Applied Molecular Transport Reports Third Quarter 2023 Financial Results

Rhea-AI Summary

Applied Molecular Transport Inc. (AMTI) entered into a definitive merger agreement with Cyclo Therapeutics, focusing on advancing Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1). The merger is expected to close by year end 2023, with upcoming milestones including completion of enrollment in pivotal Phase 3 clinical trial in NPC1, reporting top line data and preparation for NDA submission. Financially, the company reported a significant decrease in research and development expenses compared to the same period in 2022, leading to a reduced net loss and cash and cash equivalents of $18.1 million as of September 30, 2023.

Positive

• The merger with Cyclo Therapeutics presents a strategic opportunity for Applied Molecular Transport Inc. to advance its focus on Trappsol® Cyclo™ for the treatment of NPC1, a significant milestone for the company's future growth and development.

Negative

• None.

Company Entered into Definitive Merger Agreement with Cyclo Therapeutics

Cash and Cash Equivalents of $18.1 million, as of September 30, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2023.

Recent Business Highlights and Anticipated Milestones

• Entered into a definitive merger agreement with Cyclo Therapeutics
  • Combined company will operate as Cyclo Therapeutics with primary focus on advancing Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1)
  • The merger is expected to close by year end 2023
  • Upcoming milestones include completion of enrollment in pivotal Phase 3 clinical trial in NPC1, reporting top line data and preparation for NDA submission

Financial Results for the Third Quarter Ended September 30, 2023

Research and development (R&D) expenses. Total R&D expenses for the third quarter of 2023 were $0.3 million, compared to $18.2 million for the same period in 2022. The overall decrease was attributable to our restructuring of operations, related reductions in workforce implemented in March 2023 and discontinuing all research and development activities.

General and administrative (G&A) expenses. Total G&A expenses for the third quarter of 2023 were $7.0 million, compared to $7.3 million for the same period in 2022. The overall decrease was attributable to our restructuring of operations and related reductions in workforce implemented in March 2023.

Net loss. Net loss for the third quarter of 2023 was $6.9 million, compared to $25.2 million for the same period in 2022. Operating expenses for the third quarter of 2023 were $7.2 million and interest income was $0.3 million.

Cash and cash equivalents. As of September 30, 2023, cash and cash equivalents were $18.1 million.

About Applied Molecular Transport Inc.

AMT is a clinical-stage biopharmaceutical company that has a proprietary technology platform that enables the design of novel biologic product candidates in patient-friendly oral dosage forms.

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, statements regarding the ability of AMT to enter into a strategic transaction and sufficiency of AMT’s cash resources. In some cases, you can identify forward- looking statements by terminology such as “believe,” “estimate,” “intend,” “may,” “plan,” “potentially,” “will,” “expect,” “enable,” “likely” 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)
	September 30, 2023				December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	18,103			$	61,145
Prepaid expenses		457				2,688
Other current assets		259				186
Total current assets		18,819				64,019
Property and equipment, net		31				8,183
Operating lease right-of-use assets		1,165				33,222
Finance lease right-of-use assets		—				584
Restricted cash		—				916
Other assets		—				522
Total assets	$	20,015			$	107,446
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	161			$	1,583
Accrued expenses		2,261				8,660
Lease liabilities, operating lease - current		1,353				4,639
Lease liabilities, finance lease - current		—				205
Total current liabilities		3,775				15,087
Lease liabilities, operating lease		—				31,228
Lease liabilities, finance lease		—				49
Other liabilities		—				244
Total liabilities		3,775				46,608
Commitments and contingencies
Stockholders’ equity:
Common stock		4				4
Additional paid-in capital		434,393				426,804
Accumulated deficit		(418,157	)			(365,970	)
Total stockholders’ equity		16,240				60,838
Total liabilities and stockholders’ equity	$	20,015			$	107,446

Applied Molecular Transport Inc. Condensed Statements of Operations (unaudited) (in thousands, except share and per share amounts)
	Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Operating expenses:
Research and development	$	250			$	18,233			$	15,796			$	72,273
General and administrative		7,007				7,281				20,804				28,052
Restructuring, impairment, and related charges		(40	)			12				16,832				3,799
Total operating expenses		7,217				25,526				53,432				104,124
Loss from operations		(7,217	)			(25,526	)			(53,432	)			(104,124	)
Interest income, net		283				321				1,281				393
Other income (expense), net		(3	)			(1	)			(36	)			5
Net loss	$	(6,937	)		$	(25,206	)		$	(52,187	)		$	(103,726	)
Net loss per share, basic and diluted	$	(0.17	)		$	(0.65	)		$	(1.32	)		$	(2.68	)
Weighted-average shares of common stock outstanding, basic and diluted		39,751,028				38,914,570				39,426,218				38,769,226

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

Investor Relations Contact:
Alexandra Santos
Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com

Media Contact:
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com

 

FAQ

What is the merger agreement between Applied Molecular Transport Inc. and Cyclo Therapeutics about?

The merger agreement focuses on advancing Trappsol® Cyclo™ for the treatment of Niemann-Pick Disease Type C1 (NPC1).

What are the upcoming milestones for Applied Molecular Transport Inc.?

Upcoming milestones include completion of enrollment in pivotal Phase 3 clinical trial in NPC1, reporting top line data and preparation for NDA submission.

What were the financial results for the third quarter of 2023?

The company reported a significant decrease in research and development expenses compared to the same period in 2022, leading to a reduced net loss and cash and cash equivalents of $18.1 million as of September 30, 2023.

How much were the research and development expenses for the third quarter of 2023?

Total R&D expenses for the third quarter of 2023 were $0.3 million, compared to $18.2 million for the same period in 2022.

What was the net loss for the third quarter of 2023?

Net loss for the third quarter of 2023 was $6.9 million, compared to $25.2 million for the same period in 2022.