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SAN DIEGO, Aug. 08, 2019 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today reported operating results for the second quarter ended June 30, 2019 and provided pipeline updates.
“In the first half of 2019, we’ve made significant progress across our entire clinical and preclinical pipeline toward achieving our mission of bringing novel treatments to patients with severe inflammatory diseases,” said Hamza Suria, president and chief executive officer of AnaptysBio. “With multiple data readouts from our etokimab and ANB019 clinical trials, and an IND planned for ANB030, the remainder of 2019 is set to be an important period for AnaptysBio.”
Etokimab (ANB020 Anti-IL-33) Program
ANB019 (Anti-IL-36 Receptor) Program
ANB030 (Anti-PD-1 Agonist) Program
Second Quarter Financial Results
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is conducting its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in approximately 300 moderate-to-severe adult atopic dermatitis patients where top-line data is anticipated in the fourth quarter of 2019. The Company is conducting its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with interim top-line data anticipated in the fourth quarter of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in the fourth quarter of 2019.
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP. AnaptysBio has previously presented data from a Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that supported advancement of ANB019 into Phase 2 studies. AnaptysBio is conducting its GALLOP trial, a Phase 2 study of ANB019 in GPP where interim top-line data is anticipated in mid-2019, and its POPLAR trial, a Phase 2 study in PPP where top-line data is anticipated in the first half of 2020.
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of moderate-to-severe atopic dermatitis, eosinophilic asthma, and adult chronic rhinosinusitis with nasal polyps, or CRSwNP; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP; and its PD-1 agonist program, ANB030, and other novel anti-inflammatory checkpoint receptor modulator antibodies for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation, or SHM platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO, a GSK company, including an anti-PD-1 antagonist antibody (dostarlimab (TSR-042)), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), and an inflammation partnership with Celgene, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including etokimab’s Phase 2b clinical trial in moderate-to-severe adult atopic dermatitis patients, etokimab’s Phase 2 clinical trial in adult patients with chronic rhinosinusitis with nasal polys and ANB019’s Phase 2 clinical trials in GPP and PPP, the timing of and our ability to launch a Phase 2b clinical trial of etokimab in eosinophilic asthma patients, and the timing of an IND filing for ANB030, a new wholly-owned anti-inflammatory antibody program. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except par value data)|
|June 30, 2019||December 31, 2018|
|Cash and cash equivalents||$||146,552||$||113,596|
|Receivable from collaborative partners||5,000||—|
|Australian tax incentive receivable||—||174|
|Prepaid expenses and other current assets||3,772||6,960|
|Total current assets||430,988||434,216|
|Property and equipment, net||1,481||1,445|
|Other long-term assets||1,913||148|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Notes payable, current portion||4,781||7,574|
|Other current liabilities||819||58|
|Total current liabilities||30,623||21,836|
|Other long-term liabilities||1,105||796|
|Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at June 30, 2019 and December 31, 2018, respectively||—||—|
|Common stock, $0.001 par value, 500,000 shares authorized, 27,045 shares and 26,922 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively||27||27|
|Additional paid in capital||640,550||633,251|
|Accumulated other comprehensive income (loss)||574||(223||)|
|Total stockholders’ equity||448,421||486,365|
|Total liabilities and stockholders’ equity||$||480,149||$||508,997|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except per share data)|
Three Months Ended
Six Months Ended
|Research and development||27,350||10,583||47,981||22,393|
|General and administrative||4,307||3,832||8,448||7,779|
|Total operating expenses||31,657||14,415||56,429||30,172|
|Loss from operations||(26,657||)||(14,415||)||(51,429||)||(30,172||)|
|Other income (expense), net:|
|Other income (expense), net||(41||)||(64||)||(34||)||(127||)|
|Total other income (expense), net||2,635||797||5,310||1,468|
|Loss before income taxes||(24,022||)||(13,618||)||(46,119||)||(28,704||)|
|Provision for income taxes||60||—||79||—|
|Other comprehensive income (loss):|
|Unrealized income (loss) on available for sale securities, net of tax of $99, $0, $214 and $0, respectively||370||124||797||(250||)|
|Other comprehensive income (loss), net of tax||$||370||$||124||$||797||$||(250||)|
|Net loss per common share:|
|Basic and diluted||$||(0.89||)||$||(0.57||)||$||(1.70||)||$||(1.20||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||27,026||23,932||27,004||23,867|