8-K
0001768446false00017684462022-05-162022-05-16

 

 

 

 

 

 

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 16, 2022

 

ELIEM THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40708

83-2273741

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

23515 NE Novelty Hill Road, Suite

B221 #125

Redmond, WA

 

98053

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (425) 276-2300

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:

 

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(s)

 

Name of each exchange on which registered

 

Common Stock, par value $0.0001 per share

 

ELYM

 

The Nasdaq Stock Market LLC

 (The Nasdaq Global 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 Condition.

 

On May 16, 2022, Eliem Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1.

 

The information in this Item and the exhibit attached hereto are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

Number

 

Description

99.1

 

Press release of Eliem Therapeutics, Inc., dated May 16, 2022

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1


 

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 thereunto duly authorized.

 

 

 

Eliem Therapeutics, Inc.

 

 

 

 

Date: May 16, 2022

 

By:

/s/ Robert W. Azelby

 

 

 

Robert W. Azelby

 

 

 

President and Chief Executive Officer

 

 

2


EX-99.1

Exhibit 99.1

https://cdn.kscope.io/e57d3fafdb9fcb85b3526fd35861b4b7-img171973770_0.jpg  

 

Eliem Therapeutics Reports First Quarter Financial and Business Highlights

 

SEATTLE and CAMBRIDGE, UK, --(GLOBE NEWSWIRE) – May 16, 2022 – Eliem Therapeutics, Inc. (Nasdaq: ELYM), a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems, today provided a business update and reported financial results for the quarter ended March 31, 2022.

 

“We are excited about the potential of our pipeline in multiple neuronal excitability disorders,” said Bob Azelby, president and chief executive officer of Eliem Therapeutics. “While disappointed by the negative outcome of ETX-810 in diabetic peripheral neuropathic pain, we look forward to providing the topline Phase 2a data for ETX-810 in lumbosacral radicular pain, the chronic pain indication with the most robust precedent clinical validation for this mechanism, in the third quarter of 2022. In addition to ETX-810, we remain committed to the development of our ETX-155 program in depression and epilepsy and will provide an update on our path forward once we complete our previously reported root cause analysis relating to the interim results from our Phase 1b photosensitive epilepsy trial. Due to our strong balance sheet, we also intend to advance our novel Kv7 channel opener program into IND-enabling studies this year and we continue to believe this program has potential to be best-in-class.”

 

Program Updates and Anticipated Key Milestones

 

ETX-810 in chronic pain: ETX-810 is a novel, new chemical entity prodrug of the bioactive lipid palmitoylethanolamide (PEA) that is currently being evaluated in a Phase 2a clinical trial in subjects with lumbosacral radicular pain (LSRP), commonly referred to as sciatica. The Company announced the completion of enrollment of the LSRP Phase 2a trial in April 2022, with topline data expected in the third quarter of 2022. In addition, in April 2022, the Company reported topline data from its Phase 2a trial in diabetic peripheral neuropathic pain (DPNP), which did not meet the primary endpoint.

 

ETX-155 in depression and epilepsy: ETX-155 is a novel GABAA receptor positive allosteric modulator that the Company plans to evaluate in subjects with major depressive disorder (MDD), perimenopausal depression (PMD), and epilepsy. In March 2022, the Company received clearance from the U.S. Food and Drug Administration (FDA) of the investigational new drug application (IND) for two Phase 2a clinical trials for ETX-155 in patients with MDD and PMD. In April 2022, the Company reported that interim results from the first three subjects in its Phase 1b proof-of-concept trial for ETX-155 in photosensitive epilepsy were inconclusive, and that this was attributed to a lower-than-expected drug exposure in these subjects relative to exposures observed in Phase 1. The Company is in the process of investigating the root cause of this reduced exposure and has elected to delay enrollment of the Phase 2a MDD and PMD trials pending further information from this root cause investigation.

 

Kv7.2/3 channel opener program: The Company’s preclinical program targets the Kv7.2/3 potassium channel, a target that has been shown to control neuronal excitability and that has clinical validation in pain and epilepsy. The Company remains on track to initiate IND-enabling studies in 2022.

 

Anxiolytic for generalized anxiety disorder (GAD): The Company is in early preclinical development of a novel, rapid-acting, non-sedating, non-addictive anxiolytic for the potential treatment of GAD. The Company is continuing the preclinical development of this program with the intent to provide a development plan update later in 2022.

 

 


 

First Quarter 2022 Financial Results

 

Cash Position: Cash, cash equivalents and short- and long-term marketable securities was $149.9 million as of March 31, 2022, as compared to $47.9 million as of March 31, 2021. This includes net proceeds from the Company’s August 2021 initial public offering. The Company’s current cash, cash equivalents and short- and long-term marketable securities are expected to fund operations through at least 2023.
Research and Development (R&D) expenses: R&D expenses were $8.3 million for the three months ended March 31, 2022, compared to $4.7 million for the same period in 2021.
General and Administrative (G&A) expenses: G&A expenses were $4.9 million for the three months ended March 31, 2022, compared to $2.2 million for the same period in 2021.
Net loss: Net loss was $13.2 million for the three months ended March 31, 2022, compared to $18.6 million for the same period in 2021. The same period in 2021 included a non-recurring $11.7 million expense related to a change in fair value of redeemable convertible preferred stock.

 

 

About Eliem Therapeutics, Inc.

