On August 4, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Jounce Therapeutics, AUG 4, 2022, View Source [SID1234617574]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Jounce has made significant progress advancing our pipeline, and we look forward to sharing more details on our two ongoing clinical trials, INNATE and SELECT, later this year. Today, we are pleased to announce that we’ve completed enrollment in our randomized Phase 2 biomarker-selected trial SELECT, and plan to submit a clinical data abstract later this year to ESMO (Free ESMO Whitepaper)-IO being held in December. In addition, we expect to provide preliminary clinical and biomarker data across multiple cohorts from the Phase 2 portion of INNATE with an abstract submission to ESMO (Free ESMO Whitepaper)-IO in December. Our current financial position enables our continued growth and execution beyond the proof-of-concept inflection points of INNATE and SELECT, while continuing our robust, novel discovery efforts," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to focus on our mission of delivering meaningful and long-lasting benefit to cancer patients through the discovery and pursuit of therapies that target new mechanisms of immune suppression across different types of immune cells, and bringing the right immunotherapies to the right patients."

Pipeline Update & Highlights:

JTX-8064 (LILRB2/ILT4)

Continued to advance INNATE Phase 2 trial across 7 indications. Jounce is evaluating JTX-8064 in the ongoing Phase 2 portion of the INNATE clinical trial, which is comprised of indication specific expansion cohorts, including one monotherapy cohort and seven cohorts in combination with pimivalimab. Each combination cohort is a Simon’s 2-stage design, enrolling 10 patients for an initial analysis of response data, and then further expansion to a total of 29 patients if prespecified response criteria are met. Last quarter, Jounce announced the expansion of the first two combination cohorts. The expanded indications are 3rd/4th line PD-(L)1 inhibitor naive platinum-resistant ovarian cancer and 2nd/3rd line PD-(L)1 inhibitor resistant clear cell renal cell carcinoma. Having met the response criteria for expansion, both indications are continuing enrollment to 29 patients each. Jounce has seen an acceptable safety profile for both the monotherapy and combination therapy to date.

On track to report preliminary clinical data before year end. Jounce plans to submit a clinical abstract on preliminary clinical data including all 31 Phase 1 dose escalation patients and at least 80 Phase 2 combination treatment patients from INNATE, to the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2022 being held from December 7-9 in Geneva, Switzerland. Phase 2 data will include safety, preliminary efficacy based on RECIST 1.1, pharmacodynamics, and potential predictive biomarker correlation with efficacy within each cohort, by prior PD-(L)1 inhibitor history, and in a cross-cohort analysis.
Vopratelimab (ICOS) and Pimivalimab (PD-1)

Patient enrollment complete in Phase 2 SELECT trial of vopratelimab. Patient enrollment is complete in the SELECT trial, a randomized Phase 2 trial evaluating vopratelimab, Jounce’s inducible costimulator (ICOS) agonist, in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients.

On track to report clinical data before year end. Jounce plans to submit a clinical data abstract on the SELECT trial, including additional single agent data for pimivalimab, to the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022.

First-in-human manuscript from the ICONIC trial in Clinical Cancer Research. A manuscript was recently published in the journal Clinical Cancer Research from the Phase 1/2 ICONIC trial of vopratelimab alone and in combination with nivolumab in patients with advanced solid tumors. Data from ICONIC identified TISvopra as a potential predictive biomarker currently being investigated in SELECT.
JTX-1484 (LILRB4/ILT3)

Continued advancement of JTX-1484. JTX-1484 is the most recent product to emerge from Jounce’s Translational Science Platform and is a monoclonal antibody designed to block human LILRB4 (ILT3) expressed on myeloid cells in the tumor microenvironment with the potential to reduce immune suppression and enhance T cell functionality. JTX-1484 is currently in investigational new drug (IND) enabling activities, with the goal of filing an IND application in 2023. Jounce has submitted a preclinical abstract on JTX-1484 for consideration at this year’s annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting being held from November 9-11 in Boston, MA.
Discovery Pipeline

LILRB family preclinical data abstract submitted to SITC (Free SITC Whitepaper). Jounce has submitted a LILRB family preclinical data abstract for consideration at this year’s SITC (Free SITC Whitepaper) annual meeting.

Productive discovery engine with the goal of an IND every 12 to 18 months. Jounce continues to invest in and advance its growing immuno-oncology pipeline. Its discovery engine is built upon the capability to thoroughly interrogate different cell types in the tumor microenvironment, including T cells and myeloid cells. This approach has resulted in four clinical stage programs, with a fifth in IND enabling studies, over the last 6 years.
Corporate Update:

Updates regarding the Board of Directors. Jigar Raythatha has become the Chair of the Board, replacing Perry Karsen who has served as the Chair since April of 2016. Perry Karsen will remain as a member of the board.

