On December 12, 2023 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its second quarter of fiscal 2024, ended October 31, 2023 (Press release, Champions Oncology, DEC 12, 2023, View Source [SID1234638487]).

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Second Quarter and Recent Highlights:

•Second quarter revenue of $11.6 million, a decline of 19%
•Revised fiscal year 2024 revenue guidance to be generally in-line with last year’s results
•Strong quarterly bookings
•European lab received ISO accreditation and ATS certification
•Hired Brady Davis as President to develop new strategic initiatives

Ronnie Morris, CEO of Champions, commented, "As discussed during our first quarter earnings call, we’re navigating through a challenging economic environment, specifically in the biotech sector, that began approximately one year ago. While our short-term results were weaker than we’re accustomed to delivering, demand for our services has re-accelerated and we will emerge stronger over the coming quarters as we’re witnessing positive trends in customer spending and a reduction in cancellations." Morris added, "Our drug discovery initiative, operating under a wholly owned subsidiary, Corellia AI, continues to progress as we’re building therapeutic programs around two lead targets while other, new targets are being identified. We remain actively engaged with investors in an effort to raise capital to support and accelerate these programs."

David Miller, CFO of Champions, added, "As we’ve guided over the last several quarters, the increase in study cancellations during fiscal year 2023, primarily stemming from the economic impact on our customers’ R&D budgets, would lead to lower revenue in the first half of 2024, pressuring margins and profitability. Results were a bit weaker than expected and, as a result, we’re reducing our year-end

Exhibit 99.1
revenue guidance and anticipating our year over year revenue growth will be generally flat. However, we believe our quarterly results will gradually improve going forward and, long term, we are well-positioned for continued growth as the underlying fundamentals of our business are strong, our sales pipeline is healthy, and our balance sheet is sound."

Second Fiscal Quarter Financial Results

Total revenue for the second quarter of fiscal 2024 was $11.6 million compared to $14.3 million for the same period last year, a decrease of 19.0%. The decline in revenue was primarily from customer cancellations in prior quarters which led to lower study revenue in the second quarter. Total costs and operating expenses for the second quarter of fiscal 2024 were $13.5 million compared to $14.3 million for the second quarter of fiscal 2023, a decrease of $746,000 or 5.2%.

For the second quarter of fiscal 2024, Champions reported a loss from operations of $2.0 million, including $53,000 in stock-based compensation and $484,000 in depreciation and amortization expenses, compared to income from operations of $7,000, inclusive of $119,000 in stock-based compensation and $560,000 in depreciation and amortization expenses, in the second quarter of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $1.4 million for the second quarter of fiscal 2024 compared to adjusted EBITDA of $686,000 in the second quarter of fiscal 2023.

Cost of oncology solutions was $6.6 million for the three-months ended October 31, 2023, a decrease of $825,000, or 11.1% compared to $7.4 million for the three-months ended October 31, 2022. The decrease in cost of sales was primarily from a reduction in compensation and supply expenses along with lower outsourced lab service costs. For the three-months ended October 31, 2023, total gross margin was 42.8% compared to 47.9% for the three-months ended October 31, 2022. The lower margin resulted primarily from a decline in top line revenue against relatively unchanged fixed costs within cost of sales.

Research and development expense for the three-months ended October 31, 2023 was $2.5 million, a slight decrease of $89,000 or 3.4%, compared to $2.6 million for the three-months ended October 31, 2022. For the second quarter of fiscal year 2024, approximately $1.2 million of the Company’s R&D expense was directed towards our target discovery program. Sales and marketing expense for the three-months ended October 31, 2023 was $1.8 million, a slight increase of $95,000, or 5.6%, compared to $1.7 million for the three-months ended October 31, 2022. General and administrative expense for the three-months ended October 31, 2023 was $2.6 million, a slight increase of $73,000, or 2.9%, compared to $2.5 million for the three-months ended October 31, 2022.

Net cash provided by operating activities was approximately $600,000 for the three-months ended October 31, 2023 and was primarily due from increases in accounts receivable collections and deferred revenue. Net cash used in investing activities was approximately $150,000 for investment in additional lab and computer equipment. Net cash provided by financing activities was approximately $200,000 primarily from proceeds from options exercises.

Year-To-Date Financial Results

For the first six months of fiscal 2024, revenue decreased 13.9% to $24.1 million compared to $28.0 million for the first six months of fiscal 2023. The decline in revenue was primarily from customer cancellations in fiscal year 2023 resulting in lower study revenue in the first half of fiscal year 2024.

Total costs and operating expenses for the first six months of fiscal 2024 were $28.6 million compared to $28.3 million for the first six months of fiscal 2023, an increase of $338,000 or 1.2%.

For the first six months of fiscal 2024, Champions reported a loss from operations of $4.5 million, including $476,000 in stock-based compensation and $929,000 in depreciation and amortization expenses, compared to a loss from operations of $277,000, inclusive of $325,000 in stock-based compensation and $1.1 million in depreciation and amortization expenses, in the first six months of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $3.1 million for the first six months of fiscal 2024 compared to adjusted EBITDA of $1.1 million in the first six months of fiscal 2023.

Cost of oncology solutions was $14.3 million for the six-months ended October 31, 2023, a decrease of $193,000, or 1.3% compared to $14.5 million for the six-months ended October 31, 2022. For the six-months ended October 31, 2023, total gross margin was 40.7% compared to 48.3% for the six-months ended October 31, 2022. The lower margin resulted from lower revenue against a generally unchanged cost base.

Research and development expense for the six-months ended October 31, 2023 was $5.3 million, a slight decrease of $183,000 or 3.3%, compared to $5.5 million for the six-months ended October 31, 2022. The decrease was primarily from a reduction in core product R&D expenses. Approximately $2.5 million of the Company’s R&D expense was directed towards our target discovery program for the first half of fiscal year 2024. Sales and marketing expense for the six-months ended October 31, 2023 was $3.5 million, a slight increase of $99,000, or 2.9%, compared to $3.4 million for the six-months ended October 31, 2022. General and administrative expense for the six-months ended October 31, 2023 was $5.5 million, an increase of $615,000, or 12.5%, compared to $4.9 million for the six-months ended October 31, 2022. The increase was primarily due to an increase in compensation and recruiting expenses offset by a reduction in IT costs.

Net cash used in operating activities was $3.4 million for the six-months ended October 31, 2023. The cash used in operating activities was primarily due to an increase in net loss from operations excluding non-cash expenses. Net cash used in investing activities was $800,000 and was primarily from investment in additional lab equipment. Net cash used in financing activities was approximately $382,000 and was primarily from repurchases of common stock related to our stock buy-back program offset by proceeds from options exercises.

The Company ended the quarter with cash and cash equivalents on hand of approximately $5.5 million. The Company has no debt.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 589886, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by December 13, 2023 in the Company’s Form 10-Q at www.championsoncology.com.

On December 12, 2023 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) to improve overall survival (Press release, Candel Therapeutics, DEC 12, 2023, View Source [SID1234638485]).

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"We are pleased with the FDA’s decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer," said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. "This milestone follows our first interim data report from the randomized phase 2 clinical trial in patients with borderline resectable PDAC that showed prolonged and sustained survival after experimental treatment with CAN-2409, especially when compared to real-world data on patients receiving radiotherapy treatment. Candel remains on track to release updated overall survival data from the interim analysis of this clinical trial in the second quarter of 2024. We are grateful to the patients, caregivers, investigators and clinical sites that have taken part in this clinical trial."

In November 2023, the Company presented encouraging overall survival and immunological biomarker data based on an interim analysis of the randomized, phase 2 clinical trial of CAN-2409 plus prodrug together with standard of care (SoC) neoadjuvant chemoradiation followed by resection for borderline resectable non-metastatic PDAC at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. An estimated survival rate of 71.4% at both 24 and 36 months in patients who received 2 or 3 injections of the CAN-2409 plus prodrug regimen, together with SoC chemoradiation prior to surgery was observed, versus only 16.7% estimated survival at both 24 and 36 months in patients treated with SoC chemoradiation prior to surgery alone. In parallel, the immunological changes observed in the resected pancreatic tissue after CAN-2409 administration suggested that this investigational treatment can activate an effective immunologic antitumoral response in this otherwise "cold" tumor.

