On May 5, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the first quarter ended March 31, 2022 (Press release, Puma Biotechnology, MAY 5, 2022, View Source [SID1234613714]). Unless otherwise stated, all comparisons are for the first quarter of 2022 compared to the first quarter of 2021.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2022 was $40.7 million, compared to product revenue, net of $45.8 million in the first quarter of 2021.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net loss of $3.4 million, or $0.08 per basic and diluted share, for the first quarter of 2022, compared to net income of $16.5 million, or $0.41 per basic share and $0.40 per diluted share, for the first quarter of 2021.

Non-GAAP adjusted net loss was $0.3 million, or $0.01 per basic and diluted share, for the first quarter of 2022, compared to non-GAAP adjusted net income of $22.4 million, or $0.56 per basic share and $0.55 per diluted share, for the first quarter of 2021. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2022 was $26.9 million, compared to $15.7 million provided by operating activities in the first quarter of 2021. At March 31, 2022, Puma had cash, cash equivalents and marketable securities of $73.9 million, compared to cash, cash equivalents and marketable securities of $82.1 million at December 31, 2021.

"2021 was an important year for Puma as we made operational changes to maximize the efficiency of the Puma team and the environment with which we operate," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We remain committed to increasing awareness of and access to NERLYNX as an option to reduce the risk of recurrence for patients battling HER2-positive breast cancer; the inclusion of NERLYNX in the updated NCCN guidelines is an important step to expanding the awareness and utilization of neratinib for high-risk patients."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in HER2-mutated HR-positive breast cancer (H1 2022); (ii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in HER2-mutated biliary tract cancer (H1 2022); (iii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2 2022); (iv) conducting a pre-NDA meeting with the FDA to discuss the potential for an accelerated approval pathway of neratinib in HER2-mutated HR-positive breast cancer (H2 2022); (v) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2022); (vi) reporting Phase II TBCRC-022 trial data from Cohort 4B and 4C of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2 2022); and (vii) reporting Phase II data from the SUMMIT trial of neratinib in cervical cancer patients with HER2 mutations (H2 2022)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the first quarter ended March 31, 2022, total revenue was $45.7 million, of which $40.7 million was net product revenue and $5.0 million was royalty revenue. This compares to total revenue of $98.2 million in the first quarter of 2021, of which $45.8 million was net product revenue, $50.0 million was license revenue and $2.4 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $46.4 million for the first quarter of 2022, compared to $78.0 million for the first quarter of 2021.

Cost of Sales

Cost of sales was $10.8 million for the first quarter of 2022, compared to $29.6 million for the first quarter of 2021. Cost of sales in the first quarter of 2021 included $20.0 million for a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China, partially offset by higher royalties due on increased non-U.S partner sales.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $20.4 million for the first quarter of 2022, compared to $28.2 million for the first quarter of 2021. The $7.8 million decrease resulted primarily from decreases of approximately $3.1 million in professional fees and expenses, primarily related to a decrease in consulting costs for marketing and commercialization support; $2.9 million in payroll and related costs due to reduced headcount; and $1.4 million in stock-based compensation also due to reduced headcount.

Research and Development Expenses

Research and development expenses were $15.2 million for the first quarter of 2022, compared to $20.2 million for the first quarter of 2021. The $5.0 million decrease resulted primarily from decreases of $2.5 million in internal R&D costs related primarily to reduced payroll costs; $1.3 million in stock-based compensation due to the impact of headcount reductions in 2021; $0.7 million in consultants and contractors due to the close of the CONTROL study and the winding down of the SUMMIT study; and $0.5 million in clinical trial expenses due to reduced study costs as noted above.

Total Other Income (Expenses)

Total other expenses were $2.7 million for the first quarter of 2022, compared to total other expenses of $3.7 million for the first quarter of 2021. The $1.0 million decrease in other expenses resulted primarily from lower interest expense on the milestone installment payments to Pfizer as well as lower costs related to our outstanding debt.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2022 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 5, 2022. The call may be accessed by dialing (866) 682-6100 (domestic) or (862) 298-0702 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On May 5, 2022 Insilico Medicine ("Insilico"), a clinical-stage end-to-end artificial intelligence (AI)-driven drug discovery company, reported that the company has nominated a preclinical candidate (PCC) targeting methionine adenosyltransferase 2A (MAT2A) from AI-designed molecules for the treatment of methylthioadenosine phosphorylase (MTAP)-deleted cancers (Press release, Insilico Medicine, MAY 5, 2022, View Source [SID1234613731]). The PCC is part of Insilico’s growing portfolio of synthetic lethality assets in development.