Key promotions across leadership team. Jounce is announcing that Hugh Cole is being promoted from Chief Business Officer to Chief Operating Officer, and Dr. Haley Laken is being promoted from Senior Vice President of Program and Portfolio Strategy to Chief Development Officer. Both Mr. Cole and Dr. Laken are impactful leaders within Jounce and Jounce congratulates them on their respective promotions.
Second Quarter 2022 Financial Results:

Cash position: As of June 30, 2022, cash, cash equivalents and investments decreased to $162.3 million, compared to $220.2 million as of December 31, 2021. The decrease was due to operating expenses incurred during the period.

License and collaboration revenue: Jounce did not recognize any revenue during the second quarter of 2022. License and collaboration revenue of $25.4 million was recognized during the second quarter of 2021 and was comprised of a $25.0 million clinical development and regulatory milestone for FDA clearance of the IND for GS-1811 and $0.4 million related to non-cash revenue for the performance of research and transition services, both under the Gilead License Agreement.

Research and development expenses: Research and development expenses were $26.2 million for the second quarter of 2022, compared to $22.1 million for the same period in 2021. The increase in research and development expenses was primarily due to increased manufacturing activities performed for Jounce’s development programs, increased clinical and regulatory costs for INNATE, and increased payroll and lab supplies.

General and administrative expenses: General and administrative expenses were relatively flat at $7.5 million for the second quarter of 2022, compared to $7.3 million for the same period in 2021.

Net loss: Net loss was $33.5 million for the second quarter of 2022, resulting in basic and diluted net loss per share of $0.65. Net loss was $4.0 million for the same period in 2021, resulting in a basic and diluted net loss per share of $0.08. The increase in net loss is attributable to increased operating expenses and no revenue recognized under the Gilead License Agreement in the second quarter of 2022.
Financial Guidance:

Based on its current operating and development plans and cost containment efforts, Jounce is updating its financial guidance for 2022. Gross cash burn on operating expenses and capital expenditures for the full year 2022 is now expected to be at the lower end of the range of $115.0 million to $130.0 million. Jounce now expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements into the first quarter of 2024.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, participants may register here1.It is advised to register at least 10 minutes prior to joining the call. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

On August 4, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported that it will release its second quarter 2022 financial results and Company update before the market open on Thursday, August 11, 2022 (Press release, Hookipa Biotech, AUG 4, 2022, View Source [SID1234617573]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company will not be conducting a conference call in conjunction with this earnings release.

On August 4, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Arvinas, AUG 4, 2022, View Source [SID1234617572]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This is an exciting time at Arvinas as we remain on track to initiate two pivotal programs with ARV-471 in metastatic breast cancer in the second half of this year, have a clear development pathway for bavdegalutamide in molecularly defined metastatic castration-resistant prostate cancer, and are preparing to initiate our Phase 2 trial with ARV-766 by end of year," said John Houston, Ph.D., president and chief executive officer at Arvinas. "In June, we had a collaborative meeting with the U.S. Food and Drug Administration to gain alignment on the registrational trial design for bavdegalutamide. Based on our goal of advancing this important potential treatment for prostate cancer as quickly as possible, the promising clinical data we’ve seen to date, and a productive meeting with the Agency, we have decided to move directly into a pivotal Phase 3 trial. If successful, we think this approach may lead to the fastest potential path to availability for patients in need, both inside and outside the United States, and who are most likely to benefit from this innovative therapy."

Business Highlights and Recent Developments

Arvinas met with the U.S. Food and Drug Administration (FDA) to discuss the potential for an accelerated approach for bavdegalutamide based on a single arm Phase 2 trial and a confirmatory Phase 3 trial for full approval. FDA provided advice on the proposed registrational trial design, including patient eligibility, study design, and follow-up expectations.
After considering multiple factors, including input provided by the FDA, Arvinas believes a randomized, pivotal Phase 3 trial provides the best opportunity to enable simultaneous global regulatory submissions.
The planned Phase 3 trial will evaluate the safety and efficacy of bavdegalutamide in patients with AR T878X/875Y tumor mutations and is expected to initiate in 2H 2023.
Final dose selection for the planned Phase 3 trial will be based on data from additional patients enrolled in the ongoing Phase 1/2 trial, which the company expects will confirm 400 mg as the Phase 3 dose. This further dose exploration will run concurrently with the company seeking regulatory guidance on final Phase 3 design.
Arvinas finalized an agreement with Foundation Medicine to develop the FoundationOneLiquid CDx as a companion diagnostic for use with bavdegalutamide.
Arvinas launched the Global Early Career Researcher Award, which seeks to recognize the efforts of up-and-coming researchers bringing innovation, new approaches, and creative thinking to advance the field of targeted protein degradation.
Arvinas appointed John Northcott to newly created position of Chief Commercial Officer, effective August 1, 2022.
Anticipated Upcoming Milestones and Expectations

