On August 11, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the second quarter ended June 30, 2022 and provided updates on preclinical, clinical and corporate progress (Press release, Affimed, AUG 11, 2022, View Source [SID1234618159]). "During the second quarter, we completed a public offering that enables Affimed to invest in its lead programs through key inflection points," said Dr. Adi Hoess, CEO of Affimed. "The second half of 2022 is shaping up to be very exciting with data updates from AFM13 monotherapy and combination studies and our AFM24 program at scientific conferences."

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CLINICAL STAGE PROGRAM UPDATES
AFM13 (CD30/CD16A)

The Company completed enrollment of its REDIRECT study (AFM13-202). REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed/refractory CD30-positive peripheral T-cell lymphoma (PTCL).
Top-line data are expected to be reported in the fourth quarter of 2022. The focus of the initial data release will be on the overall response rate assessed by a blinded independent review committee and the preliminary assessment of response duration.

Enrollment continues in the phase 1/2 study in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) evaluating cord-blood derived NK cells pre-complexed with AFM13 followed by single agent AFM13 in patients with relapsed/refractory CD30+ lymphomas.

Data presented at the 2022 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2022) in the Clinical Trials Plenary Session by Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, reported that after a second cycle of treatment at the recommended phase 2 dose (RP2D), the complete response rate increased from 38% (5/13) as reported in December 2021 to 62% (8/13).

The overall objective response rate (ORR) remained at 100% and the treatment was safe and well tolerated by patients, enabling MD Anderson to continue treatment with up to four cycles as per the approved amended protocol. The main treatment- related side effect being infusion-related reactions. Investigators did not observe any cases of cytokine release syndrome (CRS), neurotoxicity or graft versus host disease often associated with T-cell therapies. In general, side effects observed in the trial were transient and did not lead to treatment delays or discontinuation.

Durability of response data presented at AACR (Free AACR Whitepaper) 2022 for patients treated at the RP2D was also promising. Of the eight patients who achieved a complete response (CR), seven remained in CR at median follow-up of 6.5 months, including two patients who remained in response after 10 months and two who received a consolidation autologous stem cell transplant (SCT).

The approved amendment to the AFM13-104 trial protocol allows for an increase in the number of CD30-positive lymphoma patients treated at the RP2D to 40 – including Hodgkin and non-Hodgkin’s lymphoma patients. Furthermore, under the amended protocol, patients can receive up to four cycles of treatment.

Enrollment continues to progress and as of July 31, 2022 30 patients have now been treated, including 24 at the RP2D. 11 additional patients have been treated at the RP2D since the AACR (Free AACR Whitepaper) 2022 data cutoff date.

The Company and MD Anderson expect to report updates on the study at a scientific conference in the fourth quarter of 2022.

The Company continues to make progress with third parties to ensure access to an off-the-shelf, cryopreserved NK cell product and expects to announce the development path for AFM13 with a specific NK cell in the second half of 2022.

Affimed is preparing for a meeting with the FDA later this year to discuss next development steps for this program and expects to provide an update once it receives feedback.

AFM24 (EGFR/CD16A)

The Company is continuing enrollment in the expansion phase of the monotherapy study at the RP2D (480 mg). The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EGFR mutant), and colorectal cancer (KRAS wild-type, MSS).

Enrollment also continues in two combination studies: a phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) (AFM24-102) and a phase 1/2a combination of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy (AFM24-103).

AFM24-102 is now enrolling patients at the 480 mg dose level of AFM24. The first cohort (160 mg) was completed successfully with no reports of dose limiting toxicities. AFM24-102 includes the treatment of patients with non-small cell lung cancer (EGFR wild-type), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer. AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR wild-type), squamous cell carcinoma of the head and neck, and colorectal cancer (KRAS wild-type/mutant, MSS).

Updates from the monotherapy study, including clinical data from the dose escalation phase will be shown at ESMO (Free ESMO Whitepaper) 2022. An additional update including correlative science data is expected to be presented at a scientific conference later this year. Affimed also expects to provide updates from the combination studies in the second half of 2022, including data from the dose escalation phase of AFM24-102 at a scientific conference in the fourth quarter of 2022.

