Accomplished enrollment of ATYR1923 medical trial in sufferers with pulmonary sarcoidosis. Knowledge is predicted within the third quarter.
Outcomes from ATYR1923 medical trial in sufferers with COVID-19 extreme respiratory issues demonstrated favorable security profile and indicators of exercise primarily based on medical readouts and inflammatory biomarkers.
COVID-19 findings offered first-in-patient mechanistic proof-of-concept for ATYR1923.
Firm to host convention name and webcast right this moment, March 23, at 5:00 p.m. EDT / 2:00 p.m. PDT.
SAN DIEGO, March 23, 2021 (GLOBE NEWSWIRE) — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics firm engaged within the discovery and growth of revolutionary medicines primarily based on novel organic pathways, right this moment introduced fourth quarter and full yr 2020 outcomes and offered a company replace.
“Amidst the backdrop of the COVID-19 pandemic, 2020 was a extremely productive yr for aTyr that included important medical, analysis and discovery developments that we anticipate to yield worth for the corporate all through 2021,” mentioned Sanjay S. Shukla, M.D., M.S., President and Chief Govt Officer of aTyr. “We’re extremely inspired by our progress and stay up for constructing upon our applications and novel tRNA synthetase biology platform as we transfer ahead this yr.”
“Most notably, we’ve superior and expanded our medical program for ATYR1923. We accomplished enrollment in our Section 1b/2a trial for our lead interstitial lung illness (ILD) indication, pulmonary sarcoidosis, and knowledge from this proof-of-concept examine is predicted within the third quarter of this yr. We additionally reported optimistic outcomes from a Section 2 trial in sufferers with COVID-19, which demonstrated ATYR1923’s favorable security profile and a sign of medical exercise. Moreover, we gained key mechanistic insights from the examine’s biomarker knowledge, which confirmed that ATYR1923 is impacting irritation in sufferers according to what we’ve seen preclinically, together with inflammatory cytokines which might be implicated in sarcoidosis and different types of ILD.”
“As a way to accomplish such progress, we’ve remained steadfast with the environment friendly and considered use of our capital. The capital we generated in 2020, together with the upfront fee obtained below the Kyorin Settlement, and elimination of debt allowed us to finish 2020 with roughly $31.7 million in money. The year-end money quantity, together with the greater than $25.0 million we’ve obtained since yr finish from the receipt of a milestone fee and use of our fairness autos, place us effectively to hold out our catalysts for the yr forward.”
Fourth Quarter 2020 and Subsequent Interval Highlights
- Accomplished enrollment in its Section 1b/2a multiple-ascending dose, placebo-controlled examine of ATYR1923 in 37 sufferers with pulmonary sarcoidosis. Knowledge is predicted within the third quarter of this yr.
- Reported optimistic outcomes from its Section 2 randomized, double blind, placebo-controlled examine of ATYR1923 in 32 COVID-19 sufferers with extreme respiratory issues. The examine met its main security endpoint and demonstrated a sign of exercise via medical enchancment within the 3.0 mg/kg cohort in comparison with placebo. Biomarker knowledge from the examine confirmed that sufferers handled with ATYR1923 demonstrated a development of general enchancment in 82% (14 of 17) of biomarkers analyzed in comparison with placebo. ATYR1923 diminished a number of inflammatory cytokines and chemokines, together with these which might be implicated in sarcoidosis and different ILD, which is according to findings from animal fashions. The info gives the first-in-patient mechanistic proof-of-concept for ATYR1923.
- Beneath the collaboration and licensing settlement with Kyorin Pharmaceutical, Co., Ltd. (Kyorin) (the Kyorin Settlement) entered in early 2020 for the event and commercialization of ATYR1923 for ILD in Japan, aTyr has obtained $10.0 million in upfront and milestone funds.
- Offered preclinical findings in a poster on the Keystone Symposia: Tumor Metabolism and the Microenvironment demonstrating that NRP2 is expressed on key immune suppressive cells, additional validating NRP2 as a possible regulator of stable tumor development.
- Appointed main most cancers researcher Judith Varner, PhD, as a scientific advisor to the corporate to help the event of its NRP2 antibody applications. Dr. Varner, whose experience consists of myeloid cell biology and tumor macrophage sign transduction, presently serves as Professor within the Departments of Pathology and Medication on the Moores Middle on the College of California, San Diego.
