On November 4, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the third quarter ended September 30, 2021 (Press release, Athenex, NOV 4, 2021, View Source [SID1234594456]).

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"Following our recent Type A meeting with U.S. FDA to discuss our New Drug Application for oral paclitaxel and encequidar (Oral Paclitaxel) in metastatic breast cancer, we determined that deploying our resources towards other ongoing clinical programs of Oral Paclitaxel and our cell therapy programs would be a better way to maximize value for all of our shareholders and stakeholders," said Johnson Lau, Chief Executive Officer of Athenex. "Our management team is focused on advancing the clinical pipeline where we believe Athenex has a strong competitive advantage, as well as exploring various other approaches for our assets that will unlock shareholder value. We are particularly pleased with the continued positive momentum and increasing visibility of our cell therapy programs."

Third Quarter 2021 and Recent Business Highlights

Clinical Programs

Orascovery

Held a Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Oral Paclitaxel in metastatic breast cancer.
Presented positive interim data from a Phase 1 trial evaluating Oral Paclitaxel in combination with pembrolizumab in patients with advanced solid malignancies at ESMO (Free ESMO Whitepaper) 2021.
Received confirmation from the Innovative Licensing and Access Pathway (ILAP) in the UK that encequidar in combination with oral anticancer medicines has been awarded the innovative medicine designation, the Innovation Passport. ILAP was set up by the UK Medicines & Healthcare products Regulatory Agency (MHRA) and other UK government agencies to efficiently accelerate the time to market and facilitating patient access to innovative medicines.
Cell Therapy

Interim data from the ongoing Phase 1 ANCHOR trial evaluating KUR-502 in patients with CD19-positive relapsed or refractory lymphoma and leukemia have been accepted for poster presentation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting.
The U.S. Patent and Trademark Office allowed patent claims around the NKT cellular immunotherapy platform developed by Athenex and the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital.
Opened enrollment in Phase 1 trial to evaluate TCRT-ESO-A2 (high-affinity TCR-T targeting NY-ESO-1 solid tumors).
Commercial Update

Klisyri (tirbanibulin)

Athenex’s partner, Almirall (Almirall, S.A., BME: ALM), launched Klisyri (tirbanibulin) in Germany and the UK. Klisyri received approval by the European Commission and the UK MHRA in July and August of 2021, respectively, for the topical treatment of actinic keratosis (AK) of the face and scalp in adults.
Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 33 products with 64 SKUs.
Athenex Pharma Solutions (APS) currently markets 5 products with 16 SKUs.
Corporate

Dr. Michael Smolinski promoted to Chief Scientific Officer. Dr. Smolinski has been with Athenex for 13 years and previously served as Vice President of Preclinical Operations.
Key Anticipated Milestones

ANCHOR Phase 1 poster presentation at 2021 ASH (Free ASH Whitepaper) in December
Results from the I-SPY 2 trial of oral paclitaxel plus anti PD-1 expected in 2022
Almirall to continue phased roll-out of Klisyri in other European countries in 2022
Third Quarter 2021 Financial Highlights

Revenues from product sales increased to $27.0 million for the three months ended September 30, 2021, from $24.8 million for the three months ended September 30, 2020, an increase of $2.2 million or 9%. This increase was primarily attributable to an increase in 503B product sales of $2.1 million as the result of the increase in demand for certain drugs used to treat patients hospitalized with COVID-19. API product sales and contract manufacturing sales each experienced an increase of $0.4 million. These increases were offset by a decrease in APD product sales of $0.7 million, resulting primarily from a significant prior year increase in demand for COVID-19 related drugs and for FDA shortage products during 2020, including some significant non-recurring orders.

License fees and other revenue decreased by $5.4 million, for the three months ended September 30, 2021. This decrease was primarily due to the recognition of $5.1 million in license and royalty revenue from Almirall for the launch of Klisyri in Europe in September 2021, while we recognized $10.4 million in license revenue during the three months ended September 30, 2020, pursuant to license agreements with Xiangxue and PharmaEssentia.

