On November 8, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the third quarter ended September 30, 2022 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, NOV 8, 2022, View Source [SID1234623436]).

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Chief Executive Officer John Valliant, Ph.D. commented, "During the third quarter of 2022, we continued to advance our pipeline of targeted alpha therapy programs to treat multiple cancer types not currently addressed by available radiopharmaceutical therapies. Leveraging our platform and radiopharmaceutical expertise, we now have three Phase 1 clinical programs. Our lead program, FPI-1434, remains on track to report Phase 1 data in the first half of 2023. Following the initiation of dosing in our Phase 1/2 study of FPI-1966, we have opened multiple study sites and are actively recruiting patients with FGFR3-expressing solid tumors. We also continue to make progress in our newest clinical program, FPI-2059, which, based on clinical imaging and preclinical data, we believe has the potential to precisely target and kill tumor cells in colorectal, pancreatic and neuroendocrine prostate cancers. Furthermore, we’ve demonstrated Fusion’s proficiency in targeted alpha therapy (TAT) development with the first candidate under our collaboration agreement with AstraZeneca moving promptly through investigational new drug (IND) enabling studies. Our rich pipeline of cancer therapies is underpinned by an experienced internal radiopharmaceutical R&D team, and early investments in actinium supply, bolstered by our manufacturing capabilities. We look forward to providing meaningful updates on our diverse and growing pipeline of TATs in the months ahead."

Portfolio Update

FPI-1434

In the Phase 1 study, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company anticipates reporting Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023. Fusion continues to anticipate the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.

FPI-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3 is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Patient enrollment and dosing is ongoing. The company plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort following experience with patient screening in order to better predict the cadence of patient enrollment.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors, including neuroendocrine differentiated (NED) prostate, colorectal, and pancreatic cancers. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, which is overexpressed in several solid tumors. FPI-2059 is based upon Ipsen’s IPN-1087 (previously studied in a Phase 1 clinical trial as a beta-emitting radiopharmaceutical), which Fusion acquired in 2021, and converted to an alpha-emitting radiopharmaceutical using actinium-225.

The U.S. Food and Drug Administration (FDA) cleared Fusion’s IND application for FPI-2059 in June 2022 and study initiation activities are ongoing in a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing NTSR1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Fusion plans to provide guidance on timelines for the FPI-2059 program following site activations and initial experience with patient screening and patient enrollment.

Recent Updates

In August, Fusion announced first patient dosed in Phase 1/2 study of FPI-1966 in patients with advanced solid tumors expressing FGFR3. The Phase 1/2 multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-1966 in patients with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumors. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake and pharmacokinetics. As part of the trial, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who upon imaging meet predefined tumor uptake will go on to receive FPI-1966. The Phase 2 portion of the study will consist of two tumor-specific cohorts and one basket cohort.
In September, Fusion drew down $25 million under the previously announced debt agreement with Oxford Finance LLC. To date, the Company has drawn down a total of $35 million. The loan agreement, as amended, provides for up to four tranches totaling $75 million. With the additional $25 million in debt funding, Fusion now expects its cash, cash equivalents and investments will be sufficient to fund operations into the third quarter of 2024.
On November 7, Fusion announced the appointment of Dmitri Bobilev, M.D., as chief medical officer. Dr. Bobilev joins Fusion from Checkmate Pharma, where he was vice president, head of clinical development until the company’s acquisition by Regeneron earlier in 2022. At Checkmate, he was responsible for clinical development and registration strategy for vidutolimod.
Third Quarter 2022 Financial Results

Cash and Investments: As of September 30, 2022, Fusion held cash, cash equivalents and investments of $205.5 million, compared to cash, cash equivalents and investments of $220.8 million as of December 31, 2021. Fusion expects its existing cash, cash equivalents and investments as of September 30, 2022, will be sufficient to fund operations into the third quarter of 2024.
Collaboration Revenue: For the third quarter of 2022, Fusion recorded $0.2 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the third quarter of 2022 were $16.6 million, compared to $12.7 million for the same period in 2021. The increase was primarily due to discrete items that occurred during the third quarter of 2022, including a common share issuance and cash payment pursuant to our asset purchase agreement to acquire vofatamab from Rainier Therapeutics. Additionally, there was an increase in direct costs related to FPI-2059, specifically related to the initiation of the Phase 1 clinical trial as well as preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the third quarter of 2022 were $7.4 million, compared to $7.2 million for the same period in 2021. The increase was primarily due to an increase in personnel-related costs, partially offset by a decrease in corporate costs and professional fees.
Net Loss: For the third quarter of 2022, Fusion reported a net loss of $24.0 million, or $0.55 per share, compared with a net loss of $19.4 million, or $0.45 per share, for the same period in 2021.

On November 8, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an oncology company, today provided a corporate update and reported financial results for the third quarter of 2022 (Press release, Corbus Pharmaceuticals, NOV 8, 2022, View Source [SID1234623435]).

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Key Corporate and Program Updates:

Anti-integrin monoclonal antibody (mAb) programs targeting the inhibition of TGFβ are progressing on schedule
CRB-601, an anti-αvβ8 mAb, is being developed as a potential treatment for solid tumors.
Across models explored to-date, CRB-601 demonstrates an enhancement of anti-tumor activity when combined with anti PD-1 therapy compared to either single agent alone. Latest data to be presented this Thursday at SITC (Free SITC Whitepaper) 2022.
Data supports the hypothesis that blockade of latent TGFb production by CRB-601 can lead to changes in immune cell infiltration in the tumor microenvironment, potentially enhancing the benefit of PD-1 blockade.
IND-enabling activities for CRB-601 are ongoing and the program is on schedule for an IND submission in mid-2023.
Recent clinical updates from investigational therapies also targeting latent TGFb reinforce the promise of this novel approach in oncology.
CB1 inverse agonist program for obesity / metabolism
CRB-913, a novel CB1 inverse agonist with highly differentiated PK from other members of its class, has demonstrated weight loss and improvement in multiple metabolic parameters, as monotherapy and in combination within liraglutide, semaglutide and tirzepatide in animal models of diet-induced obesity.
New data was shared in an oral presentation at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2022. View the presentation here.
Data is being prepared for publication.
Corbus is actively exploring partnerships to advance CRB-913 into clinical studies.
A detailed update on the Corbus pipeline can be found in the most recent Corporate Presentation available on the Company’s website here.
"We continue to progress CRB-601 toward the clinic on schedule and on budget. Our latest pre-clinical data, to be presented this Thursday at SITC (Free SITC Whitepaper) 2022, further reinforces our belief that this could be a highly impactful drug in oncology therapy, and we look forward to the latest clinical updates from this field," commented Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "We continue to be actively engaged in business development activities with the goal of expanding our pipeline while also bringing in non-dilutive funding by monetizing our portfolio of endocannabinoid assets through new partnerships."

Financial Results for Third Quarter Ended September 30, 2022:

The Company reported a net loss of approximately $8.8 million, or a net loss per diluted share of $0.07, for the three months ended September 30, 2022, compared to a net loss of approximately $2.2 million, or a net loss per diluted share of $0.02, for the same period in 2021. The prior year third quarter included a $12.3 million refundable tax credit received from a foreign tax authority.

Operating expenses for Q3 2022 decreased by $5.8 million to approximately $8.2 million for the three months ended September 30, 2022, compared to $14.0 million in the comparable period in the prior year. The decrease was primarily attributable to decreased clinical trial and drug manufacturing costs, and an overall reduction in compensation expense.

In October of 2022, the Company amended its debt agreement with K2 HealthVentures LLC to defer commencement of principal payments by one year until September 2023 which improved the Company’s liquidity and cash runway. As of September 30, 2022, the Company has $67 million of cash and investments on hand which is expected to fund operations through the second quarter of 2024, based on the current planned expenditures.

On November 8, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter of 2022 and recent corporate updates (Press release, Mirati, NOV 8, 2022, https://www.prnewswire.com/news-releases/mirati-therapeutics-reports-third-quarter-2022-financial-results-and-recent-corporate-updates-301672203.html [SID1234623434]).

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"In the third quarter, we made notable advancements within our targeted oncology portfolio, while executing on strategic priorities to position Mirati for continued success," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "The fourth quarter includes several exciting milestones for Mirati, including our anticipated Prescription Drug User Fee Act (PDUFA) date for adagrasib, which we are prepared to launch upon approval, the release of topline interim data for our phase 3 SAPPHIRE study, and an expected update on our KRYSTAL-7 first-line non-small cell lung cancer (NSCLC) study in combination with pembrolizumab. We continue to advance our pipeline and capabilities, further enabling Mirati to transform the lives of people living with cancer."

