On May 5, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the first quarter ended March 31, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAY 5, 2022, View Source [SID1234613711]).

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!

"In the first quarter, we began enrollment in the Phase 2 expansion cohorts with CYT-0851 monotherapy and continued enrolling in the Phase 1 combination study. Our R&D Day in April highlighted the exceptional work of our discovery research team that has provided us with a greater understanding of the mechanism of action for CYT-0851, potentially expanding the opportunity of the drug into new tumor types," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "I am proud of the entire Cyteir team and look forward to delivering on key data reporting milestones in the second half of the year."

First Quarter 2022 Accomplishments

Advanced CYT-0851 Clinical Program

Progress continues to advance CYT-0851 in monotherapy and combination clinical studies. Enrollment is ongoing in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. Completion of stage 1 of this study is expected before the end of 2022. Enrollment is also ongoing in a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: (1) rituximab plus bendamustine; (2) gemcitabine; and (3) capecitabine, in both hematologic malignancies and solid tumors. Initial safety data from this combination study is expected before the end of 2022.
A poster with updated data from the Phase 1 dose-escalation portion of the first-in-human Phase 1/2 trial of CYT-0851 will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5, 2022.
Continued to Advance Our Synthetically Lethal Preclinical Pipeline

Cyteir continues to advance two previously reported discovery projects focused on identifying inhibitors of DNA damage repair. The first of these undisclosed targets (Target 2) plays a key role in Non-Homologous End Joining (NHEJ) and the second (Target 3) in Microhomology-Mediated End Joining (MMEJ) DNA repair pathways. Both undisclosed target projects are currently in lead generation, and we anticipate reaching the drug candidate nomination stage in 2023.
Cyteir expects to complete IND-enabling studies for CYT-1853 in the first half of 2022, and if the data supports an overall risk-benefit improvement and differentiation from CYT-0851, Cyteir plans to file an IND application with the FDA before the end of 2022.
CYT-0851 Mechanism of Action Due to Inhibition of Monocarboxylate Transporters, Essential Proteins in Cancer Metabolism

Based on molecular, bioinformatic, and biochemical characterization research that has been done at Cyteir to elucidate the mechanism of action of CYT-0851, management believes that the observed effects of CYT-0851 on the viability of cancer cells are due to inhibition of monocarboxylate transporter (MCT) activity and the subsequent disruption of lactate transport. Monocarboxylate transporters are essential proteins in cancer metabolism making MCTs an attractive target for cancer therapy. Based on the newly identified mechanism of action, the patient selection biomarker discovery strategy has been modified while all aspects of the trial design remain appropriate and unchanged. This new understanding of the mechanism of action of CYT-0851 could potentially accelerate development of a biomarker and allow for expansion into additional opportunities in other tumor types. The initial results from the work on our biomarker were presented in a virtual R&D Day in April.
First Quarter 2022 Financial Results

Cash and cash equivalents: Cash and cash equivalents as of March 31, 2022 were $177.4 million, which are expected to fund planned operations into 2024.

Research and development (R&D) expenses: R&D expenses were $10.1 million for the first quarter of 2022 versus $5.6 million for the same period in 2021. The year-over-year increase in R&D spending in the comparative periods was due primarily to increased research activity, clinical trial expenses, and headcount, including the ongoing of Phase 1 and Phase 2 studies for CYT-0851.

General and administrative (G&A) expenses: G&A expenses were $4.0 million for the first quarter of 2022 compared to $1.7 million for the same period in 2021. The year-over-year increase in G&A expenses in the comparative periods was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.

Net loss: Net loss was $14.1 million, or $0.40 per share, in the first quarter of 2022 compared to $7.3 million, or $3.40 per share, for the same period in 2021.

On May 5, 2022 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the first quarter ended March 31, 2022 (Press release, ViewRay, MAY 5, 2022, View Source [SID1234613728]).

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!

First Quarter 2022 Highlights

Total revenue for the first quarter 2022 was approximately $18.9 million, primarily from three revenue units, compared to approximately $15.5 million, primarily from two revenue units, in the first quarter of 2021.
Received seven new orders for MRIdian systems totaling $40.9 million.
Total backlog increased to $330.9 million as of March 31, 2022, compared to approximately $264.3 million as of March 31, 2021.
Cash and cash equivalents, inclusive of a customer deposit reflected in restricted cash was $183.2 million as of March 31, 2022. Cash usage as of March 31, 2022 was approximately $35.2 million, consistent with historical seasonality trends.
"Our performance in the first quarter 2022 demonstrates strong customer demand and progress on our mission to improve the paradigm of care for cancer patients globally, despite the on-going macroeconomic challenges," said Scott Drake, President and CEO. "MRIdian’s clinical, strategic, and economic value propositions continue to gain momentum with customers. Our accelerating installation cycle also positions us well on our path to deliver industry-leading revenue growth, expand gross margin and achieve cash flow breakeven."