Cost of sales for the three months ended September 30, 2021 totaled $25.6 million, an increase of $1.1 million, or 5%, as compared to $24.5 million for the three months ended September 30, 2020. The increase was primarily due to an increase of $2.9 million in cost of 503B product sales as production levels increased. Cost of APD product sales increased by $0.9 million, while the cost of API product sales decreased by $0.1 million. Additionally, cost of sales related to royalties for license income decreased by $2.5 million due to the royalty payment that incurred in 2020 on the license revenue from Xiangxue.

R&D expenses for the three months ended September 30, 2021 totaled $17.7 million, a decrease of $0.7 million, or 4%, as compared to $18.4 million for the three months ended September 30, 2020. This was primarily due to a decrease in costs of clinical operations of $2.4 million after the completion of the Phase 3 studies for tirbanibulin ointment and Oral Paclitaxel, a decrease in Oral Paclitaxel product development and medical affairs costs of $1.8 million incurred in connection with the potential product launch, a decrease in costs of preclinical operations of $1.0 million, and a decrease in R&D related compensation expenses of $0.4 million. The decrease in these R&D expenses was partially offset by a $2.6 million increase in cell therapy development costs, a $2.0 million increase in drug licensing costs related to licenses for specialty drug products, and a $0.3 million increase in costs of other product development.

SG&A expenses for the three months ended September 30, 2021 totaled $22.8 million, an increase of $0.6 million, or 3%, as compared to $22.2 million for the three months ended September 30, 2020. This was primarily due to a $3.2 million increase from the change in fair value of contingent consideration, a $2.1 million increase in operating costs including insurance and IT costs and professional fees, a $1.9 million increase in compensation related costs, and a $1.1 million increase in site preparation costs related to the manufacturing facility in Dunkirk. The increase was partially offset by a $7.7 million decrease in costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and slowed upon receipt of the Complete Response Letter in February 2021.

Interest expense totaled $5.1 million and $3.6 million for the three months ended September 30, 2021 and 2020, respectively. Interest expense in the current period was incurred from the Senior Credit Agreement with Oaktree, while interest expense in the prior period was primarily incurred from debt under a former credit agreement with Perceptive Advisors LLC and its affiliates.

Income tax expense for the three months ended September 30, 2021 amounted to $0.3 million, compared to income tax expense of $1.1 million for the same period in 2020. The income tax expense in the prior year was primarily attributable to foreign income tax withholdings on our revenue earned under our out-license arrangements.

Net loss attributable to Athenex for the third quarter was $36.1 million or 33 cents per diluted share, as compared to a net loss of $36.8 million or 44 cents per diluted share, for the same period in 2020.

For further details on the Company’s financial results, including the results for the nine months ended September 30, 2021, refer to the Form 10Q filed with the SEC.

Financial Guidance

In terms of product sales guidance, the Company is limiting financial guidance to the existing Athenex product portfolio only. In 2020, the Company recorded a significant amount of revenues from international customers as a result of the global pandemic. However, it does not see these revenues as recurring in nature. In the first nine months of 2021, the Company experienced significant COVID-related challenges in our Indian supply chain and to a lesser extent China, which slowed down APD product sales during the period. As a result, the Company now expects its full year product sales in 2021, excluding any royalties from Klisyri, to decline by 6% to 12% year-over-year compared with 2020 levels.

Cash Conservation Update

As of September 30, 2021, the company had cash and cash equivalents of $73.6 million, restricted cash of $16.5 million, and short-term investments of $14.9 million, for a total of $105.0 million. Given the earlier uncertainty stemming from the CRL for Oral Paclitaxel in metastatic breast cancer, the Company has already identified and adopted certain cash conservation measures. The Company is seeking additional cash conservation and funding opportunities to further extend the cash runway.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, November 4, 2021, at 10:00 am Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

On November 4, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it has entered into an agreement with BVF Partners L.P. (BVF) and RA Capital Management (RA) to raise gross proceeds of $65 million (Press release, Concert Pharmaceuticals, NOV 4, 2021, View Source [SID1234594455]). In addition, Concert will have the potential to receive an additional $103 million upon the full exercise of warrants being issued in connection with the agreement. Closing of the financing is expected on or about November 5, 2021. With the $65 million raised in this financing, Concert now expects to be able to fund its operations into the fourth quarter of 2022. If the warrants being issued in connection with this financing are fully exercised, Concert expects to be funded beyond the anticipated submission of its New Drug Application for CTP-543, which is expected in early 2023.

