AnaptysBio Announces First Quarter 2017 Financial Results and Provides Pipeline Update
“We have advanced our anti-IL-33 antibody, ANB020, into multiple Phase 2a clinical trials in patients and our anti-IL-36R antibody, ANB019, into a Phase 1 clinical trial,” said Hamza Suria, president and chief executive officer of
Pipeline and Business Highlights
ANB020 (Anti-IL-33 Program)
- Presented detailed Phase 1 clinical trial data at the 2017
American Academy of Dermatology(AAD) Annual Meeting on March 3, 2017and the American Academy of Allergy, Asthma and Immunology (AAAAI) 2017 Annual Meeting on March 4, 2017. Data demonstrated that ANB020 was well-tolerated and no dose-limiting toxicities were observed at any dose level. An ex vivo pharmacodynamic assay illustrated that a single dose of ANB020 at certain dose levels was sufficient to suppress IL-33 function for approximately three months post-dosing.
- Initiated enrollment of a Phase 2a clinical trial for ANB020 in adult patients with severe peanut allergy. Top-line results from this trial are anticipated during the second half of 2017.
- Initiated enrollment of a Phase 2a clinical trial for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis. Top-line results from this trial are anticipated during the second half of 2017.
- Submitted a UK Clinical Trial Authorisation seeking regulatory clearance to initiate a Phase 2a trial in patients with severe adult eosinophilic asthma. Top-line results from this trial are anticipated during the first half of 2018.
- Scientific collaborators at the
Benaroya Research Institutepresented a translational research study regarding the potential role of IL-33 in severe peanut allergy at AAAAI. The research concluded that IL-33 is a key checkpoint of allergic responses, and blocking IL-33 has the potential to reduce expression of the effector cytokines involved in severe peanut allergy.
ANB019 (Anti-IL-36 Receptor Program)
- Initiated a Phase 1 clinical trial in healthy volunteers in
Australiain which ANB019 is being administered in single and multiple doses, through subcutaneous and intravenous routes of administration. Top-line results are expected during the second half of 2017. AnaptysBioplans to initiate Phase 2 studies for the treatment of two orphan inflammatory diseases, generalized pustular psoriasis and palmo-plantar pustular psoriasis, using ANB019 during 2018.
April 2017, TESAROinitiated a registration program for an AnaptysBio-generated anti-PD-1 antagonist antibody (TSR-042) resulting in a $3.0 millionmilestone payment being earned. We expect to recognize as revenue and receive this milestone payment during the second quarter of 2017.
May 2017, TESAROsubmitted an IND to the FDAfor an AnaptysBio-generated anti-LAG-3 antagonist antibody (TSR-033). Upon clearance of the IND, we expect to receive a $4.0 millionmilestone payment.
First Quarter 2017 Financial Results and Financial Guidance
- Cash, cash equivalents and investments totaled
$123.8 millionas of March 31, 2017, which includes net proceeds of $80.2 millionfrom the Company’s initial public offering completed in January 2017, compared to $51.2 millionas of December 31, 2016. The Company expects that it has sufficient capital to fund its operating plan through the end of 2018.
- There was no revenue recorded for the quarter ended
March 31, 2017, compared to $4.9 millionfor the quarter ended March 31, 2016. The quarter ended March 31, 2016included revenue of $0.7 millionrelated to the amortization of the upfront payment from TESARO, $1.2 millionrelated to research and development service and $3.0 millionof milestone related revenues. The upfront payment was fully recognized and the research and development services were completed as of December 31, 2016.
- Research and development expenses were
$7.9 millionfor the quarter ended March 31, 2017, compared to $4.8 millionfor the quarter ended March 31, 2016. The increase was primarily due to an increase in preclinical and clinical trial expenses offset by the recognition of certain tax incentives.
- General and administrative expenses were
$2.1 millionfor the quarter ended March 31, 2017, compared to $1.2 millionfor the quarter ended March 31, 2016. The increase was attributable to additional personnel-related expenses, including non-cash stock-based compensation, and an increase in public company related expenses.
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 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; and the timing of the release of data from our clinical trials, including ANB020’s Phase 2a clinical trials for the treatment of severe peanut allergy, moderate-to-severe adult atopic dermatitis and severe adult eosinophilic asthma and our Phase 1 clinical trial of ANB019; 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)|
|March 31, 2017||December 31, 2016|
|Cash and cash equivalents||$||96,754||$||51,232|
|Receivable from collaborative partners||—||1,225|
|Australian tax incentive receivable||4,965||4,118|
|Prepaid expenses and other current assets||1,694||1,633|
|Total current assets||110,155||58,208|
|Property and equipment, net||569||471|
|Deferred financing costs||—||3,441|
|LIABILITIES, CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY (DEFICIT)
|Notes payable, current portion||1,250||—|
|Other current liabilities||—||1|
|Total current liabilities||8,126||5,708|
|Notes payable, net of current portion||12,709||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 March 31, 2017 and December 31, 2016, respectively||—||28,220|
|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 March 31, 2017 and December 31, 2016, respectively||—||6,452|
|Series C-1 convertible preferred stock, $0.001 par value, no shares and 474 shares authorized, issued and outstanding at March 31, 2017 and December 31, 2016, respectively||—||2,156|
|Series D convertible preferred stock, $0.001 par value, no shares and 5,491 shares authorized, issued and outstanding at March 31, 2017 and December 31, 2016, respectively||—||40,688|
|Stockholders’ equity (deficit):|
|Preferred stock, $0.001 par value, 10,000 shares and no shares authorized, issued or outstanding at March 31, 2017 and December 31, 2016, respectively||—||—|
|Common stock, $0.001 par value, 500,000 and 17,214 shares authorized, 20,249 shares and 2,651 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively||20||3|
|Additional paid in capital||176,507||16,672|
|Accumulated other comprehensive income (loss)||(13||)||—|
|Total stockholders’ equity (deficit)||110,115||(38,248||)|
|Total liabilities, convertible preferred stock and stockholders’ equity (deficit)||$||131,111||$||62,180|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except per share data)|
|Three Months Ended
|Research and development||7,935||4,786|
|General and administrative||2,053||1,219|
|Total operating expenses||9,988||6,005|
|Loss from operations||(9,988||)||(1,139||)|
|Other income (expense), net|
|Change in fair value of liability for preferred stock warrants||(1,366||)||379|
|Other income (expense), net||347||(13||)|
|Total other income (expense), net||(1,447||)||251|
|Unrealized loss on available for sale securities||(13||)||—|
|Other comprehensive loss||(13||)||—|
|Net loss per common share:|
|Basic and diluted||$||(0.75||)||$||(0.34||)|
|Weighted-average number of shares outstanding:|
|Basic and diluted||15,295||2,629|
Monique AllaireTHRUST Investor Relations 617.895.9511 firstname.lastname@example.org