Financial Results

Total revenue for the three months ended March 31, 2022 was $18.9 million compared to $15.5 million for the same period last year.

Total cost of revenue for the three months ended March 31, 2022 was $18.8 million compared to $15.2 million for the same period last year.

Total gross profit for the three months ended March 31, 2022 was $0.1, compared to $0.3 for the same period last year.

Total operating expenses for the three months ended March 31, 2022 were $27.6 million, compared to $25.0 million for the same period last year.

Net loss for the three months ended March 31, 2022 was $25.8 million, or $(0.14) per share, compared to $26.7 million, or $(0.17) per share, for the same period last year.

ViewRay had total cash and cash equivalents of $180.1 million at March 31, 2022.

Financial Guidance

The Company reiterated its 2022 guidance of total revenue in the range of $84 million to $104 million, and total cash usage to be in the range of $68 million to $83 million.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, May 5, 2022 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 9988699. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until May 12, 2022. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 9988699.

On May 5, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the first quarter ending March 31, 2022 (Press release, Akoya Biosciences, MAY 5, 2022, View Source [SID1234613754]).

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!

"Akoya remains on an exciting trajectory, delivering record revenue and system placements in the first quarter," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "This quarter was highlighted by the commercial launch of the PhenoCycler-Fusion System and showcasing powerful new data of our 100+ plex antibody panels as well as the new universal chemistry capabilities at the recent AACR (Free AACR Whitepaper) meeting. We continued to execute on all segments of the business and are confident in our updated full year revenue guidance."

First Quarter 2022 Financial Highlights

Total revenue was $16.9 million in the first quarter of 2022, compared to $12.2 million in the prior year period; an increase of 38%.
Product revenue was $13.3 million in the first quarter of 2022, compared to $10.0 million in the prior year period; an increase of 34%; within product revenue, reagent revenue was $4.6 million for the quarter, versus $2.5 million in the prior year period; an increase of 82%.
Services and other revenue totaled $3.6 million in the first quarter of 2022, compared to $2.2 million in the prior year period; an increase of 58%.
Gross profit was $10.1 million in the first quarter of 2022, compared to $7.4 million in the prior year period; an increase of 36%; gross profit margin was 60% in the first quarter of 2022.
51 instruments were sold in the first quarter of 2022; 14 PhenoCyclers, 37 PhenoImagers (which includes Fusion and HT).
Instrument installed base of 748 as of March 31, 2022; 196 PhenoCyclers, 552 PhenoImagers (of which 28 are the new Fusion instruments).
Combined-unit PhenoCycler-Fusion installed base of 23 as of March 31, 2022.
First Quarter 2022 Business Highlights

As of March 31, 2022, there have been 531 total publications featuring Akoya’s platforms; 112% growth from 251 total publications as of March 31, 2021.
Appointment of Dr. Ehab El-Gabry, M.D. as Akoya’s new Chief Medical Officer, who brings over 20 years of leadership experience in pathology and IVD development that are critical for Akoya’s vision of advancing spatial phenotyping in precision medicine and cancer care.
Showcased new data for a panel of 100+ protein markers for deep spatial phenotyping at single-cell resolution across an entire tissue sample at AACR (Free AACR Whitepaper).
Previewed the new universal chemistry to enable accelerated validation of biomarkers discovered using deep spatial phenotyping at AACR (Free AACR Whitepaper).
Launched world tour for PhenoCycler-Fusion across 29 cities in North America, Europe, and Asia-Pacific; please visit View Source for a full list of the world tour cities and dates to experience the PhenoCycler-Fusion at a city near you.
$94 million of cash and cash equivalents as of March 31, 2022, well capitalized to deliver on our existing strategic plan.
2022 Outlook

The company, based on its updated plans and initiatives, is raising its full year 2022 revenue guidance range to $70-73 million.

Webcast and Conference Call Details

Akoya will host a conference call today, May 5, 2022, at 5:00 p.m. Eastern Time to discuss its first quarter 2022 financial results. The dial-in numbers are (833) 562-0146 for domestic callers or (661) 567-1226 for international callers, followed by Conference ID: 7363649. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On May 5, 2022 Novartis reported a temporary, voluntary suspension of production at its radioligand therapy production sites in Ivrea, Italy and Millburn, New Jersey (Press release, Novartis, MAY 5, 2022, View Source [SID1234614187]). The company has taken this action out of an abundance of caution as it addresses potential quality issues identified in its manufacturing processes. Novartis is conducting a thorough review of the situation and currently expects to resolve the issues and resume some supply in the next six weeks.

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!

As a result, the company is temporarily suspending delivery of Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide) in the US and Canada, and 177Lu-PSMA-617 (INN: lutetium (177Lu) vipivotide tetraxetan), marketed as Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in the US. Some doses of Lutathera (lutetium (177Lu) oxodotreotide) will be available in Europe and Asia from Novartis radioligand therapy production site in Zaragoza, Spain, although there may be some delays in supply.