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The financing consists of the sale of common and preferred stock, warrants and a portion of Concert’s right to receive potential future AVP-786 royalties under an existing licensing agreement with Avanir Pharmaceuticals, Inc. (Avanir).

As part of the financing, BVF and RA will receive an aggregate of 16,250,000 common stock equivalents, warrants to purchase up to 8,125,000 common stock equivalents at an exercise price of $5.34 per share and warrants to purchase up to 8,125,000 common stock equivalents at an exercise price of $7.35 per share. The common stock equivalents will be issued as either shares of common stock or convertible preferred stock.1

Previously, Concert granted Avanir, a subsidiary of Otsuka America, Inc., worldwide rights to develop and commercialize AVP-786 for the treatment of neurologic and psychiatric disorders in exchange for potential future milestones and royalties. Pursuant to this financing, BVF and RA will also receive a portion of potential future AVP-786 royalties currently payable to Concert by Avanir. AVP-786 is currently being evaluated in a number of clinical trials, including Phase 3 trials for the treatment of agitation in patients with dementia of the Alzheimer’s type. Upon the closing of the financing, BVF and RA will collectively own 35% of such royalties, with the percentage increasing incrementally up to 50% if all of the warrants issued in connection with the financing are exercised by the holders.

The securities described above are being offered by Concert pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (SEC), which the SEC declared effective on November 16, 2020. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On November 4, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported it will host a live webcast presentation highlighting the clinical data being presented at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) on Friday, November 12, 2021 at 8:00 a.m. ET (Press release, Shattuck Labs, NOV 4, 2021, https://ir.shattucklabs.com/news-releases/news-release-details/shattuck-labs-host-conference-call-and-webcast-highlighting-data [SID1234594454]).

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The event will be led by Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck, and will include presentations by Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck and Andrew Neill, M.B.A., Chief Financial Officer of Shattuck. During the event, the company will highlight dose-escalation data for SL-172154 (SIRPα-Fc-CD40L), its lead bi-functional fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor, in platinum-resistant ovarian cancer patients, and dose-escalation data for SL-279252 (PD1-Fc-OX40L), which is designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor, in patients with advanced solid tumors or lymphoma. Members of Shattuck leadership will be available to answer questions at the end of the event.

The live call may be accessed by dialing (833) 614-1555 (domestic) or (516) 575-8754 (international) and entering the conference code: 4068596. The live and archived webcast will be available on the Events & Presentations section of the Company’s website. A replay of the webcast will be archived for up to 90 days following the presentation date.

On November 4, 2021 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 third quarter ended September 30, 2021 and provided recent corporate updates (Press release, Bicycle Therapeutics, NOV 4, 2021, View Source [SID1234594453]).

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"We recently provided a clinical update for our ongoing Phase 1 dose escalation trials in BT5528 and BT8009, the data from which support our conviction that the Bicycle platform offers a potentially differentiated approach to traditional targeted payload delivery," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We were encouraged to see preliminary anti-tumor activity in both trials and across two tumor types, providing further insights as we continue to expand the application of our technology. We look forward to providing additional clinical data on BT5528 and BT8009 next year."

"Beyond our Bicycle Toxin Conjugates (BTC), we are also making progress across our other programs, including BT7480, our novel, fully synthetic Bicycle tumor-targeted immune cell agonist (Bicycle TICA), which recently entered the clinic, as well as in our partnership with Genentech, which is now being expanded to include a new program under the collaboration. In addition, we recently entered into a collaboration agreement with Ionis Pharmaceuticals to develop targeted oligonucleotide therapeutics, which we believe further demonstrates the potential of the platform outside of oncology. Our plans to advance our programs and platform in oncology and beyond are supported by a strong balance sheet that has been further enhanced by the recent proceeds from an upsized public equity offering completed in October."

