Scleroderma, Systemic

Phase 3 EFZO-FIT™ study of efzofitimod in pulmonary sarcoidosis anticipated to complete enrollment in the second quarter of 2024. Company launches Individual Patient Expanded Access Program (EAP), allowing access to efzofitimod for patients who complete EFZO-FIT™. Phase 2 EFZO-CONNECT™ study of efzofitimod in SSc-ILD currently enrolling. Ended 2023 with $101.7 million in cash, cash equivalents and investments. Company to host conference call and webcast today, March 14th, at 5:00 p.m. EDT / 2:00 p.m. PDT. SAN DIEGO, March 14, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced fourth quarter and full year 2023 results and provided a corporate update. “Throughout 2023 we made meaningful progress with our clinical development program for our lead therapeutic candidate, efzofitimod, in interstitial lung disease (ILD),” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. “Our primary focus for 2024 is completing enrollment in our global pivotal Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, which is anticipated in the second quarter.” “We ended 2023 with more than $100 million in cash, restricted cash, cash equivalents and investments. Based on our current cash position and operational plans, we believe our financial resources are sufficient to fund the Company’s operations through the filing of a Biologics License Application (BLA) for efzofitimod in pulmonary sarcoidosis." Fourth Quarter 2023 and Subsequent Period Highlights Continued enrollment in the global pivotal Phase 3 EFZO-FIT™ study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously monthly for a total of 12 doses. The study intends to enroll up to 264 patients with pulmonary sarcoidosis. The study is currently enrolling at more than 90 centers in 9 countries. A positive data and safety monitoring board review assessed that the study could continue unmodified. Based on current enrollment projections, the Company anticipates completing enrollment in the study in the second quarter of 2024.Announced an Individual Patient Expanded Access Program (EAP) for efzofitimod for patients with pulmonary sarcoidosis. The EAP has been initiated based on blinded EFZO-FIT™ study investigator and patient participant feedback. The program is designed to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.Continued enrollment in the Phase 2 EFZO-CONNECT™ study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD. This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll up to 25 patients with SSc-ILD and is open for enrollment at multiple centers in the U.S.Poster for efzofitimod accepted for presentation at the upcoming American Thoracic Society (ATS) 2024 International Conference. The conference is scheduled to take place May 17 – 22, 2024, in San Diego, CA. Poster 8837 – Efzofitimod is an Immunomodulator of Myeloid Cell Function and Novel Therapeutic Candidate for Interstitial Lung Diseases on Sunday, May 19, 2024, at 2:15 p.m. PDT. Presented two posters highlighting the importance of neuropilin-2 (NRP2) in immune regulation at the Keystone Symposia on Myeloid Cell Diversity. The findings further demonstrate that efzofitimod modulates myeloid cells via the NRP2 receptor to promote a unique anti-inflammatory mechanism and validates the role of NRP2 in the immune system by the activity of an NRP2 blocking antibody in preclinical models. Announced Wayne A. I. Frederick, M.D., President Emeritus of Howard University, as an advisor to the Company. Dr. Frederick is a distinguished physician executive with extensive knowledge on disparities in healthcare and will advise the Company on its efzofitimod program in ILD.Poster for ATYR0750 accepted for presentation at the upcoming Gordon Research Conference Fibroblast Growth Factors in Development and Disease. The conference is scheduled to take place March 24 – 29, 2024, in Galveston, TX. Poster – Alanyl-tRNA Synthetase Fragment Binds to FGFR4 and Induces Morphological Changes and Downstream Signaling in Liver Cells with Functional Similarities to FGF2. Year Ended 2023 Financial Highlights and Cash Position Cash & Investment Position: Cash, cash equivalents, restricted cash and investments as of December 31, 2023, were $101.7 million. Based on the Company’s current operational plans and existing cash, the Company maintains its prior guidance and believes its cash runway will be sufficient to fund the Company’s operations through the filing of a BLA for efzofitimod in pulmonary sarcoidosis.R&D Expenses: Research and development expenses were $42.3 million for the year ended 2023, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT™ and Phase 2 EFZO-CONNECT™ studies, manufacturing costs for the efzofitimod program and research and development costs for the efzofitimod and discovery programs.G&A Expenses: General and administrative expenses were $13.0 million for the year ended 2023. Conference Call and Webcast Details aTyr will host a conference call and webcast today at 5:00 p.m. EDT / 2:00 p.m. PDT to discuss its financial results and provide a corporate update. Interested parties may access the call by registering here in order to obtain a dial in, personalized passcode and webcast information. Links to a live audio webcast and replay may be accessed on the aTyr website Events page at: http://investors.atyrpharma.com/events-and-webcasts. An audio replay will be available for at least 90 days