On December 12, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported clinical data from the ongoing Phase 1 dose escalation portion of its Phase 1/2 clinical trial of CFT7455, a MonoDAC degrader of IKZF1/3, for the potential treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL) (Press release, C4 Therapeutics, DEC 12, 2023, View Source [SID1234638484]). These data include results from CFT7455 as a monotherapy for relapsed/refractory (R/R) MM patients, which has completed dose escalation, and interim results from CFT7455 in combination with dexamethasone for R/R MM patients, which continues to enroll patients. C4T also continues to enroll patients in the Phase 1 dose escalation trial exploring CFT7455 as a monotherapy for NHL patients.

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"We are excited CFT7455 monotherapy is showing promising signs of anti-myeloma and immunomodulatory activity and anti-myeloma activity when combined with dexamethasone, particularly in patients who have undergone numerous lines of prior therapy for multiple myeloma, including BCMA therapies," said Len Reyno, M.D., chief medical officer of C4 Therapeutics. "We have established 14 days on/14 days off as the optimal dosing schedule, which is consistent with our preclinical data supporting CFT7455 as a rationally designed IKZF1/3 degrader with the potential to offer a new therapy for patients with relapsed/refractory multiple myeloma."

CFT7455 Phase 1 Dose Escalation
The goal of the CFT7455 Phase 1 dose escalation trial is to define the safety profile of CFT7455, determine the maximum tolerated or administered dose, and identify signs of anti-tumor activity in R/R MM and R/R NHL. The Phase 1 dose escalation portion of the trial includes three arms: CFT7455 as a monotherapy for R/R MM patients, which is complete; CFT7455 in combination with dexamethasone for R/R MM patients, which continues to advance through dose escalation; and CFT7455 as a monotherapy for NHL patients, which also continues to advance through dose escalation. The Phase 1 dose escalation portion of the ongoing Phase 1/2 trial has utilized a 14 days on/14 days off dosing schedule within which both daily dosing and Monday/Wednesday/Friday (MWF) dosing were explored.

CFT7455 as a Monotherapy for R/R MM Patients
Monotherapy dose escalation is complete. As of the November 28, 2023 data cutoff date, 22 patients had received CFT7455 as a monotherapy. The maximum dose administered was 75 µg daily for 14 days on/14 days off. A maximum tolerated dose was not defined. Patients were heavily pretreated, with a median of seven prior therapies. The majority of patients (n=12) received prior CAR-T or T-cell engager therapy.

Pharmacokinetic and Pharmacodynamic Results

Clearance of CFT7455 is consistent with a 48-hour half-life.
Daily dosing (14 days on/14 days off) resulted in deep IKZF1/3 degradation.
After day 14, as plasma concentrations of CFT7455 begin to decline, degraded proteins recover through day 28, enabling neutrophil recovery.
Safety and Evidence of Anti-Tumor Effect

CFT7455 was well tolerated.
22 patients were evaluable for safety. The most common adverse events (AEs) Grade 3 or above were neutropenia (n=11), anemia (n=4) and leukopenia (n=4).
No dose-limiting toxicities (DLTs) resulted in discontinuation of therapy.
As of the November 28, 2023 data cutoff date, 20 patients were evaluable for evidence of anti-tumor effect.
Four patients received the maximum dose administered of 75 µg daily. Three patients were refractory to BCMA therapies. Responses were measured in accordance with the International Myeloma Working Group (IMWG) criteria for multiple myeloma. All four patients achieved Stable Disease (SD) or better and one patient achieved a Partial Response (PR).
Immunomodulatory Results

CFT7455 induced CD8+ T-cell activation by increasing the effector memory T-cell subset, as required for effective adaptive immunity.
T-cell activation was observed at well tolerated monotherapy doses, supporting the potential use of CFT7455 in combination with bi-specific T-cell engagers and monoclonal antibody therapies.
CFT7455 in Combination with Dexamethasone for R/R MM Patients
As of the November 28, 2023 data cutoff date, nine patients had received CFT7455 in combination with dexamethasone across two initial dose escalation cohorts (50 µg MWF for 14 days on/14 days off; or 37.5 µg daily for 14 days on/14 days off). Patients were heavily pretreated, with a median of six prior therapies. The majority of patients (n=5) received prior CAR-T or T-cell engager therapy. This arm is ongoing; patients are currently enrolling in either the 62.5 µg escalation cohort or the 37.5 µg expansion cohort.