Third Quarter 2021 and Recent Highlights

Presented Interim BT5528 Phase I Clinical Trial Results at AACR (Free AACR Whitepaper)-NCI-EORTC Conference. In October 2021, Bicycle presented interim Phase I results for BT5528, a BTC targeting EphA2, a target for which prior antibody-based approaches have been unsuccessful. A total of 24 patients were dosed both prior to, and after, the implementation of the EphA2 immunohistochemistry (IHC) assay, with a median of seven prior lines of therapy. Among these patients, preliminary anti-tumor activity, including three partial responses, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was observed in seven EphA2 positive urothelial and ovarian cancer patients. Based on the totality of the findings, Bicycle expects the recommended Phase 2 dose to be in the range of 6.5mg/m2 to 8.5mg/m2 every other week, a dose that Bicycle believes is within the therapeutic range based on both preclinical studies and preliminary clinical anti-tumor activity. Bicycle plans to initiate expansion cohorts in urothelial and ovarian cancers, as well as a basket cohort that includes head and neck, non-small cell lung, gastroesophageal and triple negative breast cancers in 2022.
Announced Preliminary Results from Ongoing BT8009 Phase I Clinical Trial. In October 2021, Bicycle announced preliminary Phase I results for BT8009, a Nectin-4 targeting BTC with a potentially differentiated profile as compared to an FDA approved, Nectin-4 targeting antibody-drug conjugate. As of September 30, a total of 11 response evaluable urothelial cancer patients had been dosed in monotherapy cohorts, including four patients in the 2.5mg/m2 dose cohort and seven in the 5.0mg/m2 dose cohort. Among the four patients dosed at 2.5mg/m2 weekly, three patients were observed to have at least stable disease, with a disease control rate of 75%, and one patient (25%) was observed to have a tumor reduction of 37%, meeting the criteria of a partial response under RECIST 1.1. Among the seven patients dosed at 5.0mg/m2, five were observed to have at least stable disease, with a disease control rate of 71%, and three patients (43%) were observed to have tumor reductions meeting the criteria of a partial response under RECIST 1.1. The magnitude of tumor reductions ranged from 44% to 89%. In both cohorts, BT8009 has been tolerated, with no dose limiting toxicities observed to-date. Dose escalation remains ongoing, and patients are currently being enrolled in 7.5mg/m2 weekly and every other week cohorts. A total of 14 clinical sites are active globally, including nine outside of the United States, and Bicycle expects to have up to 21 sites active this year.
Announced First Patient Dosed in Phase I/II Trial of Bicycle Tumor-targeted Immune Cell Agonist BT7480 in Patients with Advanced Solid Tumors Associated with Nectin-4 Expression. This is the Company’s fourth product candidate to enter the clinic in as many years and is its first immuno-oncology asset to enter a clinical trial.
Raised Gross Proceeds of $201.3 Million in Public Offering. In October 2021, Bicycle Therapeutics announced the closing of an upsized underwritten public offering which yielded gross proceeds of approximately $201.3 million. All of the ADSs in the offering were offered by Bicycle Therapeutics.
Genentech, a Member of the Roche Group, Has Exercised an Option to Initiate an Additional Program. Genentech has expanded the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. Bicycle and Genentech are collaborating on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Pursuant to the terms of the February 2020 agreement, Genentech has exercised an option to include a new program under the agreement, triggering a $10 million payment to Bicycle. None of the compounds in Bicycle’s wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration.
Bicycle Provides Update on BT1718, a First-Generation BTC Targeting Membrane Type 1-Matrix Metalloprotease (MT1-MMP), which is Currently Being Investigated in an Ongoing Phase IIa Portion of a Phase I/IIa Clinical Trial Sponsored and Funded by the Cancer Research UK Centre for Drug Development (CRUK). Although there has been an acceleration in the second half of the year, enrollment in the Phase IIa trial has been slower than expected and remains below projections. Currently, five of the six planned clinical trial sites in the UK are open for enrollment, and CRUK may open up to two additional sites.
Announced Publication of Preclinical Data from BT7480 in the Journal for ImmunoTherapy of Cancer. The article, titled "BT7480, a novel fully synthetic Bicycle tumor-targeted immune cell agonist (Bicycle TICA) induces tumor localized CD137 agonism," outlines BT7480’s potential to elicit rapid reprogramming of the tumor immune microenvironment, which was observed to lead to complete regressions and anti-tumor immunity with only intermittent drug exposure in syngeneic mouse tumor models.
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 a December 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.
Financial Results