"Additionally, as we shared earlier today, we are thrilled to celebrate the successful career of Dr. Chuck Baum, Mirati’s founder, president and head of research and development, who will retire in the second quarter of 2023. Chuck helped build Mirati into a leading targeted oncology company based on a dedication to patients and we are grateful for his leadership," continued Meek. "We are also excited to welcome Dr. Alan Sandler, our new chief medical officer (CMO) who brings a tremendous amount of experience and expertise to the team."

Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)

PDUFA action date of December 14, 2022 as a treatment for patients with NSCLC harboring a KRASG12C mutation who have received at least one prior systemic therapy

Presented late-breaking data from the Phase 1/2 cohort of the KRYSTAL-1 study evaluating adagrasib with or without cetuximab in patients with advanced CRC harboring a KRASG12C mutation at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. (View Release)

Announced the Company entered into a clinical collaboration with Aadi Bioscience to evaluate the combination of adagrasib and nab-sirolimus, an mTOR inhibitor complexed with human albumin, in KRASG12C-mutant NSCLC and other solid tumors. (View Release)

Announced the Company entered into a clinical trial collaboration and supply agreement with Incyte to evaluate the combination of adagrasib and INCB099280, an oral PD1 inhibitor, in patients with KRASG12C-mutant solid tumors. (View Release)

Shared plans to present preliminary safety and efficacy results from the KRYSTAL-7 study evaluating adagrasib in combination with pembrolizumab in patients with advanced NSCLC harboring a KRASG12C mutation at a medical meeting in December.
Sitravatinib (Potent TAM receptor inhibitor)

The Company expects to provide topline results from the interim analysis of the global, registration-enabling Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC in the fourth quarter of 2022.
MRTX1719 (MTA cooperative PRMT5 inhibitor)

In August 2022, the Food and Drug Administration (FDA) granted Fast Track designation to MRTX1719, an MTA cooperative PRMT5 inhibitor, in MTAP-deleted cancers. The Company is enrolling in an ongoing Phase 1/2 clinical trial in patients whose tumors harbor an MTAP deletion. The Company expects to share the initial clinical data for this program in 2023.
MRTX0902 (Potent SOS1 inhibitor)

In August 2022, the FDA cleared the Investigational New Drug (IND) application for MRTX0902, a selective SOS1 inhibitor. The Company recently initiated a Phase 1 clinical study.
MRTX1133 (Potent and selective KRASG12D inhibitor)

The Company plans to file an IND application for this program by year-end 2022.
Recent Corporate Updates
Announced the appointment of Alan Sandler, M.D., as CMO and the planned retirement of Charles Baum, M.D., Ph.D., president, founder and head of research and development in the second quarter of 2023. Dr. Baum remains on the Mirati board of directors. (View Release)
Third Quarter 2022 Financial Results
Cash, cash equivalents, and short-term investments of approximately $1.2 billion as of September 30, 2022.

Sold approximately 1.9 million shares of common stock under its At the Market Facility, which generated net proceeds of $155.0 million.

Revenue for the third quarter of 2022 was $5.4 million, which was driven by the recognition of a $5 million milestone payment from Zai Lab that was contingent on starting a pivotal clinical study for adagrasib in a second indication in the Zai Lab designated territories. This compares to revenue of $71.8 million in third quarter of 2021, where we recognized $66.6 million of revenue associated with the transfer of the license and know-how of adagrasib as part of our agreement with Zai Lab, and a $5 million milestone payment from BeiGene, associated with the start of the first pivotal sitravatinib clinical study in the BeiGene designated territories.

Research and development expenses for the third quarter of 2022 were $131.1 million, compared to $116.1 million for the same period in 2021. Research and development expenses for the nine months ended September 30, 2022 were $390.4 million, compared to $354.8 million for the same periods in 2021. The increases were primarily related to an increase in headcount-related costs, including share-based compensation and salaries, due to the growth of our portfolio, offset by a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program. The Company recognized research and development-related share-based compensation expenses of $28.3 million during the third quarter of 2022, compared to $15.7 million for the same period in 2021, and $77.3 million during the nine months ended September 30, 2022, compared to $46.7 million for the same period in 2021.

