On November 3, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the third quarter ended September 30, 2022 (Press release, Autolus, NOV 3, 2022, View Source [SID1234623121]).

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"Autolus has continued to deliver further strategic and operational progress during the third quarter of 2022, with our pivotal FELIX trial on track for a Q4 2022 update, the commercial manufacturing facility build on schedule for the handover of the first clean rooms to Autolus, and the announcement post-period end of an agreement for our proprietary technology with Bristol Myers Squibb and an option exercise by Moderna," said Dr. Christian Itin, CEO of Autolus "Alongside this, we have continued progressing our pipeline candidates through Phase 1 clinical trials through our long-standing collaboration with UCL, laying the foundations for our clinical pipeline beyond obe-cel. We are looking forward to updating the market with our progress over the coming months as we remain fully focused on bringing obe-cel to market."

Key Pipeline Programs:

Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL – The FELIX Trial
The pivotal FELIX Phase 2 clinical trial is on track to report initial results in Q4 2022. Autolus plans to present FELIX Phase 2 data at a medical conference in mid-2023. Assuming a positive outcome from the FELIX trial, the Company expects the data to form the basis of a Biologics License Application (BLA) submission for obe-cel to the FDA at the end of 2023.
Obe-cel in r/r adult ALL patients – ALLCAR19 Trial
In collaboration with University College London (UCL), Autolus expects to present long term follow-up data from the Phase 1 ALLCAR19 trial in Q4 2022 at the 2022 ASH (Free ASH Whitepaper) meeting, to be held December 10-13, 2022. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
Obe-cel in r/r B-NHL patients – ALLCAR19 Extension Trial
In collaboration with UCL, patients continue to be enrolled into the Phase 1 ALLCAR19 extension trial. Data were presented at the European Hematology Congress (EHA) (Free EHA Whitepaper) in June 2022, and longer-term follow up will be presented at the 2022 ASH (Free ASH Whitepaper) meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
Obe-cel in Primary CNS Lymphoma patients – CAROUSEL Trial
In collaboration with UCL, patients continue to be enrolled into the Phase 1 CAROUSEL trial. Data were presented at EHA (Free EHA Whitepaper) in June 2022 – and longer-term follow up data is planned in 2023.
AUTO1/22 in pediatric ALL patients – CARPALL Trial
In collaboration with UCL, patients continue to be enrolled into the AUTO1/22 Phase 1 CARPALL trial. Data were presented at EHA (Free EHA Whitepaper) in June 2022, and longer-term follow up data will be presented at the 2022 ASH (Free ASH Whitepaper) Meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
AUTO4 in T Cell Lymphoma patients – LibrA T1 Trial
Autolus has optimized the manufacturing process for AUTO4, and is currently enrolling additional patients into the trial to test this manufacturing change. Data were presented at EHA (Free EHA Whitepaper) in June 2022, and longer-term follow up data will be presented at the 2022 ASH (Free ASH Whitepaper) Meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
AUTO8 in Multiple Myeloma – MCARTY Trial
In collaboration with UCL, patients continue to be enrolled into the AUTO8 Phase 1 clinical trial, with first data expected in H2 2023.
AUTO6NG in Neuroblastoma – MCARGD2 Trial
In collaboration with UCL, the first patient is expected to be dosed in the Phase 1 MCARGD2 clinical trial in H1 2023, with initial data expected towards the end of 2023.
Key Operational Updates during Q3 2022

The build phase of the Company’s new 70,000 square foot commercial manufacturing facility in Stevenage, UK has continued to progress on track with the planned schedule during Q3 2022, with Phase 1 of the buildout scheduled to complete in Q4 2022. This first phase includes the first of three cell product commercial manufacturing clean rooms in Stevenage. Final equipment installations and qualification by Autolus are on track for the commencement of Good Manufacturing Practice (GMP) operations in H2 2023. This facility has been designed for a capacity of 2,000 batches per year with the option to expand capacity as needed.
Autolus is on schedule to complete the development work and report generation for the Chemistry Manufacturing and Controls (CMC) package planned to be submitted to the FDA. All work including process qualification activities in the new Stevenage facility are on track for submission of a BLA by the end of 2023.
Post Period End:

In October 2022, Autolus announced a new collaboration with Bristol Myers Squibb, and the exercise of an option by Moderna under an existing license and option agreement announced in August 2021. These two technology deals underscore the scientific capabilities and expertise at Autolus.