Safety and Evidence of Anti-Tumor Effect

CFT7455 in combination with dexamethasone is well tolerated to date.
The most common AEs Grade 3 or above were consistent with the monotherapy safety signal.
No AEs have led to dose reductions, discontinuations or DLTs.
All three patients evaluable for efficacy at 37.5 μg daily achieved SD or better according to IMWG criteria. These assessments include:
One patient achieved a Stringent Complete Response (sCR), after initially achieving a Very Good Partial Response (VGPR). This patient was refractory to BCMA therapies.
One patient achieved a PR. This patient was refractory to BCMA therapies.
One patient achieved SD.
Upcoming Data Presentations for CFT7455
C4T expects to present the following data on CFT7455 in 2024:

Complete Phase 1 dose escalation data from the ongoing Phase 1/2 clinical trial in R/R MM.
Complete Phase 1 dose escalation data from the ongoing Phase 1/2 clinical trial in NHL.
C4T Webcast for Analysts and Investors
C4T will host an investor webcast today, December 12, 2023, at 4:30 pm Eastern Time, to discuss the CFT7455 Phase 1 clinical data in relapsed/refractory multiple myeloma. To join the webcast, please visit this link or the "Events & Presentations" page of the Investors section on the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived and available following the event.

On December 12, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that it has entered into an exclusive license and collaboration agreement with Merck (known as MSD outside of the U.S. and Canada) to develop degrader-antibody conjugates (DACs), an emerging modality designed to selectively target and neutralize disease-causing proteins in cancer cells (Press release, C4 Therapeutics, DEC 12, 2023, View Source [SID1234638483]).

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"We are thrilled to collaborate with Merck to innovate within the growing field of antibody-drug conjugates and evaluate the potential for combining the catalytic efficiency, potency, target specificity, and durability of degraders with the specific binding and delivery capabilities of antibodies," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "We look forward to leveraging our powerful TORPEDO platform in collaboration with Merck’s antibody-drug conjugation expertise to engineer novel medicines with the potential to transform patients’ lives."

Under the terms of the agreement, C4T will receive a $10 million upfront payment. C4T and Merck will collaborate to develop DACs directed to an initial undisclosed oncology target that is exclusive to the collaboration. For DACs directed to this initial target, C4T is eligible to receive milestone payments totaling approximately $600 million, as well as tiered royalties on future sales. The agreement also provides Merck with the option to extend the collaboration to include three additional targets that would be exclusive to the collaboration, which could yield option exercise payments as well as potential milestones and royalties. If Merck exercises all of its options to extend the collaboration, C4T would be eligible to receive up to approximately $2.5 billion in potential payments across the entire collaboration.

"This collaboration combines Merck’s significant biological chemistry expertise with C4T’s leading protein degradation technology," said George Addona, senior vice president, discovery, preclinical development and translational medicine, Merck Research Laboratories. "At Merck, we continue to evaluate new ways to advance the science of targeted medicine."

As part of the collaboration, C4T will be responsible for using its proprietary TORPEDO platform to develop degrader payloads in the discovery phase. Merck will be responsible for antibody conjugation to create DACs in the discovery phase and for advancing these DAC candidates through preclinical and clinical development as well as commercialization.

On December 12, 2023 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable immune response, reported the completion of an oversubscribed $165 million Series C financing (Press release, Bicara Therapeutics, DEC 12, 2023, View Source [SID1234638481]). The financing was co-led by Braidwell LP and TPG, which is investing in the company through TPG Life Sciences Innovations (TPG LSI) and The Rise Fund, with additional new investors including Deerfield Management, Fairmount, Aisling Capital and a leading biotechnology investor associated with one of the largest alternative asset managers. All existing Series B investors also participated in the round.

