On August 9, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported it will host a conference call and live webcast at 8:30 a.m. EDT on Monday, August 15, 2022 to provide a corporate update and discuss the Company’s financial results for the second quarter ended June 30, 2022 (Press release, Scynexis, AUG 9, 2022, View Source [SID1234617949]).

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A live audio webcast can be accessed by visiting the Investor Relations section of the Company’s website, www.scynexis.com. A replay of the webcast will be archived on the SCYNEXIS website for 90 days following the event.

On August 9, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported results from preclinical in vitro studies for its highly selective CDK9 inhibitor, GFH009, in solid cancer and acute myeloid leukemia (AML) cell lines (Press release, Sellas Life Sciences, AUG 9, 2022, View Source [SID1234617948]). The data shows that GFH009 demonstrated significant anti-tumor effects in all four selected cell lines. In three out of the four cell lines, GFH009 inhibited cancer cell growth by 90 to 100 percent.

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The in vitro studies were conducted at an independent, third-party contract research organization, Translational Drug Development (TD2), and the following cell lines were selected for the studies based on their unique characteristics, combined with GFH009’s mechanism of action:

RH30: a pediatric soft tissue sarcoma cell line that is a model for studying high-risk pediatric rhabdomyosarcoma, an indication for which currently available treatments are limited to high-dose chemotherapy with unsatisfactory results. RH30 cells are driven by PAX3-FOXO1, a transcription factor whose expression is strictly needed for tumor cell survival. RH30 is also dependent on MYCN, a major target of CDK9 inhibition. Treatment with GFH009 resulted in 90 percent or more cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at the highest dose levels.

NCI-H209: a small cell lung cancer cell line characterized by the loss of function of two major tumor suppressor genes, RB1 and TP53. This cell line also expresses MCL-1, a major target of CDK9 inhibition. Treatment with GFH009 resulted in 90 percent or more cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at highest dose levels.

SKOV-3: an ovarian cancer cell line containing the wild type BRCA1 gene and highly expresses CDK9. Treatment with GFH009 resulted in more than 50 percent cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial.

OCI-AML-2: an AML cell line that develops resistance to the chemotherapy venetoclax on exposure. Treatment with GFH009 resulted in 90 to 100 percent cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at the highest dose levels.
"The data from preclinical studies that we are reporting today demonstrates that certain cancer cell lines, whose survival depends on specific changes in the cell, can be identified and treated with GFH009," said Dragan Cicic, MD, Senior Vice President, Clinical Development, of SELLAS. "Through identifying specific genes in cancer cells, GFH009 has shown in these preclinical studies the ability to stop the transcription and expression from gene to protein, inhibiting cancer cell growth altogether. We will utilize this important information as we design our clinical development program for GFH009 in adult and pediatric tumor types."

About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

On August 9, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported financial results for the second quarter of 2022 and provided an update on recent corporate developments (Press release, Viracta Therapeutics, AUG 9, 2022, View Source [SID1234617947]).

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"We are pleased with our corporate progress in the first half of 2022, having advanced both of our Nana-val clinical trials towards important milestones anticipated later this year, while maintaining a strong cash position that provides a projected runway into the middle of 2024," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "The Phase 1b/2 trial in EBV-positive solid tumors is now enrolling patients in the second dose escalation cohort, and we are on track to report preliminary data in the fourth quarter. For the pivotal NAVAL-1 trial in EBV-positive lymphoma, we incorporated an important amendment into our clinical trial protocol, which allows for the evaluation of Nana-val as a second-line therapy in patients with EBV-positive peripheral T-cell lymphoma. Now, both T-cell lymphoma subtypes in NAVAL-1, extranodal NK/T-cell and peripheral T-cell, are enrolling second-line patients. We believe this is an acknowledgment of the high unmet medical need in T-cell lymphoma and the strength of our data to date."

Second Quarter 2022 and Recent Highlights

Clinical

Amended the protocol for NAVAL-1, the pivotal trial of Nana-val in relapsed/refractory EBV+ lymphoma to enable enrollment of second-line peripheral T-cell lymphoma patients. The recently enacted protocol amendment is designed to enable the evaluation of Nana-val as an earlier therapeutic option, as the protocol previously required patients in this cohort be third-line or later. NAVAL-1 employs a Simon two-stage design with Stage 1 enrolling patients into six cohorts based on lymphoma subtype. If a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. Lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded. If successful, Viracta believes NAVAL-1 could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. The trial has sites open globally, including in the U.S., Canada, Europe, and Asia. An update on the initial cohort(s) that may advance into Stage 2 of the trial is anticipated in the fourth quarter of 2022.
Advanced to the second dose escalation cohort within the Phase 1b part of the Phase 1b/2 trial of Nana-val in patients with EBV+ recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) and other EBV+ solid tumors. Initiation of the second dose escalation cohort followed a favorable review of safety data from the first dose escalation cohort by the trial’s independent Safety Monitoring Committee, which noted no dose-limiting toxicities in the trial to date. Enrollment is ongoing in the second dose cohort of the trial’s Phase 1b portion, which is designed to evaluate safety and determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ R/M NPC. In Phase 2 of the trial, up to 60 patients with EBV+ R/M NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety and preliminary efficacy. The trial also includes a Phase 1b dose expansion cohort designed to evaluate Nana-val at the RP2D in patients with other EBV+ solid tumors. Preliminary safety and efficacy data from the Phase 1b dose escalation portion of the trial are anticipated in the fourth quarter of 2022.
Corporate and Thought Leadership

Dr. Royston honored with the Science History Institute’s Biotechnology Heritage Award. First bestowed in 1999, the Award honors extraordinary individuals whose work in biotechnology is helping to heal, fuel, and feed the world through discovery, innovation, commercialization, or public understanding. It was presented to Dr. Royston by the Science History Institute alongside the Biotechnology Innovation Organization (BIO), which represents more than 1,200 biotech companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.
Hosted key opinion leader (KOL) webinar on Nana-val for the treatment of advanced EBV+ solid tumors. During the webinar, KOL Ezra Cohen, M.D., FRCPSC, FASCO (University of California, San Diego) and members of the Viracta management team discussed the current treatment landscape and unmet medical need in NPC, the design of the Phase 1b/2 trial of Nana-val in advanced EBV+ solid tumors, and preclinical data supporting the trial. A replay of the webinar is available here.
Scientific Presentations

Highlighted the design of the Phase 1b/2 trial of Nana-val in advanced EBV+ solid tumors in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The poster was presented by A. Dimitrios Colevas, M.D. (Stanford Cancer Institute), during a session titled, "Head and Neck Cancer." A copy of the poster is available here.
Presented an overview of the Company’s novel "Kick and Kill" approach to targeting EBV-associated malignancies at the 20th International Symposium on EBV and Associated Diseases. The presentation was delivered by Viracta’s Chief Scientific Officer, Dr. Ayman Elguindy, and included previously announced data demonstrating Nan-val’s mechanism of action and anti-cancer activity. The symposium was sponsored by the International Association for Research on Epstein-Barr Virus and Associated Diseases.
Anticipated 2022 Milestones

Provide preliminary Phase 1b safety and efficacy data from the Phase 1b/2 trial in advanced EBV+ solid tumors: Q4 2022
Update on NAVAL-1 cohort(s) that may progress from Stage 1 to Stage 2: Q4 2022
Second Quarter 2022 Financial Results