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MTAP deletion is one of the most common gene deletions seen in cancers including lung, bladder, and pancreatic cancer, and is associated with poor prognosis. MAT2A is defined as a synthetic lethality target in MTAP-deleted cancers and plays an essential role in producing S-adenosylmethionine (SAM), a molecule involved in cell function and survival. Inhibitors of MAT2A lead to a selective anti-proliferative effect on MTAP-deleted cancer cells by reducing the level of SAM to affect PRMT5-Dependent mRNA splicing, inducing DNA damage.

Insilico’s PCC is a potent and selective MAT2A inhibitor. It demonstrated excellent drug-likeness with good solubility and permeability, good activity at low doses in animal models, and a favorable safety profile in preclinical studies. Insilico is progressing the PCC in IND-enabling studies and anticipates IND filing in early 2023.

"Powered by AI, the MAT2A program team was able to discover the PCC molecule with high selectivity of MTAP-deleted cancer cells over wide-type cells, which we believe provides key differentiation compared to reported MAT2A inhibitors," said Feng Ren, PhD, Chief Scientific Officer of Insilico Medicine. "This is the second PCC in our growing synthetic lethality pipeline, and we are progressing the molecule in IND-enabling studies towards clinical trials for the treatment of MTAP-deleted cancers."

Insilico has built a strong portfolio of synthetic lethality assets supported by scientists with deep drug discovery expertise and its AI-driven small molecule design and generation engine, Chemistry42. The company announced its first synthetic lethality PCC, which targets USP1 for tumors with homologous recombination deficiency, in mid-April. Continuing this success, Insilico delivered the PCC for the MAT2A program approximately 12 months after its initiation.

"This PCC continues the expansion of our synthetic lethality portfolio, driven by our end-to-end AI drug discovery platform," said Insilico founder and CEO Alex Zhavoronkov, PhD. "With this latest discovery, we continue to utilize the power of AI to treat the most aggressive cancers with the highest unmet needs."

Insilico is developing a growing portfolio in frontier areas. In just over 12 months, it has delivered 7 PCCs, including AI-discovered therapeutics of novel targets with novel structures and AI-designed therapeutics of known targets with desired properties. It also successfully completed a Phase 0 microdose trial and entered a Phase I clinical trial with its first internally developed program for fibrosis.

On May 5, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported financial results for the first quarter 2022 and provided a business update (Press release, argenx, MAY 5, 2022, View Source [SID1234613607]).

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In a separate press release issued today, argenx also announced positive results from the Phase 3 ADVANCE trial evaluating VYVGART for the treatment of adult patients with ITP. The primary endpoint, demonstrating a significantly higher proportion of VYVGART-treated patients achieved a sustained platelet response than patients receiving placebo, and additional key secondary endpoints were met.

"Our VYVGART commercial launch is off to a strong start, underscoring the significant unmet need for a new treatment option in gMG. We are very encouraged by the early demand from patients and physicians and our team continues to meet the challenge with outstanding execution and deep engagement with our key stakeholders. We look forward to our imminent commercial launch in Japan and an upcoming regulatory decision in Europe, which support our goal to make VYVGART available worldwide. We are confident that the relationships we are building today with the gMG community will establish a strong foundation to continue to deliver on behalf of patients," commented Tim Van Hauwermeiren, Chief Executive Officer of argenx.

"The positive readout from our first registrational ITP trial highlights the promise of efgartigimod as a pipeline-in-a-product with the potential to reach a variety of IgG-mediated autoimmune diseases, even beyond the ten indications we are currently evaluating. We are on track to achieve our argenx 2025 goal to build the next great immunology company while bringing breakthrough innovations to patients and creating long-term value for our stakeholders."

FIRST QUARTER 2022 AND RECENT BUSINESS UPDATE

VYVGART Launch Progress

VYVGART is the first-approved neonatal Fc receptor (FcRn) blocker in the U.S. and Japan. VYVGART is approved in the U.S. for the treatment of adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for adult gMG patients. The global launch strategy is on track to make VYVGART available in Europe, China and Canada, as well as select additional regions.

Generated net product revenues of $21.2 million for first full quarter of VYVGART commercial launch in U.S.
Japan commercial launch to start this month following addition of VYVGART to National Health Insurance (NHI) drug price list on April 20, 2022
Decision from European Medicines Agency on Marketing Authorization Application expected in second half of 2022
Zai Lab to file for approval in China in mid-2022 and Medison in Israel in second quarter of 2022
Efgartigimod Research and Development

argenx is positioned to expand its leadership position in FcRn blockade to include ten total autoimmune indications by the end of 2022. Six registrational trials are ongoing with four new proof-of-concept trials to start this year across multiple therapeutic franchises.

