On August 4, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported its financial results for the second quarter ended June 30, 2022 (Press release, Aurinia Pharmaceuticals, AUG 4, 2022, View Source [SID1234617587]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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Second Quarter 2022 and Recent Highlights & Upcoming Milestones

Net product revenues were $28.2 million for the quarter ended June 30, 2022, compared to $6.6 million for the same period ended June 30, 2021.
Aurinia added 409 patient start forms (PSFs) during the second quarter 2022, as compared to 415 in the second quarter of 2021. As of Friday, July 29, 2022, the Company recorded 981 total PSFs since January 1, 2022.
PSF conversion rates after 90 days and confirmed patient access remain at peak levels since launch.
There were approximately 1,274 patients on LUPKYNIS therapy at June 30, 2022, compared with 1,071 at March 31, 2022.
At 6 months post-treatment-start, an average of approximately 70% of patients remain on treatment; and at 9 months, approximately 60% of patients are still on treatment.
Received positive CHMP opinion for LUPKYNIS (voclosporin) for the treatment of adults with active lupus nephritis in Europe. Regulatory review of the European Medicines Agency (EMA) marketing authorization application (MAA) remains on track with a European Commission (EC) approval decision expected by the end of the third quarter of 2022.
The first presentations of final AURORA 2 continuation study data were presented at the following medical meetings:
59th European Renal Association (ERA) Congress;
the European Congress of Rheumatology;
the European Alliance of Associations for Rheumatology (EULAR); and,
Submission of a manuscript with the full results is expected in the second half of 2022.
Recruitment of patients and initiation of new sites into both the VOCAL pediatric study and the ENLIGHT-LN registry continue as planned.
The Company received notice regarding the U.S. Patent Office (USPTO) Patent Trial and Appeal Board (PTAB) decision to institute trial on the Inter Partes review (IPR) filed by Sun Pharmaceuticals, directed at U.S. Patent No. 10,286,036. This patent is related to the LUPKYNIS dosing protocol for lupus nephritis. A determination on patentability, relative to the IPR, is expected on or prior to July 26, 2023.
Financial Results for the Quarter and Six Months Ended June 30, 2022

Total net revenue was $28.2 million and $6.6 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. Total net revenue was $49.8 million and $7.5 million for the six months ended June 30, 2022 and June 30, 2021, respectively. Our net revenues primarily consisted of product revenue, net of adjustments, for LUPKYNIS following FDA approval in late January 2021. Revenue growth is attributed to further progress in the launch of LUPKYNIS, driven by further penetration in the lupus nephritis market coupled with improvements in a number of key revenue driving metrics as noted above. No product sales commenced and no product marketing was permitted prior to January 22, 2021.

Total cost of sales and operating expenses for the quarters ended June 30, 2022 and June 30, 2021 were $64.2 million and $53.8 million, respectively. Total cost of sales and operating expenses were $123.7 million and $105.2 million for the six months ended June 30, 2022 and June 30, 2021, respectively. Further breakdown of operating expenses drivers and fluctuations are highlighted in the following paragraphs.

Cost of sales were $1.6 million and $0.3 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. Cost of sales were $1.9 million and $0.4 million for the six months ended June 30, 2022 and June 30, 2021, respectively. The increase for both periods was primarily due to an increase in product revenue coupled with safety stock reserves.

Gross margin for the quarters ended June 30, 2022 and June 30, 2021 was approximately 94% and 95% respectively. Gross margin for the six months ended June 30, 2022 and June 30, 2021 was approximately 96% and 95% respectively.

Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $51.5 million and $44.3 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. For the six months ended June 30, 2022 and June 30, 2021, SG&A expenses, inclusive of share-based compensation, were $96.7 million and $84.1 million, respectively. The primary drivers for the increase for both periods ended June 30, 2022 as compared to June 30, 2021 were an increase in share-based compensation expense, corporate legal matters and increased investment in infrastructure to support the commercialization of LUPKYNIS.