following the event. About Efzofitimod Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes. About aTyr aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “designed,” “expects,” “intends,” “may,” “plans,” “potential,” “project,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding our belief that we will have sufficient cash runway to fund the Company’s operations through the filing of a BLA for efzofitimod for pulmonary sarcoidosis; the expected size of, and number and nationality of patients to be enrolled in, the EFZO-FIT™ and EFZO-CONNECT™ studies; the design and benefits of our EAP for efzofitimod for patients with pulmonary sarcoidosis; the potential therapeutic benefits and applications of efzofitimod; and timelines and plans with respect to certain development activities and development goals, including our expectation that our Phase 3 EFZO-FIT™ study of efzofitimod in patients with pulmonary sarcoidosis will complete enrollment in the second quarter of 2024. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations, strategies or prospects will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, our assumptions and expectations underlying our belief that we will have sufficient cash runway to fund the Company’s operations through the filing of a BLA for efzofitimod for pulmonary sarcoidosis may not be accurate, the fact that NRP2 and tRNA synthetase biology is not fully understood, uncertainty regarding the ultimate long-term impact of evolving macroeconomic and geopolitical conditions, the risk of delays in our clinical trials, risks associated with the discovery, development and regulation of our product candidates, including the risk that results from clinical trials or other studies may not support further development, the risk that we may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons, the fact that our collaboration agreements are subject to early termination, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. ATYR PHARMA INC. Consolidated Statements of Operations (in thousands, except share and per share data) Three Months Ended Years Ended December 31, December 31, 2023 2022 2023 2022 Revenues: License and collaboration agreement revenues $— $10,386 $353 $10,386 Total revenues — 10,386 353 10,386 Operating expenses: Research and development 12,755 14,910 42,293 42,808 General and administrative 3,204 3,426 12,979 13,982 Total operating expenses 15,959 18,336 55,272 56,790 Loss from operations (15,959) (7,950) (54,919) (46,404)Total other income (expense), net 1,198 427 4,522 1,061 Consolidated net loss (14,761) (7,523) (50,397) (45,343)Net loss attributable to noncontrolling interest in Pangu BioPharma Limited 1 2 8 5 Net loss attributable to aTyr Pharma, Inc. $(14,760) $(7,521) $(50,389) $(45,338)Net loss per share, basic and diluted $(0.25) $(0.26) $(0.94) $(1.60)Shares used in computing net loss per share, basic and diluted 59,261,219 29,116,524 53,606,488 28,419,569 ATYR PHARMA INC. Condensed Consolidated Balance Sheets (in thousands) December 31, December 31, 2023 2022 Cash, cash equivalents, restricted cash and available-for-sale investments $101,650 $69,311 Other receivables 2,436 11,775 Property and equipment, net 5,531 3,059 Operating lease, right-of-use assets 6,727 7,250 Financing lease, right-of-use assets 1,788 1,248 Prepaid expenses and other assets 2,521 3,143 Total assets $120,653 $95,786 Accounts payable and accrued expenses $15,088 $12,968 Current portion of operating lease liability 831 630 Current portion of financing lease liability 497 264 Long-term operating lease liability, net of current portion 12,339 9,633 Long-term financing lease liability, net of current portion 1,428 1,007 Total stockholders’ equity 90,470 71,284 Total liabilities and stockholders’ equity $120,653 $95,786 Contact:Ashlee DunstonDirector, Investor Relations and Public Affairsadunston@atyrpharma.com

LUND, SE / ACCESSWIRE / March 14, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; Nasdaq Stockholm:CANTA) today reported new data highlighting the potential of the CAN10 antibody, currently in phase I clinical development, as therapy in systemic sclerosis. All signaling systems targeted by CAN10 (IL-1, IL-33 and IL-36) were found to be highly upregulated in patient skin biopsies. These cytokines induce fibrosis in skin fibroblasts isolated from patients, and this manifestation of disease was blocked by CAN10. In mouse models, CAN10 reversed the aberrant expression of several genes involved in the systemic sclerosis pathogenesis in humans. The data is presented at the Systemic Sclerosis World Congress in Prague 14-16 March 2024. "We are very excited about the progress in the CAN10 program which is quickly advancing from the ongoing healthy volunteer investigations towards studies in patients. The new data provides important information further increasing our confidence in CAN10 as a future therapy of inflammatory diseases" said Göran Forsberg, CEO of Cantargia. CAN10 is currently in phase I clinical development with transition from healthy volunteers to patients planned for Q3, 2024. One of the lead indications, systemic sclerosis, is a life-threatening autoimmune disease resulting in fibrosis in the skin, lung, and other internal organs. Current treatments focus on symptomatic treatment rather than addressing underlying disease mechanisms. It is estimated that in the US, approximately 