In addition, Novartis is putting a temporary hold on screening and enrollment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.

Quality and patient safety are our top priorities. There is currently no indication of any risk to patients from doses previously produced at these sites. Novartis has notified treatment sites to closely monitor patients who have recently been injected and asked them to report any adverse events to Novartis patient safety.

We recognize that this situation affects patients, their families and care teams. Novartis takes this very seriously and the company is doing everything it can to resolve this issue and resume patient doses as quickly as possible. Health authorities have been informed and will receive additional updates as they are available.

On May 5, 2022 XOMA Corporation (Nasdaq: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, reported its first quarter 2022 financial results and provided a recent operations update (Press release, Xoma, MAY 5, 2022, View Source [SID1234613621]).

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!

"Our team’s ability to identify and acquire the economic interests in potential therapeutic assets that have significant potential has been further validated with two events in the first months of 2022. First, since enacting of the milestone and royalty monetization strategy, an asset in our royalty portfolio became the first to achieve regulatory and commercialization approvals, leading off with the FDA in January and Japan’s MHLW at the end of the quarter. Second, we are encouraged by Regeneron’s recently announced acquisition of Checkmate and vidutolimod (CMP-001)1," stated Jim Neal, Chairman and Chief Executive Officer of XOMA. "We congratulate our partners on their recent achievements."

"Several other partners announced milestones in their development programs. In January 2022, Rezolute dosed the final patient with RZ358 in its Phase 2 congenital hyperinsulinism (CHI) study, which triggered a $2 million milestone payment to XOMA. We congratulate Rezolute on the RIZE Study data presented at Pediatric Endocrine Society Annual Meeting, which took place on May 12,3 and its $130 million registered direct offering and private placement4. We are pleased Rezolute and its shareholders are committed to

moving RZ358 into Phase 3 clinical development. Additionally, Janssen expanded its cetrelimab clinical program to investigate the compound in patients with chronic hepatitis B virus. Furthermore, Palobiofarma launched a Phase 2 study with PBF-6880 in COPD patients. Each of these advancements reflect the dedication and desire of the scientists and clinicians to give patients and their families much needed hope."

Faricimab, Affitech, and Roche Update

In October 2021, XOMA acquired an economic interest Roche’s novel bispecific antibody from Affitech SA. During the first quarter of 2022, XOMA paid $5 million in milestones to Affitech based upon the January 2022 commercialization approval from the U.S. Food and Drug Administration (FDA)5. XOMA does not owe Affitech a milestone based upon the Japan’s Ministry of Health, Labour and Welfare (MHLW) commercialization approval6, which was granted in March 2022. On April 25, 2022, Roche reported first quarter 2022 financial results, which included initial faricimab sales7.

Financial Results

XOMA recorded total revenues of $3.1 million for the first quarter of 2022, compared with $0.4 million in the first quarter of 2021. The increase for the three months ended March 31, 2022, as compared to the corresponding period of 2021, was primarily due to the $2.0 million milestone earned under the Company’s development and commercialization agreement with Rezolute and a $0.8 million milestone earned under the Takeda Collaboration Agreement.

Research and development ("R&D") expenses were $56,000 and $61,000, respectively, for the first quarters of 2022 and 2021.

General and administrative ("G&A") expenses were $5.1 million for the first quarter of 2022, compared to $6.7 million for the first quarter of 2021. The decrease of $1.6 million for the three months ended March 31, 2022, as compared to the corresponding period of 2021, was due primarily to a $1.9 million decrease in stock-based compensation expense for stock options and a $0.2 million decrease in consulting and deal costs, partially offset by a $0.5 million increase in personnel related expenses.

In the first quarter of 2022, G&A expenses included $1.0 million in non-cash stock-based compensation expense, compared with $2.9 million in the first quarter of 2021. XOMA’s net cash used in operations in the first quarter of 2022 was $1.0 million, as compared with $0.9 million during the first quarter of 2021.

Other expense, net was $0.2 million for the first quarter of 2022, compared to other expense, net of $0.7 million in the corresponding quarter of 2021. The fluctuation in other (expense) income, net between the quarters ended March 31, 2022 and 2021, is primarily due to the change in the fair value of equity securities XOMA holds in Rezolute, Inc.

Net loss for the first quarter of 2022 was $2.3 million, compared to net loss of $7.4 million for the first quarter of 2021.

On March 31, 2022, XOMA had cash, cash equivalents and restricted cash of $88.6 million. On January 18, 2022, the Company paid cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) equal to $0.53906 per share and cash dividends on the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO) equal to $0.52344 per depositary share. The Company ended December 31, 2021, with cash and restricted cash of $95.4 million. After paying its remaining debt obligations in the second quarter of 2021, XOMA has no debt on its balance sheet. The Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.