Non-cash SG&A share-based compensation expense included above for the quarters ended June 30, 2022 and June 30, 2021 was $8.9 million and $6.5 million, respectively. Non-cash SG&A share-based compensation expense included above for the six months ended June 30, 2022 and June 30, 2021 was $14.9 million and $13.2 million, respectively. The increase in share-based compensation is primarily due to an increase in annual grants in 2022 coupled with the full year expense impact from prior year grants.

Research and Development (R&D) expenses, inclusive of share-based compensation, were $11.5 million and $10.1 million for the quarters ended June 30, 2022 and June 30, 2021, respectively. For the six months ended June 30, 2022 and June 30, 2021, R&D expenses, inclusive of share-based compensation expense, were $24.1 million and $19.9 million, respectively. The primary drivers for the increase for both periods were due to an increase in CRO and developmental expenses related to AUR200 and AUR300.

Non-cash R&D share-based compensation expense included above for the quarters ended June 30, 2022 and June 30, 2021 was $1.1 million for both periods. Non-cash R&D share-based compensation expense included above for the six months ended June 30, 2022 and June 30, 2021 was $2.0 million and $2.2 million, respectively.

For the quarter ended June 30, 2022, Aurinia recorded a net loss of $35.5 million or $0.25 net loss per common share, as compared to a net loss of $47.0 million or $0.37 net loss per common share for the quarter ended June 30, 2021. For the six months ended June 30, 2022, Aurinia recorded a net loss of $73.1 million or $0.52 net loss per common share, as compared to a net loss of $97.4 million or $0.76 net loss per common share for the six months ended June 30, 2021.

Financial Liquidity at June 30, 2022

As of June 30, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $391.7 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, conducting planned R&D programs and investing in its pipeline and operating activities 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 June 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 June 30, 2022 financial results today, Thursday, August 4, 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 August 4, 2022 invoX Pharma Limited ("invoX"), a wholly owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK), focused on research and development (R&D) and business development activities outside of China, and F-star Therapeutics, Inc. ("F-star") (NASDAQ:FSTX), a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, reported that invoX has extended the expiration of its previously announced tender offer for all of the issued and outstanding shares of F-star common stock for a price of $7.12 per share (Press release, InvoX Pharma, AUG 4, 2022, View Source [SID1234617603]). The tender offer is now scheduled to expire at 05:00 p.m., Eastern Time, on September 19, 2022, unless it is further extended. The tender offer was previously scheduled to expire at one minute after 11:59 P.M., Eastern time, on August 3, 2022.

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The tender offer is being extended in order to allow additional time for the satisfaction of the regulatory conditions to the offer. The depositary for the tender offer has advised invoX that as of the previous expiration time there were validly tendered and not withdrawn a total of approximately 13,026,582 shares of F-star common stock, and approximately 2,704,867 shares of F-star common stock tendered pursuant to a notice of guaranteed delivery.

All terms and conditions of the tender offer remain unchanged during the extension period. F-star shareholders who have already tendered their shares do not have to re-tender their shares or take any other action as a result of the extension. Complete terms and conditions of the tender offer are set forth in the Offer to Purchase, Letter of Transmittal and other related materials, which have been filed by invoX with the Securities and Exchange Commission ("SEC") on July 7, 2022, as amended. In addition, F-star filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC on July 7, 2022, as amended, which includes, among other things, the recommendation of F-star’s board of directors that F-star stockholders tender all of their shares in the tender offer.

The Information Agent for the tender offer is Innisfree M&A Incorporated. The Depositary and Paying Agent for the tender offer is Computershare Trust Company, N.A. For all questions relating to the tender offer, please call the Information Agent, Innisfree M&A Incorporated toll-free at (888) 750-5830; banks and brokers may call collect at (212) 750-5833.

Advisors

PJT Partners is acting as financial advisor to invoX, and Morgan Stanley & Co. LLC is acting as financial advisor to F-star. Shearman & Sterling LLP is serving as legal counsel to invoX and Sino Biopharm and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to F-star.

On August 4, 2022 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal third quarter ended June 30, 2022 (Press release, ESSA, AUG 4, 2022, View Source [SID1234617619]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"It is a busy and important time for ESSA as we advance our lead candidate for the treatment of prostate cancer, EPI-7386, into the dose expansion phase of the single agent trial, dose the second cohort of patients in the Company-sponsored combination trial with enzalutamide, and plan to initiate additional trials of EPI-7386 in earlier-line patients," stated David Parkinson, M.D., President and CEO of ESSA. "During this past quarter, we were pleased to report clinical results from the Phase 1a dose escalation study demonstrating that EPI-7386 was safe and well-tolerated at all dose levels tested and that tumor volume decreases were observed in a subgroup of patients with measurable disease who were on therapy for more than 12 weeks. We also shared preliminary results from the first cohort of patients in our Phase 1/2 combination trial with enzalutamide."

Clinical Highlights

EPI-7386 Monotherapy

In June 2022, ESSA reported clinical results from the Phase 1a dose escalation study of EPI-7386 in patients with metastatic castration-resistant prostate cancer ("mCRPC") resistant to current standard-of-care therapies. The initial data demonstrate that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in heavily pretreated patients. EPI-7386 was safe and well-tolerated at all dose levels and schedules tested, with no dose-limiting toxicities.

The Phase 1b expansion study is expected to begin in the third quarter of calendar 2022; the trial is expected to enroll two dose cohorts as well as an additional cohort of patients with non-metastatic castration-resistant prostate cancer ("nmCRPC") who have not yet been treated with a second-generation antiandrogen in a 12-week window of opportunity study.
EPI-7386 Clinical Collaborations

The Company has completed dosing of the first cohort of patients and is currently enrolling the second cohort of patients in the Company-sponsored Phase 1/2 study of EPI-7386 in combination with Astellas Pharma Inc.’s and Pfizer Inc.’s enzalutamide in patients with mCRPC who have not been treated with second-generation antiandrogens. In June 2022, the Company reported preliminary results from the first cohort suggesting that the drugs can be combined safely and result in active drug levels of both EPI-7386 and enzalutamide.

Janssen Research and Development LLC continues to enroll patients in the Phase 1/2 trial of EPI-7386 in combination with apalutamide or abiraterone acetate plus prednisone in earlier line mCRPC patients.

The Bayer-led Phase 1/2 trial will evaluate EPI-7386 in combination with darolutamide in earlier line mCRPC patients.

The Company expects to initiate a Phase 2 investigator-sponsored neoadjuvant study to evaluate darolutamide compared to EPI-7386 + darolutamide in patients undergoing prostatectomy for high-risk localized prostate cancer by year-end.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $8.8 million ($0.20 loss per common share based on 44,059,700 weighted average common shares outstanding) for the quarter ended June 30, 2022, compared to a net loss of $8.8 million ($0.21 loss per common share based on 41,018,024 weighted average common shares outstanding) for the quarter ended June 30, 2021. For the quarter ended June 30, 2022, this included non-cash share-based payments of $1.6 million compared to $2.8 million for the comparable period in 2021, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended June 30, 2022 were $6.4 million compared to $6.2 million for the quarter ended June 30, 2021 and included non-cash costs related to share-based payments ($872,531 for the quarter ended June 30, 2022 compared to $1.2 million for the quarter ended June 30, 2021). The increase in R&D expenditures for the fiscal quarter ended June 30, 2022 was primarily related to preclinical and clinical data analysis associated with the Phase 1a clinical study.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended June 30, 2022 were $2.9 million compared to $3.1 million for the quarter ended June 30, 2021 and included non-cash costs related to share-based payments of $718,469 for the quarter ended June 30, 2022 compared to $1.5 million for the comparable period in 2021. The decreased expenditure is the result of decreased professional fees from collaboration contracts in the prior period and decreased non-cash share-based payments.
Liquidity and Outstanding Share Capital

At June 30, 2022, the Company had available cash reserves and short-term investments of $174.6 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2024.

