On August 4, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported financial results for the second quarter of 2022 and highlighted recent achievements and developments (Press release, Oncorus, AUG 4, 2022, View Source [SID1234617469]).

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"In recent months, Oncorus has maintained momentum across our portfolio of next-generation viral immunotherapies with ongoing enrollment of patients in the ONCR-177 Phase 1 clinical trial and continued IND-enabling studies for ONCR-021, our lead self-amplifying vRNA/LNP program," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We are preparing for the next phase of our growth as our pipeline matures and as we operationalize our GMP-compliant manufacturing facility by the end of this year. In our ongoing Phase 1 clinical trial of ONCR-177, we remain on track to report initial data from 15 to 20 patients from our expansion cohort in combination with Merck’s KEYTRUDA, along with additional surface lesion monotherapy data by the end of 2022."

Second Quarter 2022 and Recent Business Highlights

On track to report combination data and additional monotherapy data for ONCR-177 in the second half of 2022. Oncorus has completed enrollment in the dose expansion portion of its Phase 1 open-label, multi-center clinical trial in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. The company continues to enroll patients in the combination cohort with initial surface lesion combination expansion data for ONCR-177 administered with Merck’s KEYTRUDA and additional surface lesion monotherapy expansion data expected in the second half of 2022.

Presented preclinical data for ONCR-021 and ONCR-788 supporting the company’s self-amplifying viral RNA (vRNA)/lipid nanoparticle (LNP) immunotherapy platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. In April 2022, Oncorus presented preclinical data for both ONCR-021 and ONCR-788 in two e-posters at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating robust preclinical anti-tumor efficacy in multiple tumor models while avoiding the challenges seen in previous studies that incorporate IV administration of RNA-based oncology therapeutics. Oncorus plans to submit an investigational new drug (IND) application for ONCR-021 with the U.S. Food and Drug Administration in mid-2023 and a subsequent IND submission for ONCR-788.

Announced debt capital facility with K2 HealthVentures (K2HV) with $20 million funded at closing and planned relocation to Andover, Massachusetts facility: In April 2022, Oncorus entered into a loan and security agreement with K2HV, a healthcare-focused specialty finance company, which provides Oncorus with up to $45 million available in multiple tranches upon the achievement of certain time-based, clinical and regulatory milestones. Oncorus also announced plans to relocate all operations to its facility in Andover, Massachusetts in the fourth quarter of 2022 to increase operational efficiency, allowing research, process development and Good Manufacturing Practice (GMP)-compliant manufacturing to occur all in one facility.
Second Quarter 2022 Financial Results

Cash and cash equivalents and investments totaled $100.2 million as of June 30, 2022 compared to $98.7 million as of March 31, 2022.

Research and development expenses for the quarter ended June 30, 2022 were $12.5 million compared to $10.7 million for the corresponding quarter in 2021. The increase was primarily attributable to increased headcount, which drove higher employee compensation and stock-based compensation, increased development costs related to the company’s nominated candidates, as well as increased rent expense related to the company’s manufacturing facility.

General and administrative expenses for the quarter ended June 30, 2022 were $6.2 million compared to $4.9 million for the corresponding quarter in 2021. The increase was primarily attributable to increased headcount, which drove higher employee compensation and stock-based compensation, as well as increased rent expense related to the company’s manufacturing facility.

Net loss for the quarter ended June 30, 2022 was $19.1 million, or $0.74 per share, as compared to a net loss of $15.5 million, or $0.60 per share for the corresponding quarter in 2021.
Financial Guidance

Oncorus expects its cash, cash equivalents and investments to fund its capital expenditures and operating expenses into early 2024.

On August 4, 2022 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, reported financial results for the second quarter ended June 30, 2022 (Press release, Allakos, AUG 4, 2022, View Source [SID1234617533]).

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Recent Allakos Events

Submitted End-of-Phase 2 briefing package to FDA to discuss Phase 2 KRYPTOS data and development pathway of lirentelimab in patients with eosinophilic esophagitis (EoE). Meeting with FDA scheduled for third quarter of 2022.
Upcoming Allakos Milestones

Report topline data from Phase 3 EoDyssey study of lirentelimab (AK002) in patients with eosinophilic duodenitis (EoD) in third quarter of 2022.
Hold End-of-Phase 2 meeting with FDA during third quarter of 2022 to discuss Phase 2 KRYPTOS data and development path.
Initiate Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in third quarter of 2022.
Complete IND-enabling studies of AK006 by end of fourth quarter of 2022 and initiate first-in-human study in first half of 2023.
Report topline data from Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in second half of 2023.
Report topline data from Phase 2 study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in second half of 2023.
Second Quarter 2022 Financial Results

Research and development expenses were $34.4 million in the second quarter of 2022 compared to $41.0 million in second quarter of 2021. Second quarter 2022 research and development expenses decreased by $6.6 million compared to the same period of 2021 primarily due to a decrease in contract research and development and clinical costs primarily relating to lirentelimab, partially offset by an increase in equipment and overhead related costs related to the Company’s corporate facility.

General and administrative expenses were $14.7 million in the second quarter of 2022 compared to $16.2 million in second quarter of 2021. Second quarter 2022 general and administrative expenses decreased by $1.5 million compared to the same period in 2021 due to decreases in equipment and overhead related costs, personnel-related costs and in other general and administrative expenses.

Allakos reported a net loss of $49.1 million in the second quarter of 2022 compared to $57.2 million in the second quarter of 2021. The second quarter of 2022 included non-cash expenses for stock-based compensation of $11.8 million, compared to $11.4 million in the same period in 2021, and depreciation of $1.9 million, compared to $0.4 million in the same period in 2021. Net loss per basic and diluted share was $0.90 for the second quarter of 2022 compared to $1.07 in the second quarter of 2021.

Allakos ended the second quarter of 2022 with $212.4 million in cash, cash equivalents and investments.

On August 4, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, reported second quarter 2022 financial results and recent operational progress (Press release, Codiak Biosciences, AUG 4, 2022, View Source [SID1234617549]).

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"During the second quarter we made strong progress supporting our approach and making advancements across our pipeline. We reported Phase 1 data sets from both our exoSTING and exoIL-12 programs, further validating our engEx platform, and demonstrating we were able to deliver repeat doses of exoSTING and exoIL-12 to the tumor with a high level of specificity. Importantly, we did so with no observed systemic exposure or associated toxicity, and an enhanced therapeutic index – while demonstrating tumor shrinkage in both injected and uninjected lesions," said Douglas E. Williams, Ph.D., President and CEO of Codiak. "We also initiated a Phase 1 study of exoASO-STAT6, our third program to enter the clinic, in patients with certain liver, gastric and colorectal cancers. These updates, in combination with preclinical data showing the promise of our engEx-AAV program and a partnership with CEPI to advance our pan Betacoronavirus program, show that Codiak is broadly advancing its portfolio programs in 2022, momentum we aim to carry through this year and into 2023."

Second Quarter 2022 and Recent Highlights

Announced platform-validating data from Phase 1 trials of exoSTING and exoIL-12; both candidates demonstrated potential for best-in-class profile; Codiak has identified a recommended Phase 2 dose for each program and intends to finalize study plans with the FDA during the second half of this year to prepare for initiation of Phase 2 trials for both candidates early next year.
In a Phase 1 trial, exoIL-12 demonstrated a differentiating safety and tolerability profile, with no detectable systemic exposure of IL-12 and no treatment-related adverse events, which has not previously been reported by others with recombinant IL-12. The two patients with cutaneous T cell lymphoma (CTCL) who have been treated each received multiple (>20) injections of exoIL-12 and experienced tumor regressions in both injected and non-injected lesions, including a partial response in one patient.
In the Phase 1/2 clinical trial evaluating exoSTING as a single agent in patients with late-stage refractory solid tumors, data across all five dose cohorts showed repeat doses of exoSTING were well-tolerated, demonstrated tumor retention with no systemic exposure of the STING agonist, and in a subset of patients, tumor shrinkage was observed in injected and uninjected lesions.
Initiated patient dosing in the Phase 1 clinical trial of exoASO-STAT6 in patients with advanced hepatocellular carcinoma, liver metastases from primary gastric cancer and colorectal cancer; exoASO-STAT6 is Codiak’s third clinical program and the first to evaluate a systemically administered exosome-based drug candidate.
Partnered with CEPI to continue the advancement of vaccine candidates from the Company’s pan Betacoronavirus program; as part of the partnership, CEPI will provide seed funding of up to $2.5 million, which Codiak anticipates will fund the completion of preclinical development and identification of a clinical candidate.
Presented preclinical data on the Company’s engEx-AAV discovery program, a novel strategy that aims to leverage exosomes to improve adeno-associated virus (AAV) vector gene therapy, at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper); data demonstrated that exosome engineering generates significant increases in AAV yield compared to unmodified exosomes, while retaining the functionality to transduce cells with AAV and resist neutralizing antibodies that impair gene therapy efficacy.
Anticipated Milestones and Events

