AnaptysBio Announces First Quarter 2022 Financial Results and Provides Pipeline Update
- Top-line data from the ongoing imsidolimab (anti-IL-36R Ab) HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa is anticipated in Q3 2022
- Top-line data from the ongoing imsidolimab GEMINI-1 Phase 3 trial in GPP is anticipated in Q4 2023
- Top-line data from the ongoing rosnilimab (anti-PD-1 agonist Ab) AZURE Phase 2 trial in moderate-to-severe alopecia areata is anticipated in H1 2023
- Ended Q1 2022 with approximately
$596.8 millionin cash with anticipated 2022 net cash burn of $90to $100 million
“We are excited with our recently released Phase 1 trial results of ANB032, our anti-BTLA agonist, and the potential to broadly treat T and B-cell driven inflammatory diseases. Our recently initiated strategic portfolio review will define the path forward across a breadth of clinical development options of potential inflammation-focused indications that could be pursued for each of our clinical and preclinical therapeutic antibody programs,” said
Imsidolimab (Anti-IL-36 receptor) Program
- Imsidolimab, our investigational wholly owned anti-IL-36R therapeutic antibody, is in Phase 3 trials in generalized pustular psoriasis (GPP), and we anticipate top-line data from the GEMINI-1 Phase 3 clinical trial in Q4 2023.
- We anticipate top-line data from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in Q3 2022.
Rosnilimab (Anti-PD-1 agonist) Program
- Rosnilimab, our investigational wholly owned anti-PD-1 agonist therapeutic antibody, previously known as ANB030, is in the AZURE Phase 2 clinical trial in moderate-to-severe alopecia areata, and we anticipate top-line data in H1 2023.
ANB032 (Anti-BTLA agonist) Program
- Announced positive top-line phase 1 data in
April 2022of ANB032, our investigational wholly owned anti-BTLA agonist antibody, demonstrating favorable safety and tolerability with no dose limiting toxicities were observed and no serious adverse events (SAEs) reported.
- ANB032 pharmacokinetic analyses demonstrated a favorable profile including an approximate two-week half-life and Full BTLA receptor occupancy rapidly within hours and was maintained for greater than 30 days.
- ANB032 also demonstrated rapid and sustained target engagement on both T cells and B cells.
- We are advancing ANB032 with an IND filing for a Phase 2 clinical trial anticipated in H2 2022.
First Quarter Financial Results
- Cash, cash equivalents and investments totaled
$596.8 millionas of March 31, 2022, compared to $615.2 millionas of December 31, 2021, for a decrease of $18.4 million. The decrease relates primarily to cash used for operating activities offset by cash received from stock option exercises.
- Collaboration revenue was
$1.0 millionfor the three months ended March 31, 2022, compared to $11.2 millionfor the three months ended March 31, 2021. The decrease relates primarily to one milestone achieved for JEMPERLI in the first quarter of 2021 for $10.0 million, and no milestones achieved in the first quarter of 2022.
- Research and development expenses were
$22.5 millionfor the three months ended March 31, 2022, compared to $24.2 millionfor the three months ended March 31, 2021. The decrease was due primarily to reduced imsidolimab manufacturing costs offset by increased costs for the Company’s clinical programs. The R&D non-cash, stock-based compensation expense was $1.7 millionfor the three months ended March 31, 2022as compared to $1.2 millionin the same period in 2021.
- General and administrative expenses were
$10.2 millionfor the three months ended March 31, 2022, compared to $5.4 millionfor the three months ended March 31, 2021. The increase was due primarily to $3.8 millionof costs incurred for our former President and CEO’s resignation in the first quarter of 2022. The G&A non-cash, stock-based compensation expense was $6.1 millionfor the three months ended March 31, 2022which includes $3.2 millionof the $3.8 millionone-time costs described earlier as compared to $2.1 millionin the same period in 2021.
- Net loss was
$36.3 millionfor the three months ended March 31, 2022, or a net loss per share of $1.31, compared to a net loss of $18.2 millionfor the three months ended March 31, 2021, or a net loss per share of $0.66.
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibodies focused on unmet medical needs in inflammation. The Company’s proprietary anti-inflammatory pipeline includes imsidolimab, its anti-IL-36R antibody, previously referred to as ANB019, for the treatment of dermatological inflammatory diseases, including generalized pustular psoriasis, or GPP, and moderate-to-severe hidradenitis suppurativa; rosnilimab, its anti-PD-1 agonist program, previously referred to as ANB030, for the treatment of moderate-to-severe alopecia areata; and its anti-BTLA agonist program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. 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 collaboration with GSK, including an anti-PD-1 antagonist antibody (JEMPERLI (dostarlimab-gxly) GSK4057190), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).
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 3 clinical trial in GPP, Phase 2 clinical trial in hidradenitis suppurativa, and rosnilimab’s Phase 2 clinical trial in alopecia areata; and the timing of ANB032’s IND filing for a Phase 2 clinical trial; and our projected use of our cash resources. 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||$||166,412||$||495,729|
|Receivables from collaborative partners||921||876|
|Prepaid expenses and other current assets||5,869||4,903|
|Total current assets||512,411||553,876|
|Property and equipment, net||2,162||2,283|
|Operating lease right-of-use assets||19,147||19,558|
|Other long-term assets||256||256|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current portion of operating lease liability||1,537||1,505|
|Total current liabilities||19,781||16,099|
|Liability related to sale of future royalties||255,584||251,093|
|Operating lease liability, net of current portion||19,059||19,450|
|Additional paid in capital||691,161||678,575|
|Accumulated other comprehensive loss||(2,434||)||(422||)|
|Total stockholders’ equity||330,747||356,428|
|Total liabilities and stockholders’ equity||$||625,171||$||643,070|
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
|Three Months Ended
|Research and development||22,516||24,185|
|General and administrative||10,203||5,423|
|Total operating expenses||32,719||29,608|
|Loss from operations||(31,749||)||(18,361||)|
|Other income (expense), net:|
|Non-cash interest expense for the sale of future royalties||(4,854||)||—|
|Other income, net||6||3|
|Total other income (expense), net||(4,506||)||198|
|Unrealized loss on available for sale securities||(2,012||)||(107||)|
|Net loss per common share:|
|Basic and diluted||$||(1.31||)||$||(0.66||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||27,713||27,361|
Source: AnaptysBio, Inc.