UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 March 7, 2022, Eliem Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2021. 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 |
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Description |
99.1 |
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Press release of Eliem Therapeutics, Inc., dated March 7, 2022 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
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Eliem Therapeutics, Inc. |
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Date: March 7, 2022 |
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By: |
/s/ Robert Azelby |
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Robert Azelby |
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President and Chief Executive Officer |
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Exhibit 99.1
Eliem Therapeutics Reports Fourth Quarter and Year-End Financial and Business Highlights
Completed dosing in Phase 2a clinical trial of ETX-810 in subjects with diabetic peripheral neuropathic pain; topline data to be presented in 1H 2022
Interim data from Phase 1b clinical trial of ETX-155 in subjects with photosensitive epilepsy to be presented in 1H 2022
Submitted Investigational New Drug (IND) application for ETX-155 to the U.S. Food and Drug Administration (FDA)'s psychiatry division
SEATTLE and CAMBRIDGE, UK, --(GLOBE NEWSWIRE) – March 7, 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 reported financial results and business highlights for the quarter and year ended December 31, 2021.
“In 2021, we made significant progress on our pipeline and raised sufficient capital to fund the company through multiple catalysts,” said Bob Azelby, president and chief executive officer of Eliem Therapeutics. “We were excited to start off the new year by completing our Phase 2a clinical trial of ETX-810 in diabetic peripheral neuropathic pain and look forward to presenting the topline data from this trial in the first half of this year. Even with a polypharmacy approach, a majority of patients with chronic pain are unable to achieve clinically significant reductions in pain and are often balancing tolerability tradeoffs to achieve additional pain reduction. With ETX-810, we believe we have the potential to introduce a differentiated chronic pain therapy that is both efficacious and well-tolerated. On our ETX-155 program, we expect to report interim data on our proof-of-concept Phase 1b study for photosensitive epilepsy, and we look forward to dosing patients in our depression studies assuming FDA clearance of our IND.”
Recent Highlights
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 two Phase 2a clinical trials in subjects with DPNP and lumbosacral radicular pain (LSRP), commonly referred to as sciatica.
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.
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 plans 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.
Fourth Quarter and Year-End 2021 Financial Results
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 ETX-155 and ETX-810; Eliem’s plans to initiate clinical trials of ETX-155 and the timing thereof; anticipated enrollment, dosing, and data readouts of ETX-810 and ETX-155 and the timing thereof; timing of regulatory filings and approvals; the progression of the Kv7.2/3 and next-generation anxiolytic preclinical programs; the expectation that Eliem’s current cash, cash equivalents and marketable securities will fund operations through late 2023; and Eliem’s commitment to developing therapies targeting debilitating disorders. Words such as “excited,” “look forward,” “believe,” “potential,” “on track,” “expects,” “opportunity,” “continues,” “plans,” “runway,” “initiate,” “support,” 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 Annual Report on Form 10-K for the year ended December 31, 2021. 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.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
Assets |
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December 31, 2021 |
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December 31, 2020 |
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Current assets: |
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Cash and cash equivalents |
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$ |
46,922 |
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$ |
20,487 |
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Short-term marketable securities |
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89,558 |
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— |
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Prepaid expenses and other current assets |
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11,772 |
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1,511 |
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Total current assets |
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$ |
148,252 |
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$ |
21,998 |
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Long-term marketable securities |
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24,919 |
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— |
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Other long-term assets |
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70 |
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2,633 |
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Total assets |
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$ |
173,241 |
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$ |
24,631 |
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Liabilities, redeemable convertible preferred stock, and stockholders’ deficit |
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Current liabilities: |
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Accounts payable |
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1,404 |
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1,086 |
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Accounts payable, related party |
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— |
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207 |
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Accrued expenses |
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4,588 |
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1,219 |
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Accrued expenses, related party |
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39 |
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— |
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Redeemable convertible preferred stock tranche liability |
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— |
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551 |
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Total current liabilities |
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$ |
6,031 |
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$ |
3,063 |
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Other long-term liabilities |
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7 |
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$ |
— |
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Total liabilities |
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$ |
6,038 |
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$ |
3,063 |
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Redeemable convertible preferred stock, $0.0001 par value per share, 10,000,000 and 12,909,389 shares authorized, 0 and 7,140,157 shares issued and outstanding with aggregate liquidation preference of $0 and $49,891 at December 31, 2021 and 2020, respectively |
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— |
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46,551 |
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Stockholders’ equity (deficit): |
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Common stock, $0.0001 par value per share, 250,000,000 and 40,000,000 shares authorized and 26,235,317 and 3,418,751 shares issued and outstanding at December 31, 2021 and 2020, respectively |
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3 |
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1 |
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Additional paid-in capital |
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242,939 |
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3,152 |
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Accumulated other comprehensive income |
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(123 |
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— |
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Accumulated deficit |
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(75,616 |
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(28,136 |
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Total stockholders’ equity (deficit) |
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$ |
167,203 |
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$ |
(24,983 |
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Total liabilities, redeemable convertible preferred stock, |
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$ |
173,241 |
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$ |
24,631 |
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Eliem Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(unaudited)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
6,591 |
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$ |
4,125 |
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$ |
22,046 |
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$ |
8,769 |
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Research and development, related party |
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288 |
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287 |
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1,276 |
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573 |
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In-process research and development |
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— |
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9,158 |
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— |
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9,158 |
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General and administrative |
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3,824 |
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1,537 |
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12,350 |
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2,425 |
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Total operating expenses |
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10,703 |
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15,107 |
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35,672 |
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20,925 |
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Loss from operations |
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(10,703 |
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(15,107 |
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(35,672 |
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(20,925 |
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Other income (expense): |
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Change in fair value of redeemable convertible preferred stock tranche liability |
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— |
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— |
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(11,718 |
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— |
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Foreign currency gain (loss) |
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98 |
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244 |
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(170 |
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257 |
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Other income, net |
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60 |
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— |
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80 |
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— |
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Total other income (expense) |
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158 |
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244 |
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(11,808 |
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257 |
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Net loss |
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$ |
(10,545 |
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$ |
(14,863 |
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$ |
(47,480 |
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$ |
(20,668 |
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Accretion of redeemable convertible preferred stock to redemption value and cumulative preferred stock dividends |
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— |
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(933 |
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(4,548 |
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(2,285 |
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Net loss attributable to common stockholders |
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$ |
(10,545 |
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$ |
(15,796 |
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$ |
(52,028 |
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$ |
(22,953 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.40 |
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$ |
(4.99 |
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$ |
(4.24 |
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$ |
(10.49 |
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Weighted-average number of shares outstanding used to compute net loss per share attributable to common stockholders, basic and diluted |
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26,225,842 |
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3,164,981 |
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12,260,551 |
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2,187,813 |
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