Neuromuscular franchise
Biologics License Application (BLA) on track to be filed by end of year for subcutaneous (SC) efgartigimod for gMG, following positive topline results from Phase 3 ADAPT-SC trial
Topline data from registrational ADHERE trial of SC efgartigimod for chronic inflammatory demyelinating polyneuropathy (CIDP) expected in first quarter of 2023
Registrational ALKIVIA trial on track to start this quarter for three subtypes of idiopathic inflammatory myopathies (myositis), including immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis; interim analysis planned of first 30 patients of each subtype
Hematology franchise
Positive topline data of VYVGART for primary ITP reported today
Primary endpoint was met; significantly higher proportion of patients receiving VYVGART achieved a sustained platelet response than patients receiving placebo
Statistically significant separation from placebo in key platelet-derived secondary endpoints
Safety and tolerability profile confirmed in second indication
Topline data from second registrational ADVANCE-SC trial of SC efgartigimod for primary ITP expected in first quarter of 2023
Dermatology franchise
Enrollment expanded in registrational ADDRESS trial of SC efgartigimod for pemphigus vulgaris and foliaceus in order to manage ongoing impact of war in Ukraine; topline data now expected in second half of 2023
Registrational BALLAD trial ongoing of SC efgartigimod for bullous pemphigoid with interim analysis planned of first 40 patients
Proof-of-concept trials to be launched in collaboration with Zai Lab and IQVIA
Zai Lab to launch Phase 2 trials in lupus nephritis and membranous nephropathy in 2022 with argenx to lead global registrational programs for each potential indication
IQVIA to launch Phase 2 trials in primary Sjogren’s syndrome in second half of 2022 and COVID-19-mediated postural orthostatic tachycardia syndrome (POTS) in mid-2022
Pipeline Progress

argenx is developing ARGX-117 and ARGX-119, which both have pipeline-in-a-product potential for multiple autoimmune indications.

ARGX-117 (C2 inhibitor)
Proof-of-concept ARDA trial ongoing to evaluate safety, tolerability, and potential dosing regimen in multifocal motor neuropathy (MMN)
Phase 2 proof-of-concept trial expected to start in 2022 for prevention of delayed graft function and/or allograft failure after kidney transplantation
ARGX-119 (muscle-specific kinase (MuSK) agonist)
Phase 1 dose-escalation trial in healthy volunteers expected to start after Clinical Trial Application filing in fourth quarter of 2022
A subsequent Phase 1b trial will assess early signal detection in patients with congenital myasthenic syndrome and MuSK-associated myasthenia gravis
Upcoming Medical Meeting Presentations

14th Myasthenia Gravis Foundation of America International Conference on Myasthenia and Related Disorders (May 10-12, Miami, FL)
Society for Investigative Dermatology Annual Meeting (May 18-21, Portland, Oregon)
Annual Meeting of the Japanese Society of Neurology (May 18-22, Tokyo, Japan)
8th Congress of the European Academy of Neurology (June 25-28, Vienna, Austria)
17th International Congress on Neuromuscular Diseases (July 5-9, Brussels, Belgium)
DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three months ended March 31, 2022 was $31.5 million, compared to $178.6 million for the three months ended March 31, 2021, and consists of:

Product net sales from sales of VYVGART in the U.S. for the three months ended March 31, 2022 were $21.2 million, following the approval of VYVGART by the U.S. Food and Drug Administration (FDA) on December 17, 2021. No product sales were recognized during the comparable prior period.
Collaboration revenue for the three months ended March 31, 2022 was $2.2 million, compared to $158.2 million for three months ended March 31, 2021, resulting in a decrease of $155.9 million. The collaboration revenue for the three months ended March 31, 2021 was primarily attributable to the closing of the strategic collaboration for efgartigimod with Zai Lab, resulting in the recognition of $151.9 million in collaboration revenue.
Other operating income for the three months ended March 31, 2022 was $8.1 million, compared to $20.4 million for three months ended March 31, 2021, resulting in a decrease of $12.3 million. During the three months ended March 31, 2021, the fair value of the argenx profit share in AgomAb Therapeutics NV increased by $11.2 million. There was no change in the fair value during the three months ended March 31, 2022.
Total operating expenses for the three months ended March 31, 2022 were $254.2 million, compared to $178.6 million for the three months ended March 31, 2021, and consists of:

Cost of sales for the three months ended March 31, 2022 amounted to $1.4 million. The cost of sales was recognized with respect to the sale of VYVGART in the U.S. during the first quarter of 2022. There was no cost of sales recognized in the comparable prior period.
Research and development expenses increased by $29.6 million for the three months ended March 31, 2022 to $152.0 million, compared to $122.3 million for the three months ended March 31, 2021. The increase resulted primarily from higher external research and development expenses, mainly related to the efgartigimod program in various indications and other clinical and preclinical programs.
Selling, general and administrative expenses totaled $100.9 million for the three months ended March 31, 2022, compared to $56.3 million for the three months ended March 31, 2021. The increase resulted primarily from higher professional and marketing fees linked to the commercialization of VYVGART in the U.S. and Japan and higher personnel expenses increased due to a planned increase in headcount.
Exchange losses totaled $7.2 million for the three months ended March 31, 2022, compared to $28.9 million for the three months ended March 31, 2021 and are mainly attributable to unrealized exchange rate losses on cash, cash equivalents and current financial assets position in Euro.

Income tax totaled $2.9 million of tax income for the three months ended March 31, 2022, compared to $11.2 million of tax expense for the comparable prior period. Tax income for the three months ended March 31, 2022 consists of $5.0 million of income tax expense and $7.9 million of deferred tax income, compared to $6.2 million of income tax expense and $5 million of deferred tax expense for the comparable prior period.

Net loss for the three months ended March 31, 2022 was $227.2 million compared to $40.4 million for the comparable prior year period. On a per weighted average share basis, the net loss was $4.36 and $0.81 for the three months ended March 31, 2022 and 2021, respectively.

Cash, cash equivalents and current financial assets totaled $2,855.4 million as of March 31, 2022, compared to $2,336.7 million as of December 31, 2021. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering of shares, including a U.S. offering and a European private placement, which resulted in the receipt of $761.0 million in net proceeds in March 2022, partially offset by the net cash flows used in operating activities, primarily towards the commercial launch of VYVGART in the U.S. and Japan and continued investment in pipeline expansion.

FINANCIAL GUIDANCE

As of March 31, 2022, argenx had $2.9 billion in cash, cash equivalents and current financial assets. Based on current plans to fund anticipated operating expenses and capital expenditures, argenx expects to utilize approximately $1 billion of its available cash in 2022. The increased spend will support the global VYVGART launches, clinical development of efgartigimod in 10 indications and ARGX-117 in two indications, investment in the global supply chain, and continued focus on pipeline expansion through the Immunology Innovation Program.

EXPECTED 2022 FINANCIAL CALENDAR

July 28, 2022: HY 2022 financial results and business update
October 27, 2022: Q3 2022 financial results and business update
CONFERENCE CALL DETAILS

The first quarter 2022 business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

On May 5, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases, enhance gene therapies and mitigate unwanted immune responses to biologics, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Selecta Biosciences, MAY 5, 2022, View Source [SID1234613636]).

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"In the first quarter of 2022, we executed across our pipeline and proactively took measures to extend our cash runway into mid-2024," said Carsten Brunn, Ph.D., president and chief executive officer of Selecta. "In early April, we successfully completed an underwritten offering, raising an additional $38.7 million in gross proceeds, further strengthening our financial resources which we believe will carry us through key value-driving milestones and help Selecta realize the full potential of our leading precision immune tolerance platform. The synergistic effects of ImmTOR in combination with a Treg-selective IL-2 (ImmTOR-IL) has the potential to be a first-in-class, antigen-specific immunotherapy, with broad applications across all three pillars of our pipeline. Furthermore, we believe we are well-positioned to deliver on our clinical development strategy across our wholly owned pipeline while continuing to pursue strategic partnerships in gene therapy and biologics. We remain on track to deliver on multiple upcoming catalysts in 2022, including the initiation of a Phase 1 trial of SEL-302, our wholly owned gene therapy in combination with ImmTOR for the treatment MMA, the completion of the Phase 3 DISSOLVE clinical program in chronic refractory gout and several IND-enabling studies that collectively advance our strategy for re-imagining immunotherapy for autoimmune disease, unlocking the potential of AAV gene therapy and amplifying the efficacy of biologics."

