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Evotec SE reports first half-year 2022 results on 11 August 2022

On August 4, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that it will announce its financial results for the first half-year 2022 on Thursday, 11 August 2022 (Press release, Evotec, AUG 4, 2022, View Source [SID1234617516]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage www.evotec.com shortly before the event.

The on-demand version of the webcast will be available on our website: View Source

C4 Therapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights

On August 4, 2022 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported financial results for the second quarter ended June 30, 2022, as well as recent business highlights (Press release, C4 Therapeutics, AUG 4, 2022, View Source [SID1234617481]).

"We have seen continued progress across our portfolio and governance initiatives that help us advance targeted protein degrader medicines towards patients," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "In the second quarter, we successfully initiated our Phase 1/2 clinical trial of CFT8634 in synovial sarcoma and SMARCB1-null solid tumors and continued to enroll patients in the dose escalation portion of our ongoing Phase 1/2 clinical trial of CFT7455 in multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL). As we prepare to submit the IND for CFT1946, a BRAF V600X degrader, in the second half of the year, our strong balance sheet allows us to execute on our clinical programs and further advance our research platform to develop the next wave of degrader medicines."

SECOND QUARTER 2022 AND RECENT HIGHLIGHTS

CFT7455: CFT7455 is a novel degrader targeting IKZF1/3 for the treatment of MM and NHL, including peripheral T-cell lymphoma and mantle cell lymphoma.

Advanced Enrollment in Phase 1/2 Clinical Trial: C4T progressed the Phase 1/2 clinical trial of CFT7455 by enrolling patients in Cohort B1, exploring CFT7455 as a monotherapy for relapsed or refractory MM, and Cohort C, exploring CFT7455 as a monotherapy for NHL.
CFT8634: CFT8634 is a degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Dosed First Patient in Phase 1/2 Clinical Trial: In May 2022, C4T dosed the first patient in the Phase 1/2 clinical trial of CFT8634. The trial continues to progress, with sites open and enrolling patients in Cohort A, the Phase 1 dose escalation arm, to evaluate CFT8634 as an oral, single-agent therapy for patients with synovial sarcoma or SMARCB1-null solid tumors.
Corporate

Appointed Dr. Laura Bessen and Dr. Donna Grogan to Board of Directors: In August 2022, C4T appointed Dr. Laura Bessen and Dr. Donna Grogan to its board of directors. Dr. Bessen has more than two decades of experience across medical affairs and clinical development in support of successful product launches. Dr. Grogan is an accomplished drug development and regulatory strategy leader with more than 25 years of experience in developing novel therapeutics.
KEY UPCOMING MILESTONES

The company anticipates the following milestones:

CFT7455: Continue to enroll Cohorts B1 and C; data from these efforts will inform the identification of a recommended Phase 2 dose(s) and schedule(s) for single agent CFT7455 in MM and NHL.
CFT8634: Continue to enroll patients in the Phase 1/2 trial throughout 2022. Data from these efforts will inform the identification of a recommended Phase 2 dose for synovial sarcoma and SMARCB1-null solid tumors.
CFT1946: Submit an IND application and initiate a Phase 1 trial of CFT1946 in BRAF V600X-driven cancers including melanoma, colorectal and non-small cell lung cancer in 2H 2022.
CFT8919: Complete IND-enabling activities for CFT8919, a potent and selective degrader of EGFR L858R for the treatment of non-small cell lung cancer, by year-end 2022.
UPCOMING EVENTS

Research & Development Presentations to Highlight MonoDACTM Degrader Platform and Library: C4T has been accepted to present at Discovery on Target, to be held October 17-20, 2022, and the 5th Annual Targeted Protein Degradation Summit, to be held October 25-28, 2022. These presentations will include research highlighting how C4T’s platform has been built to enable rational and efficient discovery of MonoDAC degraders through the design and evolution of a diverse chemical library combined with various screening approaches.

Investor Conference: C4T management is scheduled to participate in the Wells Fargo Healthcare Conference to be held September 7-8, 2022.

SECOND QUARTER 2022 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2022 was $13.8 million, compared to $9.8 million for the second quarter of 2021. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico. The increase in revenue was primarily due to additional progress made on our targets under the Biogen collaboration agreement, offset by the decrease in reimbursement for full-time employees recognized under our collaboration agreement with Calico.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2022 was $31.3 million, compared to $23.3 million for the second quarter of 2021. The increase in R&D expense was primarily attributable to increased personnel expenses including increases in stock compensation expenses, facility costs from additional leased space, and clinical expenses as a result of the ongoing Phase 1/2 clinical trial of CFT7455 and commencement of the CFT8634 Phase 1/2 trial.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2022 was $9.9 million, compared to $8.6 million for the second quarter of 2021. The increase in G&A expense was primarily attributable to increased personnel expenses, including an increase in stock compensation expense.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2022 was $27.4 million, compared to $22.6 million for the second quarter of 2021. Net loss per share for the second quarter of 2022 was $0.56, compared to $0.51 for the second quarter of 2021.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2022, were $397.8 million, compared to $451.5 million as of December 31, 2021. The decrease in cash was primarily driven by expenditures to fund operations. C4T expects that its cash, cash equivalents and marketable securities as of June 30, 2022, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund planned operating expenses and capital expenditures to the end of 2024.

Lineage Cell Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 11, 2022

On August 4, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that it will report its second quarter 2022 financial and operating results on Thursday, August 11, 2022, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, AUG 4, 2022, View Source [SID1234617480]). Lineage management will also host a conference call and webcast on Thursday, August 11, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2022 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and (646) 307-1952 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" or provide conference ID number 6448886. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 18, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6448886.

Replimune Reports Fiscal First Quarter Financial Results and Provides Corporate Update

On August 4, 2022 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported financial results for the fiscal first quarter ended June 30, 2022 and provided a business update (Press release, Replimune, AUG 4, 2022, View Source [SID1234617479]).

"Our ambition to establish a major skin cancer franchise, built off of our lead RP1 program, is progressing to plan. We are pleased to have reached target enrollment in the CERPASS registration-directed clinical trial in CSCC and expect to complete enrollment in the IGNYTE clinical trial cohort evaluating RP1 combined with Opdivo in anti-PD1 failed melanoma around the end of year. We look forward to sharing the primary analysis data from the CERPASS clinical trial in H1 2023 and a data snapshot from the first 75 patients enrolled in the IGNYTE anti-PD1 failed melanoma cohort in the fourth quarter of 2022. In addition to RP1, we remain excited about the previously reported data with RP2 and look forward to providing further updates from the RP2/3 program as we move towards initiation of our Phase 2 programs in head and neck cancer, hepatocellular carcinoma and colorectal cancer. Looking even further ahead, we are well financed as we continue to prepare for the potential commercialization of our oncolytic immunotherapies and remain on course to achieve our ultimate ambition of establishing our products as a cornerstone treatment for a variety of solid tumor indications."

Corporate Updates & Upcoming Milestones

RP1 Update

Reached target enrollment in the CERPASS registration-directed clinical trial evaluating RP1 combined with Libtayo (cemiplimab-rwlc) in cutaneous squamous cell carcinoma (CSCC)

Replimune has enrolled the pre-specified target of 180 patients in the CERPASS trial evaluating RP1 combined with Libtayo in patients with CSCC; additional patients screened this month will also be enrolled with the last patient expected to initiate dosing this quarter.
Topline primary analysis data from this clinical trial is expected to be released in H1 2023.

Recruited the first 75 patients treated with RP1 combined with Opdivo in the anti-PD1 failed melanoma cohort with registrational intent of the IGNYTE clinical trial with a data snapshot from the first 75 patients with 6 months follow-up expected in Q4 2022

The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial of RP1 combined with Opdivo is intended to ultimately enroll a total of approximately 125 patients, with enrollment expected to complete around the end of this year. The data snapshot from the first 75 patients followed for 6 months will be investigator assessed as compared to the primary endpoint of ORR for all patients in the cohort which is to be assessed by central review.
Other IGNYTE cohorts with RP1 combined with Opdivo: Recruitment remains ongoing into the cohorts of patients with anti-PD1 failed non-melanoma skin cancers, including CSCC, anti-PD1 failed non-small cell lung cancer, and anti-PD1 failed MSI-high cancers, with a data update expected in H1 2023.

RP1 in solid organ transplant recipients with skin cancers (ARTACUS): The Company continues to enroll patients into its ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers and expects to provide a data update in H1 2023.

Development of RP1 for the neoadjuvant treatment of CSCC: Protocol development is underway for the testing of RP1 alone and combined with anti-PD1 therapy for the neoadjuvant treatment of CSCC, with clinical trial initiation expected in H1 2023.
RP2 and RP3 Update

RP2 alone and in combination with Opdivo in difficult-to-treat cancers: The Company continues to enroll patients in the expansion cohorts of the Phase 1 clinical trial evaluating RP2 in patients with tumor types of particular interest (gastro-intestinal [GI] cancers, breast cancer, lung cancer, head and neck cancer and uveal melanoma). The Company had previously fully enrolled the cohorts evaluating RP2 monotherapy (n=9) and RP2 in combination with Opdivo (n=30) (data presented in Nov 2020 and Nov 2021). Initial data from the RP2 expansion cohorts is expected around the end of this year.

RP3 alone and in combination with Opdivo in difficult-to-treat cancers: The Company completed enrollment in the initial part of its Phase 1 clinical trial with RP3 alone. Following determination of the recommended Phase 2 dose (RP2D), the Company is enrolling patients in the cohort evaluating RP3 combined with Opdivo, with focus on patients with GI cancers, breast cancer, lung cancer and head and neck cancer. Initial data for this RP3 combination cohort is expected around the end of this year. Additional monotherapy patients will also be enrolled.

Phase 2 development program: The Company remains on track to initiate its Phase 2 development program with RP2/3 in the first quarter of 2023. As previously announced, this program is intended to include Phase 2 clinical trials in squamous cell carcinoma of the head and neck (SCCHN; locally advanced and recurrent/metastatic), hepatocellular carcinoma (HCC; first line and second line) and colorectal cancer (CRC; third line), combined with current standard of care where appropriate.
Financial Highlights

Cash Position: As of June 30, 2022, cash, cash equivalents and short-term investments were $395.1 million, as compared to $395.7 million as of March 31, 2022. Cash utilized in operating activities in advancing the Company’s expanded clinical development plan was offset by $31.0 million in net proceeds generated from the sale of common stock under the Company’s at-the-market facility.

Based on the current operating plan, Replimune believes that existing cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required by the FDA or other regulatory body.
R&D Expenses: Research and development expenses were $29.5 million for the first quarter ended June 30, 2022, as compared to $18.6 million for the first quarter ended June 30, 2021. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $2.6 million in stock-based compensation expenses for the first quarter ended June 30, 2022.

S,G&A Expenses: Selling, general and administrative expenses were $11.4 million for the first quarter ended June 30, 2022, as compared to $8.8 million for the first quarter ended June 30, 2021. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $4.6 million in stock-based compensation expenses for the first quarter ended June 30, 2022.

Net Loss: Net loss was $42.3 million for the first quarter ended June 30, 2022, as compared to a net loss of $27.3 million for the first quarter ended June 30, 2021.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo (cemiplimab-rwlc) alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial comprises approximately 180 evaluable patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two independent primary efficacy endpoints as assessed by independent review, as well as secondary endpoints including duration of response, progression-free survival (PFS), and overall survival (OS). The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi. Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo (nivolumab). There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma with registrational intent. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

Avalo Reports Second Quarter 2022 Financial Results and Provides Business Updates

On August 4, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX), reported business updates and financial results for the second quarter of 2022 (Press release, Avalo Therapeutics, AUG 4, 2022, View Source [SID1234617478]).

"We have made significant progress advancing our clinical trials while also securing critical nondilutive capital since our first quarter business update," said Dr. Garry Neil, President and Chief Executive Officer of Avalo Therapeutics. "We are pleased to have enrolled the first patient in both our Phase 2 PEAK trial of AVTX-002 in NEA as well as our pivotal LADDER trial of ATX-803 in LAD II. Additionally, it’s critically important that we secured approximately $15 million of initial consideration from our license and transfer of our AVTX-007 program. The transaction allows us to operationally and financially focus on our most promising programs, most notably AVTX-002."

Business Updates:

In July 2022, Avalo granted an exclusive license to Apollo Therapeutics Group Limited (Apollo) granting rights to Apollo to research, develop, manufacture and commercialize AVTX-007. The AVTX-007 program was originally licensed to Avalo by MedImmune Limited, a subsidiary of AstraZeneca plc, and such license was transferred to Apollo as part of the transaction.
Avalo received approximately $15 million of upfront consideration.
Avalo is also entitled to up to $74 million of milestone payments, as well as a royalty payment of a low single digit percentage of annual net sales.
On July 7, 2022, Avalo effected a 1-for-12 reverse stock split to increase the per share price of its common stock to regain compliance with the listing requirements of the Nasdaq Capital Market. On July 22, 2022, the Company received written notification from Nasdaq that Avalo had regained compliance and that the matter is now closed.
In June 2022, Avalo, prepaid $15 million under its loan venture loan and security agreement (the Loan Agreement), of which $14.8 million was applied to principal and the remainder applied to accrued interest. As of June 30, 2022, the remaining principal payments were $21.2 million.
Program Updates and Milestones:

AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases.
NEA: Avalo has initiated its Phase 2 PEAK trial (A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma K) evaluating the safety and efficacy of AVTX-002 in 80 patients with poorly controlled NEA. The first patient was dosed in May 2022. Top-line data from the trial are expected in the first half of 2023.
AVTX-800 programs (AVTX-803 and AVTX-801): Monosaccharide therapies for two congenital disorders of glycosylation (CDGs): leukocyte adhesion deficiency type II (LAD II, also known as SLC35C1-CDG) and PGM1-CDG.
LAD II: Avalo has initiated its pivotal LADDER trial (A Phase 3, Randomized, Double-blind, Two-period, Crossover, Withdrawal Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II) ER) evaluating the safety and efficacy of AVTX-803 in patients with LAD II (n=2). The first patient was dosed in July 2022. Data from this pivotal trial are expected in the first half of 2023.
PGM1-CDG: Milestone timing and the development plan is under review as a result of recent feedback from the U.S. Food and Drug Administration (FDA).
Second Quarter 2022 Financial Update:

Avalo had $11.2 million in cash and cash equivalents as of June 30, 2022, representing a $43.4 million decrease as compared to December 31, 2021. The decrease was primarily driven by operating expenditures to fund and support pipeline development and a $15.0 million partial prepayment under the Loan Agreement. Subsequent to June 30, 2022, Avalo received the approximate $15 million of upfront payment from its transfer of AVTX-007.

Total operating expenses decreased $16.7 million for the six months ended June 30, 2022 as compared to the same period in 2021. Research and development expenses decreased $19.7 million due to a $10.0 million upfront license fee incurred in the first quarter of 2021, which did not repeat, and a $9.2 million reduction due to specific timing of manufacturing, non-clinical activities and clinical trial activities. Selling, general and administrative expenses increased $1.7 million mainly due to severance and stock-based compensation expense driven by headcount reductions from the pipeline prioritization plan announced in the first quarter of 2022 and other separations, partially offset by decreases to legal, consulting and marketing expenses from cost savings initiatives. Cost of product sales increased $2.1 million due to the net profit share of our non-core commercialized product, Millipred, that began in the third quarter of 2021. Additionally, in the second quarter of 2022, we fully reserved the $1.0 million receivable due in December 2024 pursuant to the transition service agreement with the third party that previously managed Millipred’s commercial operations. The net loss and change in net loss was largely driven by operating expenses.

The unaudited condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021 have been derived from the reviewed financial statements, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

The unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2022 and 2021 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.