AnaptysBio Announces Fourth Quarter and Full Year 2017 Financial Results and 2018 Pipeline Milestones
ANB020 Top-Line Phase 2a Readouts Anticipated For Peanut Allergy in
ANB019 GPP and PPP Phase 2 Studies to be Initiated During 2018
“AnaptysBio made significant progress on multiple program and corporate milestones during 2017,” said Hamza Suria, president and chief executive officer of
ANB020 (Anti-IL-33 Program)
October 2017, the Company reported positive proof-of-concept data for ANB020, its potentially first-in-class anti-IL-33 therapeutic antibody, from a Phase 2a clinical trial in adult patients with moderate-to-severe atopic dermatitis. In February 2018, AnaptysBioreported positive updated data upon completion of this clinical trial during an oral presentation at the American Academy of DermatologyAnnual Meeting. The Company plans to initiate a Phase 2b randomized, double-blinded, placebo-controlled study in 200-300 adult patients with moderate-to-severe atopic dermatitis to evaluate different dose levels and dosing frequencies of subcutaneous administration of ANB020 in the first half of 2018, with data expected in 2019.
- Completed enrollment in the company’s ongoing Phase 2a double-blinded, placebo-controlled trial assessing the tolerance of oral food challenge before and after administration of a single dose of ANB020 or placebo in a total of 20 adult patients with severe peanut allergy. Top-line data are expected in
- Currently enrolling the company’s ongoing double-blinded, placebo-controlled Phase 2a trial in 24 adult patients with severe eosinophilic asthma, where efficacy will be assessed using improvement in Forced Expiratory Volume in
One Secondafter administration of a single dose of ANB020 or placebo. Top-line data are expected in the second quarter of 2018.
ANB019 (Anti-IL-36 Receptor Program)
November 2017, AnaptysBioannounced positive top-line results from an interim analysis of an ongoing single and multiple ascending dose healthy volunteer Phase 1 trial of ANB019, its potentially first-in-class anti-interleukin-36 receptor, or IL-36R therapeutic antibody. Top-line data showed favorable safety, pharmacokinetics and pharmacodynamic properties that support advancement of ANB019 into Phase 2 studies for GPP and PPP which the Company plans to initiate during 2018. The Company submitted a Clinical Trial Authorization, or CTA, filing with the U.K. Medicines and Healthcare Products Regulatory Agency, or MHRA, supporting the initiation of a 10-patient open-label multi-dose Phase 2 study of ANB019 in GPP patients and anticipates filing additional regulatory applications to support the initiation of a randomized placebo-controlled multi-dose study of ANB019 in PPP.
- Completed Public Offering and Follow-on Offering - In
January 2017, the Company completed an initial public offering of 5,750,000 shares of its common stock at a public offering price of $15.00per share, which includes the exercise in full by the underwriters of their option to purchase an additional 750,000 shares of common stock. AnaptysBioreceived net proceeds from the offering of $80.2 million, after deducting underwriting discounts and commissions. In October 2017, the Company completed an underwritten follow-on public offering selling a total of 3,271,380 shares of common stock at a price to the public of $68.50per share, which includes the exercise by the underwriters of their option to purchase an additional 271,380 shares of common stock in November 2017. AnaptysBio, received net proceeds from the offering of $212.3 million, after deducting underwriting discounts and commissions.
- Strengthened Board Leadership - In
August 2017, the company appointed J. Anthony Ware, M.D. to its board of directors. Dr. Ware served as the senior vice president of product development of Lilly Bio-Medicines at Eli Lilly and Company, where he was responsible for the clinical development and regulatory approval of new medicines in multiple therapeutic areas. In March 2018, the company appointed Dr. Dennis Fentonto its board of directors. From 1982 until his retirement in 2008, Dr. Fenton worked at Amgen, where he held positions of increasing responsibility, including Vice President of Research, Senior Vice President of Sales and Marketing, Senior Vice President of Operations and Executive Vice President.
Fourth Quarter and Year-End 2017 Financial Results
- Cash, cash equivalents and investments totaled
$324.3 millionas of December 31, 2017, which includes net proceeds of $292.5 millionfrom the Company’s underwritten public offerings, compared to $51.2 millionas of December 31, 2016.