ARV-471

Present data from the VERITAC Phase 2 expansion trial (200 mg and 500 mg) (4Q 2022)
Initiate two Phase 3 trials in patients with metastatic breast cancer (as monotherapy and in combination) (2H 2022)
Initiate a Phase 1b combination trial with cyclin dependent kinase (CDK) inhibitors or other targeted therapies (2H 2022)
Initiate a Phase 1b combination trial with everolimus (2H 2022)
Initiate a Phase 2 neoadjuvant trial in patients with early breast cancer (2H 2022)
Present safety data from the Phase 1b combination trial with palbociclib at a medical conference (1H 2023)
Bavdegalutamide (ARV-110)

Initiate a Phase 3 trial in metastatic castration-resistant prostate cancer, or mCRPC, for patients with AR T878/H875 tumor mutations (2H 2023)
ARV-766

Share Phase 1 dose escalation trial data in mCRPC (2H 2022)
Initiate Phase 2 expansion trial in mCRPC (2H 2022)
Financial Guidance
Based on its current operating plane, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of June 30, 2022 is sufficient to fund planned operating expenses and capital expenditure requirements multiple years beyond 2024.

Second Quarter Financial Results

Cash, Cash Equivalents, Restricted Cash and Marketable Securities Position: As of June 30, 2022, cash, cash equivalents, restricted cash and marketable securities were $1,347.7 million as compared with $1,507.1 million as of December 31, 2021. The decrease in cash, cash equivalents, restricted cash and marketable securities of $159.4 million for the first six months of 2022 was primarily related to cash used in operating activities of $141.5 million (net of $6.5 million received from two collaborators), unrealized loss on marketable securities of $17.4 million, and the purchase of lab equipment and leasehold improvements of $3.5 million, partially offset by proceeds from the exercise of stock options of $3.0 million.

Research and Development Expenses: Research and development expenses were $75.3 million for the quarter ended June 30, 2022, as compared with $43.0 million for the quarter ended June 30, 2021. The increase in research and development expenses of $32.3 million for the quarter was primarily due to an increase in our continued investment in our platform and exploratory programs of $19.6 million, as well as an increase in expenses related to our ER program of $14.1 million, which is net of the cost sharing of ARV-471 under the global Pfizer collaboration agreement to develop and commercialize ARV-471 that was initiated in July 2021 (ARV-471 Collaboration Agreement), offset by a decrease in our AR program (which includes bavdegalutamide and ARV-766) of $1.4 million.

General and Administrative Expenses: General and administrative expenses were $24.3 million for the quarter ended June 30, 2022, as compared with $14.4 million for the quarter ended June 30, 2021. The increase of $9.9 million was primarily due to an increase in personnel and facility related costs of $6.9 million and insurance, taxes and professional fees of $2.9 million.

Revenues: Revenues were $31.3 million for the quarter ended June 30, 2022 as compared with $5.5 million for the quarter ended June 30, 2021. Revenue is related to the ARV-471 Collaboration Agreement, the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The increase in revenues of $25.8 million was primarily due to revenue from the ARV-471 Collaboration Agreement.

Income Tax Expense: Income tax expense was $3.4 million for the quarter ended June 30, 2022, as compared with zero for the quarter ended June 30, 2021 due to taxable income projected for fiscal year 2022 primarily related to revenue recognized in 2022 for tax purposes from the ARV-471 Collaboration Agreement.

Net Loss: Net loss was $70.0 million for the quarter ended June 30, 2022, as compared with $50.3 million for the quarter ended June 30, 2021. The increase in net loss for the quarter was primarily due to increased research and development expenses, general and administrative expenses, and income tax expense, partially offset by increased revenue.

About bavdegalutamide (ARV-110)
Bavdegalutamide (ARV-110) is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

Bavdegalutamide has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About ARV-471
ARV-471 is an investigational orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of ARV-471; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

About ARV-766
ARV-766 is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade AR. In preclinical studies, ARV-766 degraded all resistance-driving point mutations of AR, including L702H, a mutation associated with treatment with abiraterone and other AR-pathway therapies.