Cash was $259.5 million as of September 30, 2021, compared to $136.0 million as of December 31, 2020. The increase in cash is primarily due to financing activities, including net proceeds of $102.6 million from Bicycle’s at-the-market (ATM) offering program and net proceeds of $15.0 million from Bicycle’s debt facility with Hercules Capital, as well as the $45.0 million received from Ionis under the 2021 collaboration agreement, offset by cash used for operating activities. Cash of $259.5 million at September 30, 2021 excludes the net proceeds from the public offering received in October 2021.
Research and development expenses were $10.5 million for the three months ended September 30, 2021, compared to $7.4 million for the three months ended September 30, 2020. The increase in expense of $3.1 million for the three months ended September 30, 2021 as compared to the same period in the prior year was primarily due to direct program spend for BT8009 and other discovery and platform related expenses, as well as increased personnel related expenses, including $0.6 million of incremental non-cash share-based compensation expense.
General and administrative expenses were $8.1 million for the three months ended September 30, 2021, compared to $7.2 million for the three months ended September 30, 2020. The increase of $0.9 million for the three months ended September 30, 2021 as compared to the same period in the prior year was primarily due to increased costs to support operations as a public company and increased personnel-related costs, including $0.6 million of incremental non-cash share-based compensation expense.
Net loss was $14.7 million, or $(0.59) basic and diluted net loss per share, for the three months ended September 30, 2021, compared to net loss of $10.1 million, or $(0.52) basic and diluted net loss per share for three months ended September 30, 2020.

On November 4, 2021 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 that the first patient has been dosed in the Phase I dose escalation portion of a company-sponsored Phase I/II trial of BT7480, a novel, fully synthetic Bicycle tumor-targeted immune cell agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137 (Press release, Bicycle Therapeutics, NOV 4, 2021, View Source [SID1234594452]). Preclinical studies have demonstrated that BT7480 activates CD137 only in the presence of Nectin-4 expressing tumor cells. The Phase I/II trial of BT7480 will be conducted in patients with advanced solid tumors associated with Nectin-4 expression.

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"BT7480 is our first Bicycle TICA to enter the clinic and is one of a new class of tumor-targeting agents," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Overexpression of Nectin-4, a well-validated tumor antigen, has been observed in several common tumor types and is associated with poor disease prognosis. Activation of CD137, a co-stimulatory receptor expressed on multiple components of the immune system, can drive anti-tumor immunity, but activation outside of the tumor may give rise to toxicity. Preclinical studies have shown encouraging results, and we look forward to studying the safety and efficacy of this unique asset as we begin the dose escalation portion of the trial."

The Phase I/II multi-center, open-label trial will evaluate BT7480 administered once weekly. Enrollment is ongoing in the Phase I dose escalation of BT7480 given as a monotherapy, and the Company plans to evaluate BT7480 dosed in combination with nivolumab in future Phase I dose escalation cohorts. The Phase I portion of the trial is primarily designed to assess the safety and tolerability of BT7480, and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, Bicycle expects to initiate a Phase II dose expansion portion with the primary objective of evaluating the clinical activity of BT7480 as monotherapy and in combination with nivolumab in patients with Nectin-4-positive tumors.