- Revenue was
$3.0 millionand $10.0 millionfor the quarter and year ended December 31, 2017, which related to milestones earned from the Company’s partnership with TESARO, compared to $2.8 millionand $16.7 millionfor the quarter and year ended December 31, 2016 which related to the amortization of the upfront payment from TESARO, research and development services reimbursed by TESAROand milestone-related revenues from TESAROand Celgene.
- Research and development expenses were
$7.6 millionand $29.4 millionfor the quarter and year ended December 31, 2017, as compared to $5.0 millionand $15.4 millionfor the quarter and year ended December 31, 2016. The increase was primarily due to continued advancement of the Company’s ANB020 and ANB019 clinical programs offset by the recognition of lower research and development tax incentives in the year ended December 31, 2017.
- General and administrative expenses were
$2.5 millionand $9.3 millionfor the quarter and year ended December 31, 2017, as compared to $0.9 millionand $4.3 millionfor the quarter and year ended December 31, 2016. The increase was attributable to additional personnel-related expenses and an increase in public company related expenses to support the company's growth.
2018 Financial Guidance
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including ANB020’s Phase 2a trials in severe adult peanut allergy patients and severe adult eosinophilic asthma patients, and Phase 2b clinical trial in moderate-to-severe adult atopic dermatitis patients; our ability to launch a Phase 2b clinical trial of ANB020 in moderate-to-severe adult atopic dermatitis patients and Phase 2 clinical trials of ANB019 in GPP and PPP; and the success of our partnership with
THRUST Investor Relations
|CONSOLIDATED BALANCE SHEETS|
|(in thousands, except par value data)
|December 31, 2017||December 31, 2016|
|Cash and cash equivalents||$||81,189||$||51,232|
|Receivable from collaborative partners||—||1,225|
|Australian tax incentive receivable||1,601||4,118|
|Prepaid expenses and other current assets||2,688||1,633|
|Total current assets||252,696||58,208|
|Property and equipment, net||665||471|
|Long-term vendor deposits||46||—|
|Deferred financing costs||—||3,441|
|LIABILITIES, CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY (DEFICIT)
|Notes payable, current portion||6,875||—|
|Other current liabilities||17||1|
|Total current liabilities||14,090||5,708|
|Notes payable, net of current portion||7,553||13,809|
|Preferred stock warrant liabilities||—||3,241|
|Commitments and contingencies|
|Series B convertible preferred stock, $0.001 par value, no shares and 3,963 authorized, issued and
outstanding at December 31, 2017 and December 31, 2016, respectively
|Series C convertible preferred stock, $0.001 par value, no shares and 1,887 shares authorized, no
shares and 1,593 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively
|Series C-1 convertible preferred stock, $0.001 par value, no shares and 474 shares
authorized, issued and outstanding at December 31, 2017 and December 31, 2016, respectively
|Series D convertible preferred stock, $0.001 par value, no shares and 5,491 shares authorized,
issued and outstanding at December 31, 2017 and December 31, 2016, respectively
|Stockholders’ equity (deficit):|
|Preferred stock, $0.001 par value, 10,000 shares and no shares authorized, issued or outstanding at
December 31, 2017 and December 31, 2016, respectively
|Common stock, $0.001 par value, 500,000 and 17,214 authorized, 23,791 shares and 2,651
shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively
|Additional paid in capital||393,017||16,672|
|Accumulated other comprehensive loss||(426||)||—|
|Total stockholders’ equity (deficit)||307,581||(38,248||)|
|Total liabilities, convertible preferred stock and stockholders’ equity (deficit)||$||329,364||$||62,180|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS|
|(in thousands, except per share data)|
|Three Months Ended
|Research and development||7,606||5,016||29,443||15,419|
|General and administrative||2,545||912||9,338||4,290|
|Total operating expenses||10,151||5,928||38,781||19,709|
|Loss from operations||(7,151||)||(3,174||)||(28,781||)||(3,025||)|
|Other income (expense), net|
|Change in fair value of liability for preferred stock warrants||—||(1,091||)||(1,366||)||(756||)|
|Other income (expense), net||(116||)||(231||)||229||(147||)|
|Total other income (expense), net||290||(1,404||)||(1,289||)||(1,234||)|
|Unrealized loss on available for sale securities||(383||)||—||(426||)||—|
|Other comprehensive loss||(383||)||—||(426||)||—|
|Net loss per common share:|
|Basic and diluted||$||(0.30||)||$||(1.73||)||$||(1.52||)||$||(1.62||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||23,089||2,647||19,782||2,637|
Source: AnaptysBio, Inc.