Cash position – Cash, cash equivalents and short-term investments totaled approximately $83.1 million as of June 30, 2022, which Viracta expects will be sufficient to fund its operations into mid-2024, excluding any incremental borrowing under its previously announced $50.0 million credit facility from Silicon Valley Bank and Oxford Finance.
Research and development expenses – Research and development expenses were approximately $6.3 million and $12.4 million for the three and six months ended June 30, 2022, respectively, compared to approximately $5.4 million and $9.5 million for the same periods in 2021. The increase in research and development expenses was primarily due to increases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our pivotal trial in R/R EBV+ lymphoma, and the initiation of our Phase 1b/2 trial for the treatment of EBV+ solid tumors, as well as an increase in headcount and non-cash share-based compensation.
Acquired in-process research and development – The acquired in-process research and development for the six months ended June 30, 2021 included non-cash and non-recurring cost of $84.5 million associated with the estimated fair value of the in-process research and development projects acquired in the asset acquisition with no alternative future use, which was charged to expense upon the completion of the transaction in February 2021.
General and administrative expenses – General and administrative expenses were approximately $4.2 million and $8.5 million for the three and six months ended June 30, 2022, respectively, compared to approximately $3.9 million and $7.7 million for the same periods in 2021. The change was primarily driven by an increase in non-cash share-based compensation.
Gain on royalty purchase agreement – The gain on royalty purchase agreement for the six months ended June 30, 2021, was associated with upfront proceeds of $13.5 million recorded in connection with the multi-license milestone and royalty monetization transaction with XOMA (US) LLC.
Adjusted loss from operations – There was not a comparative adjustment to loss from operations for the quarters ended June 30, 2022, and 2021. There was not a comparative adjustment to loss from operations for the six months ended June 30, 2022. Adjusted loss from operations for the six months ended June 30, 2021, excluding the non-recurring and non-cash operating expenses associated with the write-off of in-process research and development acquired in the merger (a non-GAAP measure) was $3.7 million, compared to an unadjusted loss from operations of $88.2 million.
Net loss – Net loss was approximately $10.6 million, or $0.28 per share (basic and diluted) for the quarter ended June 30, 2022, compared to a net loss of $9.2 million or $0.25 per share (basic and diluted) for the same period in 2021. Net loss was approximately $21.1 million, or $0.56 per share (basic and diluted) for the six months ended June 30, 2022, compared to a net loss of $88.4 million or $3.37 per share (basic and diluted) for the same period in 2021.
About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma and gastric cancer.

On August 9, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and six months ended June 30, 2022 (Press release, Eagle Pharmaceuticals, AUG 9, 2022, View Source [SID1234617946]).

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Business and Recent Highlights:

Completed the acquisition of Acacia on June 9, 2022, providing Eagle with two currently marketed, acute care, hospital products, both of which are new chemical entities ("NCEs") with strong patent protection:
BARHEMSYS4 is the first and only antiemetic approved by the FDA for rescue treatment of postoperative nausea and vomiting despite prophylaxis5
BYFAVO6 for injection is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, with an estimated total addressable market in procedural sedation of more than $0.4 billion per year7 in the U.S.
Combined addressable market is an estimated $3.1 billion per year8
Projected annual peak sales of $275 million9 in the United States
Acquired an equity stake in, with an option to purchase, Enalare, adding a portfolio of novel NCEs with strong intellectual property protection, from the mid-2030s into the 2040s, including composition of matter patents. Enalare’s lead compound, ENA-001 is an investigational, one-of-a-kind NCE being developed as an agnostic respiratory stimulant for multiple patient populations experiencing acute respiratory depression. The initial targeted indications include: post-operative respiratory depression, the most advanced development program; community drug overdose; and Apnea of Prematurity, a common condition in preterm infants. The Company believes this acquisition strengthens Eagle’s position as a diversified pharmaceutical company and a leader in hospital/anesthesia.
Supported AOP’s submission of new drug application ("NDA") for landiolol, an ultra-selective Beta-1 Adrenergic Blocker, seeking approval for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. FDA decision with respect to approval is expected mid-2023, and enrollment of the study of pediatric patients with supraventricular tachycardia is underway in Europe.
Appointed pharmaceutical industry veteran, Debra M. Hussain, as Senior Vice President, Head of Commercial.
Financial Highlights