As of June 30, 2022, the Company had 44,073,076 common shares issued and outstanding.

In addition, as of June 30, 2022 there were 3,234,750 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted average exercise price of $49.69. There were 7,852,061 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.15 per common share.

About EPI-7386

EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with CRPC and mCRPC whose tumors have progressed on current standard-of-care therapies. The Phase 1 clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of ESSA’s Investigational New Drug application and Health Canada acceptance. The Phase 1b component of the study comprises two cohorts enrolling in parallel. Cohort A – a dose expansion study of EPI-7386 to evaluate the safety, tolerability, pharmacokinetic, and preliminary anti-tumor activity and Cohort B – a window of opportunity study with clinical endpoints to assess the anti-tumor activity in nmCRPC patients unperturbed by previous second generation anti-androgen therapies or chemotherapy. EPI-7386 is also being studied in earlier line mCRPC patients in Phase 1/2 trials in combination with enzalutamide, apalutamide and abiraterone acetate with prednisone. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to EPI-7386 worldwide.

On August 4, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported that Company’s management will participate in one-on-one investor meetings at the BTIG Biotechnology Conference 2022, to be held virtually and in New York City from August 8-9, 2022 (Press release, Synthetic Biologics, AUG 4, 2022, View Source [SID1234617704]).

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BTIG hosted events are intended for prospective and existing BTIG clients only. To schedule a meeting with the Company, please contact your BTIG representative.

On August 4, 2022 Cellectis reported provided business update and announced its results for the six-month period ending June 30, 2022 (Press release, Cellectis, AUG 4, 2022, View Source [SID1234618558]).

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"This is a very exciting time at Cellectis: earlier this week, we were proud to announce the FDA clearance of our Investigational New Drug application for UCART20x22, our product candidate being developed for patients with relapsed and refractory Non-Hodgkin Lymphoma" said André Choulika, Ph.D., Chief Executive Officer at Cellectis. "UCART20x22 is a very promising product candidate. Dual targeting of CD20 and CD22, both validated targets in B-cell malignancies, represents a potential therapeutic alternative to CD19-directed therapies.

In 2018, Cellectis made the decision to internalize manufacturing for its therapeutic product candidates, with the goal of providing the company with manufacturing independence. UCART20x22 is the first example of achieving this milestone, as our first product candidate with fully integrated in-house development. It showcases our transformation into an end-to-end cell and gene therapy company, from discovery & product development, transfer, and GMP manufacturing and clinical development. We are very excited to start the clinical trial for patients with relapsed or refractory Non-Hodgkin Lymphoma in the second half of this year.

We continue to make progress enrolling patients in our three Cellectis-sponsored Phase 1 dose escalation trials and take notable steps forward with our partnerships programs. These updates illustrate our potential and ability to advance the field of allogeneic CAR T cell therapy."

Pipeline highlights

Cellectis continues to make progress, enrolling patients throughout its sponsored Phase 1 dose escalation trials:

BALLI-01 (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

UCART22 is an allogeneic CAR T-cell product candidate targeting CD22 and is being evaluated in patients with r/r B-ALL in the BALLI-01 Phase 1 dose escalation clinical study.
BALLI-01 is currently enrolling patients at dose level 3 (DL3) (5 × 106 cells/kg) with fludarabine, cyclophosphamide and alemtuzumab (FCA) preconditioning regimen.
Cellectis plans to initiate dosing patients with UCART22 product candidate manufactured fully in-house in the second half of this year.

AMELI-01 (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML)

UCART123 is an allogeneic CAR T-cell product candidate targeting CD123 and is being evaluated in patients with r/r AML in the AMELI-01 Phase 1 dose-escalation clinical study.

MELANI-01 (evaluating UCARTCS1) in relapsed or refractory multiple myeloma (r/r MM)

UCARTCS1 is an allogeneic CAR T-cell product candidate targeting CS1 and is being evaluated in patients with r/r MM in the MELANI-01 Phase 1 dose-escalation clinical study.
Cellectis is currently enrolling patients at dose level 1 (DL1) (1 × 106 cells/kg) with fludarabine and cyclophosphamide (FC) preconditioning regimen.

NatHaLi-01 (evaluating UCART20x22) in relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL)

UCART20x22 is Cellectis’ first allogeneic dual CAR T-cell product candidate being developed for patients with relapsed or refractory Non-Hodgkin Lymphoma (r/r NHL).
UCART20x22 is Cellectis’ first product candidate fully designed, developed and manufactured in-house, showcasing the Company’s transformation into an end-to-end cell and gene therapy platform spanning discovery, product development, manufacturing of both starting materials and final cell therapy product candidate, as well as clinical development.
On August 1st, the FDA allowed Cellectis’ IND to proceed for UCART20x22 for patients with r/r NHL. Cellectis plans to begin enrolling patients in the NatHaLi-01 Phase 1/2a clinical trial in the second half of the year.
UCART Preclinical Data & Programs

Novel universal CAR T-cell

On May 16, Cellectis presented research data on the development of a novel universal CAR T-cell with immune-evasive properties using TALEN-gene editing, at an oral presentation at the American Society of Cell and Gene Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper). Click here to access the presentation.
Following its oral presentation at ASGCT (Free ASGCT Whitepaper), Cellectis published its research data in Nature Communications on June 30. Click here to access the article.
Cellectis’ next generation of universal CAR T-cells have the potential to improve the persistence and to allow large-scale deployment of T-cell product candidates in allogeneic settings against multiple malignancies. This novel immune-evasive CAR T-cell scaffold is deficient in Class 1 major histocompatibility complex (MHC-1) and expresses the Natural Killer (NK) inhibitor HLA-E. These two genomic modifications enable CAR T-cells to evade NK (Natural Killer) cells as well as alloresponsive T-cells attacks and impart efficient antitumor activity in vitro and in vivo.
Licensed Allogeneic CAR-T Cell Development Programs

Allogene Therapeutics, Inc.’s CAR T programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Les Laboratoires Servier ("Servier") and Allogene Therapeutics, Inc. ("Allogene") based on an exclusive license granted by Cellectis to Servier[1]. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. Allogene’s anti-BCMA and anti-CD70 programs are licensed exclusively from Cellectis to Allogene and Allogene holds global development and commercial rights to these programs.

[1] Servier is a global independent pharmaceutical group.

Anti-CD19 program

In June 2022, Allogene announced that FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in relapsed/refractory Large B Cell Lymphoma (r/r LBCL). The RMAT designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies and follows positive data from the Phase 1 ALPHA2 trial in heavily pretreated patients with r/r LBCL.
Allogene previously announced that enrollment in the Phase 1 portion of the ALLO-501A ALPHA2 trial in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) re-opened with the goal of offering AlloCAR T to patients while Allogene prepares to launch the pivotal Phase 2 ALPHA2 trial. They also previously said that the single-arm pivotal ALPHA2 trial of ALLO-501A in r/r LBCL is on track to begin mid-year 2022 with FDA discussions directed at finalizing clinical trial design and Chemistry Manufacturing and Controls (CMC) requirements. AlloCAR T is a trademark of Allogene Therapeutics, Inc.
Anti-BCMA program

In May 2022, Allogene announced that the FDA has granted Orphan Drug Designation (ODD) for ALLO-605 for the treatment of r/r MM.
Allogene previously announced that enrollment had resumed in trials targeting BCMA for the treatment of patients with r/r MM, including the UNIVERSAL trial with ALLO-715 and the IGNITE trial with the TurboCAR candidate, ALLO-605.
Anti-CD70 program

In April 2022, Allogene presented preclinical data at the 2022 AACR (Free AACR Whitepaper) Annual Meeting which support the ongoing clinical evaluation of ALLO-316 for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma (RCC) and other CD70 expressing cancers. The findings were simultaneously published in AACR (Free AACR Whitepaper)’s Cancer Research.
Allogene previously announced that the Phase 1 TRAVERSE trial of ALLO-316 in RCC, now in its second dose level cohort, continues to accrue patients.
Gene Editing Partnerships

Iovance Biotherapeutics, Inc. ("Iovance")

First in human trial of genetically modified Iovance TIL therapy IOV-4001: site activation and patient recruitment are underway in the IOV-GM1-201 clinical trial of Iovance’s first genetically modified TIL therapy, IOV-4001, for the treatment of previously treated advanced melanoma or mNSCLC. IOV-4001 leverages the gene editing TALEN technology licensed from Cellectis to inactivate PD-1 expression.
Research Programs for Next-Generation TIL Therapies and Related Technologies: Several targets for genetic modification using the gene-editing TALEN technology, including double genetic knock-out programs, are advancing in preclinical development.
Cytovia Therapeutics, Inc. ("Cytovia")

The research and development collaboration with Cytovia to develop TALEN-edited induced pluripotent stem cells (iPSC) NK and CAR-NK cells is progressing. Cellectis has developed custom TALEN which Cytovia is using to edit iPSCs in a safe and effective manner.
Cytovia has generated promising preclinical data of TALEN-edited iPSC-derived NK cells that it expects to present at upcoming scientific conferences later this year.
Corporate Updates

On June 28, 2022, Cellectis announced that during the annual shareholders meeting, Axel-Sven Malkomes and Donald Bergstrom, M.D., Ph.D., were appointed as Directors of the Company’s Board of Directors, with immediate effect.
Previously, Donald A Bergstrom, M.D., Ph.D., was appointed as a Board Observer on the Company’s Board of Directors on November 4, 2021. Dr. Bergstrom currently serves as Executive Vice President, Head of Research and Development at Relay Therapeutics, Inc., a clinical-stage precision medicines company.
Axel-Sven Malkomes served as Chief Financial Officer & Chief Business Officer at Medigene AG, a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, until March 31st, 2022. He brings with him over 25 years of experience in the healthcare sector.
Financial Results

The interim condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis owned approximately 51.3% of outstanding shares of common stock (as of June 30, 2022), have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board ("IFRS").

We present certain financial metrics broken out between our two reportable segments – Therapeutics and Plants – in the appendices of this Q2 2022 financial results press release.

Cash: As of June 30, 2022, Cellectis, including Calyxt, had $135 million in consolidated cash, cash equivalents, and restricted cash of which $123 million are attributable to Cellectis on a stand-alone basis. This compares to $191 million in consolidated cash, cash equivalents and restricted cash as of December 31, 2021, of which $177 million was attributable to Cellectis on a stand-alone basis. This net decrease of $56 million primarily reflects (i) $56 million of net cash flows used in operating, investing and lease financing activities of Cellectis, (ii) $13 million of net cash flows used in operating, capital expenditures and lease financing activities of Calyxt, and (iii) a $4 million defavorable FOREX impact which was partially offset by (i) $10 million of net proceeds from capital raise at Calyxt and, (ii) $5 million of cash received related to research tax credit prefinancing. Based on the current operating plan, Cellectis excluding Calyxt anticipates that the cash, cash equivalents, and restricted cash of $123 million as of June 30, 2022 will fund its operations into early 2024.