General and administrative expenses for the third quarter of 2022 were $60.8 million, compared to $35.2 million for the same period in 2021. General and administrative expenses for the nine months ended September 30, 2022 were $169.0 million, compared to $93.1 million for the same period in 2021. The increases were primarily due to an increase in commercial readiness costs, including increases in headcount-related costs, as we prepare for a potential product launch. The Company recognized general and administrative-related share-based compensation expenses of $14.7 million in the third quarter of 2022, compared to $11.2 million for the same period in 2021, and $47.2 million during the nine months ended September 30, 2022, compared to $32.9 million for the same period in 2021.

Net loss for the third quarter of 2022 was $173.6 million, or $3.09 per share basic and diluted, compared to a net loss of $80.1 million, or $1.55 per share basic and diluted for the same period in 2021. Net loss for the nine months ended September 30, 2022 was $538.4 million, or $9.66 per share basic and diluted, compared to a net loss of $382.2 million, or $7.45 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on November 8, 2022 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the third quarter of 2022 and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 866-409-1555, confirmation code: 8269398.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.

On November 8, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by harnessing the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the third quarter ended September 30, 2022 (Press release, Purple Biotech, NOV 8, 2022, View Source [SID1234623433]).

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"As we prepare for 2023, we are advancing the clinical development of our two lead investigational assets, CM24 and NT219, and exploring additional options to build the Company’s pipeline of first-in-class assets for treatment of cancers with high unmet clinical need," said Gil Efron, Chief Executive Officer of Purple Biotech. "Purple is well positioned with a cash runway to meet clinical milestones through 2024. In addition to our financial results, we are proud to provide our corporate update focused on enhancing our clinical program."

Corporate Updates

CM24 Study Design Update

The Company has amended the Phase 2 clinical trial evaluating the use of its monoclonal antibody CM24, a new immune checkpoint inhibitor, in combination with the PD-1 inhibitor Opdivo (nivolumab) plus chemotherapy for patients with 2L metastatic pancreatic cancer (PDAC). The clinical trial design has been amended to randomize the study comparing CM24+nivolumab+standard-of-care (SoC) chemotherapy against SoC chemotherapy alone. The study is ongoing, and patients are already being treated in a run-in portion of the study, which includes up to 18 patients followed by approximately 60 patients in the randomized part of the study. Interim analysis expected in the second half of 2023 and a topline report on the overall study at the end of 2024.

NT219 Study Progress

In the monotherapy arm of the Phase 1/2 clinical trial for NT219, participants are being treated at the 50mg/kg dose level, which is the last dose to be evaluated for monotherapy. In the combination arm of NT219+cetuximab of the same study, participants are receiving a 24 mg/kg dose of NT219, the penultimate dose being evaluated in this arm. As this trial progresses, we expect to report the recommended Phase 2 dose (RP2D) for monotherapy in the first quarter of 2023, and RP2D for the combination with cetuximab in the second quarter of 2023.

CFO Appointment

The Purple Biotech team welcomed Lior Fhima, CPA, MBA, as Chief Financial Officer of the Company in November. Mr. Fhima brings deep expertise in financial management in the pharmaceutical industry and strong managerial capabilities. We look forward to his contributions in growing Purple Biotech as we advance our first-in-class oncology assets.

"We anticipate that 2023 will be an important year for Purple Biotech, as we plan to report data from our ongoing clinical programs for our two investigational oncology assets. Additionally, we will continue to pursue potential collaborations and commercial opportunities for CM24 and NT219, as well as acquisitions or collaborations related to other first-in-class oncology therapeutics that may be able to address large unmet clinical needs for patients living with devastating cancers," added Mr. Efron.

Financial Results for the three Months Ended September 30, 2022

Research and Development Expenses were $3.5 million, an increase of $1.9 million, or 118.8%, compared to $1.6 million in the same period of 2021. The increase was mainly due to an increase of $0.5 million in CMC expenses in support of our clinical studies, an increase of $0.8 million for our clinical trials expenses and $0.3 million in payroll and share based payment expenses in support our growing development activities.

Selling, General and Administrative Expenses were $1.6 million, an increase of $0.2 million, or 14.3%, compared to $1.4 million in the same period of 2021. The increase was mainly due to increase of $0.2 million in payroll expenses.