Second Quarter 2022

Total revenue for Q2 2022 was $74.1 million, compared to $48.1 million in Q2 2021, primarily reflecting product sales of vasopressin and PEMFEXY.
Q2 2022 net loss was $(9.5) million, or $(0.74) per basic and diluted share, compared to net income of $3.6 million, or $0.28 per basic and $0.27 diluted share, in Q2 2021.
Q2 2022 adjusted non-GAAP net income was $20.3 million, or $1.58 per basic and $1.56 per diluted share, compared to adjusted non-GAAP net income of $12.4 million, or $0.95 per basic and $0.93 diluted share, in Q2 2021.
Cash and cash equivalents were $36.6 million, net accounts receivable was $85.9 million, and debt was $50.0 million, as of June 30, 2022.
________________________

4 View Source
5 FDA labels for other recommended treatments do not include treatment after failed prophylaxis.
6 View Source
7 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.
8 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.
9 These estimates are the result of market research performed by or for Eagle Pharmaceuticals.

"Our 2022 results to date are bearing out the vision that we have been articulating for Eagle for some time. It’s only midyear, and we have already turned in the best earnings performance in the history of our company. Our first-half earnings per share are more than twice our full-year 2021 numbers. As we look to sustain and accelerate this growth, we continue to support our commercial launches and broaden our portfolio through acquisitions, such as Acacia and the potential to acquire Enalare, both of which enhance our position in hospitals and critical care," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"The addition of BARHEMSYS and BYFAVO, the planned launch of landiolol next year, if approved, CAL02, and now our investment in Enalare, puts us well on our way to becoming a diverse pharmaceutical company. We are pleased that we have delivered on our previously stated aspirations and believe we are well positioned to use 2022 as a springboard for further growth," concluded Tarriff.

Second Quarter 2022 Financial Results

Total revenue for the three months ended June 30, 2022 was 74.1 million, as compared to $48.1 million for the three months ended June 30, 2021.

Q2 2022 PEMFEXY product sales were $16.5 million and vasopressin product sales were $11.3 million.

Q2 2022 RYANODEX product sales were $8.8 million, compared to $7.9 million in the second quarter of 2021.

Q2 2022 BELRAPZO product sales were $8.1 million, compared to $7.6 million in the second quarter of 2021.

Royalty revenue was $24.9 million in the second quarter of 2022, compared to $28.5 million in the second quarter of 2021. BENDEKA royalties were $23.0 million in the second quarter of 2022, compared to $27.8 million in the second quarter of 2021.

A summary of total revenue is outlined below:

Gross margin was 68% during the second quarter of 2022, as compared to 78% in the second quarter of 2021. The decrease in gross margin was driven by revenue mix, primarily the launch of PEMFEXY and vasopressin.

R&D expense was $11.4 million for the second quarter of 2022, compared to $9.9 million for the second quarter of 2021. The increase was primarily due to clinical expense for fulvestrant and spend on CAL02. Excluding stock-based compensation and other non-cash and non-recurring items, adjusted non-GAAP R&D expense during the second quarter of 2022 was $10.8 million.

SG&A expenses in the second quarter of 2022 totaled $36.8 million compared to $16.6 million in the second quarter of 2021. This increase was primarily related to external legal spend for the acquisition of Acacia, severance costs, and sales and marketing expenses associated with the launch of PEMFEXY. Excluding stock-based compensation and other non-cash and non-recurring items, second quarter 2022 adjusted non-GAAP SG&A expense was $15.2 million.

Net loss for the second quarter of 2022 was $(9.5) million, or $(0.74) per basic and diluted share, compared to net income of $3.6 million, or $0.28 per basic and $0.27 per diluted share, in the second quarter of 2021, as a result of the factors discussed above.

Adjusted non-GAAP net income for the second quarter of 2022 was $20.3 million, or $1.58 per basic and $1.56 per diluted share, compared to adjusted non-GAAP net income of $12.4 million, or $0.95 per basic and $0.93 diluted share, in the second quarter of 2021.

2022 Full Year Expense Guidance

Adjusted non-GAAP R&D expense for the full year 2022 is expected to be in the range of $46 million to $50 million, as compared to $32.5 million in 2021.
Adjusted non-GAAP SG&A expense for the full year 2022 is expected to be in the range of $62 million to $66 million, as compared to $54.9 million in 2021.
Liquidity

As of June 30, 2022, Eagle had $36.6 million in cash and cash equivalents and $85.9 million in net accounts receivable, and $50.0 million in outstanding debt. Therefore, as of June 30, 2022, Eagle had cash plus net receivables of $122.5 million.

