amti-8k_20210513.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):
May 13, 2021

applied molecular traNsport inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-39306

 

81-4481426

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer
Identification No.)

1 Tower Place, Suite 850

South San Francisco, CA 94080

(Address of principal executive offices, including zip code)

(650) 392-0420

(Registrant’s telephone number, including area code)

Not Applicable

(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))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol

 

Name of exchange on which registered

Common Stock, par value $0.0001 per share

 

AMTI

 

The Nasdaq Global Select Market

 

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 May 13, 2021, Applied Molecular Transport Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2021. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits.

 

Exhibit No.

 

Description

 

 

99.1

 

Press Release of Applied Molecular Transport Inc. dated May 13, 2021

 


 


 

SIGNATURES

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.

 

applied molecular transport INC.

 

 

By:

 

/s/ Tahir Mahmood

 

 

Tahir Mahmood, Ph.D.

 

 

Co-Founder and Chief Executive Officer

Date: May 13, 2021

 

amti-ex991_6.htm

   Exhibit 99.1

Applied Molecular Transport Reports First Quarter 2021 Financial Results and

Provides Corporate Update

 

Enrollment ongoing in each of oral AMT-101’s four Phase 2 trials

 

On track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials, being conducted in multiple ulcerative colitis populations and rheumatoid arthritis, beginning in the second half of 2021 and into 2022

 

Expanded clinical pipeline with second product candidate, AMT-126, an oral IL-22 fusion biologic therapy for diseases associated with intestinal epithelial barrier defects; Initiated Phase 1a trial in healthy volunteers

 

Received acceptance to present full AMT-101 Phase 1b ulcerative colitis data at ECCO’21 Virtual Congress in July

 

Strengthened balance sheet with successful follow-on offering in April

 

SOUTH SAN FRANCISCO, Calif., May 13, 2021 -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today provided a corporate update and reported financial results for the first quarter ended March 31, 2021.

 

“Our proprietary technology platform and internal CMC capabilities have enabled AMT to generate differentiated novel oral biologics, and this broad platform continues to generate exciting pipeline opportunities,” said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. “Following the initiation of our second clinical program, oral AMT-126, in a Phase 1a trial in healthy volunteers, we further strengthened our balance sheet with a successful follow-on offering in April. Importantly, these proceeds will enable AMT to optimize the development plan for oral AMT-126 and our next pipeline programs as they advance towards the clinic.  We continue to believe that our most advanced programs, AMT-101 and AMT-126, have broad potential for targeting intestinal and systemic inflammatory indications and other diseases. With topline readouts from the four Phase 2 trials beginning in the second half of the year, we expect the next twelve to eighteen months to be a data-rich period for the company.”

 

Recent Business Highlights

 

Initiated Phase 2 trials for oral AMT-101:

 

o

MARKET combination trial of oral AMT-101 with anti-TNFα in biologic-naïve patients with moderate-to-severe ulcerative colitis (UC)

 

o

FILLMORE monotherapy trial for patients with chronic pouchitis

 

o

CASTRO combination trial of oral AMT-101 with anti-TNFα for patients with rheumatoid arthritis who are partial or non-responders to anti-TNFα therapy

 

Expanded clinical pipeline with second wholly internally-developed biologic therapeutic, AMT-126, a GI-selective oral fusion of IL-22 and our proprietary carrier molecule, for diseases associated with intestinal epithelial barrier defects; Initiated Phase 1a trial in healthy volunteers and expect the full Phase 1 development plan to resemble our AMT-101 approach; Expect to conduct a Phase 1b trial in patients with impaired intestinal epithelial barrier function

 

Closed an underwritten public offering in April of 2,875,000 shares of our common stock, at a public offering price of $42.00 per share, resulting in net proceeds of approximately $112.9 million. Cash, cash equivalents, and investments as of March 31, 2021 pro-forma for the public offering were approximately $229.1M

 

Successfully manufactured oral AMT-101 and AMT-126 GMP biologics at AMT’s internal manufacturing facility

 

Received acceptance for our submission to present the full AMT-101 Phase 1b multiple ascending dose UC data set at the ECCO’21 Virtual Congress in July 2021

 

Strengthened the executive leadership team with key new hires, including Douglas Rich, chief technical officer, and Earl Douglas, executive vice president and general counsel

 

Anticipated Upcoming Milestones

 

Top-line data readouts from the four oral AMT-101 Phase 2 trials beginning in 2H 2021 and into 2022

 

Top-line oral AMT-126 Phase 1a/b data in healthy volunteers and patients in 2022

 


 

Financial Results for the First Quarter Ended March 31, 2021

 

Research and development (R&D) expenses. Total R&D expenses for the first quarter of 2021 were $14.9 million, compared to $13.0 million for the same period in 2020. The increase was primarily due to higher expenses associated with clinical trials, preclinical studies, compensation and facilities related expenses, offset by a decrease in materials and contract manufacturing.

 

General and administrative (G&A) expenses. Total G&A expenses for the first quarter of 2021 were $5.6 million, compared to $2.5 million for the same period in 2020. The increase was primarily due to an increase of $1.9 million in personnel and administrative costs due to an increase in headcount and an increase of $1.1 million in professional fees.

 

Net loss. Net loss for the first quarter of 2021 was $20.5 million, compared to $15.3 million for the same period in 2020.