Operating Loss was $5.1 million, an increase of $2.1 million, or 66.67%, compared to $3.0 million in the same period of 2021. The increase was mainly due to the increase in research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $4.4 million, an increase of $1.7 million, compared to $2.7 million in the same period of 2021.

Net Loss for the three months ended September 30, 2022 was $4.8 million, or $0.27 per basic and diluted ADS, compared to a net loss of $3.1 million, or $0.17 per basic and diluted ADS, in the three months ended September 30, 2021. Adjusted net loss for the three months ended September 30, 2022 was $4.1 million, an increase from $2.6 million in the three months ended September 30, 2021.

Financial Results for the Nine Months Ended September 30, 2022

Research and Development Expenses were $11.5 million, an increase of $2.9 million, or 33.7%, compared to $8.6 million in the same period of 2021. The increase was mainly due to an increase of $1.06 million in CMC expenses in support of our clinical studies, an increase of $0.9 million for our clinical trials expenses and $0.7 million in payroll and share based payment expenses in support our growing development activities.

Sales, General and Administrative Expenses were $4.5 million, compared to $4.6 million in the same period of 2021, a decrease of $0.1 million.

Operating Loss from continuing operations was $16 million, an increase of $2.8 million, or 21.2%, compared to $13.2 million in the same period of 2021. The increase was mainly due to the increase in research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $14.4 million, an increase of $3.0 million, compared to $11.4 million in the same period of 2021, mainly due to an increase in R&D expenses.

Net Loss for the first nine months ended September 30, 2022 was $15.7 million, or $0.87 per basic and diluted ADS, compared to a net loss of $13 million, or $0.75 per basic and diluted ADS, in the same period of 2021. The increase in net loss was mainly due to an increase of $2.8 million in operating expenses. Adjusted net loss for nine months ended September 30, 2022 was $14.1 million, an increase from $11.3 million in the nine months ended September 30, 2021.

As of September 30, 2022, the Company had a total amount of $35.7 million in cash, cash equivalent and short and long term deposits.

During the nine months ended September 30, 2022, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 453 thousand ADSs, at an average price of $2.92 per ADS. Net proceeds to the Company, were approximately $1.3 million, net of issuance expenses.

On November 8, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results and business updates for the third quarter ending September 30, 2022 (Press release, Adaptimmune, NOV 8, 2022, View Source [SID1234623432]). For the quarter ending September 30, 2022, Revenue was $7.0 million, Total Operating Expenses (Research and Development and General and Administrative) were $50 million, and Net Loss was $41.4 million. The Company provided a clinical update earlier today which is available here: https://bit.ly/3TYsqcZ.

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"We are seeing the positive impact that our therapies can have on people with cancer with afami-cel and unprecedented data with our next-gen T-cell therapy in the SURPASS trial," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "We now have full control of our T-cell program directed to PRAME, an equally important T-cell target in solid tumors. It is evident that we need to focus on developing these two programs which have immense therapeutic potential. We have taken decisive action to deprioritize non-core programs and made the difficult decision to restructure to extend our cash runway into early 2025."

Afami-cel update: Adaptimmune’s first-generation cell therapy targeting MAGE-A4

BLA strategy for Adaptimmune’s first potential commercial product

●Adaptimmune had a productive pre-BLA meeting with the FDA on October 13th (final minutes of the meeting remain pending)
●The FDA agreed that Adaptimmune’s clinical package supports submission of the BLA for the proposed indication for the treatment of synovial sarcoma
●FDA and Adaptimmune reached agreement on the overall content of the BLA submission
●FDA agreed that the application is eligible for a rolling review submission strategy
●Adaptimmune plans to initiate the rolling submission in Q4 of this year with target for completion in mid-year 2023
●With its RMAT status for synovial sarcoma, the BLA application will be eligible for priority review by the FDA

Positive and confirmatory data from Cohort 1 of the registrational SPEARHEAD-1 trial to be presented at the Connective Tissue Oncology Society (CTOS) annual meeting on November 18th

●Data continue to indicate that afami-cel is efficacious in heavily pre-treated patients with synovial sarcoma with an overall response rate of 38.6% by independent review
●Responses are durable with a median duration of 50.3 weeks
●Safety profile includes cytokine release syndrome and reversible hematologic toxicities, in line with previous findings indicating an acceptable benefit to risk profile
●Translational data indicate that afami-cel drives tumor infiltration of activated and proliferative cytotoxic ("killer") T-cells, shifting the balance in the tumor from immuno-suppressive to pro-immune and aiding in clinical response
●Dr. Brian Van Tine, Professor of Medicine at the Washington University School of Medicine, will present these data at the CTOS annual meeting on November 18th