Initiate Phase 2 study of exoIL-12 in an expanded group of tumor types in 1H 2023; continue to monitor patients enrolled in Phase 1 study.
Initiate Phase 2 study of exoSTING in bladder cancer in 1H 2023; continue to monitor patients enrolled in ongoing Phase 1/2 study, reporting additional data at an upcoming scientific conference.
Continue enrollment for ongoing Phase 1 trial for exoASO-STAT6, with initial data expected in 1H 2023.
Advance exoVACC pan Betacoronavirus program toward identification of a clinical candidate through new partnership with CEPI.
Second Quarter 2022 Financial Results
Total revenues for the quarter ended June 30, 2022, were $13.1 million, compared to $0.9 million for the same period in 2021. These results reflect deferred revenue recognized under the Company’s collaboration with Jazz Pharmaceuticals.

Net loss for the quarter ended June 30, 2022, was $6.8 million, compared to a net loss of $21.8 million for the same period in 2021. The decrease in net loss for the quarter was driven primarily by an increase in revenues in connection with the Company’s agreement with Jazz Pharmaceuticals.

Research and development expenses were $12.8 million for the quarter ended June 30, 2022, compared to $15.4 million for the same period in 2021. The decrease in research and development expenses was driven primarily by decreases in lab expenses and personnel-related costs in connection with the Company’s agreement with Lonza.

General and administrative expenses were $7.4 million for the quarter ended June 30, 2022, compared to $6.9 million for the same period in 2021. The increase was due primarily to professional services driven by legal fees for intellectual property rights.

As of June 30, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $41.8 million.

On August 4, 2022 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported financial results for its second quarter ended June 30, 2022 (Press release, NantHealth, AUG 4, 2022, View Source [SID1234617565]).

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"For the 2022 second quarter, we reported net revenue of $16.5 million, representing the third consecutive quarter of top-line growth," said Ron Louks, Chief Operating Officer, NantHealth. "We are pleased to note that our overall gross margin was a solid 55 percent for the quarter and has remained relatively steady over the last three years.

"Operationally, we are committed to further enhancing our products and services offering. Our development efforts include expanding our pipeline of pilot programs for The OpenNMS Group, as well as for our Artificial Intelligence (AI) and Quadris businesses. Regarding our Eviti Connect for Autoimmune Diseases program, we continue to roll out new drugs and new drug regimens, including the upcoming launch of the Intravenous Immunoglobulin (IVIG) treatment. Our Eviti Connect for Autoimmune Diseases customers are already realizing meaningful savings; we expect those savings to grow as we expand the product’s coverage."

Software and Services Q2 Highlights:

Clinical Decision Support (Eviti):
In June, Eviti Connect for Oncology won the Spring Digital Health "Connected Digital Health Merit Award," in recognition of the product’s credibility and relevance of content and design
Received approval for full Delegated Entity status in three additional states (Mississippi, Virginia and Iowa). This designation allows customer needs to be fully supported for Delegated Entity Services and provides growth opportunities with new customers in those states
Significantly grew the autoimmune offering, with coverage for more diseases, drugs and treatments. This expanded offering ensures a greater number of patients receive appropriate care while further growing the hard savings that Eviti for Autoimmune Diseases provides to customers
Introduced new site-of-service functionality to increase cost-savings opportunities for customers using Eviti Connect for Autoimmune Diseases. Now, users are seamlessly redirected to the appropriate site of service for each drug in the treatment plan
Payer Engagement (NaviNet):
In May, won the MedTech Breakthrough "Healthcare Insurance Innovation Award," in recognition of the platform’s ability to break through digital health and technology markets, as previously reported
Won the Spring Digital Health "Connected Digital Health Merit Award" from the Health Information Resource Center, which honors the world’s best health resources created for consumers and health professionals
Added a new line of business with a major healthcare payer and strategic partner which, along with two other lines of business, is expected to go live in the second half of the current year
Added new capabilities to NaviNet’s Open Authorizations including the ability to collect situational patient information as part of a prior authorization submission, making it easier for health plans to meet state and federal regulatory requirements
Network Monitoring and Management (The OpenNMS Group, Inc.):
Released OpenNMS Horizon 30, which introduced advancements that help organizations detect anomalies and changes in network traffic, ensuring that networks stay healthy and bandwidth-related issues are promptly identified
Released Grafana Plugin (OpenNMS Helm) version 8.0. Grafana dashboards, built using OpenNMS Helm, can now incorporate filtering by monitoring location, improve flow metrics and support to display data more dynamically
Released AI component ALEC (Architecture for Learning-Enabled Correlation) version 2.0. Users can now view correlated situations and their alarms directly in the topology map
Released the OpenNMS Plugin API 1.0, which provides a development ecosystem that clearly identifies, documents and provides ongoing compatibility guarantees for integration points
Second Quarter Financial Results: 2022 vs 2021

