AnaptysBio Announces Third Quarter 2018 Financial Results and Provides Pipeline Updates
- Reported positive top-line data from an interim analysis of its ongoing Phase 2a proof-of-concept clinical trial of etokimab in severe eosinophilic asthma
- Initiated Phase 2 ECLIPSE trial of etokimab in chronic rhinosinusitis with nasal polyps and Phase 2 POPLAR trial of ANB019 in palmo-plantar pustulosis
- Four top-line clinical efficacy readouts from wholly-owned pipeline anticipated in 2019
“We continued to advance the clinical development of our wholly-owned etokimab and ANB019 programs for severe inflammatory disease indications during the third quarter of 2018,” said Hamza Suria, president and chief executive officer of
Etokimab (ANB020 Anti-IL-33 Program)
- In September, the Company announced positive topline proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in an ongoing single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second, or FEV1, which is a measure of lung function, with an eight percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11 percent increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31 percent reduction at Day 2 and a 46 percent reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis. This Phase 2a trial is currently ongoing and the company plans to report full data from this trial at a medical conference in 2019 following trial completion. AnaptysBio plans to continue development of etokimab in eosinophilic asthma with a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial, which is expected to be initiated in 2019.
- The Company is enrolling a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adult patients with moderate-to-severe atopic dermatitis, also referred to as the ATLAS clinical trial, to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab for a 16-week treatment period followed by an eight-week monitoring period, with data expected in the second half of 2019.
- The Company has cleared an IND and initiated a randomized, placebo-controlled Phase 2 trial, also referred to as the ECLIPSE trial, in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps. Patients will be treated with two multi-dosing frequencies of subcutaneous-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy, for a treatment period of 16 weeks followed by an eight-week monitoring period. The Company anticipates top-line data from the ECLIPSE trial will be available in the second half of 2019.
ANB019 (Anti-IL-36 Receptor Program)
AnaptysBiohas initiated a 10-patient, single arm, open-label Phase 2 trial of ANB019 in generalized pustular psoriasis, or GPP, also known as the GALLOP trial, and top-line data are anticipated in mid-2019. All patients will be treated with an intravenous loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019 for a treatment period of up to 16 weeks post enrollment and followed by an eight-week monitoring period. AnaptysBiohas cleared an IND with the FDAand has initiated a randomized, placebo-controlled 50-patient multi-dose Phase 2 trial in palmoplantar pustulosis, or PPP, also known as the POPLAR trial, where top line data are anticipated in the second half of 2019. Patients will be treated with a (i) a subcutaneously-administered loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019, or (ii) placebo, each for a treatment period of 16 weeks post enrollment and followed an eight-week monitoring period.
September 28, 2018, the Company completed an underwritten public offering of 2,530,000 shares of common stock at a price to the public of $94.46, which included the exercise by the underwriters of their option to purchase an additional 330,000 shares of common stock. AnaptysBio, received net proceeds from the offering of $227.5 million, after deducting underwriting discounts and commissions.
Third Quarter Financial Results
- Cash, cash equivalents and investments totaled
$512.4 millionas of September 30, 2018 compared to $324.3 millionas of December 31, 2017, for an increase of $188.1 million. The increase primarily relates to net proceeds received by the Company of $227.5 millionfrom the public offering, offset by operating cash outflow for clinical and manufacturing related expenses, as well as personnel costs.
- Collaboration revenue was
$5.0 millionfor the three and nine months ended September 30, 2018related to a milestone for the first Phase 3 trial of TSR-042 by TESAROcompared to no revenue and $7.0 millionfor two TESAROmilestones for the three and nine months ended September 30, 2017, respectively.
- Research and development expenses were
$17.9 millionfor the three months ended September 30, 2018, as compared to $6.7 millionfor the three months ended September 30, 2017. The increase was primarily due to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses including share based compensation during the three months ended September 30, 2018.
- General and administrative expenses were
$4.0 millionfor the three months ended September 30, 2018, as compared to $2.4 millionfor the three months ended September 30, 2017. The increase was primarily attributable to additional personnel-related expenses, including share based compensation, to support the Company’s growth.
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 enrolling its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where data is anticipated in the second half of 2019. The company has also initiated its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with data anticipated in the second half 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 2019.
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which
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 2a clinical trial in severe adult eosinophilic asthma patients, 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, and the timing of and our ability to launch a Phase 2b clinical trial of etokimab in eosinophilic asthma patients, and the success of our partnership with
CONSOLIDATED BALANCE SHEETS
(in thousands, except par value data)
|September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||293,408||$||81,189|
|Receivable from collaborative partners||5,000||—|
|Australian tax incentive receivable||173||1,601|
|Prepaid expenses and other current assets||4,035||2,688|
|Total current assets||503,022||252,696|
|Property and equipment, net||1,344||665|
|Other long-term assets||79||46|
|LIABILITIES, PREFERRED STOCK AND
|Notes payable, current portion||7,500||6,875|
|Other current liabilities||48||17|
|Total current liabilities||20,873||14,090|
|Notes payable, net of current portion||2,409||7,553|
|Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at September 30, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.001 par value, 500,000 shares authorized, 26,749 shares and 23,791 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively||27||24|
|Additional paid in capital||629,887||393,017|
|Accumulated other comprehensive loss||(541||)||(426||)|
|Total stockholders’ equity||499,677||307,581|
|Total liabilities, preferred stock and stockholders’ equity||$||523,121||$||329,364|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|Three Months Ended
|Nine Months Ended
|Research and development||17,883||6,697||40,276||21,837|
|General and administrative||4,004||2,390||11,783||6,793|
|Total operating expenses||21,887||9,087||52,059||28,630|
|Loss from operations||(16,887||)||(9,087||)||(47,059||)||(21,630||)|
|Other income (expense), net:|
|Change in fair value of liability for preferred stock warrants||—||—||—||(1,366||)|
|Other income (expense), net||(40||)||91||(167||)||344|
|Total other income (expense), net||929||(3||)||2,397||(1,579||)|
|Unrealized income (loss) on available for sale securities||136||16||(115||)||(43||)|
|Other comprehensive income (loss)||136||16||(115||)||(43||)|
|Net loss per common share:|
|Basic and diluted||$||(0.66||)||$||(0.45||)||$||(1.86||)||$||(1.24||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||24,146||20,382||23,961||18,668|
Source: AnaptysBio, Inc.