On May 5, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported financial results and provided business updates for the three months ended March 31, 2022 (Press release, Dynavax Technologies, MAY 5, 2022, View Source [SID1234613653]).

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Ryan Spencer, Chief Executive Officer of Dynavax, commented: "Following a year of record revenue for both HEPLISAV-B vaccine and CpG 1018 adjuvant, 2022 is off to a great start and has the potential to be another pivotal year. In the first quarter, HEPLISAV-B grew 21% compared to the fourth quarter, exceeding the overall hepatitis B market growth of 14%. The first quarter also marked another quarter of significant revenue for CpG 1018 adjuvant supply for COVID-19 vaccines as we continue to demonstrate strong execution across our portfolio of commercial supply agreements. Looking ahead, we are on track to achieve our second consecutive profitable year with continued revenue growth fueled by HEPLISAV-B and our CpG 1018 adjuvant supply business. This year we also expect additional clinical data readouts from both of our Phase 1 pipeline programs for Tdap and shingles."

FIRST-QUARTER CORPORATE HIGHLIGHTS

HEPLISAV-B Vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is the first and only U.S. FDA-approved adult hepatitis B vaccine that enables series completion with only two doses in one month.

•HEPLISAV-B vaccine achieved net product revenue of $20.8 million for the first quarter of 2022, up 151% compared to $8.3 million for the first quarter of 2021.
•Market share in the accounts targeted by the Dynavax field sales team was approximately 33%, with a total market share of approximately 26% in the first quarter of 2022, up from approximately 27% and 14%, respectively, in the first quarter of 2021.
•The CDC’s Advisory Committee on Immunization Practices (ACIP) recommendation for hepatitis B vaccination in adults has been published (link), advising that all adults aged 19-59 should be vaccinated against hepatitis B. Dynavax believes this will enable a significantly expanded total market opportunity of up to $800 million in the U.S. by 2027, with HEPLISAV-B well positioned to secure a majority market share over time.

CpG 1018 Adjuvant Supply for COVID-19 Vaccines

Dynavax has established a global portfolio of CpG 1018 adjuvant commercial supply agreements currently focused on the development of COVID-19 vaccines across a variety of vaccine platforms.

•CpG 1018 adjuvant revenue for the first quarter of 2022 was $91.5 million, up 23% compared to $74.6 million for the first quarter of 2021.
•The Company continues to expect 2022 full-year CpG 1018 adjuvant COVID-19 supply revenue to be at least $550 million, based on committed adjuvant orders, with full-year gross margin anticipated to be approximately 50%. Revenue and margins are expected to fluctuate quarter to quarter based on customer mix and timing of product delivery.

•CpG 1018 adjuvant supply partner selected recent regulatory updates:
oBiological E (Bio E) has received Emergency Use Authorization (EUA) from the Drugs Controller General of India (DCGI) for its subunit COVID-19 vaccine candidate, CORBEVAX utilizing CpG 1018 adjuvant, for adults (December 2021), for adolescents aged 12 to less than 18 years of age (February 2022) and for use in children ages 5-12 (April 2022).
oClover Biopharmaceuticals has reported it is in the process of submitting conditional regulatory approval applications for its protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) utilizing CpG 1018 adjuvant. Clover anticipates that its submissions are to be completed in mid-2022 for the China NMPA and by the third quarter of 2022 for the WHO and EMA.
oMedigen Vaccine Biologics Corporation received EUA for MVC-COV1901, its COVID-19 vaccine candidate utilizing CpG 1018 adjuvant, from the Taiwan Food and Drug Administration in 2021 and from Paraguay’s National Directorate of Health Surveillance (DINAVISA) in February 2022.
oValneva SE recently announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for its COVID-19 vaccine candidate, VLA2001 utilizing CpG 1018 adjuvant. Valneva also reported that it now expects a decision from CHMP on its recommendation for potential conditional approval by the European Medicines Agency (EMA) in the second quarter of 2022.

Clinical Pipeline

Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

•Tdap vaccine program: Interim adult data from the ongoing Phase 1 study evaluating a new Tdap vaccine candidate utilizing CpG 1018 adjuvant demonstrated it was safe and well tolerated with immunogenicity data supporting continued advancement. Adolescent data from the same trial is expected in the second half of 2022.
•Shingles vaccine program: Topline data from an ongoing Phase 1 study evaluating the safety, tolerability, and immunogenicity in adults compared to Shingrix, the leading marketed shingles vaccine in the U.S., is anticipated by the end of 2022.
•Plague vaccine Phase 2 study: In collaboration with, and funded by, the U.S. Department of Defense, the Company plans to initiate a Phase 2 clinical trial in the second half of 2022.

FIRST-QUARTER FINANCIAL HIGHLIGHTS

Total Revenues and Product Revenue, Net.

Total revenues for the first quarter of 2022 were $114.0 million, compared to $83.3 million for the first quarter of 2021.

•HEPLISAV-B vaccine product revenue, net was $20.8 million for the first quarter of 2022, compared to $8.3 million for the first quarter of 2021.
•CpG 1018 adjuvant product revenue, net was $91.5 million in the first quarter of 2022 compared to $74.6 million in the first quarter of 2021.
Cost of Sales – Product. Cost of sales – product for the first quarter of 2022 increased to $40.0 million, compared to $24.6 million for the first quarter of 2021. The increase was primarily due to manufacturing costs for increased volumes of CpG 1018 adjuvant sold to COVID-19 supply partners and increased HEPLISAV-B vaccine sales volume.

Research and Development Expenses (R&D). R&D expenses for the first quarter of 2022 increased to $11.1 million, compared to $7.8 million for the first quarter of 2021. The increase was primarily driven by higher compensation and personnel costs, including non-cash stock-based compensation, associated with higher headcount and higher external costs as the Company continued to invest in its product candidates with CpG 1018 adjuvant through pre-clinical and clinical collaborations and additional discovery efforts.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the first quarter of 2022 increased to $32.2 million, compared to $22.4 million for the first quarter of 2021. The increase was primarily driven by compensation and related personnel costs, including non-cash stock-based compensation, primarily associated with increased headcount as the Company expanded its field sales team to support HEPLISAV-B vaccine commercialization in mid-2021.

Interest Expense. Interest expense was $1.7 million in the first quarter of 2022, a decrease of $3.0 million from $4.7 million in the first quarter of 2021, reflecting a decreased interest rate associated with the Company’s convertible senior notes due 2026.

Other income (expense). Other income (expense) includes the change in fair value of warrant liability which is a non-cash adjustment to fair value each reporting period. The change in fair value of warrant liability for the first quarter of 2022 resulted in a gain of $1.8 million, compared to a loss of $25.6 million in the first quarter of 2021 due to the final mark-to-market adjustment from January 1, 2022, through the expiration date of the warrants on February 12, 2022. There were no warrants outstanding as of March 31, 2022.

Net Income. GAAP net income was $32.9 million, or $0.26 per share (basic) and 0.22 per share (diluted) in the first quarter of 2022, compared to GAAP net income of $0.9 million, or $0.01 per share (basic and diluted) in the first quarter of 2021.

2022 Financial Guidance

Dynavax anticipates 2022 revenues, operating expenses, and other costs to be in the ranges shown below, unchanged from the Company’s previous financial guidance provided on February 28, 2022:

•Full-year CpG 1018 adjuvant net product revenues of at least $550 million, with an associated gross margin of approximately 50%
•Research and development expenses to be between approximately $55 – $70 million
•Selling, general and administrative expenses to be between approximately $120 – $140 million
•Interest expense of approximately $7 million

Conference Call and Webcast Information

Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4282730. A replay of the webcast will be available for 30 days following the live event.

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than HIV, I and transmission are on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that adults aged 19–59 years and adults aged ≥60 years with risk factors for hepatitis B should receive HepB vaccines, and that adults aged ≥60 years without known risk factors for hepatitis B may receive HepB vaccines.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults aged 19 to 59 with diabetes as soon as possible after their diagnosis, and for people aged 60 and older with diabetes at their physician’s discretion. iii Approximately 26 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year. iv

About HEPLISAV-B Vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax wholly owns HEPLISAV-B.