ARV-766 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer, and ARV-766 may also have applicability in other AR-driven diseases both in and outside oncology. ARV-766 has demonstrated activity in preclinical models of resistance to currently available AR-targeted therapies.

On August 4, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported financial results for the second quarter of 2022 (Press release, Concert Pharmaceuticals, AUG 4, 2022, View Source [SID1234617571]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very happy to have seen consistent efficacy and safety results across our two Phase 3 clinical trials of CTP-543 in alopecia areata. The positive results that we reported from THRIVE-AA1 in May and from THRIVE-AA2 earlier this week, will form the basis of our New Drug Application, which we expect to submit to the FDA in the first half of 2023," said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "We have continued to execute well on a development program for CTP-543 that provides a robust data package in support of a potential FDA approval. We are proud that CTP‑543 could offer a near-term and potentially best-in-class treatment option for adults with moderate to severe alopecia areata."

Recent Highlights and Upcoming Milestones
CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata

Positive Phase 3 Results Reported for CTP-543 THRIVE-AA1 Study. In May 2022, the Company reported positive topline results for its first CTP-543 Phase 3 clinical trial. A statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 in the THRIVE-AA1 study experienced greater scalp regrowth compared to placebo. The proportion of patients achieving a Severity of Alopecia Tool (SALT) score of 20 or less (meaning 20 percent or less scalp hair loss) at Week 24 was 41.5 percent in the 12 mg twice-daily dose group and 29.6 percent in the 8 mg twice-daily dose group, compared to 0.8 percent of patients in the placebo group. The treatment difference for both dose groups of CTP-543 relative to placebo was statistically significant (p<0.0001). The safety profile seen with CTP-543 in THRIVE-AA1 was consistent with previous studies of CTP-543.
Positive Phase 3 Results Reported for CTP-543 THRIVE-AA2 Study. In August 2022, the Company reported positive topline results for its second CTP-543 Phase 3 clinical trial. A statistically significant proportion of patients treated with either 8 mg twice-daily or 12 mg twice-daily of CTP-543 in the THRIVE-AA2 study experienced greater scalp regrowth compared to placebo. The proportion of patients achieving a SALT score of 20 or less at Week 24 was 38.3 percent in the 12 mg twice-daily dose group and 33.0 percent in the 8 mg twice-daily dose group, compared to 0.8 percent of patients in the placebo group. The treatment difference for both dose groups of CTP-543 relative to placebo was statistically significant (p<0.0001). The safety profile seen with CTP-543 in THRIVE-AA2 was consistent with previous studies of CTP-543.
JAAD Publication Highlights Significant Reduction in Severity of Hair Loss with CTP-543. The Company recently published safety and efficacy data from its randomized, double-blind, placebo-controlled dose-ranging Phase 2 clinical trial of CTP‑543 in the Journal of the American Academy of Dermatology (JAAD). The publication reported clinically meaningful and statistically significant scalp hair regrowth after 24 weeks of treatment with CTP-543 in both the 8 mg twice-daily and 12 mg twice-daily dose groups in patients with alopecia areata, as well as safety data and patient-reported outcomes of improvement. This trial supported the advancement of CTP-543 into Phase 3 development.
Concert to Participate in Alopecia Areata Awareness Month in September. Throughout the month of September, Concert, along with the alopecia areata community, will raise awareness and recognize the importance of alopecia areata, a serious autoimmune disorder that affects up to approximately 1.5 million individuals in the U.S. and which often results in poor health-related quality of life as well as high incidence of anxiety and depression. Follow our #LightItUpBlue4AlopeciaAreata campaign on Twitter at @ConcertPharma.
Second Quarter 2022 Financial Results

