- Significant recent progress achieved across pipeline of innovative Bicycle®-based therapies for oncology and beyond
- Dosing underway in Phase I dose escalation of BT5528 in combination with nivolumab
- Continued to strengthen corporate leadership with appointment of General Counsel
- Cash was
“We are very proud of the tremendous progress we’ve made executing against our 2020 goals in the first few months of this year,” said
First Quarter 2020 and Recent Highlights
-
Appointed
Zafar Qadir as General Counsel.Mr. Qadir joined Bicycle as head of the Company’s legal function inApril 2020 . -
Provided Comprehensive Pipeline Progress Update. In
April 2020 , Bicycle announced updates across its wholly-owned and partnered programs in oncology and non-oncology indications:-
The key objectives were met in the Phase I dose escalation portion of the Phase I/IIa study of BT1718, a BTC targeting MT1-MMP, in patients with solid tumors, sponsored by
Cancer Research UK . A recommended Phase II dose was set at 20 mg/m2 administered once weekly. With once-weekly dosing, BT1718 appeared tolerable, with manageable adverse events. Additionally, preliminary signs of anti-tumor activity were observed, including one partial response of a 68% reduction in a target lesion. The Company continues to expect thatCancer Research UK will initiate the Phase IIa portion of the Phase I/IIa study of BT1718 in 2020, although timing may be dependent on the impact of the COVID-19 pandemic. At present, enrollment of new patients into the Phase IIa portion of the trial atCancer Research UK clinical sites in theUK has been paused due to the COVID-19 pandemic. - To date, administered doses of BT5528, a second-generation BTC targeting EphA2, appear well-tolerated with manageable adverse events in the ongoing Phase I/II trial in patients with advanced solid tumors associated with EphA2 expression. Dosing in both the monotherapy and nivolumab combination arms is underway. The combination arm opened in the second quarter of 2020, and the monotherapy escalation continues toward clinically relevant doses.
- In 2020, Bicycle expects to initiate a Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4, in patients with advanced solid tumors, subject to potential timing and other impacts of the ongoing COVID-19 pandemic.
- IND-enabling activities for BT7480 are ongoing and on track to a potential initiation of clinical development in 2021, subject to potential timing and other impacts of the ongoing COVID-19 pandemic. BT7480 is a tumor-targeted immune cell agonist (TICA™) that targets Nectin-4 and agonizes CD137.
- The Company expanded its immuno-oncology pipeline, selecting BT7455 as a new TICA candidate. BT7455 targets EphA2 and agonizes CD137.
-
Cancer Research UK continues to advance preclinical development of BT7401, a systemic agonist of CD137. -
Progress has also been made in the Company’s partnered programs beyond oncology: preparations for Oxurion’s Phase II trial of THR-149 are ongoing; three target programs in respiratory, cardiovascular, and metabolic diseases were transitioned to AstraZeneca for subsequent optimization towards potential candidate selection; and there has been early success in the collaboration with
Dementia Discovery Fund (DDF) to develop Bicycles to modulate the activity of proteins implicated in the progression of dementia.
-
The key objectives were met in the Phase I dose escalation portion of the Phase I/IIa study of BT1718, a BTC targeting MT1-MMP, in patients with solid tumors, sponsored by
-
Entered into Strategic Collaboration with
Genentech to Discover, Develop and Commercialize Novel Bicycle-based Immuno-oncology Therapies. InFebruary 2020 , Bicycle entered into a strategic collaboration agreement withGenentech . Under the terms of the agreement, Bicycle will be responsible for discovery research and early preclinical development up to candidate selection. Bicycle received a$30 million upfront payment. The upfront payment, an early milestone payment and potential future milestone payments could total up to$1.7 billion . Bicycle will also be eligible to receive tiered royalties. None of Bicycle’s wholly-owned oncology assets, including its immuno-oncology candidates, are included in the collaboration.
Upcoming Investor Presentation
Bicycle will present at the
A live webcast of the presentation will be accessible in the Investors & Media section of Bicycle’s website at bicycletherapeutics.com. An archived replay of the webcast will be available for 60 days following the presentation date.