Status of the ongoing SPEARHEAD-1 pivotal trial and other afami-cel news

●As previously announced, Cohort 1 of the SPEARHEAD-1 trial has completed treatment and met the primary endpoint for efficacy
●Data from Cohort 1 will be used to support Adaptimmune’s BLA submission
●Cohort 2 of the SPEARHEAD-1 trial is ongoing with treatment 60% complete and an overall response rate nearly identical to Cohort 1
●On September 28th, Adaptimmune received the Vision of Hope Award from the Sarcoma Foundation of America at their annual Stand Up to Sarcoma Gala

Pipeline update

●Adaptimmune recently announced that it will gain full control of the late-stage preclinical optimized PRAME TCR as well as the NY-ESO cell therapy program
●The Company aims for the PRAME program to be IND-ready in 2023
GSK will deliver data from the ongoing Phase 2 / potential registrational trial with letetresgene autoleucel ("lete-cel", targeting NY-ESO) in sarcoma indications, with final readouts expected in late 2023
●Adaptimmune will continue to focus on its MAGE-A4 franchise while determining the optimal development path for complementary PRAME and NY-ESO assets
●The Company has taken the decision to change the cell line being used to develop its MAGE-A4 allogeneic cell therapy. This change was due to the presence of a chromosomal abnormality in the original cell line and will delay the timing of the first allogeneic IND submission to 2025. This cell line is not used in any of the Company’s partnered programs.

Corporate news

●Adaptimmune will prioritize the afami-cel BLA, the SURPASS family of trials in ovarian, urothelial, and head & neck cancers, and advancing PRAME to the clinic
●Work on the allogeneic platform (both wholly owned and in collaboration with partners) will also continue
●The Company will stop the SURPASS-2 trial in GE cancers and stop work on the TIL IL-7 program
●Adaptimmune will cease further investment into additional non-core activities including work on preclinical pipeline projects including the HiT program, additional targets, and broader HLA coverage
●The Company will delay investment in the commercialization of afami-cel based on BLA timelines and will provide further guidance on a likely commercial launch date after the BLA has been submitted
2

●To extend its cash runway into early 2025, in addition to de-prioritizing non-core programs, the Company will also undertake a restructuring with a headcount reduction of approximately 25% to 30% to be completed in Q1 2023

Financial Results for the three and nine months ended September 30, 2022

●Cash / liquidity position: As of September 30, 2022, Adaptimmune had cash and cash equivalents of $79.0 million and Total Liquidity1 of $199.7 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.
●Revenue: Revenue for the three and nine months ended September 30, 2022 was $7.0 million and $16.1 million, respectively, compared to $1.2 million and $4.7 million for the same periods in 2021. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements, in particular due to development activities under the Genentech Strategic Collaboration and License Agreement, which become effective in October 2021.
●Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2022 were $33.2 million and $104.7 million, respectively, compared to $28.2 million and $81.6 million for the same periods in 2021. R&D expenses increased due to an increase in the average number of employees engaged in research and development, increases in subcontracted expenditures and increases in in-process research and development costs. These were offset by an increase in reimbursements receivable for research and development tax and expenditure credits.
●General and administrative (G&A) expenses: G&A expenses for the three and nine months ended September 30, 2022 were $16.8 million and $48.2 million, respectively, compared to $15.2 million and $42.5 million for the same periods in 2021 due to increases in employee-related costs and other corporate costs.
●Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and nine months ended September 30, 2022 was $41.4 million and $136.2 million, respectively ($(0.04) and $(0.14) per ordinary share), compared to $42.4 million and $119.2 million, respectively ($(0.05) and $(0.13) per ordinary share), for the same periods in 2021.

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, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2022, to be filed with the Securities and Exchange Commission following this earnings release. The Company is deprioritizing non-core programs and is also undertaking a restructuring of the Company including a headcount reduction of approximately 25% to 30% with the aim of extending its cash runway into early 2025.

Conference Call Information

The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. GMT) today, November 8, 2022. 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).