Bristol Myers Squibb entered into a licensing agreement with Autolus for access to the Company’s proprietary RQR8 rituximab-induced safety switch for incorporation into a set of selected cell therapy programs, in return for an upfront payment, with potential for near term option exercise fees and development milestone payments plus royalties.

Moderna exercised an option on one of the proprietary binders being developed against an undisclosed immuno-oncology target for the delivery of pioneering messenger RNA (mRNA) therapeutics, in return for an upfront payment, development and commercial milestone payments for each product successfully commercialized, as well as royalties on net sales of all products commercialized under the agreement.

This license option stems from a deal announced on August 2, 2021, granting Moderna an exclusive option to license Autolus’ proprietary binders for incorporation in certain mRNA therapeutics.
Financial Results for the Quarter Ended September 30, 2022

Cash at September 30, 2022, totaled $163.1 million, as compared to cash of $310.3 million at December 31, 2021. Post period end the company received $19.1m in relation to its 2021 U.K research and development tax credit claim.

Net total operating expenses for the three months ended September 30, 2022, were $43.5 million, which included license revenue income of $2.4 million, as compared to net operating expenses of $40.4 million, which included grant income of $0.2 million, for the same period in 2021.

Research and development expenses increased by $5.3 million to $37.6 million for the three months ended September 30, 2022 from $32.3 million for the three months ended September 30, 2021 primarily due to:

an increase of $3.6 million in clinical costs and manufacturing costs primarily relating to the Company’s obe-cel clinical product candidate,
an increase of $2.0 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,
an increase of $0.8 million in legal fees and professional consulting fees in relation to the Company’s research and development activities,
an increase of $0.2 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations.
a decrease of $0.7 million in facilities costs related to the termination and closure of the Company’s US manufacturing facility in 2021 and a shift in the Company’s overall manufacturing strategy, and
a decrease of $0.6 million in depreciation and amortization related to property, plant and equipment and intangible assets.
General and administrative expenses decreased by $0.1 million to $8.2 million for the three months ended September 30, 2022 from $8.3 million for the three months ended September 30, 2021 primarily due to:

an increase of $1.0 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
an increase of $0.1 million in facilities costs due to the increased space utilized for general and administrative activities,
a decrease of $1.1 million primarily related to a reduction in directors’ and officers’ liability insurance premiums, as well as reduced professional fees and information technology costs, and
a decrease of $0.1 million in depreciation and amortization related to property, plant and equipment and intangible assets.
Other (expense) / income net, decreased to an expense of $3.7 million from an income of $1.0 million for the three months ended September 30, 2022 and 2021, respectively. The decrease of $4.7 million is primarily due to the weakening of the pound sterling relative to the U.S. dollar exchange rate during the three month period.

Interest expense increased to $1.9 million for the three months ended September 30, 2022 and relates primarily to the liability related to sale of future royalties and sales milestones which arose upon the Company’s entry into the strategic collaboration and financing agreement with Blackstone, in November 2021. There was no interest expense during the comparable period in 2021.

Income tax benefit increased by $0.8 million to $6.2 million for the three months ended September 30, 2022 from $5.4 million for the three months ended September 30, 2021 due to an increase in qualifying research and development expenditures for the quarter.

Net loss attributable to ordinary shareholders was $42.8 million for the three months ended September 30, 2022, compared to $34.0 million for the same period in 2021. The basic and diluted net loss per ordinary share for the three months ended September 30, 2022, totaled $(0.47) compared to a basic and diluted net loss per ordinary share of $(0.47) for the three months ended September 30, 2021.

Autolus estimates that its current cash on hand and anticipated milestone payments in the relevant period from Blackstone extends the Company’s runway into 2024.

Conference Call

Management will host a conference call and webcast at 8:30 am ET/12:30 pm GMT to discuss the Company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. The webcast can be accessed at this link.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

On November 3, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported its financial results for the three months ended September 30, 2022 (Press release, Aurinia Pharmaceuticals, NOV 3, 2022, View Source [SID1234623120]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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Total net revenue was $55.8 million for the three months ended September 30, 2022, compared to $14.7 million for the same period ended September 30, 2021. Revenues for the three months ended September 30, 2022 included net product revenues of $25.5 million and license and collaboration revenue of $30.3 million.

"During the third quarter, we demonstrated progress across many key commercial metrics for LUPKYNIS, including an increased total number of patients on therapy, improved patient start form conversion rates and processing speed, and sustained patient adherence, in comparison to the second quarter ended June 30, 2022. Unfortunately, we experienced a slight decline in new patient start forms over the second quarter ended June 30, 2022, which is potentially the result of reduced lupus nephritis diagnoses and patient visits in the quarter," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Given these current market dynamics, we are adjusting our net revenue guidance to $100-105 million from sales of LUPKYNIS for 2022. We are also providing preliminary net revenue guidance from product sales of LUPKYNIS for 2023 in the range of $120-140 million."

Mr. Greenleaf continued, "In addition to our U.S. commercial efforts, we have also made meaningful advancement in our planned globalization for LUPKYNIS, highlighted by the European Commission Marketing Authorization for LUPKYNIS for the treatment of adults with active lupus nephritis in Europe in September 2022. Working with Otsuka, we expect to achieve continued important regulatory milestones in additional geographies in 2022 and 2023."

Third Quarter 2022 and Recent Highlights

There were approximately 1,354 patients on LUPKYNIS therapy at September 30, 2022, compared with 1,274 at June 30, 2022.
Aurinia added 374 patient start forms (PSFs) during the third quarter 2022, as compared to 412 in the third quarter of 2021. As of Monday, October 31, 2022, the Company recorded 1,357 total PSFs since January 1, 2022.
PSF conversion rates after 90 days, adherence rates and confirmed patient access remain at peak levels since launch.
Persistency rates at 6 months and at 9 months remain reasonable consistent with prior periods, at approximately, 70% and 60%, respectively. At 12 months post-treatment-start, an average of approximately 50% of patients remain on treatment.
The European Commission (EC) granted Marketing Authorization for LUPKYNIS to Otsuka for the treatment of adults with active lupus nephritis in Europe in September 2022. The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.
The Company recognized a one-time $30.0 million EC approval-related milestone in connection with its collaboration and licensing agreement with its partner Otsuka Pharmaceuticals Co., Ltd., during the quarter, which was subsequently received on October 31, 2022. In addition to the milestone, the Company began recognizing revenue for the supply of product and certain reimbursable collaboration activities under a cost-plus arrangement. Going forward the Company will be eligible to receive further payments tied to additional regulatory and reimbursement milestones, along with low double digit royalties on future net sales.
Additional clinical data, including updates from AURORA 1 and AURORA 2, are expected to be presented at upcoming conferences, including LUPUS, the American College of Rheumatology Convergence 2022, and, the American Society of Nephrology.
Key ongoing clinical updates for LUPKYNIS include the advancement of both the VOCAL pediatric study and the ENLIGHT-LN registry. With the registry, which we just initiated at the beginning of the year, we now have 38 activated sites toward our goal of having 75 sites total. As a reminder, we plan to leverage real-world data collected from this study to gain further knowledge about patients taking LUPKYNIS and help clinicians and payers to improve patient care and ensure access to therapy. We also remain on track to meet our post approval FDA commitments.
As previously reported, on July 26, 2022 the U.S. Patent Office Patent Trial and Appeal Board (PTAB) determined to institute an inter partes review (IPR) petition filed by Sun Pharmaceuticals. On October 20, 2022 the PTAB notified the Company that they have denied our rehearing appeal for the institution decision. This follows a prior denial of our precedential opinion panel appeal, which was received on October 5, 2022. The IPR is related to a patent claiming LUPKYNIS dosing protocol that extends patent protection on LUPKYNIS in the United States to 2037. The Company is diligently working on its defense to the IPR, which will be filed after market on November 4, 2022. The defense will address all challenges raised in the IPR process. A determination on patentability, relative to the IPR, is expected on or prior to July 26, 2023.

