aimt-8k_20181108.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 8, 2018

 

AIMMUNE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

Delaware

 

001-37519

 

45-2748244

(State or other jurisdiction of incorporation)

 

 

(Commission File Number)

 

 

(IRS Employer Identification Number)

 

8000 Marina Blvd, Suite 300
Brisbane, CA 94005
(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 614-5220

 

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 Instructions 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 

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. 

 


Item 2.02 Results of Operations and Financial Conditions.

On November 8, 2018, Aimmune Therapeutics, Inc. (“Aimmune” or the “Company”) issued a press release announcing its financial results for the quarter and nine months ended September 30, 2018, and its financial position as of September 30, 2018. The full text of the press release is furnished as Exhibit 99.1 hereto.

The information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, or incorporated by reference into any filings of the Company made under the Securities Act of 1933, as amended, regardless of any general incorporation language in the filing unless specifically stated so therein.

 

Item 9.01 Financial Statements and Exhibits.

Exhibit No.

  

Description

99.1

 

Press release dated November 8, 2018.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

AIMMUNE THERAPEUTICS, INC.

 

 

 

 

Date: November 8, 2018

 

By:

/s/ Eric H. Bjerkholt

 

 

 

Eric H. Bjerkholt

 

 

 

Chief Financial Officer

 

 

 

aimt-ex991_6.htm

Exhibit 99.1

Aimmune Therapeutics Announces Third Quarter 2018 Financial Results and Recent Corporate Highlights

 

 

Recently completed Phase 3 RAMSES study confirms safety profile of AR101 in peanut-allergic children and teens

 

 

BLA submission for AR101 on track for December 2018

 

 

Management to host analyst event on Wednesday, December 12th, in New York

 

BRISBANE, California, November 8, 2018 – Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced financial results for the quarter and nine months ended September 30, 2018. As of September 30, 2018, cash, cash equivalents and investments totaled $255.2 million.

 

Aimmune also announced that the safety profile of AR101 demonstrated in its recently completed Phase 3 RAMSES trial was consistent with the safety profile observed in its previously reported pivotal Phase 3 PALISADE trial in peanut-allergic children and teens, ages 4-17. Approximately 80% of participants treated with AR101 completed each trial. There were no serious adverse events related to treatment with AR101 in the RAMSES study.    

 

RAMSES was a double-blind, placebo-controlled safety study, which enrolled 506 peanut-allergic children and teens, ages 4-17 years, in the United States. The study monitored treatment-emergent adverse events during the initial six-month up-dosing period. As this was a safety study, there were no oral food challenges at entry or exit.

 

“We are very pleased that RAMSES further confirms the favorable safety profile of AR101,” said Jayson Dallas, M.D., President and CEO of Aimmune. “The BLA submission is our top priority now and remains on track for December. We will have a robust data package on approximately 1,200 patients treated with AR101. PALISADE is the core of our BLA, having shown the potential for AR101 to reduce the frequency and severity of allergic reactions due to accidental ingestion of peanut.

 

“Our goal is to provide families of peanut-allergic children and teens the certainty and convenience of a once-daily, oral medication for desensitization. We believe the clinical data on AR101 support that goal, and we look forward to sharing our plans in December for making AR101 available to the peanut-allergic community, assuming approval.”  

 


 

Page 1 of 6

 


Third Quarter and Recent Highlights

 

Aimmune held a pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration to discuss requirements for submission of a BLA for AR101 for the treatment of peanut allergy in children and teens, ages 4-17 years. The encouraging outcome of the meeting supports a BLA submission in December 2018 as planned.  

 

A planned Phase 2 clinical trial of AR101 with adjunctive dupilumab was initiated in collaboration with Regeneron and Sanofi. The study is designed to assess the potential to improve desensitization to peanut with adjunctive use of dupilumab. Regeneron is the study sponsor and Aimmune is providing clinical supply of AR101.

 

Third Quarter Financial Results

For the quarter and nine months ended September 30, 2018, net loss was $51.7 million and $153.8 million, respectively, compared to net loss of $31.8 million and $90.2 million for the comparable periods in 2017.

 

On a per share basis, net loss for the quarter and nine months ended September 30, 2018, was $0.89 and $2.72, respectively, compared to net loss per share of $0.63 and $1.79 for the comparable periods in 2017. The weighted average shares outstanding for the quarter and nine months ended September 30, 2018, was 58.3 million and 56.6 million, respectively, compared to 50.5 million and 50.3 million shares for the comparable periods in 2017. In the first quarter of 2018, the Company completed an underwritten public offering with net proceeds of $190.4 million through the sale and issuance of an aggregate of 6,325,000 shares of common stock.

 

Research and development expenses for the quarter and nine months ended September 30, 2018, were $31.7 million and $100.4 million, respectively, compared to $21.1 million and $60.7 million for the comparable periods in 2017. The increase was primarily due to higher costs from the progression of certain AR101 clinical trials and higher contract manufacturing costs to support clinical development and regulatory activities.

 

General and administrative expenses for the quarter and nine months ended September 30, 2018, were $21.3 million and $56.5 million, respectively, compared to $11.2 million and $31.0 million for the comparable periods in 2017. The increase was primarily due to additional employee-related costs and external professional services as Aimmune continues to build its infrastructure to support the development and potential commercialization of AR101. Stock-based compensation expense also increased primarily due to the expansion and extension of our long-term commercial supply agreement with Golden Peanut Company and modification of certain executives’ stock options resulting from their planned separation.

