483]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "2021 is the 10th year since our company’s inception. Over the past decade, bearing the mission to develop and commercialize high-quality biopharmaceutical products that are affordable to ordinary people, Innovent has developed into a leading Chinese biopharmaceutical company with fully-integrated platform capability, strong execution with track record and a healthy financial position. For the past year, we are determined with the global innovation strategy and have made tremendous progress in all aspects including R&D, clinical development, CMC, commercialization and business collaboration. The company has rolled out development for a pipeline of 32 valuable assets in various clinic stages. We plan to expand commercial portfolio to over ten products in two years with continuous strong revenue growth, supported by our validated commercial platform capability and competitive cost advantage under large scale and high quality manufacturing facilities. Besides, we further fortified R&D structure and platform to expedite the development for over a dozens of clinical stage candidates with global potential and more preclinical projects with global innovation. For the year of 2022, as the inflection point for next decade of development, we will adhere to the company strategy of global innovation, strive to be a global premier biopharmaceutical company with steady growth prospects, and create sustainable value for patients, employees, shareholders and the society."

Business Highlight Overview

For the year of 2021, achieved RMB4,261million total revenue and RMB4,001million product revenue with an increase of 69.0% compared to the prior year.
For the year of 2021, commercial portfolio increased to six products with two innovative anti-cancer drugs approved.
Expanded strategic partnership with Eli Lilly in March 2022 added the seventh newly approved product and a ready-to-launch product at New Drug Application (NDA) stage.
TYVYT received three additional first-line indication approvals for major types of cancer and successfully included in the updated National Reimbursement Drug List (NRDL), also as the only PD-1 inhibitor globally with positive Phase 3 data in the first-line treatment for 5 major types of cancer.
6 molecules at NDA or late clinical stage.
7 molecules achieved positive Proof of Concept (PoC) data readout.
Acceleration of Global R&D and clinical development, to explore first-in-class (FIC) targets with full-functional global development platform and global talents.
About 10 strategic collaborations with global and regional partners in research, development and commercialization, unleashing the platform potential and explore synergic value of pipeline portfolio.
Commercial – Strong Track Record

Product revenue RMB4,001 million in 2021: an increase of 69.0% compared with the prior year.
Expansion of commercial portfolio into six approved products, including: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE and NAILIKE by the end of 2021.
In March 2022, expansion of strategic collaboration with Eli Lilly, which showed further recognition by the global MNC: for Innovent to obtain sole commercialization right of the 7th approved product Cyramza (ramucirumab) and NDA-stage asset Retsevmo (selpercatinib), and the right of first negotiation for future potential commercialization of late-stage asset Pirtobrutinib (BTK inhibitor) in mainland China.
Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team expanded to cover over 5,100 hospitals and 1,100 pharmacies across more than 320 cities, and a well-structured commercial team with nearly 3,000 people.
Pipeline – Expedited Speed to Launch

– TYVYT as leading brand in PD-(L)1 market:

Newly approved 3 additional indications got successfully included in the NRDL (non-squamous Non-Small Cell Lung Cancer [nsqNSCLC], sqNSCLC, hepatocellular carcinoma [HCC]).
The only PD-1 inhibitor with positive Phase 3 data in first-line treatments of five major types of cancer (1L nsqNSCLC, 1L sqNSCLC, 1L HCC, 1L esophageal squamous cell carcinoma [ESCC], 1L gastric cancer [GC]).
Multiple clinical datasets of TYVYT were published in world-renowned medical journals such as EClinicalMedicine, ESMO (Free ESMO Whitepaper) Open, BMJ etc.
– Six assets at late stage incl. NDA/pivotal trials:

Retsevmo (selpercatinib), NDA submitted
IBI-326 (BCMA CAR-T), planned NDA submission in 2022
IBI-306 (PCSK9), planned NDA submission in 2022
IBI-310 (CTLA-4), planned NDA submission in 2022
IBI-344 (ROS1/NTRK), ongoing pivotal Phase 2
IBI-376 (PI3Kδ), ongoing pivotal Phase 2[1]
– Seven innovative molecules achieved positive PoC data readout, plan to advance into the late stage in clinic:

