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
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Item 2.02 Results of Operations and Financial Condition.
On September 13, 2021, Eliem Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 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.
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99.1 |
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Press release of Eliem Therapeutics, Inc., dated September 13, 2021 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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: September 13, 2021 |
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By: |
/s/ Robert W. Azelby |
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Robert W. Azelby |
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Chief Executive Officer |
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Eliem Therapeutics Reports Second Quarter Financial Results
On track to advance two clinical programs through five proof-of-concept trials and progress two preclinical programs over the next 18-24 months
Recently completed an IPO for $92 million in gross proceeds that, along with existing cash, provides cash runway through late 2023
SEATTLE and CAMBRIDGE, UK, --(BUSINESS WIRE) – September 13, 2021 – Eliem Therapeutics, Inc., 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 ended June 30, 2021.
“It has been an exciting year thus far for Eliem, highlighted by our successful initial public offering (IPO) that we completed in August,” said Bob Azelby, Eliem’s president and chief executive officer. “In the second quarter, we continued to advance enrollment on our two Phase 2a studies for ETX-810 in patients with chronic pain conditions. We also made excellent progress toward initiating three clinical studies for ETX-155 in depressive disorders and epilepsy. The proceeds from our IPO, along with the additional capital we raised in our Series B financing in May 2021, are expected to fund our operations through late 2023. We believe this funding will take us through multiple topline clinical data readouts across five different indications and also allows us to advance our preclinical pipeline. We remain committed to developing therapies targeting debilitating disorders that impact tens of millions of people worldwide every day.”
Recent Highlights and Upcoming Milestones
Initial public offering raised $92 million gross proceeds: In August 2021, the Company announced the public offering of 7,360,000 shares of common stock, including the exercise in full of the underwriters’ option to purchase an additional 960,000 shares of common shares, at a public offering price of $12.50 per share. The Company received estimated net proceeds of $83.1 million from the IPO, after deducting underwriting discounts of $6.4 million and estimated offering costs of $2.5 million. The IPO was preceded by a Series B financing in May 2021 that raised gross proceeds of $60.0 million.
Program Updates and 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 patients with diabetic peripheral neuropathic pain (DPNP) and lumbosacral radicular pain (LSRP), commonly referred to as sciatica. ETX-810 was designed to optimize the oral absorption and systemic exposure of PEA, which is believed to play a critical role in the regulation of neuroinflammation and pain signaling in chronic pain.
ETX-155 in depression and epilepsy: ETX-155 is a novel GABAA receptor positive allosteric modulator that Eliem plans to evaluate in patients with major depressive disorder (MDD), perimenopausal depression (PMD) and focal onset seizure (FOS). ETX-155 was designed to have broad potency across both synaptic and extrasynaptic GABAA receptor subtypes. In Phase 1 clinical studies to date, ETX-155 was shown to be well tolerated with desirable pharmacokinetic properties, including no clinically meaningful food effect and at least a 24-hour half-life to enable once-a-day-dosing. The Company believes these attributes combine to position it well within the GABAA PAM therapeutic class.
Preclinical Pipeline: The Company is progressing two preclinical programs currently in the discovery stage.
Second Quarter 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: Eliem’s plans to initiate clinical trials of ETX-155 and the timing thereof; anticipated data readouts of ETX-810 and ETX-155 and the timing thereof; the progression of the Kv7.2/3 and next-generation anxiolytic preclinical programs; the sufficiency of Eliem’s current funds and anticipated cash runway through late 2023; and Eliem’s commitment to developing therapies targeting debilitating disorders. Words such as “on track,” "advance,” “progress,” “provides,” “runway,” “will,” “enable,” “expect,” “believe,” “plans,” “initiate,” 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 Eliem's compliance with applicable legal and regulatory requirements; market competition; changes in economic and business conditions; impacts on Eliem’s business due to 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 June 30, 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
Westwicke, an ICR Company
chris.brinzey@westwicke.com
339-970-2843
Media
Marites Coulter
Verge Scientific
Mcoulter@vergescientific.com
415.819.2214