On May 4, 2022 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the first quarter ended March 31, 2022 (Press release, Vericel, MAY 4, 2022, View Source [SID1234613483]).

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First Quarter 2022 Financial Highlights
•Total net revenue of $36.1 million, compared to $34.6 million in the first quarter of 2021
•MACI net revenue of $26.0 million, Epicel net revenue of $9.9 million, and NexoBrid revenue of $0.2 million related to the U.S. Biomedical Advanced Research and Development Authority ("BARDA") procurement for emergency response preparedness
•Gross margin of 65%, compared to 66% in the first quarter of 2021
•Net loss of $7.1 million, or $0.15 per share, compared to $3.3 million, or $0.07 per share, in the first quarter of 2021
•Non-GAAP adjusted EBITDA of $3.2 million, compared to $4.6 million in the first quarter of 2021
•Operating cash flow of $3.5 million
•As of March 31, 2022, the Company had approximately $130 million in cash, restricted cash and investments, and no debt

Business Highlights and Updates
•Double-digit growth in surgeons taking MACI biopsies compared to the first quarter of 2021, with the second highest monthly biopsies in March 2022 since the launch of MACI
•Growth of more than 20% in burn centers treating patients and taking Epicel biopsies compared to the first quarter of 2021, with a record monthly high in Epicel biopsies in March 2022
•Remain on track for a planned mid-year 2022 resubmission of the NexoBrid Biologics License Application to the FDA, and
1
Exhibit 99.1
•Expanded the Company’s commercial leadership team with the appointment of Mike Gilligan as Vice President, MACI National Sales

"The Company executed well in the first quarter and we remain on track to deliver another year of significant revenue growth, margin expansion, and operating cash flow driven by continued strong results for both MACI and Epicel," said Nick Colangelo, President and CEO of Vericel. "We also continue to advance important regulatory and clinical programs across both our sports medicine and burn care franchises as we remain on track for a mid-year resubmission of the NexoBrid BLA and for planned discussions with the FDA to review both the MACI arthroscopic and ankle development programs, initiatives that we believe will support continued strong growth in the years ahead."

2022 Financial Guidance
The Company reaffirmed financial guidance for full-year 2022
•Total net revenue for 2022 expected to be in the range of $178 to $189 million
◦MACI revenue expected to be in the range of $132 to $141 million
◦Epicel revenue expected to be in the range of $45.5 to $47.5 million
•Gross margin expected to be approximately 70%
•Adjusted EBITDA margin expected to be approximately 21%

First Quarter 2022 Results
Total net revenue for the quarter ended March 31, 2022 increased 4% to $36.1 million, compared to $34.6 million in the first quarter of 2021. Total net product revenue for the quarter increased 7% and included $26.0 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $9.9 million of Epicel (cultured epidermal autografts) net revenue, compared to $23.8 million of MACI net revenue and $9.8 million of Epicel net revenue, respectively, in the first quarter of 2021. Total net revenue for the quarter also included $0.2 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness, compared to $0.9 million in the first quarter of 2021.

Gross profit for the quarter ended March 31, 2022 was $23.5 million, or 65% of net revenue, compared to $23.0 million, or 66% of net revenue, for the first quarter of 2021.

Total operating expenses for the quarter ended March 31, 2022 were $30.7 million, compared to $26.3 million for the same period in 2021. The increase in operating expenses was primarily due to higher stock-based compensation expense.

Net loss for the quarter ended March 31, 2022 was $7.1 million, or $0.15 per share, compared to a net loss of $3.3 million, or $0.07 per share, for the first quarter of 2021.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2022 was $3.2 million, or 9% of net revenue, compared to $4.6 million, or 13% of net revenue, for the first quarter of 2021. A table reconciling non-GAAP measures is included in this press release for reference.

As of March 31, 2022, the Company had approximately $130 million in cash, restricted cash and investments, and no debt.

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s first quarter 2022 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

On May 4, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2022 financial results and provided a corporate update (Press release, Kura Oncology, MAY 4, 2022, View Source [SID1234613515]).

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"We continue to operate from a position of strength, armed with three independent drug development programs, near-term clinical milestones and cash runway through 2024," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Our team continues to execute, having completed enrollment of the Phase 1b expansion cohorts for our menin inhibitor, ziftomenib, and we remain very encouraged by the safety profile, tolerability and clinical activity we are observing in the study. We continue to assess patients in the Phase 1b for safety and tolerability, pharmacokinetics and exposure, as well as efficacy, and we look forward to identifying a recommended Phase 2 dose for ziftomenib and reporting topline data from the study next quarter."