- Had two posters accepted for presentation on the upcoming American Affiliation for Most cancers Analysis Annual Assembly. The posters, titled “The Neuropilin-2 concentrating on antibody ATYR2810 inhibits non-small cell lung most cancers tumor progress in monotherapy and mixture remedy” and “A site-specific antibody to NRP2 down-regulated epithelial-mesenchymal transition genes and enhanced efficacy of standard-of-care therapeutics for aggressive breast most cancers,” have been accomplished along side the corporate’s scientific advisor Dr. Arthur Mercurio and his lab on the Division of Molecular, Cell and Most cancers Biology on the College of Massachusetts Medical College.
- Offered a poster on the Society for Laboratory Automation and Screening Worldwide Convention and Exhibition describing the corporate’s novel strategy to establish receptor targets for 2 extracellular tRNA synthetase fragments Alanyl-tRNA Synthetase (AARS) and Aspartyl-tRNA Synthetase (DARS), additional validating the corporate’s biology platform.
- Introduced two tRNA synthetase discovery applications from its pipeline to research the performance of chosen fragments of AARS and DARS in most cancers, fibrosis and irritation. The applications will initially concentrate on pure killer cell biology.
Fourth Quarter 2020 Monetary Outcomes
Whole revenues have been $2.1 million and $0.1 million for the three months ended December 31, 2020 and 2019, respectively. The rise was due primarily to $2.0 million from license and collaboration settlement income below the Kyorin Settlement. Analysis and growth bills have been $4.7 million and $3.6 million for the three months ended December 31, 2020 and 2019, respectively. The rise was due primarily to the development of ATYR1923 medical actions. Normal and administrative bills have been constant between durations at $2.3 million and $2.5 million for the three months ended December 31, 2020 and 2019, respectively.
Yr Ended 2020 Monetary Outcomes and Money Place
Whole revenues have been $10.5 million and $0.4 million for the years ended December 31, 2020 and 2019, respectively. The rise was due primarily to $10.0 million from license and collaboration settlement income below the Kyorin Settlement. Analysis and growth bills have been $17.3 million and $14.0 million for the years ended December 31, 2020 and 2019, respectively. The rise was due primarily to the development of ATYR1923 medical actions. Normal and administrative bills have been constant between durations at $9.1 million and $9.4 million for the years ended December 31, 2020 and 2019, respectively.
As of December 31, 2020, aTyr had $31.7 million in money, money equivalents and investments. In November 2020, the corporate repaid all long-term loans. Since December 31, 2020, the corporate obtained $2.0 million associated to the Kyorin Settlement, raised roughly $9.9 million in gross proceeds from its on the market providing program, earlier than deducting commissions and providing bills payable by aTyr and raised roughly $15.3 million in gross proceeds from its buy settlement with Aspire Capital Fund, LLC.
The corporate expects its analysis and growth bills to extend in 2021 because it continues to develop ATYR1923 and ATYR2810 in addition to its discovery applications.
Convention Name and Webcast Particulars
aTyr will host a convention name and webcast right this moment at 5:00 p.m. Japanese Time / 2:00 p.m. Pacific Time to debate its monetary outcomes and supply a company replace. events might entry the decision by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and utilizing convention ID 3291668. Hyperlinks to a reside audio webcast and replay could also be accessed on the aTyr web site occasions web page at: http://buyers.atyrpharma.com/events-and-webcasts. An audio replay can be accessible for not less than 90 days following the occasion.
aTyr is growing ATYR1923 as a possible therapeutic for sufferers with inflammatory lung ailments. ATYR1923, a fusion protein comprised of the immuno-modulatory area of histidyl tRNA synthetase fused to the FC area of a human antibody, is a selective modulator of Neuropilin-2 that downregulates the innate and adaptive immune response in inflammatory illness states. aTyr just lately accomplished enrollment in a proof-of-concept Section 1b/2a trial evaluating ATYR1923 in sufferers with pulmonary sarcoidosis. This Section 1b/2a examine is a multi-ascending dose, placebo-controlled, first-in-patient examine of ATYR1923 that has been designed to judge the protection, tolerability, steroid sparing impact, immunogenicity and pharmacokinetics profile of a number of doses of ATYR1923. In response to the COVID-19 pandemic, aTyr accomplished a Section 2 medical trial with ATYR1923 in COVID-19 sufferers with extreme respiratory issues. This Section 2 examine was a randomized, double blind, placebo-controlled examine that was designed to judge the protection and preliminary efficacy of a single dose of ATYR1923.
aTyr is a biotherapeutics firm engaged within the discovery and growth of revolutionary medicines primarily based on novel organic pathways. aTyr’s analysis and growth efforts are targeting a newly found space of biology, the extracellular performance and signaling pathways of tRNA synthetases. aTyr has constructed a world mental property property directed to a possible pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s main focus is ATYR1923, a clinical-stage product candidate which binds to the Neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung ailments. For extra info, please go to http://www.atyrpharma.com.
