On November 10, 2022 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on development of targeted therapies for a number of different cancers, reported financial results for the third quarter ended September 30, 2022 and other recent business developments (Press release, Celcuity, NOV 10, 2022, View Source [SID1234623705]).

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"We are encouraged by the significant interest from clinical sites across the world to participate in our Phase 3 VIKTORIA-1 study for gedatolisib," said Brian Sullivan, CEO and Co-Founder of Celcuity. "We completed selection of sites for the study in the third quarter, and we are now focused on activating these selected sites. We are pleased that updated data from our Phase 1b study in advanced breast cancer will be reviewed during a Spotlight Poster Discussion Session at the 2022 San Antonio Breast Cancer Symposium in December 2022. Finally, I am excited that Dr. Polly Murphy has joined our Board of Directors. Her business development and commercial experience will provide a very helpful perspective to our board."

Third Quarter 2022 Business Highlights and Other Recent Developments

●In July, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Celcuity’s lead drug product candidate gedatolisib, an investigational pan-PI3K/mTOR inhibitor, for the treatment of HR+/HER2- locally advanced, inoperable or metastatic breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with a nonsteroidal aromatase inhibitor. This designation allows for more intensive guidance from the FDA and a potentially accelerated review time if relevant criteria are met. Gedatolisib previously received Fast Track designation from the FDA in January 2022.

●In August, Celcuity amended its existing debt facility with an affiliate of Innovatus Capital Partners, LLC to provide Celcuity with up to $75 million in term loans, a $50 million increase from the original debt facility. Among other changes, the amended facility provides Celcuity with the ability to draw on a $20 million tranche following the closing of the $100 million private placement announced in May 2022. The closing of the private placement is expected to occur shortly after the first patient in VIKTORIA-1 receives their first dose at a clinical site located in the United States, provided that such dose occurs on or before December 31, 2022.

●In September, Celcuity appointed Polly Murphy, D.V.M., Ph.D., to its Board of Directors. Dr. Murphy has over 20 years of business development and commercial strategy experience at leading global pharmaceutical companies, including 12 years in leadership positions with increasing responsibility at Pfizer.

●In the third quarter, Celcuity completed selection of 200 clinical trial sites for the Phase 3 VIKTORIA-1 clinical trial. The first clinical trial site was also activated. VIKTORIA-1 is evaluating the safety and efficacy of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease progressed while receiving prior CDK4/6 therapy.

●An abstract with updates to results from Celcuity’s Phase 1b study was accepted for a Spotlight Poster Discussion presentation at the 2022 San Antonio Breast Cancer Symposium. Ongoing enrollment in the FACT-1 and FACT-2 trials for CELsignia selected patients who have early-stage HR+/HER2- breast cancer with interim results expected in mid-2023.

Third Quarter 2022 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2022, compared to the third quarter ended September 30, 2021.

The following discussion should be read in conjunction with Celcuity’s unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2022. Total operating expenses were $10.6 million for the third quarter of 2022, compared to $5.6 million for the third quarter of 2021.

Research and development (R&D) expenses were $9.6 million for the third quarter of 2022, compared to $5.0 million for the third quarter of 2021. Of the approximately $4.7 million increase in R&D expenses in the third quarter of 2022, compared to the third quarter of 2021, $1.2 million was related to employee related expenses, including consulting fees. The remaining $3.5 million increase in R&D expenses is primarily related to activities supporting the initiation of the VIKTORIA-1 pivotal trial and costs for existing clinical trials.

General and administrative (G&A) expenses were $1.0 million for the third quarter of 2022, compared to $0.6 million for the third quarter of 2021. The approximately $0.4 million increase in G&A expenses during the third quarter of 2022, compared to the third quarter of 2021, arose primarily from approximately $0.3 million in non-cash stock-based compensation.

Net loss for the third quarter of 2022 was $10.9 million, or $0.75 loss per share, compared to a net loss of $6.0 million, or $0.41 loss per share, for the third quarter of 2021. For purposes of calculating net loss per share, the reported net loss was increased by an additional $.02 loss per share, related to the approximately $0.3 million deemed dividend resulting from a warrant modification. Non-GAAP adjusted net loss for the third quarter of 2022 was $9.5 million, or $0.63 loss per share, compared to non-GAAP adjusted net loss of $5.1 million, or $0.35 loss per share, for the third quarter of 2021. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock and non-cash interest. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2022 was $9.3 million, compared to $4.0 million for the third quarter of 2021. At September 30, 2022, Celcuity had cash and cash equivalents of $57.5 million.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter 2022 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-888-999-6281 and international callers should dial 1-848-280-6550 and reference Celcuity. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=f9185283fd. A replay of the webcast will be available on the Celcuity website following the live event.

