0001104659-22-056128.txt : 20220506 0001104659-22-056128.hdr.sgml : 20220506 20220505070600 ACCESSION NUMBER: 0001104659-22-056128 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20220505 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220505 DATE AS OF CHANGE: 20220505 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BICYCLE THERAPEUTICS plc CENTRAL INDEX KEY: 0001761612 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38916 FILM NUMBER: 22893996 BUSINESS ADDRESS: STREET 1: B900 BABRAHAM RESEARCH CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB22 3AT BUSINESS PHONE: 011441223261503 MAIL ADDRESS: STREET 1: B900 BABRAHAM RESEARCH CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB22 3AT FORMER COMPANY: FORMER CONFORMED NAME: BICYCLE THERAPEUTICS Ltd DATE OF NAME CHANGE: 20181212 8-K 1 tm2214511d1_8k.htm FORM 8-K
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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

 

May 5, 2022

Date of Report (Date of earliest event reported)

 

Bicycle Therapeutics plc

(Exact name of registrant as specified in its charter)

 

England and Wales   001-38916   Not applicable

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

B900, Babraham Research Campus

Cambridge CB22 3AT

United Kingdom

 Not Applicable
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: +44 1223 261503

 

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
Ordinary shares, nominal value £0.01 per share n/a The Nasdaq Stock Market LLC*
American Depositary Shares, each representing one ordinary share, nominal value £0.01 per share BCYC The Nasdaq Stock Market LLC

* Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.

 

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 5, 2022, Bicycle Therapeutics plc (the “Company”) issued a press release announcing financial results for the fiscal quarter ended March 31, 2022 and other business highlights. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information contained in Item 2.02 in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01Other Events

 

Also on May 5, 2022, the Company posted an updated corporate presentation on the Company’s website. To access the presentation, investors should visit the “Investor Events and Presentations” section of the Company’s website at investors.bicycletherapeutics.com.

 

The information furnished under this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filing.

 

  Item 9.01 Financial Statements and Exhibits

 

(d)       Exhibits

 

Exhibit No.   Description
99.1   Press Release issued May 5, 2022
104   The cover page of this Current Report on Form 8-K, formatted in Inline XBRL. 

 

 

 

 

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 hereunto duly authorized.

 

Date: May 5, 2022 BICYCLE THERAPEUTICS PLC
   
  By: /s/ Lee Kalowski
  Name: Lee Kalowski
  Title: Chief Financial Officer

 

 

 

 

 EX-99.1 2 tm2214511d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Bicycle Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

 

-      Continued clinical progress across pipeline, including interim BT8009 Phase I clinical data

 

-      Cash and cash equivalents of $407.4 million as of March 31, 2022 expected to provide
financial runway through 2024

 

CAMBRIDGE, England, & BOSTON, May 5, 2022 – Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the first quarter ended March 31, 2022 and provided recent corporate updates.

 

“We have made significant progress recently across our oncology pipeline,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “We reported interim data for the Phase I portion of the Phase I/II trial in BT8009, showing an overall response rate, or ORR, of 50% in the 5mg/m2 weekly cohort in patients with urothelial cancer and an encouraging tolerability profile. We believe BT8009 has the potential to offer clinically meaningful differentiation compared to currently available therapies and we look forward to advancing the program once the dose escalation phase is complete. We also look forward to initiating the BT5528 Phase II expansion cohorts soon.”

 

Dr. Lee continued: “Beyond our Bicycle Toxin Conjugates®, or BTCs, we continue to be encouraged as we progress our Bicycle TICA™ programs forward, including BT7480, which is advancing in the dose escalation portion of the Phase I clinical trial. Underscoring our efforts is a strong balance sheet and we anticipate our cash and cash equivalents will provide financial runway through 2024.”

 

First Quarter 2022 and Recent Highlights

 

•Announced Interim BT8009 Phase I Clinical Trial Results at the 2022 American Association for Cancer Research (AACR) Annual Meeting. In April 2022, Bicycle announced interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC™ targeting Nectin-4. As of March 7, 2022, thirty-seven patients have been dosed in the Phase I/II trial of BT8009. A total of twelve response evaluable urothelial cancer (UC) patients have been dosed in monotherapy cohorts of 2.5mg/m2 and 5.0mg/m2 weekly in the ongoing trial. Four response evaluable UC patients were dosed at 2.5mg/m2 weekly, with one patient observed to have tumor reductions constituting a confirmed partial response (PR) and two patients observed to have stable disease (SD). Eight response evaluable UC patients were dosed at 5.0mg/m2 weekly, with four patients observed to have a confirmed complete response (CR) or PR, including one patient with a CR and three patients with a PR, and two patients with SD, reflecting a 50% ORR and 75% disease control rate. The median duration of response has not yet been reached in either the 2.5 mg/m2 or 5.0mg/m2 cohort, with four of the five responders in these cohorts still on therapy after at least 24 weeks, and a tolerability profile that remains consistent with earlier results from this trial.

 

Exploration of additional doses and frequencies continues, and Bicycle intends to provide further updates this year.