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Proceeds from the Series C financing will be used to support the continued advancement of Bicara’s lead product candidate, BCA101, a first-in-class bifunctional EGFR/TGF-β inhibitor that is currently in clinical development for multiple cancer types including frontline human papillomavirus (HPV)-negative, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), advanced squamous non-small cell lung cancer (SqNSCLC) and cutaneous squamous cell carcinoma.
At the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting and ESMO (Free ESMO Whitepaper) Congress 2023, Bicara presented positive interim clinical data from its ongoing, open-label Phase 1/1b dose expansion study of BCA101 in combination with pembrolizumab demonstrating clinically meaningful anti-tumor activity and a tolerable safety profile in frontline HPV-negative R/M HNSCC, a cancer with limited treatment options that generally carries a poor prognosis and is increasing in prevalence.
Additional data updates from Bicara’s ongoing Phase 1/1b dose expansion study of BCA101, including in advanced SqNSCLC, are anticipated in 2024.
"Momentum at Bicara is increasing following our BCA101 Phase 1/1b data presentations at key 2023 medical meetings," said Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics. "Our proof-of-concept data in frontline HPV-negative R/M HNSCC, a very difficult patient population to treat, underscore the promise of BCA101 as a new precision therapeutic option for these patients. With additional data readouts anticipated in 2024, we remain excited about the overall potential of BCA101 to help patients with HPV-negative R/M HNSCC, as well as other solid tumor types. We are thrilled to partner with this syndicate of new and existing leading healthcare investors, who share in our vision for BCA101 and Bicara’s bifunctional antibody platform."

In connection with the Series C financing, Carolyn Ng, Ph.D., Business Unit Partner with TPG LSI, has joined Bicara’s board of directors.

"Bicara’s Phase 1/1b dose expansion study of BCA101 has delivered encouraging, clinically meaningful interim results and offers an excellent foundation from which to continue to build Bicara into a leading oncology company," said Dr. Ng. "I am excited to join Bicara’s board of directors at such an important time and look forward to working with this talented management team and distinguished board of directors to advance new treatments for cancer patients."

With the completion of the Series C financing, Bicara has raised $273 million in 2023.

About BCA101
BCA101 is a first-in-class, dual-action, bifunctional antibody designed to inhibit the epidermal growth factor receptor (EGFR) and disable transforming growth factor beta (TGF-β) directly at the tumor site. This approach is designed with the intent to allow BCA101 to inhibit tumor proliferation, while restoring the cytolytic activity of the local immune cells.

BCA101 is currently being evaluated in a dose expansion phase of an open-label Phase 1/1b study in combination with pembrolizumab in patients with unresectable R/M HNSCC and advanced SqNSCLC and as a monotherapy for cutaneous squamous cell carcinoma.

About Head and Neck Squamous Cell Carcinoma
Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck.

Oral cavity and larynx cancers are generally associated with tobacco consumption, alcohol abuse or both, whereas pharynx cancers are increasingly attributed to infection with human papillomavirus (HPV), primarily HPV-16. Thus, HNSCC can be biologically separated into HPV-negative and HPV-positive HNSCC, the latter carrying a more favorable prognosis. Treatment approaches for locally advanced HNSCC generally consist of surgery followed by chemoradiotherapy (CRT) for oral cavity cancers and primary or definitive CRT for pharynx and larynx cancers. The immune checkpoint inhibitors pembrolizumab and nivolumab are approved by the U.S. FDA for treatment of platinum-refractory recurrent or metastatic HNSCC, and pembrolizumab is approved as first-line monotherapy in patients with unresectable or metastatic disease with a CPS ≥1 or combined with platinum and 5-fluorouracil for patients with any CPS score.

HNSCC is the sixth most common cancer worldwide, with approximately 890,000 new cases and 450,000 deaths in 2018. The incidence of HNSCC continues to rise and is anticipated to increase by 30% by 2030.