 

Cash, cash equivalents, and investments. As of March 31, 2021, cash, cash equivalents, and investments were $108.3 million.

 

About AMT-101

AMT-101 is a novel GI-selective, oral fusion of hIL-10 and AMT’s proprietary carrier molecule, and is currently being developed in four Phase 2 clinical trials in inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is designed to cross the intestinal epithelial (IE) barrier with limited entry into the bloodstream, thereby focusing hIL-10 at the primary site of inflammation for UC and potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC.

 

About AMT-126

AMT-126 is a novel GI-selective, oral fusion of hIL-22 and AMT’s proprietary carrier molecule currently in development for diseases related to IE barrier defects. IL-22 is a cytokine that repairs structural and functional defects of the IE barrier and induces microbial defense. AMT-126 is designed to act locally on the epithelial cells of the intestinal tissue, thereby repairing the IE barrier and supporting mucosal healing, potentially translating into clinically meaningful improvements in a broad range of GI-focused, peripheral inflammatory and other diseases.

 

About Applied Molecular Transport Inc.

Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT’s proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelial (IE) barrier. Active transport is an efficient mechanism that uses the cell’s own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local intestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

 

AMT’s headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.


 

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements including statements relating to AMT’s plans, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMT’s technology platform and AMT’s internal manufacturing capabilities, statements regarding the optimization of our product development plans or the design of future clinical trials, statements regarding the potential of AMT-101 and AMT-126 or regarding AMT-101 and AMT-126 clinical trials, including the timing of data readouts from such trials and our ability to replicate past clinical development strategies, statements regarding the potential for AMT’s product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and assumptions regarding the biological mode of action of our product candidates and the potential to avoid side effects with our product candidates. In some cases, you can identify forward-looking statements by terminology such as “estimate,” “intend,” “may,” “plan,” “potentially,” “will,” “expect,” “enable” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual events, trends or results could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements based on various factors. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in AMT’s Annual and Quarterly Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission (the “SEC”), and AMT’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.


Applied Molecular Transport Inc.

Condensed Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,202

 

 

$

5,843

 

Short-term investments

 

 

82,063

 

 

 

124,026

 

Prepaid expenses

 

 

2,648

 

 

 

1,311

 

Deferred offering costs

 

 

659

 

 

 

 

Other current assets

 

 

393

 

 

 

321

 

Total current assets

 

 

111,965

 

 

 

131,501

 

Property and equipment, net

 

 

6,999

 

 

 

8,447

 

Operating lease right-of-use assets, net

 

 

5,450

 

 

 

 

Finance lease right-of-use assets, net

 

 

796

 

 

 

 

Restricted cash

 

 

1,025

 

 

 

108

 

Other assets

 

 

169

 

 

 

127

 

Total assets

 

$

126,404

 

 

$

140,183

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,208

 

 

$

3,174

 

Accrued expenses

 

 

4,094

 

 

 

4,173

 

Operating lease liabilities, current

 

 

2,377

 

 

 

 

Finance lease liabilities, current

 

 

235

 

 

 

 

Deferred rent, current

 

 

 

 

 

83

 

Capital lease obligations, current

 

 

 

 

 

232

 

Total current liabilities

 

 

8,914

 

 

 

7,662

 

Operating lease liabilities

 

 

3,589

 

 

 

 

Finance lease liabilities

 

 

344

 

 

 

 

Deferred rent

 

 

 

 

 

444

 

Capital lease obligations

 

 

 

 

 

404

 

Total liabilities

 

 

12,847

 

 

 

8,510

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value, 450,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 35,250,650 and 35,121,360 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

273,348

 

 

 

271,000

 

Accumulated other comprehensive income

 

 

25

 

 

 

27

 

Accumulated deficit

 

 

(159,820

)

 

 

(139,358

)

Total stockholders’ equity

 

 

113,557

 

 

 

131,673

 

Total liabilities and stockholders’ equity

 

$

126,404

 

 

$

140,183

 

 

-----------------------------------

Refer to the Company’s applicable SEC filings for previously reported periods.

 

 


 

Applied Molecular Transport Inc.

Condensed Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

$

14,881

 

 

$

12,954

 

General and administrative

 

 

5,599

 

 

 

2,489

 

Total operating expenses

 

 

20,480

 

 

 

15,443

 

Loss from operations

 

 

(20,480

)

 

 

(15,443

)

Interest income, net

 

 

40

 

 

 

83

 

Other (expense) income, net

 

 

(22

)

 

 

49

 

Net loss

 

$

(20,462

)

 

$

(15,311

)

Net loss per share, basic and diluted

 

$

(0.58

)

 

$

(2.06

)

Weighted-average shares of common stock outstanding, basic and diluted

 

 

35,217,773

 

 

 

7,417,440

 

Comprehensive loss:

 

 

 

 

 

 

 

 

Net loss

 

$

(20,462

)

 

$

(15,311

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

Unrealized (loss) gain on investments

 

 

(2

)

 

 

6

 

Total comprehensive loss

 

$

(20,464

)

 

$

(15,305

)

 

 

Investor Relations Contact:
Andrew Chang

Head, Investor Relations & Corporate Communications

achang@appliedmt.com

 

Media Contacts:

Alexandra Santos

Wheelhouse Life Science Advisors

asantos@wheelhouselsa.com

 

Aljanae Reynolds

Wheelhouse Life Science Advisors

areynolds@wheelhouselsa.com