PRECLINICAL PROGRAMS
AFM28 (CD123/CD16A)

As planned, the Company submitted an investigational new drug (IND) application to the FDA in June. Following feedback from the FDA related to the design of the dose escalation study, Affimed has made a strategic decision to voluntarily withdraw the IND. The Company plans to focus early clinical development of AFM28 in jurisdictions outside of the U.S.
The Company now anticipates initiating the phase 1 clinical study in the first half of 2023.
AFM28 is Affimed’s wholly-owned, bispecific, tetravalent innate cell engager (ICE) that targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML).

PRECLINICAL PIPELINE
Affimed is continuing to innovate and generate several novel ICE molecules derived from its proprietary ROCK platform.

PARTNERSHIPS AND COLLABORATIONS
Partnered programs with both Genentech and Roivant continue to progress according to plan. Affimed is eligible for additional proceeds from meeting pre-clinical and early regulatory achievement milestones.

SCIENTIFIC ADVISORY BOARD
During the quarter, the Company established an independent advisory panel made up of distinguished opinion leaders with scientific and clinical expertise in innate immunity and oncology. The Scientific Advisory Board (SAB) will provide guidance on the development strategy across preclinical and clinical development candidates as well as opportunities to apply our platform to cancer indications of high unmet need. All SAB members are leaders in a broad range of areas relevant to Affimed’s approach to developing cancer therapies including immuno-oncology, the biology of NK cells, lymphomas, leukemias, and solid tumors.

SECOND QUARTER 2022 FINANCIAL HIGHLIGHTS
Affimed’s consolidated financial statements are prepared in accordance with IFRS as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in euros, the Company’s functional and presentation currency.

As of June 30, 2022 cash and cash equivalents totaled €237.2 million compared to €197.6 million on December 31, 2021. Based on the Company’s current operating plan and assumptions, cash and cash equivalents are expected to support operations into mid-2024.

Net cash used in operating activities for the quarter ended June 30, 2022 was €26.5 million compared to €17.3 million for the quarter ended June 30, 2021.

Total revenue for the quarter ended June 30, 2022 was €7.3 million compared with €9.7 million for the quarter ended June 30, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.

Research and development expenses decreased by 4% from €21.8 million in the quarter ended June 30, 2021 to €20.8 million for the quarter ended June 30, 2022. The decrease was primarily due to lower expenses associated with the development of the AFM13 and AFM24 programs, a result of a decrease in procurement of clinical trial material.

General and administrative expenses increased 54% from €5.4 million in the quarter ended June 30, 2021 to €8.4 million in the quarter ended June 30, 2022. The increase predominately relates to higher personnel, higher share-based payment expenses and increased insurance premiums.

Net finance income/(costs) increased from costs of €1.6 million for the quarter ended June 30, 2021 to income of €2.3 million for the quarter ended June 30, 2022. Net finance income/(cost) is largely made up of foreign exchange gains and losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the Euro during the year.

Net loss for the quarter ended June 30, 2022 was €19.4 million, or €0.13 loss per common share compared with a net loss of €18.8 million, or €0.16 loss per common share for the quarter ended June 30, 2021.

The weighted number of common shares outstanding for the quarter ended June 30, 2022 was 147.3 million.

Additional information regarding these results is included in the notes to the consolidated financial statements as of June 30, 2022 which will be included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

CONFERENCE CALL AND WEBCAST INFORMATION
Affimed will host a conference call and webcast on August 11, 2022 at 8:30 a.m. EDT / 14:30 CEST to discuss second quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (866) 374-5140 for U.S. callers, or +1 (404) 400-0571 for international callers, and use PIN: 54780189# approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source

A replay of the webcast will be accessible at the same link for 30 days following the call.

On August 11, 2022 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported financial results for the second quarter ended June 30, 2022 and provided corporate highlights (Press release, iTeos Therapeutics, AUG 11, 2022, View Source [SID1234618157]).