Conference Call

As previously announced, Eagle management will host its second quarter 2022 conference call as follows:

A replay of the conference call will be available for two weeks after the call’s completion by dialing 800-938-0997 (U.S.) or 402-220-1541 (International) and entering conference call ID EGRXQ222. The webcast will be archived for 30 days at the aforementioned URL.

On August 9, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported financial results for the second quarter of 2022 (Press release, Agenus, AUG 9, 2022, View Source [SID1234617945]).

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"Agenus’ presentation of botensilimab/balstilimab combination data in MSS colorectal cancer at ESMO (Free ESMO Whitepaper) GI was received with great enthusiasm by many thought leaders and clinicians in the fields of GI cancers and immuno-oncology," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "Treatment-resistant MSS CRC patients lack effective options, with the standard of care offering only a 1-2% response rate and an expected median survival ranging from 6 to 7 months. Our results could potentially change the treatment paradigm and offer hope to a significant number of patients with limited options. We are working closely with regulators and advisors to expedite botensilimab’s development in pursuit of global registrations across multiple cancers."

Botensilimab/balstilimab data to drive rapid enrollment in randomized trials

Combination delivered 24% overall response rate (ORR) and 73% disease control rate (DCR) in 41 heavily pretreated MSS CRC patients at ESMO (Free ESMO Whitepaper) GI.
Treated population verified to be unlikely to respond – low mutational burden, no prior IO responses, largely PD-L1 negative.
Safety profile manageable, with no grade 4 or 5 toxicities and no hypophysitis.
Strong enthusiasm generated amongst many leading oncologists, given strong data and high unmet need.
Agenus initiating Phase 2 randomized trials in MSS colorectal cancer, melanoma, and pancreatic cancer later this year.
Clinical-stage pipeline continues to advance

Company to present additional Phase 1b botensilimab expansion cohort data with longer follow-up at a major medical conference later this year.
Dosing underway in Phase 1 study to evaluate AGEN1571 as a monotherapy and in combination with botensilimab and/or balstilimab in participants with advanced solid tumors.
Enrollment continues in Agenus directed trials, such as a combination study involving AGEN2373 (CD137 agonist) and botensilimab.
Company ends Q2 in a strong financial position

$238 million in net cash and short-term investments reflects prudent prioritization of key programs along with capital management strategy.
$25 million of QS-21 STIMULON sales-based milestone achieved, payments to be received in the second half of 2022 based on royalties owed on Shingrix sales1.
Additional potential milestone payments and business development or financing activities may significantly enhance cash position.
Second Quarter 2022 Financial Results

We ended our second quarter 2022 with a cash and short-term investment balance of $238 million as compared to $263 million and $307 million on March 31, 2022, and December 31, 2021, respectively.

We recognized revenue of $21 million for the second quarter ended June 30, 2022, which represents an increase of $10 million from the $11 million reported for the same period in 2021. Revenue for the six months ended June 30, 2022, was $47 million, an increase of $25 million from the same period in 2021. Amounts include revenue under our collaboration agreements, in 2022 milestones earned, and revenue related to non-cash royalties earned. Non-cash royalties represent royalties from Shingrix sales which are passed to HCR under our royalty purchase agreement.

For the second quarter ended June 30, 2022, our cash used in operations was $43 million compared to $56 million for the same period in 2021. Our net loss for the quarter ended June 30, 2022, was $49 million or $0.17 per share compared a net loss of $84 million or $0.37 per share for the quarter ended June 30, 2021. Non-cash operating expenses for the second quarter ended June 30, 2022, were $19 million compared to $30 million for the second quarter of 2021.

Our cash used in operations for the six months ended June 30, 2022, was $96 million with a net loss of $100 million or $0.35 per share compared to cash used in operations of $98 million and a net loss for the same period in 2021 of $138 million or $0.65 per share.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source