IBI-188 (CD47): achieved preliminary PoC data readout in Phase 1b study for 1L MDS, promising efficacy data (ORR 83.3%) and a good safety profile. Plan to initiate Phase 3 study for 1L MDS in 2022.
IBI-362 (GLP-1/GCGR): showed robust efficacy in weight loss for Phase 1b in obesity, data published in EClinicalMedicine. Robust efficacy in blood glucose lowering effects in diabetics patients. Potentially the best GLP1-/GCGR dual agonist. Plan to initiate Phase 3 studies for obesity and type 2 diabetes in 2022.
IBI-326 (BCMA CAR-T): demonstrated impressive efficacy and safety in Phase 1/2 study, with improved in-vivo persistency and encouraging efficacy in patients with prior murine BCMA CAR-T treatment failure. Plan to submit NDA in 2022.
IBI-344 (ROS1/NTRK): ORR 90.5% in the crizotinib-naïve patient and ORR 43.8% in the crizotinib-treated patient group. Received NMPA BTD for ROS1+ NSCLC. Pivotal Phase 2 study ongoing.
IBI-310 (CTLA-4): achieved positive PoC in combination with sintilimab for CC and HCC. Plan to submit NDA for CC in 2022.
IBI-302 (VEGF/C): showed visual acuity improvement with edema reduction in Phase 1b study, ongoing Phase 2 study for nAMD.
IBI-112 (IL-23p19): observed significant efficacy signal in the Phase 2 study for psoriasis with long-acting potential. Plan to initiate Phase 3 study in 2022.
– Expedite the clinical development of multiple molecule clusters with global potentials, expected PoC data readout roll out in a well-schemed plan:

CD47 cluster: IBI-188 (CD47), IBI-322 (PD-L1/CD47), IBI-397 (SIRPα)
LAG-3 cluster: IBI-110 (LAG-3), IBI-323 (PD-L1/LAG-3)
TIGIT cluster: IBI-939 (TIGIT), IBI-321 (PD-1/TIGIT)
VEGF cluster: IBI-302 (VEGF/C), IBI-324 (VEGF/ANG-2), IBI-333 (VEGF-A/VEGF-C)
R&D: Infrastructure Set for Global Innovation

– Innovent US Lab established: primarily focused on disease mechanism study and technology-platform development, accelerating the translation of scientific discovery into the next-generation drug candidates.

– The Scientific Advisory Board (SAB) established: comprising three World-renowned scientists to provide insights of frontline global innovation in cancer biology and immunology and contribute scientific advice to our research and clinical pipelines.

– The CMC Advisory Board (CAB) established: comprising industry-leading experts to provide professional advice on production structure and process streamline, resources investment and strategic development.

– The global product development team expansion and infrastructure improvement: have built a full-functional global development team and expect to have 100+ employees in near term. Have established an effective global development platform and process which enables to cooperate seamlessly with China clinical development team of 1,000 people to carry out global development for our novel assets.

– Technology platform collaborations for global innovation:

The development of the proprietary ADC technologies with Synaffix.
The development of three new therapeutic immune-stimulating antibody conjugate (ISAC) candidates with Bolt Biotherapeutics.
The development of up to three enzyme specific inhibitors with Amagma Therapeutics.
The license-out of non-exclusive commercial right of fully-human BCMA CAR construct to SANA Biotechnology for certain in vivo gene therapy and ex vivo hypo-immune cell therapy application.
BD: Meaningful Collaboration to Succeed

– Established multiple co-development and co-commercialization collaboration to unlock assets potential:

Expanded strategic collaboration with Eli Lilly for the sole commercialization right of Cyramza (ramucirumab) and Retsevmo (selpercatinib), and right of first negotiation for future commercialization of pirtobrutinib (BTK inhibitor) in mainland China.
Taletrectinib (ROS1/NTRK) – a next-generation TKI designed to effectively target ROS1 and NTRK, co-development and co-commercialization with AnHeart in China.
NAILIKE (olverembatinib) – a novel third-generation BCR-ABL TKI, co-development and co-commercialization with Ascentage Pharma in China.
GFH925 (KRAS G12C inhibitor) – a novel, orally active, potent KRAS G12C inhibitor, co-development and co-commercialization with GenFleet Therapeutics in China and opt-in right for global development and commercialization.
Orismilast (PDE4 inhibitor) – a novel, orally active PDE4 inhibitor for broad target indications, granted sole development and sole commercialization right in China from UNION therapeutics A/S.
Manufacturing Facilities Upgradation

New Commercial Facility: successfully expanded the production capacity from 24,000L to 60,000L, which is one of the largest stainless steel production capacity in China.
Quality compliance to GMP and cost advantage further strengthen market competitiveness.
Financial Highlights (Non-IFRS measure)

Total revenue was RMB 4,261 million, including product revenue 4,001 million with an increase of 69.0% compared to the prior year.
Gross profit margin was 88.6%，an increase of 3.7% compared to the prior year.
R&D expenses were RMB2,116 million an increase of 23.2% compared to the prior year.
Loss for the year was RMB2,243 million.
Cash on hand and short-term financial assets at the end of 2021 was approximately USD1,415million, which enables strategical focus on the long-term development strategies.[2]
Note: [1] In January 2022, Incyte has withdrawn the application of parsaclisib in FL, MZL and MCL in the U.S. as a business decision and is not related to any changes in either the efficacy or safety of parsaclisib. We plan to have communication with China NMPA regarding the potential submission of PI3Kδ.

[2] The financial numbers mentioned above was based on non-IFRS measure which excluded certain non-cash items and non-recurring events. Detailed disclosure can be found at the Company’s annual result announcement.

On March 29, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided an update on recent business developments (Press release, CorMedix, MAR 29, 2022, View Source [SID1234613387]).

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Recent Corporate Highlights:

CorMedix announced on March 28 that the resubmission of the DefenCath NDA has been accepted for filing by the FDA as a complete Class 2 response, with a six month review cycle. In addition, our third-party manufacturer was notified that FDA will conduct an inspection during the review period.
CorMedix announced on February 28 that the DefenCath NDA has been resubmitted to FDA in parallel with our third-party contract manufacturer submitting responses to the FDA regarding deficiencies identified at the manufacturing facility previously.
Joseph Todisco was appointed as Chief Executive Officer by the CorMedix Board of Directors and expected to begin on or before May 16. Joe brings significant leadership and commercial operations experience, most recently serving as Chief Commercial Officer of Amneal’s Specialty business.
Cash and short-term investments, excluding restricted cash, at December 31, 2021 amounted to $65.5 million.
Dr. Matt David, CorMedix interim CEO, commented, "We are very pleased to share the updates this week regarding the FDA acceptance for filing of our DefenCath resubmission. The CorMedix team is working hard as we continue to lay the groundwork for a potential commercial launch of DefenCath following its anticipated approval. Catheter related bloodstream infections are a frequent occurrence in patients receiving hemodialysis via central venous catheters and are associated with significant morbidity and mortality. We look forward to providing updates as we aim to deliver on our commitment to these patients."

4th Quarter 2021 Financial Highlights

For the fourth quarter of 2021, CorMedix recorded a net loss of $7.8 million, or $0.20 per share, compared with a net loss of $6.1 million, or $0.19 per share, in the fourth quarter of 2020. The increase in net loss in the fourth quarter of 2021 compared with 2020 was primarily driven by increases in costs related to the manufacturing of DefenCath prior to its potential marketing approval and non-cash charges for stock-based compensation. Operating expenses during the fourth quarter of 2021 were $7.8 million, compared with $6.1 million in the fourth quarter of 2020, an increase of approximately $1.7 million.

Full Year 2021 Financial Highlights

For the year ended December 31, 2021, CorMedix recorded a net loss of $28.2 million, or $0.75 per share, compared with a net loss during the year ended December 31, 2020 of $22.0 million, or $0.77 per share. The increase in net loss was driven primarily by increases in operating expenses.