Recent Highlights

Enrollment completed in Phase 1b expansion cohorts for ziftomenib – Kura has completed enrollment of the patients in the Phase 1b portion of KOMET-001 required to identify a recommended Phase 2 dose for ziftomenib. The Phase 1b portion was designed to enroll two expansion cohorts – 200 mg and 600 mg – with each cohort comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed and/or refractory acute myeloid leukemia (AML). The goal of the Phase 1b portion is dose optimization, and the two doses were selected based on the encouraging clinical activity, safety profile and tolerability demonstrated in the Phase 1a portion of KOMET-001. Kura remains on track to identify the recommended Phase 2 dose for ziftomenib and report topline data from the Phase 1b portion of KOMET-001 in the third quarter of 2022, with a more complete dataset reserved for presentation at a medical meeting in the fourth quarter of 2022.

Expanded opportunity for tipifarnib in head and neck squamous cell carcinoma – Enrollment continues in the Phase 1/2 clinical trial (KURRENT-HN) of tipifarnib in combination with the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The initial cohort includes patients who have PIK3CA-dependent HNSCC, and Kura expects to dose the first patient in an HRAS overexpression cohort in the third quarter of 2022. The Company believes the combination with alpelisib has the potential to drive deeper and more durable responses than either agent as monotherapy and to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC.

Preclinical data support use of tipifarnib to prevent relapse to osimertinib – In April 2022, preclinical data supporting the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR mutant non-small cell lung cancer (NSCLC) were reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Kura is now preparing to initiate a Phase 1 trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutated NSCLC and expect to dose the first patient in the third quarter of 2022. The Company intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, Kura’s next-generation farnesyl transferase inhibitor (FTI), through investigational new drug (IND)-enabling studies.
Financial Results

Research and development expenses for the first quarter of 2022 were $20.9 million, compared to $20.3 million for the first quarter of 2021. The increase in R&D expenses was primarily due to increases in ziftomenib clinical trial and personnel costs.

General and administrative expenses for the first quarter of 2022 were $11.9 million, compared to $10.6 million for the first quarter of 2021. The increase in G&A expenses was primarily due to increases in professional fees and non-cash share-based compensation.

Net loss for the first quarter of 2022 was $32.5 million, compared to a net loss of $30.7 million for the first quarter of 2021. This included non-cash share-based compensation expense of $6.7 million, compared to $5.1 million for the same period in 2021.

Cash, cash equivalents and short-term investments totaled $480.1 million as of March 31, 2022, compared with $518.0 million as of December 31, 2021. Based on its current plans, management expects that current cash, cash equivalents and short-term investments will fund current operations through 2024.
2022 Milestones

Identify the recommended Phase 2 dose of ziftomenib and report topline data from the Phase 1b study in the third quarter.

Present updated data from KOMET-001 at a medical meeting in the fourth quarter.

Dose the first patient in the HRAS overexpression cohort of the KURRENT-HN trial by the third quarter.

Dose the first patient in the KURRENT-LUNG trial in the third quarter.

Submit an IND application for KO-2806 in the fourth quarter.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, May 4, 2022, to discuss the financial results for the first quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (844) 826-3035 for domestic callers and (412) 317-5195 for international callers and entering the conference code: 10166202. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On May 4, 2022 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported the company will release its first quarter 2022 financial results and provide a business update on Thursday, May 12, 2022 (Press release, Chemomab, MAY 4, 2022, View Source [SID1234613532]). The company will host a conference call at 8:00 am Eastern Time, which will be webcast at the link below and on the company’s investor relations website.

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Chemomab’s management team will review first quarter 2022 performance, discuss recent and upcoming events and conduct a live question-and-answer session.

Conference Call and Webcast Information:

Live Webcast at 8:00 am ET, May 12, 2022

Click this Webcast link to access the live webcast or replay.

The live webcast and replay can also be accessed at the News & Events section of the Investors page on the Chemomab website at investors.chemomab.com/events.

On May 4, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research reported new clinical biomarker data demonstrating pelareorep’s immunotherapeutic effects, synergy with checkpoint inhibition, and potential to improve the outlook for patients with HR+/HER2- breast cancer (Press release, Oncolytics Biotech, MAY 4, 2022, View Source [SID1234613550]). The data, which are featured in a poster presentation at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Meeting, are from cohorts 1 and 2 of the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.

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Patients in AWARE-1’s first two cohorts were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1), or with (cohort 2), the PD-L1 checkpoint inhibitor atezolizumab approximately 21 days prior to the surgical resection of their tumors. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with HR+/HER2- disease, the breast cancer subtype that Oncolytics intends to examine in a future registrational study. Previously reported results showed AWARE-1 met its primary translational endpoint, with cohort 2 achieving the pre-specified success criteria for treatment-induced increases in CelTIL score (link to the PR). CelTIL score is a metric for tumor inflammation and cellularity and is associated with improved clinical outcomes in breast cancer patients.