Financial Results for the Three and Nine Months Ended September 30, 2022

Total net revenue was $55.8 million and $14.7 million for the three months ended September 30, 2022 and September 30, 2021, respectively. Total net revenue was $105.6 million and $22.2 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. The increase in both periods is primarily due to the recognition of a $30.0 million regulatory milestone from Otsuka following the EC marketing authorization of LUPKYNIS in September 2022, coupled with an increase in product sales to our two main customers for LUPKYNIS, which was driven predominantly by further penetration in the lupus nephritis market.

Total cost of sales and operating expenses for the three months ended September 30, 2022 and September 30, 2021 were $65.3 million and $65.0 million, respectively. Total cost of sales and operating expenses were $189.0 million and $170.2 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. Further breakdown of operating expenses drivers and fluctuations are highlighted in the following paragraphs.

Cost of sales were $2.4 million and $0.3 million for the three months ended September 30, 2022 and September 30, 2021, respectively. Cost of sales were $4.3 million and $0.6 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. The increase for both periods was primarily due to an increase in product related revenue, coupled with safety stock inventory reserves.

Gross margin for the three months ended September 30, 2022 and September 30, 2021 was approximately 96% and 98% respectively. Gross margin for the nine months ended September 30, 2022 and September 30, 2021 was approximately 96% and 97%, respectively.

Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $52.2 million and $44.6 million for the three months ended September 30, 2022 and September 30, 2021, respectively. For the nine months ended September 30, 2022 and September 30, 2021, SG&A expenses, inclusive of share-based compensation, were $148.9 million and $128.8 million, respectively. The primary drivers for the increase for both periods ended September 30, 2022 as compared to September 30, 2021 were an increase in professional fees and services related to corporate legal matters, and travel and sponsorships to support the commercialization of LUPKYNIS. For the nine months ended September 30, 2022, the primary drivers were salaries, incentive pay and employee benefits due to employee related expenses such as increased headcount, promotions and inflation, along with an increase in professional fees for corporate legal matters and travel related costs, which increased once the impacts from COVID started to normalize.

Non-cash SG&A share-based compensation expense included above for the three months ended September 30, 2022 and September 30, 2021 was $6.6 million and $6.0 million, respectively. Non-cash SG&A share-based compensation expense included above for the nine months ended September 30, 2022 and September 30, 2021 was $21.5 million and $19.2 million, respectively.

Research and Development (R&D) expenses, inclusive of share-based compensation, were $11.0 million and $20.1 million for the three months ended September 30, 2022 and September 30, 2021, respectively. For the nine months ended September 30, 2022 and September 30, 2021, R&D expenses, inclusive of share-based compensation expense, were $35.1 million and $40.0 million, respectively. The primary drivers for the decrease were the upfront license and accrued milestone expense for AUR300 from the periods ended September 30, 2021 offset year to date by additional developmental expenses related to AUR200 and AUR300 for the periods ended September 30, 2022. In accordance with U.S. GAAP, AUR300 was recorded as an asset acquisition during the period ended September 30, 2021 and expensed as R&D expense at the acquisition date.

Non-cash R&D share-based compensation expense included above for the three months ended September 30, 2022 and September 30, 2021 was $1.5 million and $1.0 million, respectively. Non-cash R&D share-based compensation expense included above for the nine months ended September 30, 2022 and September 30, 2021 was $3.5 million and $3.2 million, respectively.