100,000 patients suffer from the disease. CAN10 has orphan drug status in the US for treatment of systemic sclerosis. The new results demonstrate that both the target for CAN10, IL1RAP, and the IL1RAP-dependent signaling molecules IL-1, IL-33 and IL-36, are upregulated in skin from systemic sclerosis patients. This disease develops as fibroblasts promote the formation of an excessive buildup of connective tissue in skin and internal organs, so-called fibrosis. The results show that IL-1, IL-33 and IL-36 collagen production on skin fibroblasts from systemic sclerosis patients, leading to fibrosis. These disease-associated mechanisms can be reduced by CAN10. These new data strengthen previously reported beneficial effects of IL1RAP-blockade in three mouse models of systemic sclerosis, where treatment with a mouse surrogate of CAN10 reduced both skin and lung fibrosis. Additional gene expression analysis of mouse systemic sclerosis skin showed decreased expression of several key disease-related profibrotic factors in the skin by CAN10. In summary, the data show that CAN10 targets central processes important for systemic sclerosis and that CAN10 provides an opportunity to treat underserved systemic sclerosis patients. These data were generated in collaboration with a world-leading research group headed by Prof. Dr. Jörg Distler at the Heinrich-Heine University, Düsseldorf, Germany and will be presented as a poster at the 8th Systemic Sclerosis World Congress March 14-16, 2024 in Prague, Czech Republic. The poster is now also available at Cantargia's web page . Title: Combined blockade of IL-1, IL-33 and IL-36 signaling by targeting IL1RAP ameliorates skin and lung fibrosis in preclinical models of systemic sclerosis Session Title: Innovative therapies Session Date and Time: Friday March 15th 1.30-2.30 pm and Saturday March 16th 1-2 pm Poster Number: 317 This information is information that Cantargia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-03-14 17:31 CET. About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. The main program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . About CAN10 The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: myocarditis and systemic sclerosis. In preclinical in vivo models of myocarditis, a CAN10 surrogate antibody significantly reduced the development of inflammation and fibrosis, and significantly counteracted the deterioration of the cardiac function. The CAN10 surrogate also inhibited disease development in models of systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis and peritonitis. A clinical phase I study, investigating CAN10 in healthy volunteers and psoriasis patients, is ongoing. Up to 80 subjects may be included in the trial, the first clinical data set shows good safety. Additional data from the trial are expected continuously during 2024. Attachments Cantargia presents new human data further supporting CAN10 in the treatment of systemic sclerosis SOURCE: Cantargia View the original press release on accesswire.com

Company reported positive initial clinical data for QRX003 from first six evaluable subjects in ongoing open-label Netherton Syndrome study with positive benefits observed across a number of clinical endpoints Eligibility age for enrollment into both studies has been lowered to fourteen years and older No safety concerns have been observed to date in either ongoing clinical study Quoin expects its cash runway will extend into the second half of 2025 following $6.5 million offering on March 5th Cash Runway to be further extended by $8 million Equity Line of Credit arrangement signed January 25, 2024 ASHBURN, Va., March 13, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today provides a business update and announces financial results for the quarter and year ended December 31, 2023. Quoin CEO, Dr. Michael Myers, said, “2023 marked another year of significant progress for Quoin and for the development of QRX003 for the treatment of Netherton Syndrome. Notably, we released initial positive data from our open label clinical study, representing a first for the very underserved Netherton community. That progress has continued, and based on the strength of the initial positive clinical data, we implemented a number of important protocol changes that we believe could lead to a more streamlined development program overall. “We have also strengthened our balance sheet through the recently completed $6.5 million capital raise and we have the capacity to further solidify our cash position via the $8.0 million equity line of credit transaction we entered into earlier this year, once shareholder approval is received. We continue to believe that Quoin is in position to deliver the first approved treatment for this terrible disease.” Recent Corporate Highlights – On March 4th, Quoin announced FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical studies. On February 8th, 2024, Quoin filed U.S. and International patent applications for a novel Netherton Syndrome combination product. On December 13th, Quoin announced FDA clearance of the Clinical Optimization Plan for QRX003 for Netherton Syndrome On October 24th, Quoin announced positive clinical data from the first six evaluable patients in the company’s open-label clinical trial in Netherton Syndrome patients. Five of the six subjects reported that their pruritus, or itch, was either negligible