Tosatoxumab

Received two grant awards from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health LOS GATOS, Calif., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc., (OTCQB: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today reported financial and corporate results for its third quarter ended September 30, 2023. Third Quarter Highlights Received a grant award from the National Institute of Allergy and Infectious Diseases (NIAID) division of the National Institutes of Health (NIH), in collaboration with researchers at Eitr Biologics in San Diego, California, to develop pan-coronavirus human monoclonal antibody (‘mAb’). Received a grant award from NIAID in collaboration with researchers at Emory University in Atlanta, Georgia, to apply the Company's APEXTM human mAb discovery and production platform technology to discover and develop antibacterial mAbs from patients. Positive non-human primate efficacy data from the Company’s COVID-19 mAb program AR-701 was accepted for publication in the peer reviewed scientific journal Nature Communications. AR-701 mAbs exhibit broad pan-coronavirus neutralization activity, including recent Omicron variants. The Company has been uplisted to the OTCQB market, joining over 900 other companies that are currently on this market. OTCQB companies must be current in their financial reporting and undergo an annual verification and management certification process. Raised gross proceeds of $2.0 million through issuance and sale of approximately 10 million shares of common stock and common stock equivalents at market price and approximately 10 million common stock warrants. “With multiple late clinical stage assets and a strong platform technology, our company has been actively pursuing partnering discussions to maximize the value of these assets for our shareholders. We remain optimistic of successful outcomes from these efforts in the coming months,” commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. “Continuing our long-standing history of procurement of non-dilutive grant funding, we are pleased to announce multiple NIH grants that we expect will begin funding in the fourth quarter.” Clinical Programs Update AR-501 (gallium citrate): AR-501 is being developed in collaboration with and with funding support from the Cystic Fibrosis Foundation. Aridis reported preliminary top-line results from the randomized, double blinded, placebo-controlled Phase 2a study of AR-501, that the study’s primary and secondary endpoints of safety and pharmacokinetics (PK) were met. Key findings of the study include: CF patients achieved high uptake of AR-501 in the respiratory tract, as measured by sputum concentrations, at levels that were more than 50-fold higher than required for inhibition of the target bacteria Pseudomonas aeruginosa; inhaled delivery achieved more than 10-fold higher respiratory uptake of gallium (AR-501) than past clinical studies of intravenous (IV) gallium which resulted in lung function improvement and P. aeruginosa reduction. The safety margin was further expanded by evaluating a higher dose cohort of 80mg comprising of 6 CF subjects. The independent Data Safety Monitoring Board (DSMB) also did not express any safety concerns at the 80mg dose level and agreed with the ongoing development of the product. Details of the Phase 1/2a clinical trial can be viewed at using identifier NCT03669614. AR-320 (suvratoxumab): AR-320 is a fully human monoclonal antibody (mAb) targeting Staphylococcus aureus alpha toxin being developed as a preemptive treatment of mechanically ventilated ICU patients who are colonized with S. aureus but do not yet have ventilator-associated pneumonia (VAP). This program is currently placed on temporary clinical hold while the Company discusses potential resolution with AstraZeneca on the commercial license. AR-301 (tosatoxumab): AR-301 is an anti-S. aureus mAb with similar target and mechanism of action as AR-320 but being developed as an adjunctive therapeutic treatment of ICU patients with VAP caused by S. aureus. Top-line data from the first of two Phase 3 superiority clinical studies showed strong clinical and pharmacoeconomic benefit trends in patients treated with AR-301, especially in the prespecified older adults (65+ years) patients. Aridis received concurrence from the FDA (U.S. Food Drug Administration) and EMA (European Medicines Agency) on the Company’s proposed single confirmatory Phase 3 study, study endpoints, and patient populations. AR-301 received Priority Review