AnaptysBio Announces Third Quarter 2020 Financial Results and Provides Pipeline Updates
- Positive topline data from GALLOP Phase 2 clinical trial of imsidolimab in moderate to severe Generalized Pustular Psoriasis (GPP) announced in
- FDA end-of-Phase 2 meeting anticipated in Q4 2020 to outline registration path of imsidolimab for the treatment of GPP, in accordance with the orphan drug designation obtained in
- POPLAR Phase 2 clinical trial of imsidolimab monotherapy in palmoplantar pustulosis (PPP) fully enrolled and topline data anticipated in Q1 2021
- Expansion of imsidolimab program into two new clinical indications, EGFRi-mediated skin toxicities and ichthyosis, with Phase 2 trials to be initiated in Q4 2020
- US BLA approval for dostarlimab, our PD-1 antagonist antibody partnered with GlaxoSmithKline (GSK), anticipated for endometrial cancer in Q4 2020, resulting in payment of
$20 millionof the $75 millionin FDA BLA and EMA MAAregulatory milestone payments anticipated in upcoming 18 months
- Amended strategic immuno-oncology collaboration with GlaxoSmithKline to increase dostarlimab royalties, add ZejulaTM royalty effective
January 2021and receive additional $60 millioncash in Q4 2020
“We are excited with the recent interim results from our GALLOP trial and look forward to engaging with regulatory authorities to progress imsidolimab into registration trials for the treatment of GPP,” said
Imsidolimab (Anti-IL-36 Receptor) Program
- In July, we announced that the
U.S. Food and Drug Administration(FDA) has granted orphan drug designation for imsidolimab, our proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP. Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial.
- Patients demonstrated rapid onset, overall safety and promising efficacy upon imsidolimab monotherapy in a Day 29 interim analysis of our GALLOP Phase 2 GPP trial. Six of 8 patients achieved the primary endpoint of disease improvement upon Day 29, while erythema with skin pustules, which clinically defines GPP, decreased by 94% on Day 29 relative to baseline.
- An end-of-Phase 2 meeting, based upon data available from the 8 patients enrolled in the GALLOP trial, is anticipated in Q4 2020.
- We are also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in approximately 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, which is now fully enrolled with topline data anticipated in Q1 2021.
- We anticipate expanding the imsidolimab program in two new indications, EGFR-mediated skin toxicities and ichthyosis, based upon human translational data that suggests each of these conditions are mediated by dysregulated signaling through the IL-36 pathway. Initiation of Phase 2 trials for each of these indications is anticipated in Q4 2020.
- Worldwide registry of GPP and PPP patients, named RADIANCE, to be initiated in Q1 2021, to improve understanding of the patient journey and support enrollment of future trials.
ANB030 (Anti-PD-1 Agonist) Program
- We anticipate topline data from our ongoing Phase 1 healthy volunteer clinical trial of ANB030, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of ANB030 in single and multiple ascending dose cohorts in mid-2021. Preclinical translational data using ANB030 was presented in
March 2020at the Festival of Biologics Meeting.
ANB032 (Anti-BTLA Modulator) Program
- We anticipate filing an investigational new drug application (IND) for ANB032, our wholly-owned BTLA modulator antibody, in Q4 2020. We presented preclinical data regarding ANB032 at the 2020
Federation of Clinical Immunology Societies (FOCIS) VirtualAnnual Meeting in October 2020.
Etokimab (ANB020 Anti-IL-33) Program
- In an interim analysis at week 8 of the ongoing ECLIPSE Phase 2 trial of etokimab in chronic rhinosinusitis with nasal polyps, patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant improvement in their bilateral nasal polyps score (NPS), an endoscopic measure of nasal occlusion, and their sino-nasal outcome test (SNOT-22), a patient reported quality-of-life assessment, versus placebo at the week 8 timepoint. Both endpoints demonstrated statistically significant improvement over baseline levels of NPS and SNOT-22. Blood eosinophil levels, which are a biomarker of etokimab’s mechanism, demonstrated statistically significant reduction relative to baseline in both etokimab treatment arms. We intend to decide on a path forward for the etokimab program after reviewing week 16 primary endpoint data by year-end 2020.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK
October 2020, we amended our immuno-oncology collaboration with GSK resulting in increased financial consideration to AnaptysBio. Royalties due to AnaptysBiofor dostarlimab were increased to 8-25% of global net sales, where AnaptysBiowill receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. The $1.1 billionin cash milestone payments due under the collaboration agreement remain unchanged, and AnaptysBioanticipates receiving $75 millionin such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 millionin sales milestones is anticipated by AnaptysBioupon achievement of certain dostarlimab annual sales revenues. GSK has also agreed, starting January 1, 2021, to pay AnaptysBioa 1% royalty on all of GSK’s global net sales of Zejula™. In addition, GSK has agreed to pay AnaptysBioa one-time cash payment of $60 millionwithin 30 days. In exchange, AnaptysBiohas provided GSK with freedom to conduct development and commercialization of Zejula™ in combination with third-party molecules and settled the ongoing legal dispute between AnaptysBioand GSK.
Third Quarter Financial Results
Cash, cash equivalents and investments totaled
Collaboration revenue was zero and
Research and development expenses were
General and administrative expenses were
Net loss was
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 imsidolimab’s Phase 2 clinical trial in PPP; the timing of initiation of imsidolimab’s Phase 2 clinical trials in EGFRi and ichthyosis; and etokimab’s week 16 data for the ECLIPSE Phase 2 clinical trial in chronic rhinosinusitis with nasal polyps; the timing of an end-of-Phase 2 meeting with the FDA for GPP; the timing of an IND filing for ANB032; the milestones and royalty payments to be received under the GSK collaboration; 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 data)
|Cash and cash equivalents||$||209,154||$||171,017|
|Prepaid expenses and other current assets||7,468||3,506|
|Total current assets||345,814||377,733|
|Property and equipment, net||1,585||1,618|
|Other long-term assets||1,114||1,481|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Notes payable, current portion||—||1,375|
|Other current liabilities||851||871|
|Total current liabilities||24,474||29,535|
|Other long-term liabilities||33||654|
|Additional paid-in capital||657,560||648,669|
|Accumulated other comprehensive income||259||338|
|Total stockholders’ equity||360,243||405,008|
|Total liabilities and stockholders’ equity||$||384,750||$||435,197|
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
|Three Months Ended
||Nine Months Ended
|Research and development||19,542||29,931||58,458||77,912|
|General and administrative||4,794||3,814||13,766||12,262|
|Total operating expenses||24,336||33,745||72,224||90,174|
|Loss from operations||(24,336||)||(33,745||)||(57,224||)||(85,174||)|
|Other income (expense), net:|
|Other (expense) income, net||(56||)||144||64||110|
|Total other income (expense), net||569||2,661||3,647||7,971|
|Loss before income taxes||(23,767||)||(31,084||)||(53,577||)||(77,203||)|
|Provision for income taxes||—||51||—||130|
|Other comprehensive (loss) income:|
|Unrealized (loss) income on available for sale securities, net of tax of
|Net loss per common share:|
|Basic and diluted||$||(0.87||)||$||(1.15||)||$||(1.96||)||$||(2.85||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||27,316||27,058||27,286||27,022|
Source: AnaptysBio, Inc.