Operating expenses during the year ended December 31, 2021 amounted to $29.5 million compared with $27.3 million during the comparable period in 2020, an increase of $2.2 million, or 8%, due to a 18% increase in SG&A expense, offset by a 2% decrease in R&D expense.

Total cash on hand and short-term investments as of December 31, 2021 amounted to $65.5 million, excluding restricted cash of $0.2 million. Including approximately $3.0 million in net proceeds from ATM issuances during 1Q of 2022, CorMedix has December 31, 2021 pro forma cash and equivalents and short-term investments of $68.5 million. The Company believes that it has sufficient resources to fund operations through the first half of 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 29, 2022, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows

On March 29, 2022 The Company reported that entered into a Securities Purchase Agreement (the "Fourth Man Purchase Agreement"), with Fourth Man, LLC ("Fourth Man"), pursuant to which the Company issued a convertible promissory note in the aggregate principal amount of $0.25 million (the ‘Fourth Man Note") (Filing, 8-K, Mateon Therapeutics, MAR 29, 2022, View Source [SID1234611397]). The Note are convertible into shares of the Company’s common stock, par value $0.01 per share ("Common Stock").

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The Purchase Agreement and the Note were entered into for aggregate gross proceeds to the Company of up to $0.25 million (the "Financing"), undertaken by the Company pursuant to that certain Finder’s Fee Agreement between the Company and JH Darbie & Co., Inc. ("JH Darbie"), dated October 26, 2021 (the "Agreement"). Pursuant to the Agreement, JH Darbie will be entitled to a finder’s fee of: (a) 10% of the gross proceeds received by the Company in cash; and (b) warrants equal 10% warrant coverage of the amount raised, with a purchase price equal to the Conversion Price, with such warrants to expire five years from the date of issuance. The Purchase Agreement and the Note contain identical terms to the securities purchase agreements (and promissory notes issued thereunder), to Talos Victory Fund, LLC on November 24, 2021 and Mast Hill Fund, LP on November 30, 2021 (the "Prior Issuances"), except with reference to the name of the holders, the use of proceeds, which include repayment of certain debt, general corporate expenses and payroll, as applicable, and the law governing the terms of the Prior Issuances. The Prior Issuances were previously reported on our Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on December 1, 2021.

The Notes carry an interest rate of 12% per annum and matures on the earlier of (a) the one-year anniversary of the date of the Purchase Agreements, or (b) the acceleration of the maturity of the Notes by the applicable holder upon occurrence of an Event of Default (as defined below). The Notes contain a voluntary conversion mechanism whereby the applicable holder may convert the outstanding principal and accrued interest under the terms of the Notes into shares of Common Stock (the "Conversion Shares"), at a fixed price of $0.10 per share (the "Conversion Price"), subject to adjustments upon the occurrence of certain corporate events. The Company also issued 1,250,000 warrants to purchase shares of Common Stock of the Company at an exercise price of $0.20. Prepayment of the Notes may be made at any time upon three trading days’ prior written notice to the respective holder, by payment of the then outstanding principal amount plus accrued and unpaid interest and reimbursement of such holder’s administrative fees. The Notes contains customary events of default (each an "Event of Default"). If an Event of Default occurs, at the respective holder’s election, the outstanding principal amount of the Notes, plus accrued but unpaid interest, will become immediately due and payable in cash. The Purchase Agreements require the Company to use the proceeds for general working capital, and not for (i) the repayment of any indebtedness owed to officers, directors or employees of the Company or their affiliates, (iii) any loan to or investment in any other corporation, partnership, enterprise or other person (except in connection with the Company’s currently existing operations), (iv) any loan, credit, or advance to any officers, directors, employees, or affiliates of the Company, or (v) in violation or contravention of any applicable law, rule or regulation.

The issuance of the Notes are exempt from the registration requirements of the Securities Act of 1933, as amended ("Securities Act"), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act. The shares of Common Stock issuable upon conversion of the Notes have not been registered under the Securities Act or any other applicable securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.