status from the Qualified Infectious Disease Designation (QIDP) and was deemed eligible for consideration under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). The Company is in active discussions with potential pharmaceutical partners and investors to advance the program toward the confirmatory Phase 3 trial and BLA application. Third Quarter Financial Results: Cash: Total cash, cash equivalents and restricted cash as of September 30, 2023, were approximately $0.5 million. Revenues: Grant revenue was approximately $0.4 million for the quarter ended September 30, 2023, primarily due to the recognition of revenue from a grant from the Cystic Fibrosis Foundation. A total of $0.4 million in grant revenue was reported for the quarter ended September 30, 2022. Research and Development Expenses: Research and development expenses decreased by approximately $5.9 million, from approximately $6.1 million for the quarter ended September 30, 2022, to approximately $0.2 million for the quarter ended September 30, 2023. The decrease was primarily due to decreases in spending associated with our paused clinical trials for AR-320 and AR-301 and reduced clinical trial activities for AR-501 and our COVID-19 programs. General and Administrative Expenses: General and administrative expenses decreased to approximately $1.1 million for the three months ended September 30, 2023, from approximately $1.7 million for the three months ended September 30, 2022. Headcount reductions contributed to decreases in salaries and wages and related benefit expenses. Interest Income (Expense) net: Net interest income was approximately $1,000 for the quarter ended September 30, 2023, compared to approximately $27,000 interest expense for the quarter ended September 30, 2022. Due to fair value option valuation of our notes payable, there was no interest expense recorded during the third quarter of 2023. Other Income: Other income increased to $26,000 for the quarter ended September 30, 2023, compared to approximately $23,000 for the quarter ended September 30, 2022. The income was primarily due to a sublease agreement we entered into with a tenant in March 2021 for a small portion of our Los Gatos facility. Common Stock: During the three-month period ended September 30, 2023, a total of 8,496,489 shares were issued resulting in common stock outstanding of 44.6 million shares. Net Loss: The net loss available to common stockholders for the quarter ended September 30, 2023, was approximately $83,000, a $0.00 net loss per share, compared to a net loss available to common stockholders of approximately $8.2 million or $0.47 net loss per share for the quarter ended September 30, 2022. The weighted average common shares outstanding used in computing net loss per share available to common stockholders was approximately 37.4 million and approximately 17.7 million for the third quarter of 2023 and 2022, respectively. About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as first-line treatments to combat antimicrobial resistance (AMR) and viral pandemics. The Company is utilizing its proprietary ʎPEX TM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized by the natural human immune system for high potency. Hence, they are already fit-for-purpose and do not require further engineering optimization to achieve full functionality. The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antibacterial and antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care, which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below: Aridis’ Pipeline AR-301 (VAP/HAP/CAP). AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in ventilator associated pneumonia (VAP), ventilated hospital acquired pneumonia (HAP), and ventilated community acquired pneumonia (CAP) patients. AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients. This program is currently in a Phase 2a clinical study in CF patients. AR-320 (VAP). AR-320 is a fully human mAb targeting S. aureus alpha-toxin for prevention of VAP. Statistically significant Phase 2 data in the target population of those ≤ 65 years of age was published in the September 2021 Lancet Infectious Diseases journal. The Company has completed discussions with the EMA and FDA on study design and recently launched the Phase 3 study. AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that target multiple sites on the spike proteins of the SARS-CoV-2 virus. AR-101 (HAP). AR-101 is a fully human IgM mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa HAP cases worldwide. This program is licensed to the Serum Institute of India and Shenzhen Arimab. AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb directed against the F-protein of diverse clinical isolates of respiratory syncytial virus (RSV). This program is licensed exclusively to the Serum Institute of India. AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii . For additional information on Aridis Pharmaceuticals, please visit . Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the need for additional financing, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2022, and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Aridis Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (In thousands) September 30, December 31, 2023 2022 (unaudited) Cash and cash equivalents $ 35 $ 4,876 Other current and noncurrent assets 6,499 9,819 Total assets $ 6,534 $ 14,695 Total liabilities $ 18,336 $ 38,927 Total stockholders' deficit (11,802 ) (24,232 ) Total liabilities and stockholders’ deficit $ 6,534 $ 14,695 Aridis Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 (unaudited) (unaudited) (unaudited) (unaudited) Revenue: Grant revenue $ 417 $ 399 $ 1,544 $ 1,878 License revenue — — 19,602 — Total revenue 417 399 21,146 1,878 Operating expenses: Research and development 175 6,118 10,374 18,916 General and administrative 1,111 1,693 4,235 5,535 Total operating expenses 1,286 7,811 14,609 24,451 Loss from operations (869 ) (7,412 ) 6,537 (22,573 ) Other income (expense): Interest income (expense), net 1 (27 ) 31 (267 ) Other income 26 23 77 68 Change in fair value of note payable 759 (823 ) (1,400 ) (1,212 ) Net loss $ (83 ) $ (8,239 ) $ 5,245 $ (23,984 ) Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic and diluted Basic 37,428,943 17,701,592 35,562,129 17,701,592 Diluted 37,428,943 17,701,592 47,178,967 17,701,592 Earnings (net loss) per share: Basic $ 0.00 $ (0.47 ) $ 0.15 $ (1.35 ) Diluted $ 0.00 $ (0.47 ) $ 0.11 $ (1.35 ) Net loss $ (83 ) $ (8,239 ) $ 5,245 $ (23,984 ) Other comprehensive income 1,261 — 2,736 — Total comprehensive income (loss) $ 1,178 $ (8,239 ) $ 7,981 $ (23,984 ) Contact: Investor Relations Dave Gentry, CEO RedChip Companies ARDS@redchip.com SOURCE Aridis Pharmaceuticals, Inc.

Approval is Based on Clinical Studies Conducted in Japan, Europe and North America Confirming the Efficacy and Safety of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] CUVITRU is Takeda’s First Subcutaneous Immunoglobulin Plasma Therapy in Japan, Delivering on the Company’s Commitment to Reach Patients with High Unmet Needs OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution] in patients aged 2 years and older with agammaglobulinemia or hypogammaglobulinemia1, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID)2. The approval marks Takeda’s first subcutaneous immunoglobulin (SCIG) therapy for patients in Japan. The approval is based on results from a Phase 3 clinical trial that evaluated the efficacy, safety, tolerability and pharmacokinetics of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in Japanese patients with PID (NCT04346108), as well as two Phase 2/3 clinical trials conducted in patients with PID in North America (NCT01218438) and Europe (NCT01412385). Results from the clinical trial in 17 patients in Japan confirmed its efficacy and safety pro >1. No serious or severe adverse events were reported, and CUVITRU was well-tolerated. The most frequently reported adverse reactions were injection site swelling in four patients (23.5%) and injection site erythema in three patients (17.6%)1 during CUVITRU treatment. Previously reported clinical trial results also confirmed the efficacy and safety of CUVITRU. “We are delighted that CUVITRU, approved in more than 30 countries worldwide, has now been approved in Japan as our first subcutaneous immunoglobulin treatment for agammaglobulinemia or hypogammaglobulinemia,” said Naoyoshi Hirota, regional head of research & development for Takeda’s Plasma-Derived Therapies Business Unit in Japan. “Patients with immunodeficiency often contract serious infections, including pneumonia, sepsis and other recurring infections. Immunoglobulin replacement therapy is the standard of care, and we are proud to offer a new flexible dosing regimen to patients in Japan.” Timely diagnosis of PID is problematic in Japan and treatment with immunoglobulins is currently much lower than in other parts of the world3,4. Patient demand for plasma-derived therapies (PDTs) is expected to grow significantly in the