Homology Medicines Inc
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Health Care : Biotechnology | Small Cap Blend
Company profile

Homology Medicines, Inc. is a clinical-stage genetic medicines company focused on providing treatment for rare genetic diseases. The Company’s clinical programs include HMI-102, is an investigational gene therapy candidate in clinical development for the treatment of adult patients with phenylketonuria (PKU); HMI-103, which is an investigational gene editing candidate in clinical development for the treatment of patients with PKU, and HMI-203, which is an investigational gene therapy candidate in clinical development for the treatment of patients with mucopolysaccharidosis type II (MPS II), or Hunter syndrome. Additionally, the Company is developing a gene therapy candidate, HMI-104, from its GTx-mAb platform for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), and conducting research in other diseases, including metachromatic leukodystrophy (MLD). Its platform is designed to utilize human hematopoietic stem cell derived adeno-associated virus vectors.

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COMPASS Pathways plc announces second quarter 2022 financial results and business highlights

7:00 am ET August 4, 2022 (Globe Newswire) Print


-- Kabir Nath appointed as Chief Executive Officer
-- Phase III program submitted to FDA and under review
-- COMP360 phase II study in anorexia nervosa launched
-- Cash position at 30 June 2022 of $207.2 million
Conference call today at 8:00am ET (1:00pm UK)

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the second quarter 2022 and gave an update on recent progress across its business.

George Goldsmith, Executive Chairman of COMPASS Pathways, said, "Our decision to appoint Kabir Nath as our new CEO comes at the ideal time as we enter the late stages of COMP360 development and plan for regulatory approval and commercialization. Kabir's dedication to our mission, extensive experience in leading the commercialization of innovative therapies and track record of successful strategic growth are precisely what COMPASS needs to advance our goal to bring COMP360 psilocybin therapy to the large number of patients who are not currently served by existing treatments. I look forward to working closely with him as Chairman."

Goldsmith continued, "Following our end of phase II meeting with FDA, we have submitted our Phase 3 protocols and they are under review. We are pleased with the progress and remain on track to start our phase III clinical program this year. We also continue to expand our clinical development of COMP360 therapy with the commencement of a phase II study in anorexia nervosa, a condition of significant unmet need for which there are no FDA approved pharmacological treatment options."

Business highlights

COMPASS expands leadership:

COMP360 psilocybin therapy in treatment-resistant depression (TRD):

Additional COMP360 development activities:

-- Strategic partnership formed in March 2022 to launch The Centre for Mental Health Research and Innovation to accelerate research and develop new models of mental healthcare in the UK, in partnership with South London and Maudsley NHS Foundation Trust (SLaM), and IoPPN at King's College London

Financial highlights

Conference call

The COMPASS Pathways management team will host a conference call at 8.00am ET (13.00 UK) on 4 August 2022.

Please register in advance here to access the call and obtain a local or toll-free phone number and personal pin.

A live webcast of the call will be available on COMPASS Pathway's website at: Second Quarter 2022 Financial Results.

The webcast will also be available on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

The call will also be webcast on the COMPASS Pathways website and archived for 30 days. For more information, please visit the COMPASS Pathways website (ir.compasspathways.com).

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, COMPASS' business strategy and goals, the expected timing for finalizing Phase III trial design and launching Phase III trial of COMP360 psilocybin therapy in TRD, the safety or efficacy of its investigational COMP360 psilocybin therapy, including for treatment of TRD or anorexia nervosa, and COMPASS' expectations regarding its ongoing preclinical work and clinical trials, development efforts and innovation labs. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS' control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; our development efforts and our business strategy to set up research facilities and innovation labs will involve significant costs and resources and may be unsuccessful; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS' most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC") , which are available on the SEC's website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS' current expectations and speak only as of the date hereof.


Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324


Condensed Consolidated Balance Sheets


(in thousands, except share and per share amounts)

(expressed in U.S. Dollars, unless otherwise stated)

                                                                                                                                                            June 30,      December 31,
                                                                                                                                                            2022          2021
Cash and cash equivalents                                                                                                                                   $    207,177  $      273,243
Restricted cash                                                                                                                                                  104      104
Prepaid income tax                                                                                                                                               --       332
Prepaid expenses and other current assets                                                                                                                        24,713   21,621
Total current assets                                                                                                                                             231,994  295,300
Investment                                                                                                                                                       470      525
Property and equipment, net                                                                                                                                      681      398
Operating lease right-of-use assets                                                                                                                              3,087    3,696
Deferred tax assets                                                                                                                                              1,994    766
Other assets                                                                                                                                                     410      213
Total assets                                                                                                                                                $    238,636  $      300,898
Accounts payable                                                                                                                                            $    3,354    $      2,564
Accrued expenses and other liabilities                                                                                                                           7,710    10,308
Operating lease liabilities - current                                                                                                                            2,169    2,235
Total current liabilities                                                                                                                                        13,233   15,107
Operating lease liabilities - non-current                                                                                                                        818      1,379
Total liabilities                                                                                                                                           14,051        16,486
Commitments and contingencies (Note 12)
Ordinary shares, £0.008 par value; 42,522,397 and 42,019,874 shares authorized, issued and outstanding at June 30, 2022 and December 31, 2021, respectively 440           435
Deferred shares, £21,921.504 par value; one share authorized, issued and outstanding at June 30, 2022 and December 31, 2021                                 28            28
Additional paid-in capital                                                                                                                                  451,453       444,750
Accumulated other comprehensive (loss)/income                                                                                                               (15,487)      8,840
Accumulated deficit                                                                                                                                         (211,849)     (169,641)
Total shareholders' equity                                                                                                                                  224,585       284,412
Total liabilities and shareholders' equity                                                                                                                  $    238,636  $      300,898


Condensed Consolidated Statements of Operations and Comprehensive Loss


(in thousands, except share and per share amounts)

(expressed in U.S. Dollars, unless otherwise stated)

                                                                            Three months ended June 30, Six months ended June 30,
                                                                            2022          2021          2022          2021
Research and development                                                    $     15,920  $     11,353  $     31,282  $     18,237
General and administrative                                                  11,336        8,175         21,394        14,893
Total operating expenses                                                    27,256        19,528        52,676        33,130
LOSS FROM OPERATIONS:                                                       (27,256)      (19,528)      (52,676)      (33,130)
Other income, net                                                           240           1             374           2
Foreign exchange gains (losses)                                             1,958         (550)         3,291         (1,193)
Benefit from R&D tax credit                                                 4,077         2,558         6,999         4,115
Total other income, net                                                     6,275         2,009         10,664        2,924
Loss before income taxes                                                    (20,981)      (17,519)      (42,012)      (30,206)
Income tax expense                                                          (56)          (9)           (196)         (37)
Net loss                                                                    (21,037)      (17,528)      (42,208)      (30,243)
Other comprehensive (loss) income:
Foreign exchange translation adjustment                                     (17,134)      (355)         (24,327)      1,633
Comprehensive loss                                                          (38,171)      (17,883)      (66,535)      (28,610)
Net loss per share attributable to ordinary shareholders--basic and diluted $     (0.50)  $     (0.44)  $     (1.00)  $     (0.79)
Weighted average ordinary shares outstanding--basic and diluted             42,474,987    39,802,532    42,110,161    38,194,822



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