 

 

 

 

•Announced Updated Preclinical Data on SARS-CoV-2 Antivirals at the 2022 Microbiology Society Annual Meeting. Bicycle created a wide range of <10kDa molecules with high binding affinity to the SARS-CoV-2 spike protein and then tested them in partnership with researchers at the Medical Research Council Laboratory of Molecular Biology. They were shown to be highly active in vitro at preventing SARS-CoV-2 infection of human cells. These compounds were further tested in partnership with experts at the University of Liverpool and shown to be highly potent when administered in vivo to rodent models of SARS-CoV-2 infection. These molecules have also been shown to be active in vitro across many of the SARS-CoV-2 variant strains, including Alpha, Beta, Delta and Omicron.

 

Financial Results

 

•Cash and cash equivalents were $407.4 million as of March 31, 2022, compared to $438.7 million as of December 31, 2021. The decrease in cash is primarily due to cash used in operating activities.

 

•Research and development expenses were $14.3 million for the three months ended March 31, 2022, compared to $9.7 million for the three months ended March 31, 2021. The increase in expense of $4.6 million was primarily due to increased discovery and platform-related expenses, as well as increased personnel-related expenses, including $1.2 million of incremental non-cash share-based compensation expense.

 

•General and administrative expenses were $17.0 million for the three months ended March 31, 2022, compared to $8.1 million for the three months ended March 31, 2021. The increase of $8.9 million for the three months ended March 31, 2022 as compared to the same period in the prior year was primarily due to $5.2 million incremental non-cash share-based compensation expense, personnel-related costs and increased professional and consulting costs.

 

•Net loss was $27.6 million, or $(0.93) basic and diluted net loss per share, for the three months ended March 31, 2022, compared to net loss of $16.2 million, or $(0.73) basic and diluted net loss per share, for three months ended March 31, 2021.

 

About Bicycle Therapeutics

 

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC™) targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, Massachusetts. For more information, visit bicycletherapeutics.com.

 

 

 

 

Forward Looking Statements

 

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s anticipated advancement of its product candidates, including BT8009, BT5528 and BT7480; the anticipated design of, initiation of expansion cohorts in, dosing in and progression of Bicycle’s clinical trials; the availability of data from clinical trials; the therapeutic potential for Bicycles in oncology and other applications; and Bicycle’s expected cash runway. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to clinical trial site initiation, patient enrollment and follow-up, and Bicycle’s ability to meet other anticipated deadlines and milestones presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of clinical trials and clinical development of Bicycle’s product candidates such as availability and timing of results from clinical trials, whether the outcomes of preclinical studies will be predictive of clinical trial results, whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials, the risk that trials may not have satisfactory outcomes, and potential adverse effects arising from the testing or use of Bicycle’s product candidates; the risk that Bicycle may not realize the intended benefits of its technology; the risk that Bicycle’s projections regarding its expected financial runway are inaccurate or that its conduct of its business requires more cash than anticipated; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, and which are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2022, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

 

 

 

 

Bicycle Therapeutics plc 

Condensed Consolidated Statements of Operations and Comprehensive Loss 

(In thousands, except share and per share data) 

(Unaudited)

 

         
   Three Months Ended 
   March 31, 
   2022   2021 
Collaboration revenues  $3,860   $1,808 
Operating expenses:          
Research and development   14,284    9,693 
General and administrative   16,959    8,139 
Total operating expenses   31,243    17,832 
Loss from operations   (27,383)   (16,024)
Other income (expense):          
Interest income   218    15 
Interest expense   (818)   (522)
Total other income (expense), net   (600)   (507)
Net loss before income tax provision   (27,983)   (16,531)
Benefit from income taxes   (419)   (340)
Net loss  $(27,564)  $(16,191)
Net loss per share, basic and diluted  $(0.93)  $(0.73)
Weighted average ordinary shares outstanding, basic and diluted   29,605,143    22,100,840 

 

 

 

 

Balance Sheets Data 

(In thousands) 

(Unaudited)

 

   March 31,   December 31, 
   2022   2021 
Cash and cash equivalents  $407,371   $438,680 
Working capital   394,352    422,317 
Total assets   459,563    479,792 
Total shareholders’ equity   330,258    346,254 

 

Contact: 

David Borah, CFA 

VP, Capital Markets & Investor Relations 

david.borah@bicycletx.com 

617 203-8300

 

 

 

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Cover
May 05, 2022
Document Information [Line Items]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 05, 2022
Entity File Number 001-38916
Entity Registrant Name Bicycle Therapeutics plc
Entity Central Index Key 0001761612
Entity Tax Identification Number 00-0000000
Entity Incorporation, State or Country Code X0
Entity Address, Address Line One B900
Entity Address, Address Line Two Babraham Research Campus
Entity Address, City or Town Cambridge
Entity Address, Country GB
Entity Address, Postal Zip Code CB22 3AT
City Area Code +44
Local Phone Number 1223 261503
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Common Stock [Member]  
Document Information [Line Items]  
Title of 12(b) Security Ordinary shares, nominal value £0.01 per share
No Trading Symbol Flag true
Security Exchange Name NASDAQ
American Depositary Shares [Member]  
Document Information [Line Items]  
Title of 12(b) Security American Depositary Shares, each representing one ordinary share, nominal value £0.01 per share
Trading Symbol BCYC
Security Exchange Name NASDAQ
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