Important U.S. Product Information

HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)

Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).

About CpG 1018 Adjuvant

Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response with an improved tolerability profile, which has been demonstrated in HEPLISAV-B vaccine and multiple COVID-19 vaccines that have received Emergency Use Authorization outside of the U.S. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of novel or improved vaccines.

On May 5, 2022 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, reported recent business highlights and first quarter 2022 financial results (Press release, Sangamo Therapeutics, MAY 5, 2022, View Source [SID1234613652]).

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"This quarter, we have continued to progress multiple programs through clinical development and demonstrated, once again, Sangamo’s track record of advancing groundbreaking therapies in genomic medicine," said Sandy Macrae, Chief Executive Officer of Sangamo. "We dosed a total of five patients across three programs, including the first patient in our study for the treatment of kidney transplant rejection, in what we believe was the first in human dosing of an engineered CAR-Treg cell therapy product candidate. We believe this progress positions us well to advance transformational genomic medicines for patients in need and to generate long-term value for our shareholders."
Recent Business Highlights
Fabry disease – Dosed three additional patients, resulting in a total of nine patients dosed to date, thereby completing dose escalation for the Phase 1/2 study; Phase 3 planning progresses.
•We dosed two patients in Cohort 4 in the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, our wholly owned gene therapy product candidate for the treatment of Fabry disease, at a dose level of 5e13 vg/kg.
•In addition, we dosed a third patient in Cohort 3, at the dose level of 3e13 vg/kg.
•In total, we have successfully dosed a total of nine patients across four cohorts to complete the dose escalation portion of the study.
•Enzyme replacement therapy (ERT) withdrawal was completed for a second patient, with no reports to date that the resumption of ERT is required in either patient.
•We expect to provide updated results from the STAAR study in the second half of 2022.
•We continue to actively prepare for the expansion cohorts, as well as a potential pivotal Phase 3 trial.
Sickle cell disease – Dosed fifth patient, the first with a product candidate manufactured using improved methods; Phase 3 planning progresses.
•We dosed the fifth patient in the Phase 1/2 PRECIZN-1 study of SAR445136, a zinc finger nuclease gene-edited cell therapy candidate for the treatment of sickle cell disease, which is under development with Sanofi. This is the first patient in the study to receive a product candidate manufactured using improved methods that have been shown in internal experiments to increase the number of long-term progenitor cells in the final product.
•We plan to dose the remaining patients in this study by the end of the third quarter of 2022.
•We expect to provide updated results from the PRECIZN-1 study in the second half of 2022.
•Phase 3 enabling activities and manufacturing readiness are in progress.
•We continue to collaborate with Sanofi on an orderly transition of Sanofi’s rights and obligations under this program back to Sangamo on June 28.

