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Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Conference Call, Webcast

Aimmune Therapeutics Announces Second Quarter 2019 Financial Results and Provides Operational Highlights


Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced financial results for the quarter and six months ended June 30, 2019. Operational highlights for the second quarter of 2019 include:

"The second quarter of 2019 was marked by exceptional progress on all fronts. We continue to work with the FDA to facilitate an expeditious review of AR101. This means patients with food allergies may be only months away from finally having an FDA-approved treatment option," said Jayson Dallas, M.D., President and CEO of Aimmune Therapeutics. "Our focus on commercial preparedness is ongoing and we plan to be launch ready in the fourth quarter of this year. Additionally, we submitted a MAA for AR101 to the EMA, and we are pleased to share that its review has begun."

Dr. Dallas added: "At EAACI, we presented positive results from our ARTEMIS European phase 3 trial, as well as important data that showed patients who received daily treatment with AR101 beyond one year experienced clinically meaningful improvements in disease-specific quality of life and continued immunomodulation. In addition, new and compelling patient quality of life data were presented at both EAACI and ISPOR, underscoring the urgent unmet need of people living with peanut allergy. Moreover, we began the enrollment process for our phase 2 clinical trial of AR201 in egg allergy and remain in a strong financial position to commercialize AR101 and advance our pipeline programs."

Second Quarter 2019 Clinical and Operational Highlights

In addition, patients in the open-label extension of the phase 3 PALISADE trial who received daily treatment with AR101 beyond one year experienced clinically meaningful improvements in disease-specific quality of life. Continued immunomodulation also was observed, with almost half of patients tolerating as much as 2,000 mg of peanut protein with fewer adverse events. Further, results from APPEAL 2, the first European multi-country qualitative evaluation of the impact of living with peanut allergy, found that living in fear of a potentially fatal reaction to peanuts significantly impacts the quality of life of individuals with peanut allergy and their families.

The Company also presented data at the ISPOR 2019 Annual Meeting that showed that, over a 12-month period, more than half of participants required a visit to the emergency room or urgent care facility and one-third required hospitalization as a result of peanut exposure. This was true despite 100% of those surveyed reporting actively avoiding peanut products.

Upcoming Milestones

Sept. 13, 2019

 

 

Scheduled FDA APAC meeting to review AR101 BLA

January 2020

 

 

Potential FDA approval of AR101 for peanut allergy in children and adolescents ages 4 to
17

Q1 2020

 

 

Potential U.S. commercial launch of AR101

Mid-2020

 

 

Complete enrollment of AR201 phase 2 trial

H2 2020

 

 

 

Potential EU approval of AR101 for peanut allergy in children and adolescents ages 4 to
17

H2 2020

 

 

Potential EU commercial launch of AR101

Second Quarter 2019 Financial Results

For the quarter and six months ended June 30, 2019, net loss was $62.9 million and $117.1 million, respectively, compared to net loss of $52.6 million and $102.1 million for the comparable period in 2018. On a per share basis, net loss for the quarter and six months ended June 30, 2019, was $1.01 and $1.88, respectively, compared to net loss per share of $0.91 and $1.83 for the comparable period in 2018. The weighted average shares outstanding for the quarter and six months ended June 30, 2019, were 62.3 million and 62.2 million shares, respectively, compared to 57.9 million and 55.8 million shares for the comparable period in 2018.

Research and development expenses for the quarter and six months ended June 30, 2019, were $32.0 million and $63.3 million, respectively, compared to $35.3 million and $68.7 million for the comparable period in 2018. The decrease was primarily due to lower costs related to the completion of certain AR101 clinical trials, partially offset by higher costs related to regulatory activities and increased contract manufacturing costs to support potential commercialization.

General and administrative expenses for the quarter and six months ended June 30, 2019, were $31.2 million and $54.9 million, respectively, compared to $18.6 million and $35.2 million for the comparable period in 2018. The increase was primarily due to additional employee-related costs and external professional services as Aimmune continued to build its infrastructure to support the development and potential commercialization of AR101.

Cash, cash equivalents, and investments totaled $250.3 million on June 30, 2019, compared to $303.9 million on December 31, 2018. The decrease primarily reflects net cash used in operating activities, partially offset by cash provided by financing activities, including net borrowings from our debt issuance in January 2019 of $36.1 million.

Conference Call

In connection with this announcement, Aimmune Therapeutics will host a conference call and webcast today at 4:30 p.m. ET. To access the live call by phone, dial (877) 497-1438 (domestic) or (262) 558-6296 (international) and enter the passcode 1564807. To access a live or recorded webcast of the call, please visit the Investor Relations section of the Aimmune Therapeutics website at www.aimmune.com. The recorded webcast will be available for approximately 30 days following the call.