For the 2022 second quarter:

Total net revenue was $16.5 million compared with $16.1 million.
Gross profit was $9.2 million, or 55% of total net revenue, compared with $9.1 million, or 56% of total net revenue.
Selling, general and administrative (SG&A) expenses increased to $14.0 million from $11.8 million.
Research and development (R&D) expenses increased to $5.9 million from $4.8 million.
Net loss attributable to NantHealth was $12.5 million, or $0.11 per share, compared with $15.3 million, or $0.13 per share.
On a non-GAAP basis, net loss from continuing operations was $11.4 million, or $0.10 per share, compared with $9.0 million, or $0.08 per share.
At June 30, 2022, cash and cash equivalents totaled $5.7 million.
Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the second quarter ended June 30, 2022. The conference call will be available to interested parties by dialing 800-771-6692 from the U.S. or Canada, or 212-231-2907 from international locations. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On August 4, 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 second quarter 2022 financial results and provided a recent operations update (Press release, Xoma, AUG 4, 2022, View Source [SID1234617581]).

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"The assets in our royalty and milestone portfolio made significant progress in the first half of 2022. In the second quarter, Rezolute presented the results from its Phase 2b RIZE clinical study of RZ358 in patients with congenital hyperinsulinism (CHI) at the Pediatric Endocrine Society’s 2022 Annual Meeting. The study results exceeded expectations leading Rezolute to announce its intention to launch a Phase 3 program1. Day One presented initial data from the Pivotal FIREFLY-1 trial of tovorafenib (DAY101) in patients with pediatric low-grade glioma. In its presentations, Day One’s management articulated its Phase 3 clinical trial plan, which is expected to begin in the third quarter of 20222. Both companies raised capital on their respective data to fund the Phase 3 programs3. We look forward to further public announcements from both Rezolute and Day One as children with CHI or low-grade glioma need access to new therapeutic options," stated Jim Neal, Chairman and Chief Executive Officer of XOMA.

"We have had a recent addition to our early clinical-stage assets as Sonnet BioTherapeutics launched Phase 1 development activities for SON-1010, which resulted in our earning a milestone payment. We congratulate all of our partners for their recent successes."

Financial Results
XOMA recorded total revenues of $1.0 million for the second quarter of 2022 and $0.9 million for the second quarter of 2021.

Research and development ("R&D") expenses were $40,000 and $38,000, respectively, for the second quarters of 2022 and 2021.

General and administrative ("G&A") expenses were $5.7 million for the second quarter of 2022, compared to $3.9 million for the second quarter of 2021. The increase of $1.8 million for the three months ended June 30, 2022, as compared to the corresponding period of 2021, was due primarily to a $0.9 million increase in consulting and legal expenses associated with deal costs, $0.4 million increase in personnel related costs, and a $0.2 million increase in executive search fees for XOMA’s new Chief Executive Officer.

In the second quarter of 2022, G&A expenses included $0.8 million in non-cash stock-based compensation expense, which was consistent with the second quarter of 2021. XOMA’s net cash used in operations in the second quarter of 2022 was $4.3 million, as compared with $4.0 million during the second quarter of 2021.

Other income, net was $0.1 million for the second quarter of 2022, compared to other income, net of $1.3 million in the corresponding quarter of 2021. The fluctuation in other income, net between the quarters ended June 30, 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 second quarter of 2022 was $4.7 million, compared to net loss of $2.2 million for the second quarter of 2021.

On June 30, 2022, XOMA had cash of $83.2 million. On July 15, 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.