Hemophilia A – FDA lifted clinical hold; Trial remains voluntarily paused; Pfizer expects to resume trial in Q3 2022.
•Pfizer announced that, in March 2022, the FDA lifted the clinical hold that had been placed on the Phase 3 AFFINE trial of giroctocogene fitelparvovec, an investigational gene therapy we are developing with Pfizer for patients with moderately severe to severe hemophilia A. Pfizer previously paused this trial when some of the patients experienced FVIII activity greater than 150% following treatment.
•Pfizer also announced that the voluntary pause remains in place until all necessary conditions are met, including approval of updated trial protocols by regulatory authorities.
•In addition, Pfizer announced that a patient with elevated FVIII levels reported a below-the-knee deep vein thrombosis. The patient had a history of thrombotic events prior to participation in the trial, which is a known risk factor for subsequent events and an exclusion criterion for participation in the AFFINE trial. The case was assessed to understand all potential contributing factors, including missed doses of investigator-prescribed direct oral anti-coagulants. The patient is reported to be doing well. The information was shared with trial investigators, health authorities and the independent external Data Monitoring Committee and Pfizer responded to queries from health authorities.
•Pfizer announced that it anticipates resuming this trial in the third quarter of 2022, with a pivotal data readout estimated in the second half of 2023.
•Over 50% of the patients have been enrolled in the Phase 3 AFFINE trial.
Renal Transplant Rejection – Believed to be first-ever in human dosing with an engineered CAR-Treg cell therapy candidate.
•We dosed the first patient in our Phase 1/2 STEADFAST study evaluating TX200, our wholly owned autologous CAR-Treg cell therapy treating patients receiving an HLA-A2 mismatched kidney from a living donor.
•The patient continues to do well, and no adverse events related to treatment have been reported.
•Dosing of the second patient is expected around the middle of 2022, based on their transplant schedule.
•We expect to complete dosing of the first cohort, comprised of three patients, by the end of 2022.
American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) – Eight abstracts accepted.
•A total of eight Sangamo abstracts were accepted for presentation at ASGCT (Free ASGCT Whitepaper) on May 16-19, 2022, including pre-clinical updates across our CAR-Treg autoimmune cell therapy platform, innovations in our genome engineering platform and advances in our AAV capsid engineering program.
First Quarter 2022 Financial Results
Consolidated net loss for the first quarter ended March 31, 2022 was $44.0 million, or $0.30 per share, compared to a net loss of $45.9 million, or $0.32 per share, for the same period in 2021.
Revenues
Revenues for the first quarter ended March 31, 2022 were $28.2 million, compared to $26.3 million for the same period in 2021.
The increase of $2.0 million in revenues was primarily attributed to an increase of $1.0 million related to our collaboration agreement with Novartis, an increase of $0.7 million related to our collaboration agreement with Biogen, and an increase of $0.4 million related to our collaboration agreement with Sanofi.

Total operating expenses on a GAAP basis for the first quarter ended March 31, 2022 were $73.5 million, compared to $72.6 million for the same period in 2021. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the first quarter ended March 31, 2022 were $65.8 million, compared to $65.1 million for the same period in 2021.
The increase in total operating expenses on a GAAP basis was primarily driven by our higher preclinical, clinical and lab supply and other R&D expenses along with our increased headcount to support the advancement of our clinical trials and our ongoing collaborations. Manufacturing and overhead costs also increased as we ramp up our internal manufacturing operations.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of March 31, 2022 were $400.3 million, compared to $464.7 million as of December 31, 2021.
Financial Guidance for 2022 Reiterated (initial guidance provided on February 24, 2022)
On a GAAP basis, we continue to expect total operating expenses in the range of approximately $320 million to $350 million in 2022, which includes non-cash stock-based compensation expense.
We continue to expect non-GAAP total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $40 million, in the range of approximately $280 million to $310 million in 2022.
Conference Call
Sangamo will host a conference call today, May 5, 2022, at 4:30 p.m. Eastern Time, which will be open to the public. The call will also be webcast with live Q&A and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 3090098. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 3090098.

On May 5, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2022 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 5, 2022, View Source [SID1234613651]).

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"Our XmAb Fc domains and protein engineering expertise have enabled a broad portfolio of clinical-stage drug candidates, which we and our partners are investigating across many therapeutic areas. Internally we are focused on efficiently using our resources to advance the most promising clinical-stage programs, as well as the next wave of Xencor innovations to enter the clinic – more reduced-potency XmAb cytokines, CD28 T cell engagers and 2+1 CD3 T cell engagers," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Today we are pleased to announce we have dosed the first patient in a potentially registration-enabling study for plamotamab to evaluate the chemotherapy-free, triple combination with tafasitamab and lenalidomide for patients with an aggressive form of non-Hodgkin’s lymphoma."