 

Cash, cash equivalents, and investments totaled $255.2 million at September 30, 2018, compared to $182.4 million at December 31, 2017. The increase primarily reflects net cash proceeds of $190.4 million received as of September 30, 2018, from the sale of common stock, partially off-set by cash used in operating activities of $117.6 million and cash used for purchase of plant and equipment of $8.3 million.

Page 2 of 6

 


 

Anticipated Upcoming Milestones

 

Timing

Anticipated Milestone

Q4 18

Initiate a study of AR101 in infants and toddlers 1 – 4 years old (ARC005)

Q4 18

Data cut from the pivotal Phase 3 (PALISADE) rollover study (ARC004)

Q4 18

Submit BLA for AR101 to the U.S. Food and Drug Administration

Q4 18

Publication of PALISADE data in peer-reviewed medical journal

Q4 18

Submit Investigational New Drug Application for AR201 in egg allergy

1H 19

European clinical study data available (ARTEMIS)

1H 19

Submit MAA for AR101 to the European Medicines Agency  

1H 19

Initiate Phase 2 clinical trial of AR201 in egg allergy

2H 19

Submit Investigational New Drug Application for AR301 in walnut allergy

2H 19

Initiate Phase 2 clinical trial of AR301 in walnut allergy

2H 19

Potential approval and commercial launch of AR101 in the U.S.

 

 

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age. Aimmune plans to submit regulatory filings for marketing approval of AR101 in the United States and Europe based on data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in 4-17 year-old subjects met all its primary and secondary endpoints, and additional ongoing and completed AR101 clinical trials. 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 for the ARTEMIS and ARC004 trials, including the expected timing of data readouts and data cuts for these trials; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 in the United States and Europe, including the timing of these submissions; Aimmune’s expectations regarding the potential commercial launch of AR101, including the timing of a potential approval of AR101 in

Page 3 of 6

 


the United States; Aimmune’s expectations regarding the timing of initiating additional clinical trials for AR101, including ARC005; Aimmune’s expectations on the timing of submitting an IND and initiating Phase 2 clinical trials for AR201 in egg allergy and AR301 in walnut allergy; and Aimmune’s expectations regarding potential applications of the CODIT™ 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 ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that the results of early clinical trials may not be predictive of future results; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of its 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 September 30, 2018. 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 a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.

 

# # #

 

Contacts:

Investors:

Laura Hansen, Ph.D.

(650) 396-3814 or

lhansen@aimmune.com

Media:

Alison Marquiss

(650) 376-5583 or

amarquiss@aimmune.com

 

 

 

Page 4 of 6

 


AIMMUNE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

 

 

2018

(Unaudited)

 

 

December 31,

2017 (1)

 

 

Assets

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

78,420

 

 

$

73,487

 

 

Short-term investments

 

 

176,829

 

 

 

108,943

 

 

Prepaid expenses and other current assets

 

 

6,543

 

 

 

6,681

 

 

Total current assets

 

 

261,792

 

 

 

189,111

 

 

Property and equipment, net

 

 

25,045

 

 

 

17,205

 

 

Prepaid expenses and other assets

 

 

626

 

 

 

618

 

 

Total assets

 

$

287,463

 

 

$

206,934

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

 

Current liabilities

 

$

37,451

 

 

$

26,599

 

 

Other liabilities

 

 

2,848

 

 

 

2,530

 

 

Stockholders’ equity

 

 

247,164

 

 

 

177,805

 

 

Total liabilities and stockholders’ equity

 

$

287,463

 

 

$

206,934

 

 

 

 

 

 

 

 

 

 

 

 

(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2017.

 

 

 

Page 5 of 6

 


AIMMUNE THERAPEUTICS, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(In thousands, except per share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Quarter Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

$

31,691

 

 

$

21,063

 

 

$

100,391

 

 

$

60,671

 

General and administrative(1)

 

 

21,285

 

 

 

11,226

 

 

 

56,517

 

 

 

30,963

 

Total operating expenses

 

 

52,976

 

 

 

32,289

 

 

 

156,908

 

 

 

91,634

 

Loss from operations

 

 

(52,976

)

 

 

(32,289

)

 

 

(156,908

)

 

 

(91,634

)

Interest income, net

 

 

1,303

 

 

 

497

 

 

 

3,233

 

 

 

1,475

 

Loss before provision for income taxes

 

 

(51,673

)

 

 

(31,792

)

 

 

(153,675

)

 

 

(90,159

)

Provision for income taxes

 

 

29

 

 

 

 

 

 

79

 

 

 

 

Net loss

 

$

(51,702

)

 

$

(31,792

)

 

$

(153,754

)

 

$

(90,159

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

 

$

(0.89

)

 

$

(0.63

)

 

$

(2.72

)

 

$

(1.79

)

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

 

 

58,274

 

 

 

50,458

 

 

 

56,602

 

 

 

50,254

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes stock-based compensation expenses of:

 

 

 

 

 

 

 

 

 

 

 

Quarter Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Research and development

 

$

2,406

 

 

$

1,305

 

 

$

7,376

 

 

$

3,482

 

General and administrative

 

 

5,976

 

 

 

2,774

 

 

 

17,287

 

 

 

8,389

 

Total stock-based compensation expenses

 

$

8,382

 

 

$

4,079

 

 

$

24,663

 

 

$

11,871

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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