"The latest data from AWARE-1 further demonstrate pelareorep’s potential to improve clinical outcomes in breast cancer patients through its ability to activate T cells and remodel the tumor microenvironment," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Notably, pelareorep treatment increased markers of tumor cell death and, perhaps even more impressive, 100% of evaluable pelareorep-treated patients had a favorable Risk of Recurrence Score (ROR-S) compared to 55% at baseline. Together, these latest AWARE-1 results further establish pelareorep’s ability to attack tumors through multiple mechanisms."

Key data and conclusions from the ESMO (Free ESMO Whitepaper) Breast Cancer poster include:

Gene expression analyses showed 100% of evaluable patients had a Risk of Recurrence Score (ROR-S) classified as "low" at surgery vs. 55% with a "low" ROR-S at baseline (information pertaining to prognostic testing of gene signature assays in breast cancer can be found by clicking here)
Treatment with pelareorep with (cohort 2) or without (cohort1) atezolizumab led to the conversion of tumors from the more aggressive luminal B to the luminal A subtype, which is associated with improved clinical outcomes
100% of evaluable cohort 2 tumors were luminal A at surgery (21 days post-treatment) vs. 70% at baseline (pre-treatment)
70% of evaluable cohort 1 patients had luminal A tumors at surgery vs. 40% at baseline
Pooled analysis of tumors from cohorts 1 and 2 shows a statistically significant 4-fold post-treatment increase in the average expression of caspase 3, which is a marker of apoptotic cell death
Pooled analysis across cohorts 1 and 2 shows statistically significant increases in markers of T cell activation and no significant changes in markers of T cell exhaustion from baseline to surgery
Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "AWARE-1’s results continue to exceed our expectations. With each new dataset, we gain additional clarity on how pelareorep’s immunologic mechanism of action synergistically combines with checkpoint inhibition. The study has also identified changes in blood T cell populations as a potential biomarker to predict patient response. We are now working to confirm these promising findings with efficacy data and additional biomarker analyses from our ongoing BRACELET-1 trial. If positive, we expect BRACELET-1’s results to inform the design of a registrational study in HR+/HER2- breast cancer and validate our broader strategy of developing pelareorep in combination with leading anti-cancer agents."

BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The trial includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with a checkpoint inhibitor. Top-line data from the trial are expected in Q4 2022.

The poster, entitled, The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients – Results from AWARE-1 study, is being presented during the "Biomarkers and translational research and precision medicine" session of the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting. Following the conclusion of the meeting, the poster will be available on the Posters & Publications page of Oncolytics’ website (LINK).

About AWARE-1

AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.

On May 4, 2022 Microba Life Sciences Limited (ASX: MAP) ("Microba" or the "Company") reported it has identified three therapeutic leads for the Company’s Immuno-Oncology program significantly earlier than expected (Press release, Microba Life Sciences , MAY 4, 2022, View Source [SID1234613568]). This will enable preclinical animal studies to be brought forward to the end of calendar year 2022 which is approximately 12 months ahead of schedule.

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Microba’s Cancer Immuno-Oncology program is targeting the discovery and development of a microbiome therapy to improve response rates in cancer patients receiving immune checkpoint inhibitor (ICI) therapy, with a specific focus on Melanoma and Lung cancer patients. The new therapeutic leads that will be trialled in pre-clinical models later this year have been discovered through a recently completed, comprehensive meta-analysis of newly available data with Microba’s proprietary MCP microbiome profiling technology.

Further supporting Microba’s Immuno-Oncology program is the Company’s partnership and awarded grant together with the Garvan Institute of Medical Research (Garvan), targeting the collection of data on thousands of cancer patients over the coming years to establish a leading cancer microbiome dataset. This is expected to broaden the number of cancers for which Microba can identify a clear microbiome signature.

The combination of the new leads and the partnership with Garvan will enable Microba to save over US$1m of expenditure on discovery activities which were scheduled to take place over the next 18 months under the ORBIT-m study.

The leading existing ICI therapies from Merck and BMS generate in excess of $20bn1 in sales per year despite 42-80%2 of patients not responding to therapy. Development of an adjuvant therapy that can improve response rates to ICI therapies could have a significant impact on cancer treatment globally and represents a substantial commercial opportunity.

Commenting on the accelerated oncology strategy, CEO Dr Luke Reid said:

"This acceleration of our oncology program is really pleasing. The discovery of these leads enables us to advance our timelines for this program. Developing an effective adjuvant therapy for cancer patients receiving immune checkpoint inhibitors has the potential to impact outcomes for millions of patients globally."

Chief Scientific Officer Associate Professor, Lutz Krause said:

"Through applying Microba’s proprietary technology, we have uncovered therapeutic leads sooner than we had anticipated. We are excited to progress these into pre-clinical models and ultimately into human clinical trials pending the results. This exemplifies the power of Microba’s data-driven Therapeutic Platform, which enables the rapid discovery and development of these novel monoclonal microbial therapies."

This announcement has been authorised for release by the Board.