Avalo Therapeutics(AVTX)
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Avalo Therapeutics(AVTX) - 2022 Q1 - Quarterly Report
2022-05-04 16:00
Financial Performance - Net product revenue for the three months ended March 31, 2022, was $1.2 million, an increase from $0.5 million in the same period of 2021[128]. - The company reported a net loss of $22.1 million for the three months ended March 31, 2022, with negative cash flows from operations of $16.1 million[143]. - Interest expense for the three months ended March 31, 2022, was $1.2 million, related to a venture debt financing agreement[140]. - Net cash used in operating activities was $16.1 million for Q1 2022, primarily due to a net loss of $22.1 million driven by research and development activities[149]. - The company experienced a decrease in cash and cash equivalents of $16.1 million in Q1 2022, compared to an increase of $19.5 million in Q1 2021[150]. - The company reported a net cash used in operating activities of $18.3 million for Q1 2021, with a net loss of $30.7 million[151]. Expenses - Research and development expenses decreased by $15.6 million for the three months ended March 31, 2022, compared to the same period in 2021, primarily due to a $10 million upfront license fee recognized in Q1 2021 that did not repeat[131]. - General and administrative expenses increased by $4.8 million for the three months ended March 31, 2022, compared to the same period in 2021, largely due to severance and stock-based compensation expenses[134]. - Sales and marketing expenses rose by $1.5 million for the three months ended March 31, 2022, compared to the same period in 2021, driven by severance and stock-based compensation expenses[138]. Cash Position and Funding - As of March 31, 2022, Avalo had $38.5 million in cash and cash equivalents and an accumulated deficit of $284.2 million[143]. - Management has expressed substantial doubt regarding the company's ability to continue as a going concern within one year due to uncertainty in obtaining additional funding[146]. - The company plans to use current cash along with potential dilutive and non-dilutive financings, federal and private grants, and strategic alliances to meet capital requirements[145]. - The company has not breached any covenants or received notices of default from lenders as of the filing date of the Quarterly Report[145]. - The company has no off-balance sheet arrangements as defined by SEC rules[154]. Strategic Focus - The company is focusing on advancing its pipeline programs, including AVTX-002 and AVTX-803, with expected pivotal data in Q4 2022[124]. - A cost reduction plan was approved to prioritize the development of promising programs, resulting in a reduction in workforce and related expenses[125]. - The company anticipates decreases in salary and stock-based compensation expenses beginning in Q2 2022 due to the cost reduction plan[126]. - The ultimate ability to achieve profitability will depend on the development and commercialization of pipeline assets and potential receipt of priority review vouchers[146]. - The company uses cash primarily to fund ongoing development of research and development pipeline assets and organizational infrastructure[147].
Avalo Therapeutics(AVTX) - 2020 Q3 - Quarterly Report
2020-11-09 21:35
Table of Contents Title of each class Trading Symbol Name of each exchange on which registered Common Stock, $0.001 par valueCERC Nasdaq Capital Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-37590 CERECOR INC. ...
Cerecor (CERC) Presents At Wedbush Pacgrow Healthcare Virtual Conference - Slideshow
2020-08-13 22:04
Pipeline Highlights - CERC-002 (anti-LIGHT mAb) is expected to deliver definitive topline POC data in Q4 2020 for COVID-19 ARDS [4] - CERC-007 (anti-IL-18 mAb) is expected to deliver initial data in multiple myeloma in 1Q 2021 and top line data in 2Q 2021, with initial data in Adult Onset Still's Disease (AOSD) by 2Q 2021 [4] - CERC-801 pivotal trial expected to start in 4Q 2020, with topline data expected in 4Q 2021 [4] - CERC-802 pivotal trial expected to start in 4Q 2020, with topline data expected in 3Q 2021 [4] - CERC-803 pivotal trial expected to start in 1H 2021, with topline data expected in 2H 2021 [4] - CERC-006 (dual mTOR inhibitor) initial data expected 2Q 2021 [4] CERC-007 (Anti-IL-18 mAb) in Multiple Myeloma and Adult Onset Still's Disease (AOSD) - Elevated IL-18 levels correlate with poor survival in multiple myeloma patients [15] - Patients with high IL-18 have significantly worse median survival (42 months vs >84 months, p value= 0.0026, HR = 1.84) [16] - Serum IL-18 correlates with disease severity in Adult Onset Still's Disease (AOSD) [19] CERC-006 (Dual mTOR Inhibitor) for Complex Lymphatic Malformations - Complex Lymphatic Malformations are orphan diseases with a combined US prevalence of 30,000 to 60,000, associated with high mortality rates of 20% to 50% over 3 to 7 years [27] CERC-002 (Anti-LIGHT mAb) for COVID-19 ARDS - Approximately 1,500 people in the United States die each day from COVID-19 [52] - In ventilated patients, LIGHT levels were higher in those patients that eventually died (93% mortality) than in those patients that recovered (20% mortality) [66] - In patients over 60, LIGHT levels were significantly higher in those that eventually died than in those patients that recovered (p=0.021), with an observed mortality rate of 82% compared to 32% in patients <60 years [69]
Avalo Therapeutics(AVTX) - 2020 Q2 - Quarterly Report
2020-08-06 11:36
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-37590 CERECOR INC. (Exact name of registrant as specified in its charter) 540 Gaither Road, Suite 400 Rockville, Maryland 20850 (Address of principal executi ...