 

Eliem Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel therapies for neuronal excitability disorders to address unmet needs in chronic pain, psychiatry, epilepsy and other disorders of the peripheral and central nervous systems. These disorders often occur when neurons are overly excited or inhibited, leading to an imbalance, and our focus is on restoring homeostasis. We are developing a pipeline of clinically differentiated product candidates focused on validated mechanisms of action with broad therapeutic potential to deliver improved therapeutics for patients with these disorders. Eliem channels its experience, energy, and passion for improving patients’ quality of life to fuel our efforts to develop life-changing novel therapies. At its core, the Eliem team is motivated by the promise of helping patients live happier, more fulfilling lives. https://eliemtx.com/

 

 


 

Forward-Looking Statements

 

This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical and therapeutic potential of Eliem’s pipeline; Eliem’s plans for clinical trials of ETX-155 and the timing thereof; the anticipated topline data readout of ETX-810 in LSRP and the timing thereof; the progression of the Kv7.2/3 and next-generation anxiolytic preclinical programs; the expectation that Eliem’s current cash, cash equivalents and short- and long-term marketable securities will fund operations through at least 2023; and Eliem’s commitment to developing therapies targeting debilitating disorders. Words such as “advance,” “believe,” “committed,” “continue,” “excited,” “expected,” “initiate,” “intend,” “intent,” “investigation,” “look forward,” “on track,” “plans,” “potential,” “remain,” “update,” “will,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Eliem's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the clinical, therapeutic and commercial value of ETX-810, ETX-155 and Eliem’s preclinical programs; risks related to the potential failure of ETX-810 and ETX-155 to demonstrate safety and efficacy in clinical testing; Eliem’s ability to initiate and conduct clinical trials and studies of ETX-810 and ETX-155 sufficient to achieve a positive completion; the availability of data at the expected times; Eliem's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Eliem's preclinical and clinical development activities; the sufficiency of Eliem's capital and other resources; risks and uncertainties related to regulatory application, review and approval processes and Eliem's compliance with applicable legal and regulatory requirements; market competition; changes in economic and business conditions; impacts on Eliem’s business due to external events, including health pandemics or other contagious outbreaks, such as the current COVID-19 pandemic; and other factors discussed under the caption "Risk Factors" in Eliem's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022. This filing, when available, is available on the SEC's website at www.sec.gov. Additional information will also be set forth in Eliem's other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Eliem expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Eliem's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

 

Investors

Chris Brinzey

ICR Westwicke

chris.brinzey@westwicke.com

339-970-2843

 

Media

Marites Coulter

Verge Scientific

Mcoulter@vergescientific.com

415.819.2214
 

 

 

 


 

 

Eliem Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(unaudited)
 

Assets

 

March 31, 2022

 

 

December 31, 2021

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

31,931

 

 

$

46,922

 

Short-term marketable securities

 

 

92,010

 

 

 

89,558

 

Prepaid expenses and other current assets

 

 

9,342

 

 

 

11,772

 

Total current assets

 

$

133,283

 

 

$

148,252

 

Operating lease right-of-use assets

 

 

807

 

 

 

 

Long-term marketable securities

 

 

25,911

 

 

 

24,919

 

Other long-term assets

 

 

2,418

 

 

 

70

 

Total assets

 

$

162,419

 

 

$

173,241

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

 

847

 

 

 

1,404

 

Accrued expenses

 

 

5,481

 

 

 

4,588

 

Accrued expenses, related party

 

 

109

 

 

 

39

 

Operating lease liabilities, current

 

 

459

 

 

 

 

Total current liabilities

 

$

6,896

 

 

$

6,031

 

Other long-term liabilities

 

 

 

 

 

7

 

Operating lease liabilities, net of current portion

 

 

381

 

 

 

 

Total liabilities

 

$

7,277

 

 

$

6,038

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Common stock, $0.0001 par value per share, 250,000,000 shares authorized; 26,567,681 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

244,480

 

 

 

242,939

 

Accumulated other comprehensive loss

 

 

(521

)

 

 

(123

)

Accumulated deficit

 

 

(88,820

)

 

 

(75,616

)

Total stockholders’ equity

 

$

155,142

 

 

$

167,203

 

Total liabilities and stockholders’ equity

 

$

162,419

 

 

$

173,241

 

 

 

 


 

Eliem Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

8,111

 

 

$

4,273

 

Research and development, related party

 

 

149

 

 

 

388

 

General and administrative

 

 

4,872

 

 

 

2,218

 

Total operating expenses

 

 

13,132

 

 

 

6,879

 

Loss from operations

 

 

(13,132

)

 

 

(6,879

)

Other income (expense):

 

 

 

 

 

 

Change in fair value of redeemable convertible preferred stock tranche liability

 

 

 

 

 

(11,718

)

Foreign currency loss

 

 

(157

)

 

 

(4

)

Other income, net

 

 

85

 

 

 

 

Total other income (expense)

 

 

(72

)

 

 

(11,722

)

Net loss

 

$

(13,204

)

 

$

(18,601

)

Accretion of redeemable convertible preferred stock to redemption value and cumulative preferred stock dividends

 

 

 

 

 

(1,085

)

Net loss attributable to common stockholders

 

$

(13,204

)

 

$

(19,686

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.50

)

 

$

(5.70

)

Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, basic and diluted

 

 

26,238,950

 

 

 

3,455,979

 

 

 

 

 

 

 

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(13,204

)

 

$

(18,601

)

Other comprehensive loss:

 

 

 

 

 

 

Unrealized loss on investments, net of tax of $0

 

 

(398

)

 

 

 

Comprehensive loss

 

$

(13,602

)

 

$

(18,601

)