or absent following treatment with QRX003, a significant improvement from prior to the study. All six subjects exhibited improvement in the Investigator assessed skin scoring system with three subjects showing improvement at the completion of the study and the other three at various points during the study. All six subjects expressed a favorable impression of QRX003 across multiple assessed metrics. No safety concerns have been reported to date for any subject in either of Quoin’s studies. Financial Highlights Quoin had approximately $10.7 million in cash, cash equivalents and marketable securities as of December 31, 2023. This does not include the proceeds from the $6.5 million public offering of common shares that the company announced on March 5, 2024, nor the anticipated proceeds from the $8 million equity line of credit transaction which was entered into in January of this year. Implementation of this remains subject to shareholder approval. Net loss for the quarter ended December 31, 2023 was approximately $2.0 million compared to approximately $2.0 million for the quarter ended December 31, 2022. Net loss for the twelve months ended December 31, 2023 was $8.7 million compared to $9.4 million for the twelve months ended December 31, 2022. Investors are encouraged to read the Company’s Annual Report on Form 10-K when it is filed with the Securities and Exchange Commission (the “SEC”), which will contain additional details about Quoin’s financial results as of and for the period ended December 31, 2023. Quoin will host a conference call and webcast at 8:30am ET on Thursday, March 14, 2024. The call will include a discussion of fourth quarter and full year 2023 financial results and a corporate update. The live call can be accessed by dialing 1-800-603-0527 (domestic) or 1-412-317-0688 (international). The live and archived webcast of the call will also be available on the Quoin Pharmaceuticals website under the Investors section or by following this link: About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a clinical stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: or LinkedIn for updates. Cautionary Note Regarding Forward Looking Statements The Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to the Company’s expected cash runway, the belief that certain protocol changes could lead to a more streamlined development program and the belief that the Company is in a position to deliver the first approved treatment for Netherton Syndrome. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 that the Company filed with the SEC. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. PCG Advisory Stephanie Prince sprince@pcgadvisory.com (646) 863-6341 -Tables Follow- QUOIN PHARMACEUTICALS LTD. Consolidated Balance Sheets December 31, December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents $ 2,401,198 $ 2,860,628 Investments 8,293,663 9,992,900 Prepaid expenses and other current assets 591,034 516,584 Total current assets 11,285,895 13,370,112 Prepaid expenses - long term 300,000 383,390 Intangible assets, net 583,334 704,561 Total assets $ 12,169,229 $ 14,458,063 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 526,523 $ 605,600 Accrued expenses 1,308,706 1,175,705 Accrued interest and financing expense 1,146,251 1,146,251 Due to officers - short term 600,000 600,000 Total current liabilities 3,581,480 3,527,556 Due to officers - long term 2,923,733 3,523,733 Total liabilities $ 6,505,213 $ 7,051,289 Commitments and contingencies Shareholders' equity: Ordinary shares, no par value per share, 100,000,000 and 8,333,334 ordinary shares authorized at December 31, 2023 and 2022, respectively - 987,220 (987,220 ADS's) $ - $ - ordinary shares issued and outstanding at December 31, 2023 and 403,887 (403,887 ADS's) at December 31, 2022 Treasury stock, - (2,932,000 ) -0- ordinary shares issued at December 31, 2023 and 45 ordinary shares issued at December 31, 2022 Additional paid in capital 51,867,336 47,855,521 Accumulated deficit (46,203,320 ) (37,516,747 ) Total shareholders' equity 5,664,016 7,406,774 Total liabilities and shareholders' equity $ 12,169,229 $ 14,458,063 QUOIN PHARMACEUTICALS LTD. Consolidated Statements of Operations Years Ended December 31, Three months ended December 31, 2023 2022 2023 2022 (Audited) (Audited) (Unaudited) (Unaudited) Operating expenses General and administrative $ 6,070,517 $ 6,584,868 $ 1,385,276 $ 1,472,866 Research and development 3,307,987 2,672,836 832,391 613,067 Total operating expenses 9,378,504 9,257,704 2,217,667 2,085,933 Other (income) and expenses Forgiveness of accounts payable - (416,000 ) - - Warrant liability (income) expense - (77,237 ) - - Unrealized loss (gain) 2,683 (1,307 ) (9,243 ) (4,360 ) Realized and accrued interest income (694,614 ) (95,745 ) (158,546 ) (80,613 ) Interest and financing expense - 714,081 - - Total other (income) expense (691,931 ) 123,792 (167,789 ) (84,973 ) Net loss $ (8,686,573 ) $ (9,381,496 ) $ (2,049,878 ) $ (2,000,960 ) Deemed dividend on warrant modification - (65,266 ) - - Net loss attributable to shareholders $ (8,686,573 ) $ (9,446,762 ) $ (2,049,878 ) $ (2,000,960 ) Loss per ADS Basic $ (9.64 ) $ (46.81 ) $ (2.08 ) $ (4.95 ) Fully-diluted $ (9.64 ) $ (46.81 ) $ (2.08 ) $ (4.95 ) Weighted average number of ADS's outstanding Basic 900,919 201,826 987,220 403,884 Fully-diluted 900,919 201,826 987,220 403,884