Financial Results
-
Cash and cash equivalents were
$109.6 million as ofMarch 31, 2020 , compared with$92.1 million as ofDecember 31, 2019 . Cash atMarch 31, 2020 includes the$30 million upfront payment fromGenentech . -
Research and development expenses totaled
$7.8 million for the three months endedMarch 31, 2020 , compared to$6.3 million for the three months endedMarch 31, 2019 . The increase of$1.5 million is primarily due to increased clinical and TICA program development expenses, partially offset by lower development expenses of other programs due to timing and an increase in personnel related costs, including$0.6 million of incremental non-cash share-based compensation expense. -
General and administrative expenses were
$5.0 million for the three months endedMarch 31, 2020 , compared to$3.4 million for the three months endedMarch 31, 2019 . The increase of$1.6 million is primarily due to an increase in personnel related costs, including$1.3 million of incremental non-cash share-based compensation expense as well as professional fees and costs related to operations as a public company, partially offset by a favorable effect of foreign exchange rates. -
Net loss was
$11.3 million , or$(0.63) basic and diluted net loss per share, for the three months endedMarch 31, 2020 , compared to net loss of$6.5 million , or$(7.80) basic and diluted net loss per share, for the quarter endedMarch 31, 2019 .
About
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 collaborations with multiple third parties; the discovery, development and potential commercialization of product candidates using Bicycle’s technology and under collaboration agreements with third parties; anticipated advancement of preclinical development efforts and initiation and progression of clinical trials; the therapeutic potential for Bicycles in various disease applications; the potential impacts of the ongoing COVID-19 pandemic on site initiation, patient enrollment and treatment; Bicycle’s ability to achieve planned milestones; and the potential to receive milestone payments and royalties under our collaboration agreements. 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: the risk that Bicycle may not realize the intended benefits of its technology, including that Bicycle or its collaboration partners may not identify, develop and commercialize additional product candidates; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Bicycle’s product candidates; availability and timing of results from preclinical studies and clinical trials; 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 and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle’s product candidates; risks related to Bicycle’s ability to maintain existing collaborations and realize the benefits thereof; expectations for regulatory approvals to conduct trials or to market products; risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as to Bicycle’s and its collaboration partners’ abilities to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the
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|
|
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Three Months Ended
|
||||||
|
|
2020 |
|
2019 |
||||
Collaboration revenues |
|
$ |
1,129 |
|
|
$ |
6,384 |
|
Operating expenses: |
|
|
|
|
||||
Research and development |
|
|
7,774 |
|
|
6,276 |
|
|
General and administrative |
|
|
4,998 |
|
|
|
3,402 |
|
Total operating expenses |
|
|
12,772 |
|
|
|
9,678 |
|
Loss from operations |
|
|
(11,643 |
) |
|
|
(3,294 |
) |
Other income (expense): |
|
|
|
|
||||
Interest and other income |
|
|
212 |
|
|
|
64 |
|
Other expense, net |
|
|
— |
|
|
|
(3,193 |
) |
Total other income (expense), net |
|
|
212 |
|
|
|
(3,129 |
) |
Net loss before income tax provision |
|
|
(11,431 |
) |
|
|
(6,423 |
) |
(Benefit from) provision for income taxes |
|
|
(107 |
) |
|
|
80 |
|
Net loss |
|
$ |
(11,324 |
) |
|
$ |
(6,503 |
) |
Net loss attributable to ordinary shareholders |
|
$ |
(11,324 |
) |
|
$ |
(6,503 |
) |
Net loss per share attributable to ordinary shareholders, basic and diluted |
|
$ |
(0.63 |
) |
|
$ |
(7.80 |
) |
Weighted average ordinary shares outstanding, basic and diluted |
|
|
17,997,929 |
|
|
|
834,043 |
Balance Sheets Data
|
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|
||
|
|
|
|
|
||
Cash |
|
$ |
109,637 |
|
$ |
92,117 |
Working capital |
|
|
107,193 |
|
|
95,325 |
Total assets |
|
|
129,282 |
|
|
110,194 |
Shareholders' equity |
|
|
81,813 |
|
|
93,198 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200507005114/en/
Investor and Media Contact:
maren.killackey@bicycletx.com
+1-617-203-8300
Source: