On August 9, 2023 Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative clinical-stage biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported financial results and business highlights for the second quarter ended June 30, 2023 (Press release, Century Therapeutics, AUG 9, 2023, View Source [SID1234634053]).

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"Here at Century we have continued to focus on the further advancement of our pipeline, specifically our ELiPSE-1 Phase 1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas, for which we expect to report initial data from Schedule A by year end," said Greg Russotti, Ph.D., Interim Chief Executive Officer, Century Therapeutics. "We remain confident in our differentiated scientific approach and are looking forward to spending the second half of this year working towards solidifying our position as an innovative leader in the cell therapy space."

Business Highlights & Upcoming Milestones

● The first-in-human Phase 1 ELiPSE-1 trial evaluating CNTY-101 in relapsed or refractory CD19 positive B-cell lymphomas is ongoing. The Company remains on track to report preliminary data from Schedule A of the trial, including pharmacokinetics, pharmacodynamics, and safety, by year end.

● At the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023, the Company presented a Trials in Progress poster related to its Phase 1 ELiPSE-1 trial. A copy of the poster, titled, "The ELiPSE-1 Study: A Phase 1 Multicenter Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B Cell Malignancies", is available on the Posters section of Century’s website at View Source

Second Quarter 2023 Financial Results

● Cash Position: Cash, cash equivalents, and marketable securities were $301.0 million as of June 30, 2023, as compared to $367.4 million as of December 31, 2022. Net cash used in operations was $48.5 million for the six months ended June 30, 2023, compared to net cash provided by operations of $61.2 million for the six months ended June 30, 2022 (which includes deferred revenue from the Bristol Myers Squibb (BMS) collaboration of $120.7 million).

● Collaboration Revenue: Collaboration revenue generated through the Company’s collaboration, option and license agreement with BMS was $0.1 million for the three months ended June 30, 2023, compared to $1.4 million for the same period in 2022.

● Research and Development (R&D) expenses: R&D expenses were $22.7 million for the three months ended June 30, 2023, compared to $24.5 million for the same period in 2022. The decrease in R&D expenses was primarily due to the reduction in force in January of 2023.

● General and Administrative (G&A) expenses: G&A expenses were $8.2 million for the three months ended June 30, 2023, compared to $8.3 million for the same period in 2022. The decrease in G&A expenses was primarily due to a reduction in headcount.

● Impairment of long lived assets: A one-time impairment charge of $4.2 million was recorded in connection with the strategic decision to consolidate two of the Company’s existing leased facilities in Philadelphia.

● Net loss: Net loss was $33.3 million for the three months ended June 30, 2023, compared to $31.0 million for the three months ended June 30, 2022.

Financial Guidance

● The Company expects full year generally accepted accounting principles (GAAP) operating expenses to be between $135 million and $145 million, including non-cash stock-based compensation expense of $12 million to $17 million.

● The Company estimates its cash, cash equivalents, and investments will support operations into 2026.

On August 9, 2023 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the second quarter ended June 30, 2023, and provided clinical development and operational highlights (Press release, Aura Biosciences, AUG 9, 2023, View Source [SID1234634050]).

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"As we build momentum across our portfolio, we are happy to welcome Drs. Bruce Brown and Anthony Daniels as our Therapeutic Area Heads in Urologic Oncology and Ocular Oncology, respectively, as well as Dr. Richard Mountfield as our new Senior Vice President of Regulatory Affairs and Quality. These key appointments are critical in supporting our corporate growth and expansion of our clinical programs in two important oncology therapeutic areas with high unmet medical needs for patients," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

Dr. de los Pinos added, "We are excited to announce that we have released our drug product manufactured using the commercial process to be used in the global Phase 3 trial and remain encouraged by the progress we have made with the start-up activities, with multiple sites ready to enroll patients in the United States. We remain focused on the execution of our clinical studies and plan to share 12-month data from the Phase 2 trial in choroidal melanoma in the second half of 2023."

Recent Pipeline Developments

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Global Start up Activities for the Phase 3 trial ongoing.
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The Phase 3 trial is designed as a superiority trial comparing belzupacap sarotalocan (bel-sar) versus sham. The trial is a global Phase 3, randomized, multi-center, masked study, and it is intended to enroll approximately 100 patients randomized 2:1:2 to receive high dose regimen of bel-sar, low dose regimen of bel-sar with suprachoroidal (SC) administration, or a sham control.
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The primary endpoint is time to tumor progression and the first key secondary endpoint is a composite time to event analysis that will compare the tumor control and visual acuity of the bel-sar high dose regimen to sham when the last patient completes their 12 months of follow up.

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Aura released the commercial process material for the global Phase 3 trial. The majority of sites are qualified globally, and multiple sites are ready to enroll patients in the United States.
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The first patient is expected to be dosed in the second half of 2023.

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Enrollment is complete in the Phase 2 trial evaluating SC administration of bel-sar for the first-line treatment of adult patients with early-stage choroidal melanoma (CM). Updated efficacy data with 12 months median follow up of patients treated with the therapeutic regimen intended to be used in the global Phase 3 trial is on track to be presented in the second half of 2023.

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The Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC) is currently ongoing, and Aura expects to report data in 2024. This represents an area of high unmet need with approximately 60,000 patients diagnosed in the United States every year. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in June 2022.

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The Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 19 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The primary endpoint of the Phase 1 trial is the incidence and severity of treatment-related adverse events, serious adverse events and/or the incidence of dose-limiting toxicities. The trial will provide histopathological evaluation after the local treatment to support bel-sar’s biological activity.

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Beyond early-stage CM, Aura continues to build its ocular oncology franchise. Aura’s goal is to initiate clinical development in choroidal metastasis, an indication with a high unmet medical need and no approved therapies, as the second ocular oncology indication. Aura is on track to initiate the Phase 2 trial in 2024.

Recent Corporate Events

Strengthened the clinical leadership team with the following key appointments:

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Dr. Bruce Brown joined Aura as Therapeutic Area Head Urologic Oncology. Dr. Brown is responsible for leading the bladder cancer program, including the current ongoing trial, as well as driving future strategy and development plans. Dr. Brown was previously VP, Clinical Development at Myovant Sciences. Dr. Brown is a board-certified urologist and joined the pharmaceutical industry after practicing urology for 17 years.

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Dr. Anthony Daniels is joining Aura as the Therapeutic Area Head Ocular Oncology. Dr. Daniels will be responsible for leading the ocular oncology program and driving future strategy. Dr. Daniels is a board-certified ophthalmologist who has treated ocular oncology patients for 15 years, and most recently was Chief of the Division of Ocular Oncology at Vanderbilt University Medical Center.

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Dr. Richard Mountfield joined Aura as SVP, Regulatory Affairs & Quality. Dr. Mountfield is responsible for overseeing regulatory affairs and quality activities for all programs. Dr. Mountfield was previously the SVP of Regulatory Affairs & Quality at Zenas BioPharma.

Second Quarter 2023 Financial Results

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As of June 30, 2023, Aura had cash and cash equivalents and marketable securities totaling $162.0 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the second half of 2025.

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Research and development expenses increased to $15.1 million for the three months ended June 30, 2023 from $9.5 million for the three months ended June 30, 2022, primarily due to ongoing clinical costs associated with the progression of our Phase 2 study and CRO costs associated with the start of our Phase 3 global trial, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

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General and administrative expenses increased to $5.2 million for the three months ended June 30, 2023 from $4.3 million for the three months ended June 30, 2022. General and administrative expenses include $1.2 million and $0.8 million of stock-based compensation for the three months ended June 30, 2023 and 2022, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to growth of the Company.

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Net loss for the three months ended June 30, 2023 was $18.3 million compared to $13.5 million for the three months ended June 30, 2022.

On August 9, 2023 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the second quarter ended June 30, 2023 and provided a business update (Press release, Adaptimmune, AUG 9, 2023, View Source [SID1234634049]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "The BLA submission process for afami-cel is going well with alignment with the Agency on key de-risking items. We have completed most of the wet work and we are now focused on writing and publishing the remaining sections to complete Part 3 of this submission for approval of the first engineered T-cell therapy for a solid tumor indication. We have completed the combination with TCR2 and added pipeline assets, technologies, and increased our total liquidity by approximately $85m. The transition of lete-cel back from GSK is also progressing well. We have set ourselves up to make data-driven portfolio decisions to bring medicines to market that we have high conviction can make a real difference for people with cancer."

Pipeline update and overview of near- and mid-term catalysts to make rigorous data-driven investment decisions

Adaptimmune’s lead clinical franchises utilize engineered T-cell therapies targeting MAGE-A4, NY-ESO (in process of transitioning from GSK), and mesothelin, which are expressed on a broad range of solid tumors. Use of these cell therapies is supported by compelling clinical data including results in late-stage synovial sarcoma which will form the basis of the Company’s first BLA submission. The Company has an enhanced "next-gen toolbox" and preclinical pipeline including PRAME and CD70 programs.

The following figure provides an overview of pipeline data catalysts that will be used to make data-driven investment decisions. To view an enhanced version of this graphic, please visit: View Source Note, this figure was previously provided in the Adaptimmune corporate deck and a press release issued on June 1st to announce completion of the strategic combination with TCR2.

GraphicGraphic

Afami-cel targeting MAGE-A4

● Parts 1 and 2 of the afami-cel BLA submission have been completed and the final module (Part 3) is in progress. Milestone achievements are outlined in the BLA update section below.

Lete-cel targeting NY-ESO (in process of transitioning from GSK): could offer another potential commercial treatment for people with sarcoma

● Data from the completed pivotal clinical trial with lete-cel (IGNYTE-ESO) for the treatment of synovial sarcoma or myxoid/ round cell liposarcoma (MRCLS) is expected in late 2023. The transition of lete-cel to Adaptimmune from GSK is ongoing and terms were agreed during Q2 2023. The Company will determine next steps for lete-cel, including potential for a BLA, in early 2024.

ADP-A2M4CD8: next-generation therapy targeting MAGE-A4

● Initiated the Phase 2 SURPASS-3 trial in combination with nivolumab for platinum resistant ovarian cancer. This trial has the potential to become registrational. ADP-A2M4CD8 has been granted FDA RMAT designation for the treatment of people with platinum resistant ovarian cancer.
● Initiated additional cohorts in the Phase 1 SURPASS trial in the earlier line treatment setting for head & neck and urothelial cancers in combination with checkpoint inhibitors. Data readouts anticipated in 2H 2024.
● An update on the Phase 1 SURPASS trial (ADP-A2M4CD8 alone or combined with nivolumab) will be featured as an oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2023 Congress, Monday, October 23, 11:08-11:18 CET.

Gavo-cel targeting mesothelin

● The Phase 2 portion of the trial to assess gavo-cel in people with ovarian cancer in combination with nivolumab is ongoing. All patients to be included in an interim data review have been enrolled. All enrolled patients will be treated and continue in the trial as planned. Additional patients will not be enrolled until the data review is complete.
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● Note, the Phase 1 portion of the trial in ovarian cancer, non-small cell lung cancer (NSCLC), malignant pleural/peritoneal mesothelioma (MPM) or cholangiocarcinoma has been completed. Initial data from the Phase 1 portion of the trial was reported in September 2022. Focus was subsequently narrowed to ovarian cancer.
● More mature clinical and translational Phase 1 and 2 data will be evaluated later this year to determine next steps with gavo-cel.

TC-510: next-generation therapy targeting mesothelin

● The Phase 1/2 clinical trial for TC-510 for people with MPM, ovarian cancer, pancreatic cancer, colorectal cancer, or triple negative breast cancer is ongoing in the dose-escalation phase. Initial data readouts are anticipated this year to enable further directional decisions for TC-510.

Preclinical programs targeting PRAME and CD70 (not shown in figure)

● Adaptimmune plans to be IND-ready in late 2023 with a PRAME targeted TCR T-cell therapy. PRAME is a clinically validated target which is highly expressed across a broad range of solid tumors including breast, kidney, endometrial, ovarian, gastroesophageal, non-small cell lung, and head & neck cancers as well as melanoma. A clinical trial is expected to initiate in 2024 (indications remain to be determined).
● An IND for CD70 is planned for 2024. CD70 is expressed in hematological malignancies including acute myeloid leukemia (AML), lymphoma, and solid tumors including renal cell carcinoma.

Afami-cel: Adaptimmune plans to complete BLA submission in Q4 2023

In late 2022, Adaptimmune completed submission of the preclinical module (Part 1) of the BLA. In Q1 2023, the Company completed submission of the clinical module (Part 2). The Company is currently in the process of completing the final CMC module (Part 3).

Recently, several critical milestones have been completed:

● Demonstrated comparability of afami-cel drug batches manufactured with clinical trial supply vector and commercial supply vector
● In collaboration with our companion diagnostic (CDx) partner, completed submission to FDA of the Premarket application (PMA) for the MAGE-A4 CDx assay
● Agreed confirmatory evidence plan with FDA: Cohort 2 of the SPEARHEAD-1 trial will act as confirmatory evidence for full approval, enrollment in Cohort 2 has completed
● Completed method validation for lot release assays (including potency assays)
● Completed vector process performance qualification (PPQ)
● Initiated T-cell process performance qualification (PPQ)
● Secured favorable FDA feedback on the commercial T-cell potency assay including agreement on the proposed potency dataset for inclusion in the submission. The FDA has not requested any new or additional information on T-cell potency to precede the BLA submission.
This BLA is supported by data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy. The Company has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for afami-cel for the treatment of synovial sarcoma.

Afami-cel data presentation at ASCO (Free ASCO Whitepaper) 2023

Data from SPEARHEAD-1 was presented in a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is available HERE and summarized below.

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● Approximately 39% of patients had clinical responses after a single dose of afami-cel in Cohort 1 of the pivotal SPEARHEAD-1 trial and the median duration of response was ~12 months (CTOS 2022)
● Median overall survival (mOS) was ~17 months
● Patients with a RECIST response have a 12-month OS probability of 90% and 24-month OS probability of 70%, and the mOS for responders has not yet been reached
● Historical outcomes are poor for advanced synovial sarcoma with a mOS of <12 months in the second line and beyond treatment setting

Corporate news

● In June, Adaptimmune announced completion of the strategic combination with TCR2 to form a pre-eminent cell therapy company . At completion of the combination an additional $84.6m of Total Liquidity1 was added to the group’s combined liquidity and 39 additional employees. Integration efforts, including pipeline prioritization and investment decisions, are ongoing.
● Adaptimmune and GSK agreed terms for transfer of PRAME and NY-ESO ("lete-cel") target programs back to Adaptimmune in Q2. Adaptimmune will receive ~$37 million from GSK in relation to the transition of the ongoing lete-cel clinical trials anticipated in Q4.
4

Financial Results for the three and six months ended June 30, 2023

● Cash / liquidity position: As of June 30, 2023, Adaptimmune had cash and cash equivalents of $77.0 million and Total Liquidity1 of $204.7 million, compared to $108.0 million and $204.6 million, respectively, as of December 31, 2022.
● Revenue: Revenue for the three and six months ended June 30, 2023, was $5.1 million and $52.7 million, respectively, compared to $5.5 million and $9.1 million for the same periods in 2022. Revenue has increased in the six months to June 30, 2023, compared to the same period in 2022 primarily due to the termination of the Astellas collaboration, resulting in the remaining deferred income for the collaboration being released as revenue in March 2023.
● Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2023, were $30.0 million and $55.5 million, respectively, compared to $34.7 million and $71.5 million for the same periods in 2022. R&D expenses decreased due to a decrease in the average number of employees engaged in research and development, decreases in subcontracted expenditures, a decrease in share-based compensation expenses, a decrease in in-process research and development costs and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.
● General and administrative (G&A) expenses: G&A expenses for the three and six months ended June 30, 2023, were $20.1 million and $40.5 million, respectively, compared to $14.6 million and $31.4 million for the same periods in 2022. G&A expenses increased due to restructuring and charges recognised in the first quarter of 2023, an increase in other corporate costs due to an increase in accounting, legal and professional fees incurred in relation to the TCR2 Therapeutics, Inc merger agreement and severance and other related costs for former TCR2 Therapeutics leadership, offset by a decrease in share-based compensation expenses.
● Gain on bargain purchase: a $22.2 million gain on bargain purchase was recognised in the three and six months ended June 30, 2023, from the strategic combination with TCR2 Therapeutics, Inc.
● Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and six months ended June 30, 2023, was $21.4 million and $20.4 million, respectively ($(0.02) and $(0.02) per ordinary share), compared to $44.5 million and $94.8 million, respectively ($(0.05) and $(0.10) per ordinary share), for the same periods in 2022.

Financial Guidance

The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech and payments under the Termination and Transfer Agreement with GSK, will fund the Company’s current operations into early 2026, as further detailed in the Company’s Quarterly Report on Form 10-Q for the second quarter ended June 30, 2023, to be filed with the Securities and Exchange Commission following this earnings release.

Webcast Information

The Company will host a live webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. BST) today, August 9, 2023. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

On August 9, 2023 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 115.9 million in the second quarter of 2023 (Q2 2022: NOK 99.9 million), and an EBITDA of NOK 23.4 million (NOK 1.4 million) (Press release, PhotoCure, AUG 9, 2023, View Source;utm_medium=email_campaign&utm_campaign=newsletter [SID1234634003]). The Company reiterates its 2023 annual guidance of new Saphira blue light tower installations in the U.S. expected in the range of 65 to 75, anticipated consolidated product revenue growth above 20%, and positive EBITDA excluding business development spending.

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"In the second quarter of 2023, Hexvix/Cysview revenue increased 16% year over year driven by higher unit sales in the U.S., price increases and foreign exchange. We generated over NOK 23 million in EBITDA, including a positive contribution from our commercial business and a milestone payment from Asieris related to the clinical development of Cevira. During the second quarter, we delivered 4% sequential unit sales growth in North America and 6% in Europe, demonstrating continued positive traction in the region," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 144.3 million in the second quarter of 2023 (NOK 100.6 million), and an EBITDA* of NOK 23.4 million (NOK 1.4 million). Hexvix/Cysview revenues ended at NOK 115.9 million in the quarter (Q2 2022: NOK 99.9 million), and the total group revenues includes a milestone payment related to the development of Cevira by Asieris of NOK 26.9 million. The EBIT was NOK 16.8 million (NOK -4.6 million), and the cash balance at the end of the period was NOK 258.9 million. Photocure paid off the balance of its term debt during the second quarter of 2023.

At the end of the second quarter of 2023, the total installed base of rigid blue light cystoscopes (BLC) in the U.S. was 327, an increase of 21% or 56 towers since the same period in 2022. These figures do not include the 69 flexible cystoscopy towers that were installed in the U.S. as of December 31, 2022. In early 2023, Karl Storz announced that it will no longer sell flexible BLC equipment for use in the surveillance setting and will cease servicing existing units when the availability of replacement parts has been exhausted, anticipated in late 2023. Despite Karl Storz’ decision to discontinue its flexible BLC equipment, surveillance of bladder cancer patients with flexible BLC remains a strategic priority for Photocure, and the Company plans to pursue initiatives to restore this specialized equipment in the U.S. and in international markets.

"Offsetting the loss in flexible BLC equipment, the installed base of rigid blue light capital equipment expanded once again, with 13 new Saphira towers installed in Q2. Eight new placements and five upgrades were installed prior to Karl Storz’s recent promotional discount program which went into effect in July and shifted the timing of some tower installations into the third quarter. In July alone, 40 quotes were issued for new Saphira systems, and so far in Q3, 12 purchase orders have been received. We believe that this momentum will result in a strong second half of the year for new tower placements," Schneider adds.

Photocure reiterates its guidance for 2023 and continues to expect new Saphira blue light tower installations in the range of 65 to 75, consolidated product revenue growth above 20%, and positive EBITDA excluding business development spending.

"I remain confident in Photocure’s future and our ability to bring Hexvix/Cysview to more patients and establish Blue Light Cystoscopy as standard of care. The new technology cycle of high-definition blue light equipment from multiple manufacturers is expected to significantly increase the use of Hexvix/Cysview. We continue to await information from Karl Storz and the FDA regarding the Citizen’s Petition to re-classify BLC as a Class 2 device, which we believe will enable additional equipment manufacturers to enter the U.S. market and build critical mass behind BLC. Given our prior success in creating and accelerating the use of BLC in the large untapped bladder cancer surveillance market, we are pursuing a strategy to reintroduce the technology in the near to intermediate future. For the remainder of the year, we will focus on driving sales in the rigid cystoscopy setting, and we look forward to several milestone events including the anticipated Phase 3 results for Hexvix in China and Cevira with our partner Asieris," Schneider concludes.

Photocure also announced today that Jan H. Egberts, M.D. has decided to step down from his position as Chairperson of the Company’s Board of Directors due to increased time commitments to his personal companies. Dr. Egberts will leave the Board in September 2023, and the Nomination Committee has initiated a search for a new Chairperson.

Robert Blatt, Chair of Photocure’s Nomination Committee, said, "I would like to express my gratitude to Jan, who has made important contributions to Photocure during his more than six years as Chairperson of the Board. His dedication and medical experience will be missed".

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the second quarter and first half 2023 financial report on page 23.

The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20230809_1

The presentation is scheduled to conclude at 14:45 CEST.

On August 8, 2023 Bayer reported its Half-Year Financial Report 2023 (Presentation, Bayer, AUG 8, 2023, View Source [SID1234634657]).

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