Revenues and Other Income: Consolidated revenues and other income were $7 million for the six months ended June 30, 2022 compared to $43 million for the six months ended June 30, 2021. 99% of consolidated revenues and other income was attributable to Cellectis in the first six months of 2022. This decrease between the six months ended June 30, 2022 and 2021 was mainly attributable to (i) a decrease of revenue pursuant to the recognition of a $15.0 million convertible note obtained as consideration for a "right-to-use" license granted to Cytovia and a $5.1 million Allogene milestone during the six-month period ended June 30, 2021, while revenue related to collaboration agreements for the six months of 2022 consists of the recognition of two milestones related to Cellectis’ agreement with Cytovia for $1.5 million and the recognition of $1.0 million related to a change of control of a licensee pursuant to the terms of the license agreement with Cellectis and amendment to the license agreement (extension of the option term) (ii) a decrease in other revenues of $5 million relating to a change in Calyxt’s business model for its PlantSpring technology and BioFactory, in which no significant revenue was yet recognized.

Cost of Revenues: Consolidated cost of revenues were $0,7 million for the six months ended June 30, 2022 compared to $20 million for the six months ended June 30, 2021. This decrease is driven by the change in Calyxt’s business model for its PlantSpring and BioFactory.

R&D Expenses: Consolidated R&D expenses were $59 million for the six months ended June 30, 2022 compared to $62 million for the six months ended June 30, 2021. 89% of consolidated R&D expenses was attributable to Cellectis in the first six months of 2022. The $3 million decrease between the first six months of 2022 and 2021 was primarily attributable to (i) a decrease of purchases, external expenses and other by $4.5 million (from $36 million in 2021 to $31 million in 2022) due to lower consumables, subcontracting costs and depreciation and amortization for the therapeutic segment, (ii) a $0.9 million decrease in social charges on stock option, and (iii) a $0.9 million decrease in non-cash stock-based compensation expense partially offset by an increase of $3 million in wages and salaries mainly driven by the increased R&D headcount in the therapeutic segment.

SG&A Expenses: Consolidated SG&A expenses were $17.7 million for the six months ended June 30, 2022 compared to $18.2 million for the six months ended June 30, 2021. 62% of consolidated SG&A expenses was attributable to Cellectis in the first six months of 2022. The $0.5 million decrease primarily reflects (i) a $3 million decrease in wages and salaries, (ii) a $0.3 million decrease in social charges on stock option grants and (iii) a $0.5 million decrease in purchases, external expenses and other (from $9.2 million in 2021 to $8.7 million in 2022) partially offset by (i) a $3 million increase in non-cash stock-based compensation expense mainly explained by the favorable impact in 2021 of the recapture of non-cash stock-based compensation from the forfeiture of certain of Calyxt’s former CEO’s unvested stock options, restricted stock units, and performance stock units following his departure.

Net Income (loss) Attributable to Shareholders of Cellectis: The consolidated net loss attributable to shareholders of Cellectis was $51 million (or $1.12 per share) for the six months ended June 30, 2022, of which $47 million was attributed to Cellectis, compared to $52 million (or $1.17 per share) for the six months ended June 30, 2021, of which $43 million was attributed to Cellectis. This $1 million decrease in net loss between first six months 2022 and 2021 was primarily driven by (i) an increase in net financial gain of $14.7, (ii) a decrease of $19 million of cost of revenue and, (iii) a $3.8 million decrease of research and development expenses partially offset by a decrease in revenues and other income of $36 million.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis was $46 million (or $1.00 per share) for the six months ended June 30, 2022, of which $43 million is attributed to Cellectis, compared to a net loss of 48 million (or $1.08 per share) for the six months ended June 30, 2021, of which $38 million was attributed to Cellectis. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

We currently foresee focusing our cash spending at Cellectis for the Full Year of 2022 in the following areas:

– Supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of UCART123, UCART22, UCARTCS1, and UCART20x22, and

– Operating our state-of-the-art manufacturing capabilities in Paris (France), and Raleigh (North Carolina, U.S.A); and

– Continuing strengthening our manufacturing and clinical departments.