Interest income was $1.5 million and $0.1 million for the three months ended September 30, 2022 and September 30, 2021, respectively. Interest income was $2.2 million and $0.4 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. The increase in both periods is due to higher yields on our investments as a result of increasing interest rates.

For the three months ended September 30, 2022, Aurinia recorded a net loss of $9.0 million or $0.06 net loss per common share, as compared to a net loss of $50.3 million or $0.39 net loss per common share for the quarter ended September 30, 2021. For the nine months ended September 30, 2022, Aurinia recorded a net loss of $82.1 million or $0.58 net loss per common share, as compared to a net loss of $147.6 million or $1.15 net loss per common share for the nine months ended September 30, 2021.

Financial Liquidity at September 30, 2022

As of September 30, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $376.6 million compared to $466.1 million at December 31, 2021. The decrease in cash, cash equivalents and restricted cash and investments is primarily related to the continued investment in commercialization activities, advancement of our pipeline and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from sales of LUPKYNIS.

Aurinia believes that it has sufficient financial resources to fund its operations, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, advancing its R&D programs and funding its working capital obligations for at least the next few years.

This press release is intended to be read in conjunction with the Company’s unaudited condensed consolidated financial statements and Management’s Discussion and Analysis for the quarter ended September 30, 2022 in the Company’s Quarterly Report on Form 10-Q, which will be accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter ended September 30, 2022 financial results today, Thursday, November 3, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1 (877) 407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

About Lupus Nephritis

LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

On November 4, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will present a poster on the combination module of the Phase 1 clinical study (clinicaltrials.gov NCT03447470) of RXC004 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (8-12 November 2022, Boston, MA) (Press release, Redx Pharma, NOV 4, 2022, View Source [SID1234623109]).

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The poster will present results from the combination module of the Phase 1 clinical study in which RXC004 was combined with nivolumab, an anti-PD-1 antibody, in patients with advanced solid tumours. RXC004 is a clinical stage, highly potent and selective, orally active Porcupine inhibitor being developed as a targeted therapy for Wntligand dependent cancer.

RXC004 is currently being evaluated in two Phase 2 proof-of-concept clinical studies in genetically selected metastatic colorectal cancer (mCRC) (clinicaltrials.gov NCT04907539), and in biliary tract cancers and genetically selected pancreatic cancer (clinicaltrials.gov NCT04907851). Following the completion of this Phase 1 combination study, the Company will now initiate enrolment into combination cohorts of RXC004 with anti-PD-1 antibodies in mCRC and biliary tract cancers, within these Phase 2 studies.

On November 3, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company") an AI-driven innovator of precision antibody immunotherapies, reported it is seeking to divest its contract development and manufacturing organization (iBio CDMO, LLC) in order to complete its transformation into an antibody discovery and development company (Press release, iBioPharma, NOV 3, 2022, View Source [SID1234623099]). Proceeds and cost-savings from the divestiture of the CDMO facility and reduction in operations will be invested in advancing the Company’s lead immuno-oncology assets towards the clinic, as well as the continued development of the RubrYc Discovery Engine, the artificial intelligence ("AI") platform used to create the majority of iBio’s therapeutic candidates, and intended to extend the Company’s cash runway.

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"We currently possess valuable assets in both biomanufacturing and biotech," said Tom Isett, CEO of iBio. "We believe focusing our efforts on drug discovery and development to be the path to greatest value-creation for shareholders, especially given the recent addition of RubrYc Therapeutics’ pipeline and tools to engineer precision-targeting antibodies. Concurrently, given the strong demand for biomanufacturing capacity, we are providing the opportunity for another organization to more fully utilize the advanced bioanalytical and bioprocess capacity resident in our large-scale cGMP biologics production facility located in the growing Southeast Texas ‘Biocorridor’. We are expecting to complete the CDMO divestiture in 2023, while we focus on advancing our lead preclinical program and our expanding pipeline and partnership opportunities."

