Full Press Release Details
AnaptysBio Announces 2016 Operating Results and Pipeline Progress
Data from Ongoing ANB020 Phase 2a Trials and ANB019 Phase 1 Trial Expected in Second Half 2017
SAN DIEGO, March 8, 2017 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced progress on the Company s product pipeline, business highlights and reported full year 2016
We are pleased to have advanced our novel
anti-IL-33 antibody, ANB020, through Phase 1 during 2016 and cleared both US and UK regulatory filings to enable multiple Phase 2 clinical data readouts in the second
half of 2017, said Hamza Suria, president and chief executive officer of AnaptysBio. With the success of our recently completed initial public offering, AnaptysBio is well-positioned to execute our strategy of developing novel
antibody approaches to treat severe inflammatory disease.
Pipeline and Business Highlights
ANB020 (Anti-IL-33 Program) Phase 1 Data Presented and Multiple Phase 2a
Clinical Trials Enrolling
ANB019 (Anti-IL-36 Receptor
Program) Phase 1 Clinical Data Anticipated in second half 2017
Checkpoint Receptor Agonist Antibodies Demonstrate Efficacy in Preclinical Model
Partnerships Advance Three AnaptysBio-Generated Antibodies into Clinical Trials
Initial Public Offering Completed
Year 2016 Financial Results and Financial Guidance
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 and 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) and an
anti-TIM-3 antagonist antibody (TSR-022), which are currently under clinical development with TESARO, and an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the clinic with Celgene.
Forward-Looking Statements
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: our belief that ANB020 s mechanism has advantages in the treatment
of atopic diseases over competing agents, and, specifically, our belief that ANB020 s efficacy in inhibiting IL-33 has the potential to reduce expression of the effector cytokines involved in severe
peanut allergy and effectively treat severe peanut allergy; the timing of top-line data from ANB020 s Phase 2a clinical trials for the treatment of severe peanut allergy and
moderate-to-severe adult atopic dermatitis; and expectations to seek regulatory clearance during the first half of 2017 to initiate a Phase 2a trial in patients with
severe adult eosinophilic asthma, and timing regarding the subsequent release of top-line data from any such trial. Statements including words such as anticipate, believe,
potential, estimate, plan, will, continue, expect, or future, 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.
CONSOLIDATED BALANCE SHEETS
(in thousands, except par value data)
| December 31, 2016 | December 31, 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 51,232 | $ | 51,684 | ||||
| Receivable from collaborative partners | 1,225 | 1,226 | ||||||
| Australian tax incentive receivable | 4,118 | |||||||
| Prepaid expenses and other current assets | 1,633 | 554 | ||||||
| Total current assets | 58,208 | 53,464 | ||||||
| Property and equipment, net | 471 | 551 | ||||||
| Restricted cash | 60 | 60 | ||||||
| Deferred financing costs | 3,441 | 2,205 | ||||||
| Total assets | $ | 62,180 | $ | 56,280 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,278 | $ | 1,521 | ||||
| Accrued expenses | 3,429 | 2,753 | ||||||
| Deferred revenue | 2,942 | |||||||
| Income taxes payable | 139 | |||||||
| Other current liabilities | 1 | 21 | ||||||
| Total current liabilities | 5,708 | 7,376 | ||||||
| Notes payable, net of current portion | 13,809 | 4,903 | ||||||
| Deferred rent | 154 | 115 | ||||||
| Preferred stock warrant liabilities | 3,241 | 1,549 | ||||||
| Commitments and contingencies | ||||||||
| Series B convertible preferred stock, $0.001 par value, 3,963 shares authorized, issued and outstanding at December 31, 2016 and 2015; aggregate liquidation preference at December 31, 2016 of $24,991 | 28,220 | 28,220 | ||||||
| Series C convertible preferred stock, $0.001 par value, 1,887 shares authorized, 1,593 shares issued and outstanding at December 31, 2016 and 2015; aggregate liquidation preference at December 31, 2016 of $7,246 | 6,452 | 6,452 | ||||||
| Series C-1 convertible preferred stock, $0.001 par value, 474 shares authorized, issued and outstanding at December 31, 2016 and 2015, respectively; aggregate liquidation preference at December 31, 2016 of $6,470 | 2,156 | 2,156 | ||||||
| Series D convertible preferred stock, $0.001 par value, 5,491 shares authorized, issued and outstanding at December 31, 2016 and 2015, respectively; aggregate liquidation preference at December 31, 2016 of $40,767 | 40,688 | 40,688 | ||||||
| Stockholders deficit: | ||||||||
| Common stock, $0.001 par value, 17,214 shares authorized, 2,651 shares and 2,630 shares issued and outstanding at December 31, 2016 and 2015, respectively | 3 | 3 | ||||||
| Additional paid in capital | 16,672 | 15,482 | ||||||
| Accumulated deficit | (54,923 | ) | (50,664 | ) | ||||
| Total stockholders deficit | (38,248 | ) | (35,179 | ) | ||||
| Total liabilities, convertible preferred stock and stockholders deficit | $ | 62,180 | $ | 56,280 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
| Year Ended December 31, | ||||||||
| 2016 | 2015 | |||||||
| Collaboration revenue | $ | 16,684 | $ | 17,571 | ||||
| Operating expenses: | ||||||||
| Research and development | 15,419 | 17,304 | ||||||
| General and administrative | 4,290 | 3,589 | ||||||
| Total operating expenses | 19,709 | 20,893 | ||||||
| Income (loss) from operations | (3,025 | ) | (3,322 | ) | ||||
| Other expense, net | ||||||||
| Interest expense | (458 | ) | (460 | ) | ||||
| Interest expense, related parties | ||||||||
| Change in fair value of liability for preferred stock warrants | (756 | ) | (1,277 | ) | ||||
| Other income (expense), net | (20 | ) | (207 | ) | ||||
| Total other expense, net | (1,234 | ) | (1,944 | ) | ||||
| Income (loss) before income taxes | (4,259 | ) | (5,266 | ) | ||||
| Provision for income taxes | (139 | ) | ||||||
| Net income (loss) | (4,259 | ) | (5,405 | ) | ||||
| Net income attributed to participating securities | ||||||||
| Net income (loss) attributed to common stockholders | $ | (4,259 | ) | $ | (5,405 | ) | ||
| Net income (loss) per common share: | ||||||||
| Basic and diluted | $ | (1.62 | ) | $ | (2.12 | ) | ||
| Weighted-average number of shares outstanding: | ||||||||
| Basic and diluted | 2,637 | 2,551 |