This press launch accommodates forward-looking statements throughout the that means of the Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements are often recognized by way of phrases corresponding to “anticipates,” “believes,” “estimates,” “expects,” “intends,” “might,” “plans,” “tasks,” “seeks,” “ought to,” “will,” and variations of such phrases or related expressions. We intend these forward-looking statements to be lined by such protected harbor provisions for forward-looking statements and are making this assertion for functions of complying with these protected harbor provisions. These forward-looking statements embody statements concerning the potential therapeutic advantages and functions of ATYR1923, ATYR2810 and our discovery applications; timelines and plans with respect to sure growth actions (together with the additional growth of ATYR9123, ATYR2810 and our discovery applications) and worth to be derived therefrom; anticipated actions below our collaboration agreements and sure growth targets. These forward-looking statements additionally mirror our present views about our plans, intentions, expectations, methods and prospects, that are primarily based on the knowledge presently accessible to us and on assumptions we’ve made. Though we imagine that our plans, intentions, expectations, methods and prospects, as mirrored in or instructed by these forward-looking statements, are affordable, we may give no assurance that the plans, intentions, expectations or methods can be attained or achieved. All forward-looking statements are primarily based on estimates and assumptions by our administration that, though we imagine to be affordable, are inherently unsure. Moreover, precise outcomes might differ materially from these described in these forward-looking statements and can be affected by a wide range of dangers and components which might be past our management together with, with out limitation, the truth that NRP2 and tRNA synthetase biology is just not totally understood, uncertainty concerning the COVID-19 pandemic, together with the danger of delays in enrollment in our medical trials, dangers related to the invention, growth and regulation of our product candidates, together with the danger that outcomes from medical trials or different research might not help additional growth, the danger that we might stop or delay preclinical or medical growth actions for any of our current or future product candidates for a wide range of causes, the truth that our collaboration agreements are topic to early termination, and the danger that we might not be capable to increase the extra funding required for our enterprise and product growth plans, in addition to these dangers set forth in our most up-to-date Annual Report on Kind 10-Okay, Quarterly Studies on Kind 10-Q and in our different SEC filings. Besides as required by regulation, we assume no obligation to replace publicly any forward-looking statements, whether or not on account of new info, future occasions or in any other case.
|ATYR PHARMA, INC.|
|Condensed Consolidated Statements of Operations|
|(in hundreds, besides share and per share knowledge)|
|Three Months Ended||Years Ended|
|December 31,||December 31,|
|License and collaboration settlement revenues||$||2,053||$||144||$||10,455||$||422|
|Analysis and growth||4,698||3,590||17,291||14,048|
|Normal and administrative||2,295||2,516||9,075||9,352|
|Whole working bills||6,993||6,106||26,366||23,400|
|Loss from operations||(4,940||)||(5,962||)||(15,911||)||(22,978||)|
|Whole different earnings (expense), internet||5||(171||)||(319||)||(785||)|
|Consolidated internet loss||$||(4,935||)||$||(6,133||)||$||(16,230||)||$||(23,763||)|
|Internet loss attributable to noncontrolling curiosity in Pangu BioPharma Restricted||3||160||6||160|
|Internet loss attributable to aTyr Pharma, Inc.||$||(4,932||)||$||(5,973||)||$||(16,224||)||$||(23,603||)|
|Internet loss per share, fundamental and diluted||$||(0.47||)||$||(1.54||)||$||(1.77||)||$||(7.03||)|
|Shares utilized in computing internet loss per share, fundamental and diluted||10,573,584||3,891,002||9,160,269||3,355,600|
|ATYR PHARMA, INC.|
|Condensed Consolidated Stability Sheets|
|December 31,||December 31,|
|Money, money equivalents and available-for-sale investments||$||31,689||$||31,144|
|Property and gear, internet||899||1,270|
|Pay as you go bills and different belongings||2,016||853|
|Accounts payable, accrued bills and different liabilities||$||5,003||$||3,431|
|Present portion of working lease legal responsibility||861||755|
|Time period loans, internet of debt issuance prices and low cost||—||8,737|
|Lengthy-term working lease legal responsibility, internet of present portion||1,378||2,239|
|Whole stockholders’ fairness||31,484||21,026|
|Whole liabilities and stockholders’ fairness||$||38,726||$||36,188|