On March 29, 2022, Propanc Biopharma, Inc. (the "Company") reported that 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 $120,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of ONE44 (Filing, 8-K, Propanc, MAR 29, 2022, View Source [SID1234611342]). The transaction contemplated by the Purchase Agreement closed on March 31, 2022. The Company intends to use the net proceeds ($108,000) from the Note for general working capital purposes. The Note contains an original issue discount amount of $12,000.

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The maturity date of the Note is March 29, 2023 (the "Maturity Date"). The Note shall bear interest at a rate of 10% per annum, which interest may be paid by the Company to ONE44 in shares of common stock, but shall not be payable until the Note becomes payable, 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 6th monthly anniversary of this Note, to convert all or any amount of the principal face amount of this Note then outstanding into shares of the Company’s common stock (the "Common Stock") at a price for each share of Common Stock equal to 65% of the lowest closing bid price of the Common Stock as reported on the OTC Markets on which the Company’s shares are then traded or any exchange upon which the Common Stock may be traded in the future, 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 be decreased to 55% instead of 65% 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 the Company’s common stock beneficially owned by ONE44 and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 120 days from the issuance date, then the prepayment premium shall be 130% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, up to 180 from the issuance date, 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 timely issue shares 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 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 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 description of the Note and the Purchase Agreement does not purport to be complete and is qualified in their entirety by reference to the full text of the Note and the Purchase Agreement, which are filed as Exhibits 4.1 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On March 29, 2022 Calithera Biosciences, Inc. reported that entered into an underwriting agreement, or the Underwriting Agreement, with SVB Securities LLC and H.C. Wainwright & Co., LLC, as representatives of the several underwriters named therein, collectively, the Underwriters, relating to the issuance and sale, or the Offering, of 18,518,519 shares of its common stock, par value $0.0001 per share, at a combined price to the public of $0.54 per share of common stock and accompanying common warrants (Filing, 8-K, Calithera Biosciences, MAR 29, 2022, View Source [SID1234611329]). Each share of common stock is accompanied by (1) warrants to purchase up to an equal number of shares of common stock at an exercise price of $0.54 per share, which are immediately exercisable and will expire 18 months from the date of issuance, or the Short-Term Warrants, and (2) warrants to purchase up to an equal number of shares of common stock at an exercise price of $0.54 per share, which are immediately exercisable and will expire 5 years from the date of issuance, or the Long-Term Warrants. Pursuant to the Underwriting Agreement, the Underwriters have agreed to purchase the shares of common stock and each accompanying Short-Term Warrant and Long-Term Warrant from Calithera at a combined price of $0.5022 per share and accompanying warrants. The net proceeds to Calithera from this Offering are expected to be approximately $8.8 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by Calithera. All of the shares and warrants in the Offering are being sold by Calithera. The closing of the Offering is expected to occur on or about April 1, 2022, subject to the satisfaction of customary closing conditions.

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The Offering is being made pursuant to our effective registration statement on Form S-3 (Registration Statement No. 333-243731), as previously filed with the Securities and Exchange Commission and a related prospectus and prospectus supplement.

The Underwriting Agreement contains customary representations, warranties and agreements by Calithera, customary conditions to closing, indemnification obligations of Calithera and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement.

In connection with the Offering, Calithera will also enter into a warrant agency agreement, or the Warrant Agency Agreement, with Calithera’s transfer agent, American Stock Transfer & Trust Company LLC, who will act as warrant agent for Calithera, with respect to the Short-Term Warrants and Long-Term Warrants.

The Underwriting Agreement is filed as Exhibit 1.1 hereto, the form of Short-Term Warrant is filed as Exhibit 4.1 hereto, the form of Long-Term Warrant is filed as Exhibit 4.2 hereto and the form of Warrant Agency Agreement is filed as Exhibit 4.3 hereto. The foregoing descriptions of the terms of the Underwriting Agreement, the Short-Term Warrants, the Long-Term Warrants and the Warrant Agency Agreement are qualified in their entirety by reference to such exhibits hereto. A copy of the opinion of Cooley LLP relating to the legality of the issuance and sale of the securities in the Offering is attached as Exhibit 5.1 hereto.