Following a detailed review of its pipeline and growth opportunities, iBio will focus its resources on the continued development of its lead immuno-oncology assets including, IBIO-101, an immunotherapy for the depletion of regulatory T cells, and two differentiated, antibody candidates emanating from its antibody discovery platform, EGFRvIII and CCR8. In pre-clinical research, each demonstrates specificity for its target and a high degree of cell-killing capability, with potentially reduced off-target effects.

In order to fund further pipeline and platform development, a global life science transaction firm has been engaged to lead the sale of the assets of the CDMO. This includes the 130,000-square-foot cGMP facility, which is configurable for a variety of large-scale bioproduction systems and iBio’s proprietary FastPharming Expression System and GlycaneeringTM Technology. The Company expects it may be able to complete a transaction in 2023, although there is no assurance as to when, or for how much, iBio may be able to sell its CDMO assets.

In conjunction with the divestment, iBio has commenced a comprehensive workforce reduction of approximately 60% of the current Company staffing levels, primarily focused on the workforce located at the cGMP facility in Bryan, Texas. After the conclusion of the workforce reduction, the majority of the Company is expected to operate out of the new Drug Discovery Center in San Diego, CA, which opened in September of this year.

"While parting with members of our ‘WeBio’ team will be incredibly difficult, we do so with the knowledge that demand for their talents in the Texas Biocorridor area is high," commented Michael Jenkins, iBio’s VP, Operations. "On behalf of the CDMO site leadership team, we thank our colleagues who have invested so much in our Bryan/College Station facility – and whose dedication to our mission has helped build the Company and developed iBio’s proprietary FastPharming Expression System and Glycaneering Technology."

The transition to a focused AI-Biotech business is expected to reduce iBio’s monthly burn rate by approximately half, or approximately $2.5-3.0 million per month. Assuming an asset sale at levels comparable with other similar cGMP facilities, the Company believes that cost reductions in conjunction with proceeds from asset sales could provide cash runway into the first half of calendar year 2024.

Considering its announced change in geographic location, iBio will commence a search for a new CEO. It is expected that Mr. Isett will continue as CEO of iBio through this transformation. In order to maintain consistency, William D. (Chip) Clark was appointed by the Board of Directors to assume the role of Chairman.

"On behalf of the Board of Directors, we want to thank Tom for his ongoing service to iBio. Tom’s experience will help us guide the Company through this strategic transformation," said Mr. Clark, Chairman of iBio.

On November 3, 2022 Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported financial results and provided business updates for the third quarter of fiscal year 2022 (Press release, Moderna Therapeutics, NOV 3, 2022, View Source [SID1234623098]).

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"Today’s earnings continue to show strong corporate momentum. With $13.6 billion in product sales through the first three quarters of the year, and advance purchase agreements for anticipated delivery this year now expected to produce around $18 to $19 billion of product sales, we continue to have a strong financial position as we prepare for multiple upcoming global product launches," said Stéphane Bancel, Chief Executive Officer of Moderna. "It has never been clearer that the future of medicine is upon us. As a platform company with scale and resources, Moderna is uniquely positioned to execute on exciting programs in flu, RSV, rare diseases and immuno-oncology, where we have an imminent Phase 2 data read-out. We were also just named a Top Employer by Science for the eighth consecutive year, reflective of the deep commitment of our now more than 3,700 employees globally. There has never been a more promising time for Moderna."

Recent Progress Includes:

Respiratory Vaccines

Received authorization for mRNA-1273.214 booster targeting the BA.1 Omicron subvariant in the United Kingdom, Switzerland, Australia, Canada, European Union and Japan. mRNA-1273.214 induced significantly higher titers than mRNA-1273 against the BA.1 and BA.4/5 Omicron subvariants in a clinical trial conducted before the fall booster season.
mRNA-1273.222 booster, targeting the BA.4/5 Omicron subvariant, is authorized in the United States, European Union, Taiwan and Japan. Phase 2/3 data is expected to be available in the fourth quarter of 2022.
Moderna continues to progress its respiratory vaccine pipeline, including vaccine candidates against influenza, RSV, and combination vaccines. Influenza (mRNA-1010) Phase 3 studies are ongoing. The southern hemisphere immunogenicity study of mRNA-1010 is fully enrolled with approximately 6,000 adult participants, and the data readout is expected in the first quarter of 2023. Initial regulatory feedback supports an accelerated pathway for approval based on this study.
Older adult RSV pivotal Phase 3 trial (mRNA-1345), known as ConquerRSV, is ongoing. Trial has enrolled >35,500 participants. Primary endpoints are safety and vaccine efficacy. The trial data could read out this winter,depending on the number of cases accrued and vaccine effectiveness. Pediatric RSV (mRNA-1345) is in Phase 1 and is now fully enrolled.
Combination COVID + flu (mRNA-1073) Phase 1/2 fully enrolled; combination COVID + flu + RSV (mRNA-1230) has started Phase 1; combination RSV + influenza (mRNA-1045), a new vaccine candidate, has started Phase 1/2 trial.
Latent & Public Health Vaccines:

CMV vaccine (mRNA-1647) pivotal Phase 3 study, known as CMVictory, is ongoing.
Therapeutics

Immuno-oncology

Personalized cancer vaccine (PCV) Phase 2 study evaluating mRNA-4157/V940 in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma is fully enrolled, with the primary efficacy analysis expected in the fourth quarter of 2022. As announced on October 12, Merck has exercised its option to jointly develop and commercialize mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement, and Moderna has received $250 million from Merck in the fourth quarter in connection with the option exercise.
After a portfolio review, AstraZeneca returns rights to the IL-12 program; Moderna is evaluating next steps for the program.
Rare diseases

Phase 1/2 Paramount study of propionic acidemia (PA) candidate (mRNA-3927) isongoing and enrolling additional cohorts. As reported on R&D Day, six patient-years of experience were accrued on drug as of September 8, 2022, with all eligible participants electing to continue on Open Label Extension study. mRNA-3927 has been generally well-tolerated to date and encouraging data has shown a decrease in the number of metabolic decompensation events (MDEs) among participants; initial discussions with regulators are supportive of MDE as a primary endpoint for a pivotal study.
mRNA-3139, for ornithine transcarbamylase (OTC) deficiency, a rare genetic disorder, is in preclinical development.
Moderna now has 48 programs in development across 45 development candidates[1], of which 35 are currently in active clinical trials. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 130 peer reviewed manuscripts.