Dr. Dahiyat continued, "As we progress through the year, we remain on track to present additional clinical data from our vudalimab and plamotamab programs and initial data from our IL2-Fc autoimmune program, XmAb564, in healthy volunteers. In addition, we will present data from our XmAb104 program at the ASCO (Free ASCO Whitepaper) Annual Meeting. In 2022, we also expect to start Phase 1 studies for XmAb819, our ENPP3 x CD3 bispecific antibody for renal cell carcinoma engineered with our multivalent 2+1 format for greater tumor selectivity, and for XmAb808, our B7-H3 x CD28 bispecific antibody. This broad development pipeline is supported by the recent strong revenue from our marketed partnered programs and our robust financial position."

Recent Portfolio Highlights

Plamotamab (CD20 x CD3): Xencor has dosed the first patient in a potentially registration-enabling Phase 2 study, evaluating plamotamab in combination with tafasitamab plus lenalidomide, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study consists of two parts, a safety run-in intended to establish the safety of the triple combination (Part 1) and a two-arm, open-label cohort where patients will be randomized to receive either the triple combination or tafasitamab plus lenalidomide (Part 2). Xencor is conducting the clinical study in collaboration with MorphoSys AG and Incyte Corporation. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the United States and is marketed by Incyte under the brand name Minjuvi in the European Union. Incyte has exclusive commercialization rights to tafasitamab outside the U.S.

Expansion cohorts in the Phase 1 study of plamotamab are actively recruiting patients with DLBCL and follicular lymphoma (FL) and are dosing using the recommended Phase 2 regimen to further evaluate the safety and efficacy of plamotamab as a monotherapy. Subcutaneous administration of plamotamab will be introduced this year, and the Company plans to present data from the expansion cohorts in the second half of 2022.
Vudalimab (PD-1 x CTLA-4): Xencor is supporting two newly initiated investigator-sponsored studies of vudalimab, in patients with advanced biliary tract cancers and in patients with advanced rare cancers.

The Company is currently enrolling a Phase 2 study in patients with metastatic castration-resistant prostate cancer (mCRPC), in which vudalimab is being evaluated as a monotherapy or in combination with chemotherapy or a PARP inhibitor depending on the tumor’s molecular subtype. The Company plans to present initial data from the study in the second half of 2022 and is currently initiating a Phase 2 study evaluating vudalimab monotherapy in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies.
XmAb306 (IL15/IL15Rα-Fc): Xencor’s co-development partner Genentech, a member of the Roche Group, has initiated a Phase 1 study to evaluate the combination of XmAb306 (RO7310729) and daratumumab, an anti-CD38 monoclonal antibody, in patients with relapsed/refractory multiple myeloma.

XmAb306 is a potency-reduced IL15/IL15Rα-Fc fusion protein targeting NK and T cells for the treatment of patients with cancer. In an ongoing Phase 1 dose-escalation study of XmAb306 in patients with advanced solid tumors, XmAb306 has promoted high levels of sustained NK cell expansion and evidence of peripheral effector T cell proliferation. Additional studies of XmAb306 in combination with other therapeutic agents are also being planned.
XmAb104 (PD-1 x ICOS): An abstract with initial dose-escalation data from the Phase 1 study of XmAb104 in patients with advanced solid tumors was accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022.
Preclinical Data Presentations: New data from two preclinical-stage XmAb cytokine programs, an IL18-Fc (XmAb143) and a LAG-3 targeted IL15/IL15Rα-Fc, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022.
Tidutamab (SSTR2 x CD3) and XmAb841 (CTLA-4 x LAG-3): The Company will stop internal development of the tidutamab and XmAb841 programs. Neither program demonstrated a competitive clinical profile in recent trials, and the Company has decided to focus resources on new clinical programs. The Company will continue to support patients currently enrolled and being treated.
Progress Across Partnered Programs