On November 10, 2022 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling and advanced medicinal chemistry technology, reported financial results for the quarter ended September 30, 2022 and provided recent business highlights (Press release, HTG Molecular Diagnostics, NOV 10, 2022, View Source [SID1234623703]).

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"We are delighted with the continued and rapid progress we have made this past quarter in our effort to reposition HTG as a platform-based drug discovery company. Our strategy is to build best-in-class drug candidates for known targets with high unmet medical needs. We have achieved our third quarter 2022 milestones and remain on track to begin partnering conversations for our first target and indication by the end of 2022," said John Lubniewski, Chief Executive Officer and Director at HTG.

"Our profiling business has not returned to pre-pandemic product and product-related services revenue levels. However, we have seen a slow but steady increase in first time orders and repeat orders from new pharma customers in 2022. While these trends cannot offset the significant decline in large trial cohorts that has resulted from the slowdown in clinical trials in 2020 and 2021, we see them as leading indicators that our pharma market is slowly coming back. In response to this reality, we have taken actions to reduce operating expenses and minimize the impact of these trends on our operating loss and cash runway, including a reduction in force late in the second quarter of 2022," Mr. Lubniewski continued. "We will continue to make appropriate operating adjustments to opportunistically grow our profiling business and also support our quickly evolving drug discovery capabilities."

Third Quarter Business Highlights:

Transcriptome-Informed Drug Discovery:

The company’s drug discovery unit, HTG Therapeutics, is leveraging its HTG EdgeSeq technology in conjunction with its machine learning-based chemical library design platform with the goal of ultimately yielding de-risked drug candidate molecules with a greater potential for development success. Through the completion of its planned milestones for the third quarter of 2022, HTG Therapeutics continued to drive the machine-learning component of its platform with the refinement of key proprietary algorithms and generation of internal data to support training sets. In addition, HTG Therapeutics made capital investments to establish internal cell culture capabilities. Such capabilities provide HTG Therapeutics the ability to conduct investigative cell-based studies on site, supporting the development and evolution of its transcriptome-informed drug discovery platform more efficiently and with greater flexibility.

Dr. Stephen Barat, Senior Vice President of Therapeutics at HTG said, "We continue to make rapid progress toward what we believe will be a transformational drug discovery platform, which we expect to assist in the identification of more well-informed drug candidates for known targets with high unmet medical needs. Our medicinal chemistry effort has produced a series of chemical libraries for our first target, and our most advanced library for this target has entered preclinical characterization, with a series of data generated including early efficacy in two different disease states. We will continue to characterize the most promising candidate molecules for measures of efficacy, safety and pharmaceutical considerations, and expect to have our most promising candidate molecule available to begin partnering conversations by year end, with additional follow-on indications and a second target, currently in the early stages of development, available for additional licensing or partnering opportunities in 2023."

Transcriptome-wide Profiling:

HTG’s profiling unit is leveraging its HTG EdgeSeq technology to deliver what the company believes is an exceptional technology for high plex gene expression profiling. As of September 30, 2022, the company had 77 active customers, 57 active pharma programs and 50 instruments actively producing revenue in its installed base. These numbers included orders from 21 new customers and programs associated with 15 new pharma sponsored clinical trials for the nine-month period ended September 30, 2022.

"While we continually strive to increase our period-over-period revenue, we are encouraged by the number of new customers and orders that we received during the quarter and what we see in our fourth quarter pipeline. We believe that both of these trends are indicators that the market is beginning to recover from the pandemic-induced disruptions to oncology trials," said Byron Lawson, Chief Commercial Officer at HTG.

Third Quarter 2022 Financial Highlights:

Revenue for the quarter ended September 30, 2022 was $1.3 million, compared with $2.5 million for the same period in 2021, and was comprised entirely of product and product-related services revenue. Sales of the HTP to new and existing customers as consumables and sample processing services represented 41% of revenue for the quarter ended September 30, 2022.

Net loss from operations for the quarter ended September 30, 2022 was $4.3 million, compared with $4.2 million for the same period in 2021. Net loss per share was $(0.41) for the quarter ended September 30, 2022 compared with $(0.60) for the third quarter of 2021.

Cash, cash equivalents and short-term available-for-sale securities totaled $6.5 million as of September 30, 2022, with current liabilities of approximately $6.8 million and non-current liabilities of $5.6 million.