coming years, and Takeda is leading regulatory efforts and discussions to elevate the standard of care in Japan and introduce more of Takeda’s PDT portfolio into the country. “Takeda is proud to build on our long and rich Japanese heritage by continuing to invest in and expand our PDT offerings to address the needs of patients,” said Kristina Allikmets, head of research & development for Takeda’s Plasma-Derived Therapies Business Unit. “Hand in hand with our recent investment in an end-to-end global plasma manufacturing facility in Osaka, the approval of CUVITRU marks the start of our commitment to bringing our broad and differentiated global PDT portfolio to immunodeficient patients in Japan over the next decade.” About Agammaglobulinemia or Hypogammaglobulinemia Agammaglobulinemia is an inherited disorder caused by a gene defect that blocks the growth of normal, mature immune cells called B lymphocytes, and produces antibodies5. Hypogammaglobulinemia describes a condition in which patients have low levels of antibodies and can be both due to inherited genetic conditions, or caused by secondary effects, such as chemotherapy, certain comorbid disorders, or the use of immunosuppressants2. Individuals with any form of antibody deficiency frequently experience recurring infections, and immunoglobulin replacement therapy can increase the level of antibodies in the body. About Primary Immunodeficiency and Secondary Immunodeficiency Primary immunodeficiency (PID) describes a heterogenous group of more than 480 rare genetic diseases wherein part of the immune system is missing or not functioning properly6. Secondary immunodeficiency (SID) may be defined as an impairment of the immune response resulting from conditions or factors extrinsic to the immune system. SID may occur as a consequence of malnutrition, metabolic disorders, use of immunosuppressive medications, chronic infections, malignancies, or severe trauma7. Due to their impaired immune system, patients with PID and SID may be more susceptible to infection and it may take longer to recover from it. In patients with antibody deficiency and increased susceptibility and/or persistent infections, substitution with functional antibodies (immunoglobulin replacement therapy) is the standard of care to support the immune system's functioning7. About CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution] CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated in Japan as a treatment for agammaglobulinemia or hypogammaglobulinemia in patients aged 2 years and older. It was developed as a treatment to help prevent infection in adult and pediatric patients with PID or SID. As of May 2022, it has been approved in over 30 countries. CUVITRU Product Overview in Japan Brand Name CUVITRU 20% S.C. Infusion 2 g/10 mL, 4 g/20 mL, 8 g/40 mL Generic Name pH4-Treated Acidic Normal Human Immunoglobulin (Subcutaneous injection) Indications Agammaglobulinemia or Hypogammaglobulinemia Dosage and Administration Normally, 50 ~ 200 mg (0.25 ~ 1 mL)/kg body weight of human immunoglobulin G is administered subcutaneously once a week. In case of every 2 weeks regimen, 2-fold higher dose than once-a-week regimen (100 ~ 400 mg [0.5 ~ 2 mL]/kg body weight) will be administered subcutaneously. The dose and dosing frequency of once-a-week or every-2-weeks regimen may be adjusted according to the patient's condition. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). 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Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: or at . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. References CUVITRU Subcutaneous Injection Package Insert in Japan. Pimenta et al., Hypogammaglobulinemia: a diagnosis that must not be overlooked. BJMBR, 2019;52(10): e8926, . The Marketing Research Bureau (MRB). Plasma-Derived Medicinal Products (PDMPs) and Plasma Supply into the Future. January 2020. Kohsuke et al., Physician awareness and understanding of primary immunodeficiency disorders: a web-based study in Japan, Immunological Medicine, 2023; 46:1, 45-57, doi: 10.1080/25785826.2022.2137966. National Organization for Rare Disorders: . Tangye et al., Human inborn errors of immunity: 2022 update on the classification from the international union of immunological societies expert committee. J Clin Immunol. 2022 Oct;42(7):1473-1507. doi: 10.1007/s10875-022-01289-3. Epub 2022 Jun 24. . Karen S. Tuano,y; Neha Seth, Javier Chinen. Secondary immunodeficiencies. Ann Allergy Asthma Immunol 127 (2021) 617-626.