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral treatments for life-threatening food allergies. The company's Characterized Oral Desensitization ImmunoTherapy (CODITtm) approach is intended to provide meaningful levels of protection against allergic reactions resulting from exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune's first investigational biologic product, AR101, is being developed as a treatment to reduce the frequency and severity of adverse events following exposure to peanut. The BLA for AR101 is under review by the U.S. FDA, which in 2015 granted AR101 Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4 to 17 years of age. In June 2019, Aimmune submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for AR101, which has begun its review. In July 2019, Aimmune began the enrollment process for a phase 2 clinical trial for its second product, AR201, for egg allergy. For more information, please see www.aimmune.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune's expectations regarding the potential benefits of AR101; Aimmune's expectations regarding the potential commercial launch of AR101, including the review period of the BLA and MAA for AR101; Aimmune's expectations on the timing of receipt and announcement of data for its phase 2 clinical trial for AR201; Aimmune's expectations on the planned timing for the announcement of data from its POSEIDON trial of AR101 and Regeneron's clinical trial of AR101 in combination with dupilumab; Aimmune's expectations regarding the adequacy and sufficiency of its commercial supply of AR101; Aimmune's expectations regarding the sufficiency of its cash resources; and Aimmune's expectations regarding potential applications of the CODITtm approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmune's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune's or any of its collaborative partners' clinical trials will not be successful; Aimmune's dependence on the success of AR101; Aimmune's reliance on third parties for the manufacture of Aimmune's product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This press release concerns AR101 and AR201, product candidates that are under clinical investigation. Neither AR101 nor AR201 has been approved for marketing by the FDA or the EMA. AR101 and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.

AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

 

 

 

 

 

 

2019

(Unaudited)

 

 

December 31,

2018 (1)

 

 

Assets

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

72,564

 

 

$

107,511

 

 

Short-term investments

 

 

171,108

 

 

 

196,421

 

 

Prepaid expenses and other current assets

 

 

6,859

 

 

 

8,687

 

 

Total current assets

 

 

250,531

 

 

 

312,619

 

 

 

 

 

 

 

 

 

 

 

 

Long-term investments

 

 

6,584

 

 

 

?

 

 

Property and equipment, net

 

 

29,414

 

 

 

26,328

 

 

Operating lease right-of-use assets

 

 

11,736

 

 

 

?

 

 

Prepaid expenses and other assets

 

 

511

 

 

 

608

 

 

Total assets

 

$

298,776

 

 

$

339,555

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

43,211

 

 

$

38,012

 

 

Long term debt, net of discount

 

 

38,526

 

 

 

?

 

 

Operating lease liabilities, non-current

 

 

11,036

 

 

 

?

 

 

Other liabilities

 

 

1,029

 

 

 

2,596

 

 

Stockholders' equity

 

 

204,974

 

 

 

298,947

 

 

Total liabilities and stockholders equity

 

$

298,776

 

 

$

339,555

 

 

 

 

 

 

 

 

 

 

 

 

(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K
for the year ended December 31, 2018.

AIMMUNE THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(In thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Quarter Ended June 30,

 

 

Six Months Ended
June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

$

31,988

 

 

$

35,254

 

 

$

63,304

 

 

$

68,700

 

General and administrative(1)

 

 

31,200

 

 

 

18,559

 

 

 

54,912

 

 

 

35,232

 

Total operating expenses

 

 

63,188

 

 

 

53,813

 

 

 

118,216

 

 

 

103,932

 

Loss from operations

 

 

(63,188

)

 

 

(53,813

)

 

 

(118,216

)

 

 

(103,932

)

Interest income, net

 

 

358

 

 

 

1,294

 

 

 

1,149

 

 

 

1,930

 

Loss before provision for income taxes

 

 

(62,830

)

 

 

(52,519

)

 

 

(117,067

)

 

 

(102,002

)

Provision for income taxes

 

 

48

 

 

 

33

 

 

 

77

 

 

 

50

 

Net loss

 

$

(62,878

)

 

$

(52,552

)

 

$

(117,144

)

 

$

(102,052

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

 

$

(1.01

)

 

$

(0.91

)

 

$

(1.88

)

 

$

(1.83

)

Shares used in computing net loss per common share, basic and diluted

 

 

62,332

 

 

 

57,903

 

 

 

62,178

 

 

 

55,752

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes stock-based compensation expenses of:

 

 

 

 

 

 

 

 

 

 

 

Quarter Ended June 30,

 

 

Six Months Ended
June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Research and development

 

$

2,957

 

 

$

2,923

 

 

$

5,700

 

 

$

4,970

 

General and administrative

 

 

5,783

 

 

 

5,751

 

 

 

10,805

 

 

 

11,311

 

Total stock-based compensation expenses

 

$

8,740

 

 

$

8,674

 

 

$

16,505

 

 

$

16,281

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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