Third Quarter 2022 Financial Results

Revenue: Total revenue for the third quarter of 2022 was $3.4 billion compared to $5.0 billion in the same period in 2021, mainly due to a decline in sales of the Company’s COVID-19 vaccines. Product sales for the third quarter of 2022 were $3.1 billion, a decrease of 35%, compared to the same period in 2021, primarily driven by lower sales volume due to the timing of market authorizations for our COVID-19 bivalent boosters and the related manufacturing ramp up.
Cost of Sales: Cost of sales was $1.1 billion, or 35% of product sales, for the third quarter of 2022, including third-party royalties of $106 million. Cost of sales, as a percentage of product sales, increased by 20 percentage points, from 15% in the same period in 2021. This includes a charge of $333 million for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, an expense for unutilized manufacturing capacity of $209 million, and a loss on firm purchase commitments and related cancellation charges of $102 million. These charges are driven by a shift in product demand to our Omicron-targeting COVID-19 bivalent boosters and costs associated with surplus production capacity.
Research and Development Expenses: Research and development expenses for the third quarter of 2022 increased 57% to $820 million, in comparison to the same quarter of 2021. The growth in spending was mainly due to an increase in clinical trial-related expenses, largely driven by increased clinical development activities, particularly with respect to our COVID-19 vaccines, RSV, flu and CMV programs, and increased headcount.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of 2022 increased 65% to $278 million, in comparison to the same quarter of 2021. The growth in spending was mainly due to increased headcount and external spend driven by commercial activities and to accelerate the Company’s build-out.
Effective Tax Rate: The effective tax rate was 14% for the third quarter of 2022, compared to 6% for the same period in 2021. The increase in 2022 was primarily due to the benefit recorded in 2021 related to the release of the valuation allowance on the majority of our deferred tax assets.
Net Income: Net income decreased by 69% to $1.0 billion in the third quarter of 2022, compared to the same period in 2021.
Earnings Per Share: Diluted EPS decreased by 67% to $2.53 in the third quarter of 2022, compared to the same period in 2021.
Cash Position: Cash, cash equivalents and investments as of September 30, 2022 and December 31, 2021 were $17.0 billion and $17.6 billion, respectively.
Net Cash Provided By Operating Activities: Net cash provided by operating activities was $3.3 billion for the nine months ended September 30, 2022, compared to $10.3 billion for the same period in 2021. Net cash provided by operating activities decreased in 2022, primarily attributable to revenue recognized from deferred revenue in excess of customer deposits received and increased income tax payments, partially offset by increased product sales and higher collection of receivables.
Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $308 million for the nine months ended September 30, 2022, compared to $164 million for the same period in 2021. The increase was primarily driven by the Company’s business expansion of its manufacturing and research facilities.
Cash Used for Repurchases of Common Stock: Cash used for repurchases of common stock was $2.9 billion for the nine months ended September 30, 2022. Moderna did not conduct share repurchases prior to the fourth quarter of 2021. From the end of the third quarter of 2021 to the end of the third quarter of 2022, the Company repurchased 24 million shares, reducing the number of common shares outstanding from 405 million to 387 million, more than offsetting 5 million shares of common stock issued in connection with equity compensation over this period.
2022 Financial Framework

Advance Purchase Agreements (APAs): Revenue from Moderna’s APAs for product sales for anticipated delivery in 2022 are expected to be $18-19 billion, reflecting deferrals of $2-$3 billion to 2023.
Cost of Sales: Cost of sales as a percentage of product sales are now expected to be 26-28% of sales, with the upper end of the range potentially driven by further charges due to product updates.
Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: Full-year expenses are expected to be approximately $4 billion.
Tax Rate: The Company expects an effective tax rate for the full year in the low- to mid-teen percentage range.
Capital Expenditures: The Company expects capital investments for 2022 of approximately $0.5 billion.
2023 Advanced Purchase Agreements

Confirmed APAs, as well as previously deferred product sales, currently represent $4.5-$5.5 billion in anticipated product sales in 2023. The Company expects additional sales in key markets, including the U.S., E.U., Japan, Middle East, Latin America and Asia Pacific in 2023.
Share Repurchase Program

The $3 billion share repurchase program announced in February 2022 was completed early in the fourth quarter 2022. The Company has commenced repurchases from the additional $3 billion program announced in August 2022.
Corporate Updates

Continued Growth: Moderna had approximately 3,700 employees as of September 30, 2022, compared to approximately 2,400 employees as of September 30, 2021.
Top Employer: Moderna named a Top Employer by Scienceand Science Careers for eighth consecutive year.
R&D Day: On September 8, Moderna held its annual R&D Day to review clinical trial programs across the portfolio, noting early clinical benefits in two rare disease programs, upcoming PCV data and preparation for multiple global product launches.
Executive Committee Appointments and Expansion
On September 6, Jamey Mock was appointed Chief Financial Officer of Moderna, following the retirement of David Meline.
On September 29, Moderna announced that it was expanding its Executive Committee to prepare for new product launches. As part of this expansion, Juan Andres will assume a new role as President, Strategic Partnerships and Enterprise Expansion. Jerh Collins has joined Moderna from Novartis and will succeed Juan Andres as Moderna’s Chief Technical Operations and Quality Officer. These changes will take effect on January 1, 2023.
Key 2022 Investor and Analyst Event Dates

ESG Day: November 10
Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, November 3, 2022.

To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: https://register.vevent.com/register/BI50e67285a997429fb4ca40ef36765c8a
Webcast: View Source
The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.