On November 10, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it will publish its Q3 2022 interim report on Wednesday November 16, 2022, before 09:00 CET (Press release, Scandion Oncology, NOV 10, 2022, View Source;2022,c3664593 [SID1234623700]).

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Scandion’s Executive Management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update. At the end of the presentation there will be a Q&A session.

On November 10, 2022 Seagen Inc. (Nasdaq: SGEN) reported that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (Press release, Seagen, NOV 10, 2022, View Source [SID1234623699]). The approval is based on data from a phase 3 study (AHOD1331) conducted by the Children’s Oncology Group (COG) and funded by the National Cancer Institute that showed patients receiving ADCETRIS in combination with standard of care dose-intensive chemotherapy AVE-PC (Adriamycin [doxorubicin], vincristine, etoposide, prednisone and cyclophosphamide) had superior event-free survival (EFS) compared to patients who received standard of care chemotherapy ABVE-PC (Adriamycin [doxorubicin], bleomycin, vincristine, etoposide, prednisone and cyclophosphamide). Patients had a 59% reduction in the risk of disease progression or relapse, second cancer or death (Hazard ratio 0.41 [95% Confidence Interval: 0.25, 0.67]; p=0.0002).

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Please see Important Safety Information including BOXED WARNING for PML at the end of this news release.

"ADCETRIS is a groundbreaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical HL," said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. "We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that supported this approval."

"We are excited about the approval of ADCETRIS for children and adolescents with high risk classical Hodgkin lymphoma because this medicine, which has become part of standard of care for adults with previously untreated advanced stage Hodgkin lymphoma, will now be accessible to young patients as well," said Sharon M. Castellino, M.D., M.Sc., Professor, Department of Pediatrics, Emory University School of Medicine, AHOD1331 Study Chair and COG Hodgkin Lymphoma Disease Committee Chair.

Hodgkin lymphoma is blood cancer that starts when lymphocytes, a type of white blood cell, grow out of control. It represents about 6% of all childhood cancers and is the most common cancer diagnosed in adolescents ages 15 to 19 years.1,2 About one-third of all Hodgkin lymphoma patients are classified as high risk, typically stageIIB, IIIB, and IVA or IVB.3,4 People with cHL have abnormal white blood cells that usually have a special protein on their surfaces called CD30, a key marker of cHL.

About AHOD1331

AHOD1331 is a National Cancer Institute (NCI)-sponsored study conducted by the Children’s Oncology Group (COG), and is the largest multicenter, randomized, open-label phase 3 immunotherapy study ever conducted with newly diagnosed high risk Hodgkin lymphoma (HL) pediatric patients. The study enrolled 587 patients from 2 to 21 years of age across 151 institutions who had previously untreated HL stages IIB + bulk, IIIB, IVA and IVB. Patients were randomized to five cycles of either standard of care dose-intensive chemotherapy (Adriamycin [doxorubicin], bleomycin. vincristine, etoposide, prednisone and cyclophosphamide [ABVE-PC]) or brentuximab vedotin plus AVE-PC (BV-AVE-PC) given every 21 days with granulocyte colony-stimulating factor support. The primary objective was event-free survival (EFS); events included relapse/progression, second malignant neoplasm (SMN) or death. Seagen provided brentuximab vedotin for the study.

About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

ADCETRIS is indicated for the treatment of:

Adult patients with previously untreated Stage III/IV cHL in combination with doxorubicin, vinblastine, and dacarbazine.
Pediatric patients 2 years and older with previously untreated high risk cHL in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide.
Adult patients with cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Adult patients with cHL after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
Adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
Adult patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen.
Adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.
Seagen and Takeda jointly develop ADCETRIS. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights, and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seagen and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) for injection U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

CONTRAINDICATION

Contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

WARNINGS AND PRECAUTIONS

Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay, change in dose, or discontinuation of ADCETRIS.

Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.

Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS.

Administer G-CSF primary prophylaxis beginning with Cycle 1 for adult patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL, and pediatric patients who receive ADCETRIS in combination with chemotherapy for previously untreated high risk cHL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for infections.

Tumor lysis syndrome: Patients with rapidly proliferating tumor and high tumor burden may be at increased risk. Monitor closely and take appropriate measures.

Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment. Avoid use in patients with severe renal impairment.

Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment. Avoid use in patients with moderate or severe hepatic impairment.

Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.

PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.

Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.

Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.

Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with pre-existing GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.

Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.

Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of this potential risk, and to avoid pregnancy during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

ADVERSE REACTIONS

The most common adverse reactions (≥20% in any study) are peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.

DRUG INTERACTIONS

Concomitant use of strong CYP3A4 inhibitors has the potential to affect the exposure to monomethyl auristatin E (MMAE). Closely monitor adverse reactions.

USE IN SPECIAL POPULATIONS

Lactation: Breastfeeding is not recommended during ADCETRIS treatment.

Females and Males of Reproductive Potential: Advise females to report pregnancy immediately and advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 6 months after the last dose of ADCETRIS.

On November 10, 2022 Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the "Company"), a biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported an update on its financial results and recent business developments for the fiscal quarter ended September 30, 2022 (Press release, Celyad, NOV 10, 2022, View Source [SID1234623698]).

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"This past quarter has been a pivotal moment for the Company as we focus on a new Celyad 2.0 strategy as we seek to monetize our valuable IP estate and leverage our dynamic shRNA technology for our R&D programs. We’ve bolstered our cash runway with an asset purchase agreement for our manufacturing business unit and we believe we are well-positioned to unleash the power of our IP estate and potentially redefine the cell therapy space," said Michel Lussier, interim Chief Executive Officer of the Company.

Recent Highlights

The Company entered into a €6 million asset purchase agreement with Cellistic whereby Cellistic acquired Celyad Oncology’s Good Manufacturing Practice (GMP) grade cell therapy manufacturing facility
Based on a strategic, financial and medical review, taking into account the costs associated with the pursuit of the program and the delays to reach key medical milestones following the resolution of the previously announced clinical hold, the Company has decided to discontinue the development of CYAD-101
Update on Business Model and Research Programs

As previously announced, with Celyad 2.0, Celyad Oncology is implementing a strategic shift from an organization focused on clinical development to one prioritizing R&D discovery and the monetization of its IP estate through partnerships, collaborations and license agreements. The Company intends to focus its R&D efforts on areas of expertise where it believes it can leverage the differentiated nature of its platform technology and continue to bolster its IP estate.

The Company possesses key technology and controls IP which covers the potential development of next-generation therapies, including those using short hairpin RNA (shRNA) and T cell receptor Inhibitor Molecule (TIM). Celyad Oncology has expanded the IP estate in-licensed from Dartmouth College with additional patents to broadly cover aspects of allogeneic cell therapy.Current discovery programs have the potential to create additional independent IP. The Company is developing a potential next-generation NKG2D Type I receptor CAR T candidate and a technology to potentially utilize this receptor as a basis for dual CAR technology. The Company is also considering the potential to focus R&D efforts on either B7-H6 CAR T or bispecific antibody candidates for a powerful new antigenic target in the oncology field.

In addition, the Company is seeking to advance its shRNA platform through multiplexing technology that allows it to modulate multiple genes simultaneously. This technology is potentially complementary to the Company’s All-in-One Vector approach, which allows for the expression of multiple shRNAs in a single construct within a single transduction step. Combining multiplexed shRNAs with CARs and additional genes of choice provides potential for broad therapeutic functionality.

Update on Clinical Programs

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T candidate for r/r MM

The dose-escalation Phase 1 IMMUNICY-1 trial is evaluating the tolerability and clinical activity of a single infusion of CYAD-211 following preconditioning with CyFlu (cyclophosphamide and fludarabine) in patients with relapsed / refractory multiple myeloma (r/r MM).
CYAD-211 was developed to demonstrate potential proof of concept of shRNA technology in the clinic. Our other clinical studies of shRNA disclosed to date have demonstrated encouraging safety and bioactivity signals, and its use as a technology to avoid Graft-versus-Host disease of allogeneic CAR Ts could be a viable approach
Clinical updates are expected by year end
Third Quarter 2022 Financial Review

As of September 30, 2022, the Company had cash and cash equivalents of €13.4 million ($13.1 million). Net cash burn during the first quarter of 2022 amounted to €1.0 million ($1.0 million), in line with expectations. The Company confirms its previous guidance that its existing cash and cash equivalents should be sufficient to fund operating expenses and capital expenditure requirements up to mid-2023. This guidance does not include any potential proceeds from the equity purchase agreement established with Lincoln Park Capital Fund, LLC.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2022 and 2023 which reflect the current strategy of the Company and include expenses and cash outflows estimations in relation to the development of discretionary research programs and pipeline of products candidates, the Company continues to project that its existing cash and cash equivalents will not be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date that the release is issued.