Cash and Investment Position. Cash, cash equivalents and investments as of June 30, 2022 totaled $153.7 million as compared to $141.6 million as of December 31, 2021. Under its current operating plan, the Company expects its cash, cash equivalents and investments to fund the Company into the second quarter of 2023. In June 2022, Concert closed an equity offering raising gross proceeds of $54.6 million before underwriting discounts and offering expenses. Concurrent with the initial closing of the offering, Concert received $18.9 million from the partial exercise of the Tranche 1 warrants issued to BVF Partners L.P. and RA Capital Management in connection with its November 2021 financing. The Company has the potential to receive an additional $70.1 million in 2022 upon full exercise of the remaining warrants issued in connection with the November 2021 financing.
R&D Expenses. Research and development expenses were $20.9 million for the quarter ended June 30, 2022, compared to $20.2 million for the same period in 2021. The increase in research and development expenses relates primarily to the clinical development program for CTP-543.
G&A Expenses. General and administrative expenses were $4.8 million for the quarter ended June 30, 2022, compared to $5.6 million for the same period in 2021. The decrease in general and administrative expenses relates primarily to decreased non-cash stock-based compensation.
Net (Loss) Income. For the quarter ended June 30, 2022, net loss applicable to common stockholders was $24.0 million, or $0.59 per share, as compared to net income applicable to common stockholders of $5.4 million, or $0.16 per share, for the quarter ended June 30, 2021. Net income for the quarter ended June 30, 2021 included $32.0 million in revenue from proceeds received from Vertex Pharmaceuticals, Inc. for the purchase of potential future milestones under the companies’ 2017 asset purchase agreement related to VX-561.
Conference Call and Webcast: New System to Access Call Live and On Demand
The Company will host a conference call and webcast today at 8:30 a.m. ET to provide an update on the Company and discuss second quarter financial results.

Please note that there is a new system to access the live call in order to ask questions. To join the live call, please register here. A dial in and unique PIN number will be provided to join the call.

An audio-only webcast of the call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on Concert’s website for three months.

On August 4, 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, reported financial results for the second quarter ended June 30, 2022 and provided recent corporate updates (Press release, Bicycle Therapeutics, AUG 4, 2022, View Source [SID1234617570]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with the progress of our wholly owned clinical oncology pipeline of Bicycle Toxin Conjugate, or BTC, programs and Bicycle tumor-targeted immune cell agonist, or Bicycle TICA, programs," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "In the second quarter, we initiated the expansion cohorts of our Phase I/II study of BT5528, and development of BT8009 and BT7480 remains on track as these programs advance in their respective clinical trials."

"In addition, we were delighted to announce the second expansion of our immuno-oncology collaboration with Genentech last month, highlighting the potential of the platform beyond our BTCs and Bicycle TICAs," Dr Lee continued. "We are pleased to have a strong balance sheet which helps support the advancement of our programs and which we anticipate provides a financial runway into 2025."

Second Quarter 2022 and Recent Highlights

Announced First Patient Dosed in the Expansion Cohorts of Phase I/II Trial of BT5528. In June 2022, Bicycle announced that the first patient was dosed in the expansion cohorts of the Phase I/II study of BT5528, Bicycle’s second-generation Bicycle Toxin Conjugate (BTC) targeting EphA2. Up to 56 patients will be enrolled in the initial expansion cohorts, with the ability to further expand enrollment based on the results from these cohorts. Bicycle intends to provide completed results of the dose escalation portion of the clinical trial during the third quarter of 2022.
Announced Expansion of Genentech Immuno-Oncology Collaboration. In July 2022, Bicycle announced that Genentech exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. This expansion represented the second option exercised by Genentech under the terms of the original February 2020 agreement and triggered a $10 million payment to Bicycle, which is expected to be received in the third quarter of 2022.
Presented Trials in Progress Poster Featuring BT7480 Phase I/II Clinical Trial at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In June 2022, Bicycle presented a Trials in Progress poster highlighting the Phase I/II clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137.
Announced Interim BT8009 Phase I Clinical Trial Results at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) 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, 37 patients have been dosed in the Phase I/II trial of BT8009. A total of 12 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% overall response rate and 75% disease control rate. As of March 7, 2022, the median duration of response had 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.
Exploration of additional doses and frequencies continues, and Bicycle intends to provide further updates this year.

Financial Results

Cash and cash equivalents were $372.8 million as of June 30, 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 $19.9 million for the three months ended June 30, 2022, compared to $11.7 million for the three months ended June 30, 2021. The increase in expense of $8.2 million was primarily due to increased clinical program expenses for BT5528 and BT8009, Bicycle TICA program development expenses, as well as increased personnel-related expenses, including $1.6 million of incremental non-cash share-based compensation expenses, and increased facilities-related expenses.
General and administrative expenses were $11.8 million for the three months ended June 30, 2022, compared to $7.3 million for the three months ended June 30, 2021. The increase of $4.5 million for the three months ended June 30, 2022 as compared to the same period in the prior year was primarily due to an increase in personnel-related expenses, including $1.5 million of incremental non-cash share-based compensation expense, and an unfavorable effect of foreign exchange rates.
Net loss was $26.8 million, or $(0.90) basic and diluted net loss per share, for the three months ended June 30, 2022, compared to net loss of $17.9 million, or $(0.74) basic and diluted net loss per share, for the three months ended June 30, 2021.