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"In the second quarter of 2022, we have remained focused expanding our late-stage development efforts for both of our differentiated immunotherapy programs, EOS-448, our FcγR-engaging anti-TIGIT antibody, and inupadenant, our adenosine A2A receptor antagonist," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "We’re pleased to be enrolling non-small cell lung cancer patients in a Phase 2 trial for inupadenant in combination with chemotherapy, which we described in a trial in progress poster at ASCO (Free ASCO Whitepaper) in June. We also continue to further advance our immunotherapy combinations with EOS-448, with the initiation of the Phase 2 expansion trial evaluating GSK’s anti-PD-1, Jemperli and EOS-448 in patients with head and neck squamous cell carcinoma. Notably, we have multiple clinical trials underway for EOS-448, which will help provide a comprehensive understanding of the treatment potential of TIGIT as an immunotherapy target."

Program Highlights
EOS-448/GSK4428859A: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through multifaceted mechanisms.

In collaboration with GSK, iTeos is evaluating the optimal development pathway to assess EOS-448 as a potential next-generation immune-oncology agent through multiple combination studies and emerging data in the field. Recent highlights include:
The companies have begun enrolling patients with 1L advanced or metastatic head and neck squamous cell carcinoma (HNSCC) in the Phase 2 expansion part of a trial assessing the doublet of GSK’s anti-PD-1, Jemperli (dostarlimab), with EOS-448.
The companies have initiated the Phase 1b trial evaluating the novel triplet of EOS-448 with Jemperli and GSK’s investigational anti-CD96 antibody. The companies also plan to initiate a Phase 1b trial with EOS-448, Jemperli, and inupadenant in the coming months.
Enrollment continues in the monotherapy dose escalation part of the Phase 1/2 trial evaluating EOS-448 as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in patients with multiple myeloma.
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on different immune cells found in the tumor micro-environment.

iTeos is enrolling patients in a randomized Phase 2 trial in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy. The company presented a description of this trial in a Trial in Progress poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Enrollment is ongoing for the biomarker-high cohort of IO-001, the ongoing Phase 1b/2a trial, evaluating inupadenant as a monotherapy in patients with solid tumors selected for high biomarker expression in four cohorts: NSCLC, endometrial cancer, head and neck squamous cell carcinoma and other solid tumors.
Preclinical programs: iTeos continues to focus its research programs on novel targets that address pathways of immunosuppression. This includes its candidate targeting a first-in-class mechanism in the adenosine pathway which is under evaluation in Investigational New Drug-enabling studies.

Second Quarter 2022 Financial Results

Cash Position: The company’s cash and cash equivalent position was $791.9 million as of June 30, 2022, as compared to $302.9 million as of June 30, 2021. Cash balance is expected to provide the company runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $26.9 million for the quarter ended June 30, 2022, as compared to $14.2 million for the same quarter of 2021. The increase was primarily due to an increase in activities related to EOS-448 and inupadenant clinical trials along with increased spending related to the company’s preclinical programs.
General and Administrative (G&A) Expenses: G&A expenses were $11.5 million for the quarter ended June 30, 2022, as compared to $15.1 million for the same quarter of 2021. The decrease was primarily due to one-time legal and advisory fees incurred by the Company in 2021 associated with the Collaboration and License Agreement with GSK. This decrease was partially offset by additional costs related to increased headcount.
Net Income/Loss: Net income attributable to common shareholders was $5.6 million, or net income of $0.16 per basic share and $ 0.15 per diluted share, for the quarter ended June 30, 2022, as compared to a net loss of $ 26.5 million, or a net loss of $ 0.75 per basic and diluted share, for the same quarter of 2021.

On August 11, 2022 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported second quarter 2022 financial results and summarized recent program developments (Press release, Monopar Therapeutics, AUG 11, 2022, View Source [SID1234618156]).

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Recent Program Developments

Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting

The VOICE trial continues to enroll patients and add additional clinical sites in the U.S. and Europe (now at 58 active sites). Based on findings extracted from public reporting of recently completed severe oral mucositis (SOM) trials that led to subsequent enhancements being made to Monopar’s interim analysis, the Company anticipates the interim analysis to occur in Q1 2023.
Camsirubicin – Phase 1b Dose-Escalation Clinical Trial, Actively Recruiting

Monopar has cleared the third dose-level and is currently dosing the fourth dose-level cohort. The fourth dose-level is approximately double the highest dose of camsirubicin ever tested in a prior trial.

Early signs of clinical benefit have been observed with camsirubicin in this Phase 1b trial.
MNPR-101 Radioimmunotherapeutic

Monopar is actively evaluating pathways to initiate a first-in-human study with the MNPR-101-PCTA radioimmunotherapeutic/radiodiagnostic candidate that Monopar generated with its partner NorthStar Medical Radioisotopes, LLC.
MNPR-202

Monopar’s collaborator, the Cancer Science Institute of Singapore at the National University of Singapore, tested MNPR-202 in preclinical cancer models with promising results and is currently conducting additional preclinical studies. The aim is to submit an abstract of the results to one or more scientific/medical conferences within the coming months.
Results for the Second Quarter Ended June 30, 2022, Compared to the Second Quarter Ended June 30, 2021

Cash and Net Loss

Cash and cash equivalents as of June 30, 2022 were $16.5 million. Monopar anticipates that its current cash and cash equivalents will fund: the completion of the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through at least September 2023. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development through and beyond the ongoing open-label, dose escalation Phase 1b clinical trial.

Net loss for the second quarter of 2022 was $2.8 million or $0.22 per share compared to net loss of $2.1 million or $0.17 per share for the second quarter of 2021.

Research and Development (R&D) Expenses

R&D expenses for the three months ended June 30, 2022 were $2,078,000, compared to $1,476,000 for the three months ended June 30, 2021. The increase of $602,000 is attributed to (1) an increase of $473,000 in camsirubicin clinical trial expenses including patient dosing and manufacturing-related expenses, (2) an increase of $302,000 in Validive clinical trial-related and clinical material manufacturing-related expenses, and (3) a $9,000 net increase in other R&D expenses (4) offset by a decrease of $182,000 in R&D personnel costs.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended June 30, 2022 were $685,000, compared to $616,000 for the three months ended June 30, 2021. The increase of $69,000 is primarily the result of an increase in G&A personnel expenses.

On August 11, 2022 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported financial results for the quarter and six months ended June 30, 2022 (Press release, RAPT Therapeutics, AUG 11, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-second-quarter-2022-financial-results [SID1234618155]).

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"Our operational momentum continued in the second quarter as we initiated our Phase 2b clinical trial of RPT193 in patients with moderate-to-severe atopic dermatitis and strengthened our balance sheet with a $50 million financing," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "As we head into the second half of the year, we expect to broaden the RPT193 program with the initiation of a Phase 2a trial in asthma and to continue advancing our FLX475 program in multiple cancer indications. We anticipate our pipeline of promising oral drugs will provide a number of significant data catalysts over the next 12 to 18 months."

Financial Results for the Second Quarter and Six Months Ended June 30, 2022

Second Quarter Ended June 30, 2022

Net loss for the second quarter of 2022 was $19.2 million, compared to $16.1 million for the second quarter of 2021.

Research and development expenses for the second quarter of 2022 were $14.4 million, compared to $13.2 million for the same period in 2021. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and increases in expenses for personnel and facilities, partially offset by decreases in development costs related to FLX475 and stock-based compensation expense.

General and administrative expenses for the second quarter of 2022 were $5.4 million, compared to $3.8 million for the same period in 2021. The increase in general and administrative expenses was primarily due to increases in expenses for professional services, personnel, stock-based compensation and facilities.

Six Months Ended June 30, 2022

Net loss for the six months ended June 30, 2022 was $39.7 million, compared to $32.6 million for the same period in 2021.

Research and development expenses for the six months ended June 30, 2022 were $31.0 million, compared to $27.0 million for the same period in 2021. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and increases in expenses for early-stage programs, personnel and facilities, partially offset by decreases in development costs related to FLX475 and stock-based compensation expense.

General and administrative expenses for the six months ended June 30, 2022 were $10.2 million, compared to $7.8 million for the same period of 2021. The increase in general and administrative expenses was primarily due to increases in expenses for professional services, personnel, stock-based compensation and facilities.

As of June 30, 2022, the Company had cash, cash equivalents and marketable securities of $207.3 million, which includes net proceeds of $49.8 million from our May 2022 sale of pre-funded warrants to purchase 4.0 million shares of our common stock.

On August 11, 2022 Century Therapeutics, Inc., (NASDAQ: IPSC), an innovative 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, 2022 (Press release, Century Therapeutics, AUG 11, 2022, View Source [SID1234618154]).

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"We are excited about our recent IND submission for our lead candidate, CNTY-101, and pending FDA clearance, are looking forward to initiating the Phase 1 ELiPSE-1 trial in relapsed/refractory lymphoma," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "We continue to make steady progress in building a best-in-class allogeneic cell therapy platform and achieved a key milestone this quarter in establishing the iNK 3.0 Common Progenitor, which we believe will accelerate new candidate selection. Additionally, we look forward to providing updates on our gamma delta iT platform and other program advancements in the coming months."

Business Highlights

The Company presented preclinical data on MAD7, a novel CRISPR nuclease used to enable the genetic engineering of iPSC-derived NK and T cell product candidates, during a poster presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting held on May 16-19, 2022 in Washington, D.C. A copy of the presentation is available in the Posters section of Century’s website.
During a Research and Development Event in June, Century’s management team discussed CNTY-103, the Company’s first solid tumor candidate for glioblastoma, the establishment of the Common Progenitor iNK 3.0, and progress on the Company’s next-generation iPSC-based cell therapy platform. Century expects to submit an Investigational New Drug (IND) application for CNTY-103 in 2024.
The Company’s current Good Manufacturing Practice (cGMP) manufacturing facility in Branchburg, New Jersey is operational and undergoing qualification.
Century was added to the Russell Microcap Index in June 2022.
Subsequent Events and Upcoming Milestones

Following the recent submission of the IND application for CNTY-101, the Company remains on track to initiate its Phase 1 ELiPSE-1 clinical trial in the second half of 2022, subject to U.S. Food and Drug Administration (FDA) clearance of the application. ELiPSE-1 will assess CNTY-101 in patients with relapsed/refractory CD19 positive aggressive lymphoma or indolent lymphoma after at least two prior lines of therapy, including patients who have received prior CAR-T cell therapy.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments were $429.4 million as of June 30, 2022, as compared to $358.8 million as of December 31, 2021. Net cash provided by operations was $61.2 million for the six months ended June 30, 2022 (which includes deferred revenue from the Bristol-Myers Squibb (BMS) collaboration of $120.7M) compared to net cash used in operations of $40.7 million for the six months ended June 30, 2021.
Collaboration Revenue: Collaboration revenue was $1.4 million for the three months ended June 30, 2022, generated through the Company’s collaboration, option and license agreement with BMS.
Research and Development (R&D) expenses: R&D expenses were $24.5 million for the three months ended June 30, 2022, compared to $18.9 million for the same period in 2021. The increase in R&D expenses was primarily due to an increase in personnel expenses related to increased headcount to expand the Company’s R&D capabilities, costs for pre-clinical studies, costs for laboratory supplies and facility costs, offset by a decrease in collaboration expenses with FUJIFILM Cellular Dynamics, Inc. (FCDI) as the scope of work with FCDI has narrowed down to primarily manufacturing CNTY-101 clinical supply.
General and Administrative (G&A) expenses: G&A expenses were $8.3 million for the three months ended June 30, 2022, compared to $4.1 million for the same period in 2021. The increase was primarily due to an increase in employee headcount, an increase in directors’ and officers’ insurance expense and an increase in the Company’s professional fees as a result of expanded operations to support the Company’s infrastructure as well as additional costs to operate as a public company, and increased information technology and facility costs.
Net loss: Net loss was $31.0 million for the three months ended June 30, 2022, compared to $23.3 million for the same period in 2021.
Financial Guidance

The Company expects full year GAAP Operating Expenses to be between $155 million and $165 million including non-cash stock-based compensation expense of $10 million to $15 million.
The Company expects its cash, cash equivalents, and investments will support operations into 2025.