SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report: February 28, 2018
(Date of earliest event reported)
(Exact Name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
10421 Pacific Center Court, Suite 200
San Diego, CA
(Address of Principal Executive Offices)
(Registrant’s Telephone Number, Including Area Code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8‑K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12)
⃞ Pre‑commencement communications pursuant to Rule 14d‑2(b) under the Exchange Act (17 CFR 240.14d‑2(b))
⃞ Pre‑commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act (17 CFR 240.13e‑4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 2.02 Results of Operations and Financial Condition.
On March 5, 2018, AnaptysBio, Inc. (“AnaptysBio”) issued a press release announcing its financial results for the quarter and year ended December 31, 2017. A copy of the press release is attached as Exhibit 99.01 to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibit 99.01 to this Current Report on Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the accompanying Exhibit 99.01 shall not be incorporated by reference into any registration statement or other document filed by AnaptysBio with the Securities and Exchange Commission, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in such filing (or any reference to this Current Report on Form 8-K generally), except as shall be expressly set forth by specific reference in such filing.
Item 5.02 Departure of Directors or Certain Officers; Election Of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On February 28, 2018, Carol G. Gallagher, Pharm. D. advised the Board of Directors (the “Board”) of AnaptysBio, Inc. (“AnaptysBio”) that she would resign as a Class I independent director of AnaptysBio and as a member of the audit and compensation committees of the Board, effective at 5:00 p.m. pacific time on March 5, 2018 (the “Resignation Time”). Ms. Gallagher’s resignation is not the result of any disagreement with AnaptysBio on any matter relating to its operations, policies or practices. Following Ms. Gallagher’s resignation, J. Anthony Ware, M.D. was appointed to the audit committee and Dennis Fenton, Ph.D., was appointed to the compensation committee.
Effective on March 5, 2018 immediately after the Resignation Time, the Board elected Dennis Fenton, Ph.D., to fill the vacancy on the Board created by Ms. Gallagher’s resignation as a Class I director. Dr. Fenton shall hold office for a term expiring at the 2018 Annual Meeting of AnaptysBio’s stockholders, which is the next stockholder meeting at which Class I directors will be elected. There is no arrangement or understanding between Dr. Fenton and any other persons pursuant to which Dr. Fenton was selected as a director. Dr. Fenton is not a party to and does not have any direct or indirect material interest in any transaction with AnaptysBio required to be disclosed under Item 404(a) of Regulation S-K. The Board determined that Dr. Fenton qualifies as an independent director pursuant to the Securities Act of 1933 and the listing standards of the Nasdaq Stock Market, in each case as currently in effect. Dr. Fenton also will enter into AnaptysBio’s standard form of indemnity agreement for its directors and executive officers, which was filed as Exhibit 10.01 to AnaptysBio’s Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on September 9, 2015. The indemnification agreement will be effective as of the date of his appointment to the Board.
Dr. Fenton will be compensated in accordance with the standard non-employee director compensation policy, including an annual cash retainer, an initial option grant, and an annual option refresh grant. Dr. Fenton will also receive a pro-rated annual grant for the portion of 2018 that he will serve as a director.
Item 9.01 Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 5, 2018 By: /s/ Dominic Piscitelli
Name: Dominic Piscitelli
Title: Chief Financial Officer
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 March 2018 and Eosinophilic Asthma in Second Quarter 2018
ANB019 GPP and PPP Phase 2 Studies to be Initiated During 2018
SAN DIEGO, March 5, 2018 - AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today reported operating results for the fourth quarter and year ended December 31, 2017 and anticipated 2018 pipeline milestones.
“AnaptysBio made significant progress on multiple program and corporate milestones during 2017,” said Hamza Suria, president and chief executive officer of AnaptysBio. “We are poised to continue advancing our ANB020 and ANB019 programs with additional clinical data readouts in serious inflammatory conditions during 2018. We are on-track to report top-line data on ANB020 as a treatment for both severe adult peanut allergy in March 2018 and severe adult eosinophilic asthma during the second quarter of 2018. We plan to initiate a Phase 2b study of ANB020
in moderate-to-severe adult atopic dermatitis during the first half of 2018, as well as Phase 2 studies of ANB019 in generalized pustular psoriasis, or GPP and palmo-plantar pustular psoriasis, or PPP, during 2018. These milestones are significant for the company, and important steps forward in bringing our novel treatments to patients with severe inflammatory diseases.”
ANB020 (Anti-IL-33 Program)
In 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, AnaptysBio reported positive updated data upon completion of this clinical trial during an oral presentation at the American Academy of Dermatology Annual 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 March 2018.
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 Second after 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)
In November 2017, AnaptysBio announced 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 $15.00 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 750,000 shares of common stock. AnaptysBio received 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 $68.50 per 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 Fenton to 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 million as of December 31, 2017, which includes net proceeds of $292.5 million from the Company’s underwritten public offerings, compared to $51.2 million as of December 31, 2016.
Revenue was $3.0 million and $10.0 million for the quarter and year ended December 31, 2017, which related to milestones earned from the Company’s partnership with TESARO, compared to $2.8 million and $16.7 million for 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 TESARO and milestone-related revenues from TESARO and Celgene.
Research and development expenses were $7.6 million and $29.4 million for the quarter and year ended December 31, 2017, as compared to $5.0 million and $15.4 million for 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 million and $9.3 million for the quarter and year ended December 31, 2017, as compared to $0.9 million and $4.3 million for 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
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan through the end of 2019.
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (ANB020) for the treatment of moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and severe adult eosinophilic asthma; its anti-IL-36R antibody (ANB019) for the treatment of rare inflammatory diseases, including generalized pustular psoriasis and palmo-plantar pustular psoriasis; and a portfolio of checkpoint receptor agonist antibodies for the treatment of certain autoimmune diseases where immune
checkpoint receptors are insufficiently activated, which have demonstrated efficacy in an animal model of graft-versus-host disease. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation (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 partnership with TESARO and an inflammation partnership with Celgene, including an anti-PD-1 antagonist antibody (TSR-042), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), which are currently under clinical development with TESARO, and an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the clinic with Celgene.
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 TESARO and Celgene. 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 Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
THRUST Investor Relations
CONSOLIDATED BALANCE SHEETS
(in thousands, except par value data)
December 31, 2017
December 31, 2016
Cash and cash equivalents
Receivable from collaborative partners
Australian tax incentive receivable
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Long-term vendor deposits
Deferred financing costs
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY (DEFICIT)
Notes payable, current portion
Other current liabilities
Total current liabilities
Notes payable, net of current portion
Preferred stock warrant liabilities
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
Accumulated other comprehensive loss
Total stockholders’ equity (deficit)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
Three Months Ended
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense), net
Change in fair value of liability for preferred stock warrants
Other income (expense), net
Total other income (expense), net
Unrealized loss on available for sale securities
Other comprehensive loss
Net loss per common share:
Basic and diluted
Weighted-average number of shares outstanding:
Basic and diluted