Vir Biotechnology, Inc.: In the first quarter of 2022, Xencor recognized $70.3 million in royalty revenue under the Company’s agreement with Vir. Sotrovimab, an antibody that targets the SARS-CoV-2 virus and incorporates Xencor’s Xtend Fc domain for longer duration of action, has been made available by Vir and its partner Glaxo Wellcome UK Limited and GlaxoSmithKline Biologicals S.A. Due to the rapid emergence of the sotrovimab-resistant Omicron BA.2 subvariant in the first quarter, sotrovimab’s authorization was ended in all U.S. regions.
Alexion Pharmaceuticals, Inc.: In April 2022, Ultomiris (ravulizumab-cwvz), which incorporates an Xtend Fc domain, was approved by the U.S. Food and Drug Administration for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. In the first quarter of 2022, Xencor earned $6.1 million from Alexion on net sales of Ultomiris.
Astellas Pharma, Inc.: Astellas has advanced ASP2138, a CLDN18.2 x CD3 XmAb bispecific antibody, into Phase 1 clinical development for the treatment of patients with gastric, gastroesophageal, and pancreatic cancers. Under the Astellas agreement, Xencor applied XmAb bispecific Fc technology to an antigen pair provided by Astellas.
Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc. Monjuvi and Minjuvi are registered trademark of MorphoSys AG.

Financial Results for the First Quarter Ended March 31, 2022

Cash, cash equivalents, receivables and marketable debt securities totaled $683.6 million as of March 31, 2022, compared to $664.1 million on December 31, 2021. During the first quarter of 2022, the Company received milestone payments and royalties from partners of $83.7 million, which offset spending on operations and resulted in a higher cash balance relative to the 2021 year-end amount.

Revenues for the first quarter ended March 31, 2022 were $85.5 million, compared to $34.0 million for the same period in 2021. Total revenues earned in the first quarter of 2022 included revenues earned from Xencor’s Janssen collaboration, milestone revenue from Astellas, and royalties from the Alexion, MorphoSys and Vir agreements, compared to revenue earned from the Janssen collaboration and royalties and milestones from the Alexion and MorphoSys agreements in the first quarter of 2021.

Research and development expenses for the first quarter ended March 31, 2022 were $47.8 million, compared to $41.4 million for the same period in 2021. Increased research and development spending for first quarter of 2022 compared to 2021 reflects increased spending on the Company’s new development programs including XmAb808 (B7-H3 x CD28) and XmAb662 (IL-12).

General and administrative expenses for the first quarter ended March 31, 2022 were $11.3 million, compared to $8.2 million in the same period in 2021. Increased general and administrative spending for the first quarter of 2022 compared to 2021 reflects increased staffing and additional lease expenses.

Non-cash, stock-based compensation expense for the first quarter ended March 31, 2022 was $10.8 million, compared to $8.3 million for the same period in 2021.

Net income for the first quarter ended March 31, 2022 was $23.6 million, or $0.39 on a fully diluted per share basis, compared to a net loss of $2.5 million, or $(0.04) on a fully diluted per share basis, for the same period in 2021. Net income reported for the first quarter of 2022 compared to net loss for the same period in 2021 is primarily due to increased royalties from partners in 2022.

The total shares outstanding were 59,529,192 as of March 31, 2022, compared to 58,221,953 as of March 31, 2021.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations through the end of 2025. While future royalty revenues are uncertain, based on recent guidance from GSK, Xencor expects the amount of royalty revenue that it receives from sales of sotrovimab to substantially decline in future reporting periods. The Company expects to end 2022 with between $500 million and $550 million in cash, cash equivalents, receivables and marketable debt securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the first quarter 2022 financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or +1 (224) 357-2393 for international callers and referencing conference ID number 2583486. A live webcast of the conference call will be available online from the Investors section of the Company’s website at www.xencor.com. The webcast will be archived on the company’s website for 30 days.

On May 5, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the first quarter of 2022 (Press release, Oncternal Therapeutics, MAY 5, 2022, View Source [SID1234613650]).

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"In the first quarter, we continued to advance our robust pipeline towards important inflection points, including the planned initiation of our zilovertamab registrational Phase 3 study in patients with MCL in Q3 2022, the submission of an IND for our ROR1-targeting CAR-T cell therapy candidate ONCT-808 in mid-2022, and the execution of IND-enabling studies for ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Substantial progress of our pipeline has been supported by solid collaborations with our partners and execution by our team, and is being carried out with a focus on prudent cash management. Very importantly, we narrowed our focus on hematological malignancies and prostate cancer, and deprioritized our ONCT-216 program, which helped extend our cash runway well into Q3 2023. We will continue to explore and evaluate all potential sources of capital to enable us to reach our milestones."

Recent Highlights

In January 2022, we announced that we reached consensus with the FDA on the design and major study details of the Phase 3 Study, ZILO-301, to treat patients with relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib. The agency also provided positive feedback on the proposed key clinical and regulatory requirements of our development program for zilovertamab in patients with MCL.
In April 2022, we established a clinical manufacturing agreement with the Dana-Farber Cancer Institute to conduct cGMP cell preparation and manufacturing activities for use in first-in-human studies of our ROR1-targeting CAR-T cell therapy candidate ONCT-808.
In April 2022, we announced the deprioritization of further development of ONCT-216 and the discontinuation of enrollment in the Phase 1/2 study evaluating ONCT-216 in patients with relapsed or refractory Ewing sarcoma.
Expected Upcoming Milestones

Zilovertamab, our ROR1 antibody program
Initiation of global registrational Phase 3 Study, ZILO-301, in the third quarter of 2022
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study will be presented at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting
Initiation of Phase 1b investigator sponsored trial of zilovertamab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC) in mid-2022
ONCT-808, lead candidate in our autologous ROR1-targeted CAR-T cell therapy program
Investigational New Drug (IND) application submission in mid-2022
ONCT-534, lead candidate in our DAARI program
IND-enabling GLP toxicology studies and GMP manufacturing initiated in the second quarter of 2022
First Quarter 2022 Financial Results
Our grant revenue was $0.7 million for the first quarter ended March 31, 2022. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH).

Our total operating expenses for the first quarter ended March 31, 2022 were $10.7 million, including $2.0 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $7.0 million, and general and administrative expenses for the quarter totaled $3.7 million. Net loss for the first quarter was $9.9 million, or a loss of $0.20 per share, basic and diluted.

As of March 31, 2022, we had approximately 49.4 million shares of common stock outstanding, $82.2 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations well into Q3 2023. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.

On May 5, 2022 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2022 and recent business highlights (Press release, Coherus Biosciences, MAY 5, 2022, View Source [SID1234613649]):

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RECENT BUSINESS HIGHLIGHTS

After receiving a complete response letter ("CRL") for the Biologics License Application ("BLA") for toripalimab, Coherus and partner Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences") plan to resubmit the toripalimab BLA by mid-summer with an expected six month review by the United States Food and Drug Administration ("FDA"). The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable.
The FDA review of the BLA for CIMERLI (ranibizumab-ranq), a Lucentis biosimilar, is advancing toward the target action date of August 2, 2022.
The FDA granted Orphan Drug Designation for toripalimab for the treatment of small cell lung cancer.
Two proprietary immuno-oncology research programs have advanced to preclinical development: CHS-1000, an ILT4-targeted antibody, and CHS-3318, a CCR8-targeted antibody. Coherus expects to file an investigational new drug application ("IND") for CHS-1000 in 2023.
Positive toripalimab clinical data were presented and published:
Final progression-free survival ("PFS") and interim overall survival ("OS") data from the JUPITER-02 trial evaluating toripalimab plus chemotherapy for advanced nasopharyngeal carcinoma were presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April.
Final PFS and interim OS data from the CHOICE-01 trial evaluating toripalimab plus chemotherapy for non-small cell lung cancer were presented at the March ASCO (Free ASCO Whitepaper) Plenary Series.
Final PFS and interim OS data from the JUPITER-06 trial evaluating toripalimab plus chemotherapy for first-line treatment of esophageal squamous cell carcinoma were published in the March issue of Cancer Cell.
Coherus has discontinued development of CHS-305 ("IBI-305"), an Avastin biosimilar candidate, and is returning IBI-305 rights to Innovent Biologics (Suzhou) Co., Ltd.
Coherus is lowering by $20 million the projected range for combined full year 2022 R&D and SG&A expenses. See "2022 R&D and SG&A Expense Guidance" section below.
"As we prepare for as many as four new product launches in 2022 and 2023, we continue to make strong progress transforming Coherus into an innovative immuno-oncology company supported by revenues generated by our diversified commercial portfolio of FDA-approved products," said Denny Lanfear, Coherus’ CEO. "Following the recent late-cycle review meeting with the FDA, we are finalizing our preparations to launch CIMERLI later this year, if approved, into the $7 billion anti-VEGF ophthalmology market in the United States. We expect to resubmit the toripalimab BLA by mid-summer and are preparing for the commercial launch directly upon approval. We continue to invest significantly in YUSIMRY ahead of the planned launch in July 2023, as robust supply availability is a key part of our market strategy. Our UDENYCA business continues to provide strong funding for our operations, and we look forward to the potential launch next year of our on-body injector presentation which, if approved, would allow us to compete directly with Neulasta Onpro, a greater than $1 billion market opportunity."

FIRST QUARTER 2022 FINANCIAL RESULTS

Net revenue, consisting of net sales of UDENYCA, was $60.1 million and $83.0 million during the three months ended March 31, 2022 and 2021, respectively. The decline was primarily due to a decrease in the number of units of UDENYCA sold as well as a lower net realized price due to increased competition.

Cost of goods sold (COGS) was $9.4 million and $7.5 million during the three months ended March 31, 2022 and 2021, respectively. Until the first quarter of 2021, Coherus sold inventory that was manufactured and expensed prior to the approval of UDENYCA in late 2018. This inventory was depleted in the first quarter of 2021, and since then, COGS fully reflects per unit acquisition cost. UDENYCA COGS also includes a mid-single digit royalty on net sales payable through the first half of 2024.

Research and development (R&D) expense for the three months ended March 31, 2022 was $82.9 million and included a $35 million option exercise fee to Junshi Biosciences to license CHS-006, a clinical stage TIGIT-targeted antibody, as well as development and manufacturing costs for clinical and preclinical pipeline programs. For the same period in 2021, R&D expense was $203.5 million and included a $145 million upfront fee paid to Junshi Biosciences for the license to rights to toripalimab for the United States and Canada, $11.5 million in costs related to the discontinuation of the CHS-2020 (Eylea biosimilar) program, as well as development costs for clinical and preclinical pipeline programs.

Selling, general and administrative (SG&A) expense for the three months ended March 31, 2022 was $48.8 million compared to $39.4 million for the same period in 2021. The increase was primarily driven by higher commercialization expenses to support current UDENYCA sales and in preparation for multiple anticipated new product launches in 2022 and 2023, including CIMERLI, toripalimab, YUSIMRY, and the on-body injector presentation of UDENYCA.

Net loss for the first quarter of 2022 was $96.1 million, or $(1.24) per share on a diluted basis, compared to a net loss of $172.9 million, or $(2.37) per share on a diluted basis for the same period in 2021.

Non-GAAP net loss for the first quarter of 2022 was $77.0 million, or $(1.00) per share on a diluted basis, compared to non-GAAP net loss of $144.6 million, or $(1.98) per share on a diluted basis for the same period in 2021. Beginning in the first quarter of 2022, the Company no longer regularly excludes upfront and milestone based license fee payments from its non-GAAP financial information. To conform to this change, the prior period non-GAAP financial information has been recast to include upfront and milestone based license fee payments. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $325.7 million as of March 31, 2022, compared to $417.2 million at December 31, 2021.

2022 R&D and SG&A Expense Guidance

As a result of the discontinuation of the CHS-305 development program and the delay of the toripalimab commercial launch, Coherus is lowering the projected range for combined full year 2022 R&D and SG&A expenses by $20 million to $395 million to $430 million. This range includes $55 million to $60 million of stock-based compensation expense and excludes the $35 million license fee paid in the first quarter of 2022 for CHS-006 as well as a potential $25 million milestone payable upon FDA approval of the toripalimab BLA for nasopharyngeal carcinoma. This financial guidance also excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.