AnaptysBio Announces First Quarter 2020 Financial Results and Provides Pipeline Updates
- Interim Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Anticipated in Third Quarter of 2020, Decided to Over-Enroll Trial Due to COVID-19
- Additional Topline Data from GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis on Track for Second Half of 2020
- Topline Data from POPLAR Phase 2 Clinical Trial of ANB019 Monotherapy in Palmoplantar Pustulosis on Track for Second Half of 2020
- IND Cleared For Company’s Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, and Phase 1 Trial Initiation Anticipated in First Half of 2020
- US BLA and
EU MAAfor Dostarlimab, Our PD-1 Antagonist Antibody Partnered With GlaxoSmithKline (GSK), in Endometrial Cancer Accepted by the FDA and the EMA, Respectively
“Our wholly-owned pipeline continues to advance with three Phase 2 clinical trial readouts anticipated in the remainder of 2020,” said
Etokimab (ANB020 Anti-IL-33) Program
AnaptysBiois conducting a randomized, placebo-controlled Phase 2 trial in 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. We have over-enrolled this trial beyond the first 100 patients to compensate for lost patient visits due to the COVID-19 pandemic, and hence anticipate interim top-line data from this trial to be available in the third quarter of 2020.
- As previously announced, the Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until results are available from the ECLIPSE trial.
ANB019 (Anti-IL-36 Receptor) Program
- In September,
AnaptysBioannounced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis, or GPP, also known as the GALLOP trial. In this interim analysis, both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy, demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113, and showed complete clearance of skin pustules by Day 8 and through Day 113, with CRP levels decreasing to nearly normal. The Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during the second half of 2020.
- The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the second half of 2020.
- Enrollment of the GALLOP and POPLAR trials has been enhanced by expanding clinical sites and geographies involved. While the Company does not believe that the aforementioned timelines are materially impacted by the COVID-19 pandemic at this point, some of the sites involved in the GALLOP and POPLAR trials have been affected by the COVID-19 pandemic, and the Company will continue to monitor the situation over the upcoming months.
ANB030 (Anti-PD-1 Agonist) Program
- ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented. Our Investigational New Drug Application (IND) for ANB030 has been cleared by the FDA and we plan to initiate a Phase 1 clinical trial in the first half of 2020. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.
ANB032 (Anti-BTLA Modulator) Program
- Our fourth wholly-owned program is an anti-BTLA modulator antibody, known as ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. Mutations in the BTLA signaling pathway are associated with human inflammatory disease and we believe ANB032 silences pro-inflammatory signaling by modulating BTLA binding to HVEM. We anticipate filing an IND for ANB032 in the second half of 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK
- In the first quarter of 2020, the FDA accepted the first Biologics License Application (BLA) filing for dostarlimab, an
AnaptysBio-generated PD-1 antagonist antibody under partnership with GSK, for the treatment of endometrial cancer. AnaptysBioreceived a $10.0 millioncash milestone payment upon this acceptance, and anticipates an additional $20.0 millioncash milestone upon first FDA approval of dostarlimab during 2020. Also in the first quarter of 2020, the EMA accepted GSK’s Marketing Authorization Application (MAA) for approval of dostarlimab in the EU for endometrial cancer, for which AnaptysBiohas earned a $5.0 millionmilestone payment. Including additional cash milestones due upon future development and commercialization of dostarlimab, TSR-022, an AnaptysBio-generated TIM-3 antibody, and TSR-033, an AnaptysBio-generated LAG-3 antibody, AnaptysBiocan potentially receive a total of $1.1 billionin aggregate milestone payments under this GSK partnership. In addition, AnaptysBiois due a 4% to 8% royalty from GSK, tiered upon global sales, for each of the aforementioned programs.
First Quarter Financial Results
- Cash, cash equivalents and investments totaled
$412.7 millionas of March 31, 2020compared to $428.5 millionas of December 31, 2019, for a decrease of $15.8 million. The decrease relates primarily to cash used for operating activities.
- Collaboration revenue was
$15.0 millionfor the three months ended March 31, 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab, compared to zero for the three months ended March 31, 2019.
- Research and development expenses were
$21.0 millionfor the three months ended March 31, 2020, compared to $20.6 millionfor the three months ended March 31, 2019. The increase was due primarily to continued advancement of the Company’s preclinical programs.
- General and administrative expenses were
$4.3 millionfor the three months ended March 31, 2020, compared to $4.1 millionfor the three months ended March 31, 2019. The increase was due primarily to personnel-related expenses, including share-based compensation.
- Net loss was
$8.3 millionfor the three months ended March 31, 2020, or a net loss per share of $0.30, compared to a net loss of $22.1 millionfor the three months ended March 31, 2019, or a net loss per share of $0.82.
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 2 clinical trial in adult patients with CRSwNP 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, the timing of a regulatory strategy update for GPP, the timing of initiation of a Phase 1 clinical trial for ANB030, the timing of an IND filing for ANB032, the milestones and royalty payments to be received under the GSK partnership, and our projected 2020 cash burn and cash runway. 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
CONSOLIDATED BALANCE SHEETS
(in thousands, except par value)
|Cash and cash equivalents||$||165,317||$||171,017|
|Receivable from collaborative partners||5,000||—|
|Prepaid expenses and other current assets||3,572||3,506|
|Total current assets||371,055||377,733|
|Property and equipment, net||1,610||1,618|
|Other long-term assets||1,293||1,481|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Notes payable, current portion||—||1,375|
|Other current liabilities||898||871|
|Total current liabilities||23,250||29,535|
|Other long-term liabilities||419||654|
|Additional paid in capital||651,680||648,669|
|Accumulated other comprehensive income||1,145||338|
|Total stockholders’ equity||400,564||405,008|
|Total liabilities and stockholders’ equity||$||424,233||$||435,197|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|Three Months Ended
|Research and development||20,968||20,631|
|General and administrative||4,285||4,141|
|Total operating expenses||25,253||24,772|
|Loss from operations||(10,253||)||(24,772||)|
|Other income (expense), net:|
|Other income, net||94||7|
|Total other income (expense), net||1,991||2,675|
|Loss before income taxes||(8,262||)||(22,097||)|
|Provision for income taxes||—||19|
|Other comprehensive income:|
|Unrealized income on available for sale securities, net of tax of
|Net loss per common share:|
|Basic and diluted||$||(0.30||)||$||(0.82||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||27,264||26,981|
Source: AnaptysBio, Inc.