Recent Highlights and Anticipated Upcoming Milestones:

Tolerogenic Therapies for Autoimmune Disease

ImmTOR with proprietary IL-2 protein agonist (ImmTOR-IL): Pre-clinically, Selecta has observed synergistic activity when ImmTOR is combined with engineered IL-2 molecules that are selective for Tregs. When ImmTOR-IL was co-administered with an antigen of interest in a preclinical study, the resulting preclinical data suggest that ImmTOR may have profound synergistic effects in further expanding antigen-specific Tregs when compared to ImmTOR alone, positioning it to be a potential first-in-class antigen-specific therapy for the treatment of autoimmune disease.
Selecta is working with its partner, Cyrus Biotechnology, to develop a next generation IL-2 molecule to combine with ImmTOR.
Selecta continues work toward identifying suitable target indications and accelerating the development of ImmTOR-IL to the clinic.
Primary biliary cholangitis (PBC): Selecta continues IND-enabling work on an ImmTOR platform approach to treating PBC.
Gene Therapies:

SEL-302 for methylmalonic acidemia (MMA): On March 9, 2022, the FDA removed the clinical hold on SEL-302 for the treatment of patients with MMA.
Selecta expects initiation of the Phase 1 clinical trial of SEL-302 in the second half of 2022.
SEL-018 IgG Protease (Xork): In collaboration with Genovis, Selecta continues to advance Xork, a next-generation IgG protease, to help address disease in those patients who are ineligible for gene therapies due to pre-existing anti-AAV antibodies. Selecta believes the novel combination of Xork and ImmTOR has the potential to simultaneously address two of the key hurdles in gene therapy today: pre-existing immunity and the inability to re-dose AAV gene therapies.
IND-enabling studies are expected to commence in 2022.
Biologic Therapies:

SEL-212 for chronic refractory gout: Selecta continues to advance DISSOLVE, the Phase 3 development program of SEL-212, which has been licensed to Swedish Orphan Biovitrum AB (publ.) ("Sobi").
On December 1, 2021, Selecta announced complete enrollment for DISSOLVE I, currently being run in the United States.
DISSOLVE II continues to enroll, with trial sites in the United States and four Eastern European countries. Screening and randomization in both Russia and Ukraine have been temporarily closed to preserve study supplies in these countries for those already enrolled. Moreover, 11 additional sites in the United States have been activated to speed enrollment and help mitigate any potential disruptions from the closure of screening and randomization in Russia and Ukraine, and DISSOLVE II enrollment has been increased to approximately 140 study participants.
DISSOLVE I & II studies are on track for completion in Q4 2022 with joint topline readout expected in Q1 2023.
ImmTOR with IgA1 protease for IgA nephropathy: Selecta is working with both Ginkgo Bioworks and IGAN Biosciences to identify and develop a next generation IgA protease to combine with ImmTOR.
Selecta anticipates enzyme candidate selection to be completed in 2022.
Corporate Updates:

Completed underwritten offering of common stock and warrants, raising approximately $38.7 million in gross proceeds.
Amended outstanding term loan to defer principal amortization period to April 1, 2023.
Performed strategic review and portfolio prioritization, pausing SEL-313, OTC-D gene therapy development and increasing focus on providing modality-enabling solutions to AAV gene therapy companies.
First Quarter 2022 Financial Results

Cash Position: Selecta had $118.8 million in cash, cash equivalents, marketable securities, and restricted cash as of March 31, 2022, as compared to cash, cash equivalents, marketable securities, and restricted cash of $129.4 million as of December 31, 2021. With the approximately $36.0 million in net proceeds raised from the April underwritten offering, Selecta believes its available cash, cash equivalents, restricted cash, and marketable securities will be sufficient to meet its operating requirements into mid-2024. Net cash used in operating activities was $11.9 million for the quarter ended March 31, 2022, as compared to $12.1 million of cash used in operating activities for the same period in 2021.

Collaboration and License Revenue: Collaboration and license revenue for the first quarter of 2022 was $34.0 million, as compared to $11.1 million for the same period in 2021. Revenue was primarily driven by the shipment of clinical supply and the reimbursement of costs incurred for the Phase 3 DISSOLVE clinical program under the license agreement with Sobi.

Research and Development Expenses: Research and development expenses for the first quarter of 2022 were $17.7 million, as compared to $13.0 million for the same period in 2021. The increase in cost was primarily the result of expenses incurred for the preclinical programs, salaries and contract license and milestone payments.

General and Administrative Expenses: General and administrative expenses for the first quarter of 2022 were $5.5 million, as compared to $5.2 million for the same period in 2021. The increase in costs was primarily the result of stock compensation expenses.

Net Income (loss): For the first quarter of 2022, Selecta reported net income of $28.8 million, or basic net income per share of $0.23, compared to net loss of $(24.6) million, or $(0.22) per share, for the same period in 2021.

Conference Call and Webcast Reminder
Selecta management will host a conference call at 8:30 AM ET today to provide a corporate update and review the company’s first quarter 2022 financial results. Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10157872. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

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.