- Entered exclusive license and collaboration agreement with Ionis Pharmaceuticals to develop targeted oligonucleotide therapeutics
- Cash was
- Cash expected to provide financial runway through multiple clinical milestones expected in the second half of the year and into 2024
“We have made significant progress executing on our ongoing company-sponsored clinical programs over the first half of the year and, looking forward, intend to announce interim clinical data from the Phase I portion of our Phase I/II clinical trials of BT5528 and BT8009, along with the expected Phase I/II BT7840 trial initiation, in the second half of the year,” said
Second Quarter 2021 and Recent Highlights
-
Entered into an Exclusive License and Collaboration Agreement with Ionis Pharmaceuticals to Develop Targeted Oligonucleotide Therapeutics. In
July 2021 , Ionis exercised its option under the terms of aDecember 2020 evaluation and option agreement and entered into an exclusive worldwide license and collaboration agreement for tissue-targeted delivery of oligonucleotide therapeutics using Bicycles with high affinity to the transferrin receptor (TfR1). Bicycle received$45 million upfront, which included a license fee, an option fee, and an$11 million equity investment. Bicycle is also eligible to receive development, regulatory and commercial milestone payments and royalties for programs developed under the collaboration. -
Continued to Strengthen the Balance Sheet in the Second Quarter of 2021. The Company recognized gross proceeds from Bicycle’s at-the-market (ATM) offering program during the second quarter of 2021 totaling
$14.4 million as ofJune 30, 2021 , with an additional$30.8 million received inJuly 2021 . Cash as ofJune 30, 2021 does not include$42 million of proceeds from the Ionis license and collaboration agreement or net proceeds from the ATM offering program received subsequent to the end of the second quarter of 2021.
Financial Results
-
Cash was
$198.7 million as ofJune 30, 2021 , compared to$136.0 million as ofDecember 31, 2020 . The increase in cash during the first six months of 2021 is primarily due to net proceeds of$72.8 million from the ATM offering program and net proceeds of$15.0 million from the debt facility with Hercules Capital, Inc., offset by cash used in operating activities. Cash of$198.7 million atJune 30, 2021 is expected to provide financial runway through multiple clinical milestones and into 2024. -
Research and development expenses were
$11.7 million for the three months endedJune 30, 2021 , compared to$8.0 million for the three months endedJune 30, 2020 . The increase in expense of$3.7 million for the three months endedJune 30, 2021 as compared to the same period in the prior year was primarily due to increased clinical program expenses for BT8009, a second-generation Bicycle Toxin Conjugate (BTC™) targeting Nectin-4, increased other unallocated discovery and platform related expenses due to the timing of development activities, and increased personnel-related expenses, including$0.6 million of incremental non-cash share-based compensation expense. -
General and administrative expenses were
$7.3 million for the three months endedJune 30, 2021 , compared to$6.2 million for the three months endedJune 30, 2020 . The increase of$1.1 million for the three months endedJune 30, 2021 as compared to the same period in the prior year was primarily due to an increase in personnel-related costs, including$0.7 million of incremental non-cash share-based compensation expense, offset by a decrease in professional and consulting fees. -
Net loss was
$17.9 million , or$(0.74) basic and diluted net loss per share, for the three months endedJune 30, 2021 , compared to net loss of$12.1 million , or$(0.67) basic and diluted net loss per share for three months endedJune 30, 2020 .
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 expected cash runway; the availability and timing of data from clinical trials; the initiation of clinical trials; the therapeutic potential of Bicycle’s product candidates; statements regarding Bicycle’s collaboration with Ionis; the development and potential commercialization of potential product candidates using Bicycle’s technology and under its license and collaboration agreement with Ionis; the therapeutic potential for Bicycles in multiple applications; the potential of Bicycle’s platform to develop potential precision medicines; and Bicycle’s ability to achieve planned milestones. 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 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; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Bicycle’s product candidates by Bicycle or its collaboration partners; the risk that Bicycle may not realize the intended benefits of its technology; availability and timing of results from preclinical studies and 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 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; 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 in our Quarterly Report on Form 10-Q filed with the
|
||||||||||||||||
|
Three Months Ended
|
Six Months Ended
|
||||||||||||||
|
2021 |
2020 |
2021 |
2020 |
||||||||||||
Collaboration revenues |
$ |
1,785 |
|
$ |
1,571 |
|
$ |
3,593 |
|
$ |
2,700 |
|
||||
Operating expenses: |
|
|
|
|
||||||||||||
Research and development |
|
11,722 |
|
|
7,958 |
|
|
21,415 |
|
|
15,728 |
|
||||
General and administrative |
|
7,340 |
|
|
6,196 |
|
|
15,479 |
|
|
11,197 |
|
||||
Total operating expenses |
|
19,062 |
|
|
14,154 |
|
|
36,894 |
|
|
26,925 |
|
||||
Loss from operations |
|
(17,277 |
) |
|
(12,583 |
) |
|
(33,301 |
) |
|
(24,225 |
) |
||||
Other income (expense): |
|
|
|
|
||||||||||||
Interest income |
|
23 |
|
|
371 |
|
|
38 |
|
|
583 |
|
||||
Interest expense |
|
(819 |
) |
|
— |
|
|
(1,341 |
) |
|
— |
|
||||
Total other expense, net |
|
(796 |
) |
|
371 |
|
|
(1,303 |
) |
|
583 |
|
||||
Net loss before income tax provision |
|
(18,073 |
) |
|
(12,212 |
) |
|
(34,604 |
) |
|
(23,642 |
) |
||||
Benefit from income taxes |
|
(160 |
) |
|
(97 |
) |
|
(500 |
) |
|
(204 |
) |
||||
Net loss |
$ |
(17,913 |
) |
$ |
(12,115 |
) |
$ |
(34,104 |
) |
$ |
(23,438 |
) |
||||
Net loss per share, basic and diluted |
$ |
(0.74 |
) |
$ |
(0.67 |
) |
$ |
(1.48 |
) |
$ |
(1.30 |
) |
||||
Weighted average ordinary shares outstanding, basic and diluted |
|
24,052,168 |
|
|
18,077,770 |
|
|
23,047,745 |
|
|
18,024,314 |
|
Balance Sheets Data (In thousands) (Unaudited) |
||||
|
|
|
|
|
Cash |
|
|
|
|
Working capital |
|
194,515 |
|
132,594 |
Total assets |
|
226,048 |
|
161,152 |
Total shareholders' equity |
|
142,050 |
|
95,460 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20210805005135/en/
Investors:
VP, Capital Markets & Investor Relations
david.borah@bicycletx.com
617-203-8300
Media:
bicycle@consilium-comms.com
Source: