On August 11, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported financial results for the quarter ended June 30, 2021 (Press release, Gamida Cell, AUG 11, 2021, View Source [SID1234586351]). Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020. As of June 30, 2021, Gamida Cell had total cash and cash equivalents of $150.2 million.

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During the quarter, the company continued to execute on plans to submit a Biologic License Application (BLA) for omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant. This submission is expected to occur by the end of the year, subject to a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) planned for the fourth quarter. In addition, Gamida prepared to begin a Phase 1/2 trial of GDA-201 in non-Hodgkin lymphoma (NHL), expected to occur by the end of 2021. Also, the company expanded its NAM-enabled natural killer (NK) cell pipeline targeting solid-tumor and hematological cancers, including genetically modified variants of proprietary NK therapies using both CRISPR/Cas9 and CAR methodologies.

"Our progress this quarter represents a major step forward for Gamida Cell and our mission to bring cancer patients potentially curative cell therapies," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are delivering against key process development, quality and manufacturing milestones in preparation for a BLA submission for omidubicel while also advancing our go-to-market strategy for our planned commercial launch. In parallel, we bolstered our NAM-enabled NK pipeline both by readying to advance GDA-201 into the clinic based on its encouraging clinical data in patients with hematological cancers and by expanding our NK cell pipeline to address solid and liquid tumors."

Q2 and Recent Developments

Omidubicel: Advanced Cell Therapy

Continued advancement toward planned BLA submission for omidubicel to the FDA in the fourth quarter of this year. The company’s activities included CMC qualification requirements at both the Gamida–owned facility in Israel and at Lonza, a contract manufacturing organization that will be supplying commercial material upon FDA approval. Advancements were made in analytical methods validation, analytical comparability and clinical manufacturing for Expanded Access Program patients, which are also planned to be used for clinical comparability.
Advanced launch planning activities by expanding Gamida’s commercial, operational and medical affairs teams. Conducted further market research and health economic and outcomes research (HEOR) to support planned market entry and market access activities. Readied Gamida Cell Assist, supply chain and logistics programs to facilitate positive patient and transplant center experiences at time of launch.
Announced that results of the international, multi-center, randomized Phase 3 clinical study of omidubicel were published in Blood, the official journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). This pivotal trial compared the safety and efficacy of omidubicel to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies undergoing a bone marrow transplant. The results demonstrate that transplantation with omidubicel leads to faster neutrophil and platelet recovery, and results in fewer bacterial, viral and fungal infections and less time in the hospital, compared to a standard umbilical cord blood graft.
GDA-201: NAM-Enabled NK Immunotherapy

Prepared for filing of an Investigational New Drug (IND) application with the FDA.
Finalized clinical study protocol and statistical plan for a planned Phase 1/2 clinical trial of allogeneic, cryopreserved GDA-201 in patients with follicular and diffuse large B-cell lymphoma.
Conducted study start-up activities, including contract research organization (CRO) and clinical site selections.
NAM-Enabled NK Cell Pipeline Expansion

Advanced four new development programs that involve modifications intended to direct NK cells against specific tumor markers to improve their cancer killing capabilities against both hematological and solid tumors. Newly designated product candidates include:
GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra. Designed to improve tumor killing by promoting activation and inhibiting negative feedback signals. Potential applications exist across a range of solid tumors and lymphoma.
GDA-401: Undisclosed target genetically engineered to enhance NK cell survival in the solid tumor microenvironment for potential application across a broad range of solid tumors.
GDA-501: CAR-engineered NK cells to target HER2+ solid tumors with the potential to enhance homing and activation against cancers with HER2 overexpression, including breast, ovarian, lung, bladder, gastric and others.
GDA-601: Knockout of CD38 on NK cells to avoid fratricide by CD38 targeted antibodies in combination treatment of multiple myeloma, combined with a CD38 CAR designed to enhance killing of cancerous cells.
Advanced additional NAM-enabled research programs targeting immunosuppressive pathways using both CRISPR/Cas9 and CAR, with potential to treat solid tumor and blood cancers.
Corporate

Hired Vladimir Melnikov as Senior Vice President, Global Operations and Manufacturing. Vladimir has over 25 years of experience in the biopharmaceutical industry. He previously served as general manager at Omrix Biopharmaceuticals and biologic technical operations lead at Ethicon Biosurgery, both part of a Johnson & Johnson Company. In those roles he supervised three Israeli biotech manufacturing sites and technology transfer to external partners. Vladimir will have responsibility for the company’s Israeli manufacturing site and manufacturing partnership with Lonza.
Hired Josh Patterson as General Counsel, effective August 30, 2021. Josh has over 20 years of experience as in-house legal counsel for biopharmaceutical companies. Josh will be joining Gamida Cell from Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals, where he is currently General Counsel. Josh will be responsible for building, leading and managing the legal function for Gamida Cell.
Second Quarter 2021 Financial Results

Research and development expenses in the second quarter of 2021 were $13.5 million, compared to $9.3 million for the same period in 2020. The increase was mainly due to omidubicel commercial manufacturing readiness activities, and the advancement of the GDA-201 program, including broadening scientific capabilities and talent.
Commercial expenses in the second quarter of 2021 were $5.2 million, compared to $1.0 million for the second quarter of 2020. The increase was mainly attributed to progress with omidubicel commercial readiness activities.
General and administrative expenses were $3.8 million for the second quarter of 2021, compared to $2.5 million for the same period in 2020. The increase was mainly due to the hiring of key management positions to support business growth.
Finance income, net, was $1.2 million for the second quarter of 2021, compared to $2.2 million for the second quarter of 2020. The increase was primarily due to non-cash income, resulting from revaluation of warrants offset by interest expenses that resulted from the $75 million convertible note financing in February 2021.
Net loss for the second quarter of 2021 was $21.3 million, compared to a net loss of $15.1 million for the same period in 2020.

2021 Financial Guidance

Gamida Cell reiterates its prior financial guidance and expects cash used for ongoing operating activities in 2021 to range from $110 million to $120 million. The company believes that its current cash and cash equivalents will support the ongoing operating activities into the second half of 2022. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.

Expected 2021 Developments and Milestones

Gamida Cell plans to achieve the following key milestones during the second half of 2021:

Omidubicel

Pre-BLA meeting with FDA in the fourth quarter of 2021
BLA submission to the FDA in the fourth quarter of 2021
Commercial readiness activities ongoing for potential launch following approval
GDA-201

IND submission to FDA in third quarter 2021
Initiation of a company-sponsored Phase 1/2 clinical study in NHL before year-end 2021
NK cell pipeline expansion

Advance pipeline of NAM-enabled, genetically-modified NK cells in solid tumor and blood cancers
Conference Call Information

Gamida Cell will host a conference call today, August 11, 2021, at 8:00 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 5258448. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potentially life-saving1 allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.2,3 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.gamida-cell.com.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-based cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 has been in development through an investigator-sponsored study in patients with refractory NHL and multiple myeloma. For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On August 11, 2021 Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that the first patient has been dosed in its Phase I multicentre trial evaluating AVA6000, a novel pro-drug of Doxorubicin (Press release, Avacta, AUG 11, 2021, View Source [SID1234586350]).

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AVA6000 is Avacta’s first therapeutic based on its proprietary pre|CISION technology. The platform incorporates a substrate that is specifically cleaved by the protease fibroblast activation protein alpha (FAPα), which is upregulated in most solid tumours and at low background levels in healthy tissue, providing an activation mechanism to ensure localised release of chemotherapeutic agents from their pro-drug form. By activating chemotoxins only within the tumour microenvironment, systemic exposure to healthy tissues is limited, improving the safety and therapeutic potential of these cancer therapies.

Incorporating the pre|CISION platform, AVA6000 is a tumour-activated form of Doxorubicin. Anthracyclines such as Doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 2024, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity, particularly cardiotoxicity. Avacta’s pre|CISION pro-drug approach is designed to reduce the systemic exposure of healthy tissues to the active chemotherapy, leading to improved safety and therapeutic index, potentially resulting in improved dosing regimens, better efficacy and better outcomes for patients.

The AVA6000 study is a dose-escalation Phase I study in patients with locally advanced or metastatic selected solid tumours, known to be FAP-positive. These cohorts will receive ascending doses of AVA6000 to determine the maximum tolerated dose and establish a recommended Phase II dose. The second part of the study is an expansion phase where patients receive AVA6000 to further evaluate the safety, tolerability and clinical activity at this recommended Phase II dose across selected tumour types. For more information visit www.clinicaltrials.com (NCT04969835)

The first patient has received their first dose of AVA6000 at The Royal Marsden NHS Foundation Trust, London. The Phase I study is being initiated across a small group of leading UK oncology centres with an established reputation for early clinical research in cancer. The dose escalation phase is anticipated to complete by Q2 2022 followed by completion of the dose expansion phase by Q2 2023.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

"The initiation of the first in human Phase I clinical study for AVA6000 marks the transformation of Avacta Life Sciences into a clinical stage biopharmaceutical company. It is an outstanding achievement by the team and we are extremely proud of what has been achieved since we established the collaboration with Professor William Bachovchin at Tufts University Medical School to develop the pre|CISION technology for tumour targeting.

"We are delighted to be working on the AVA6000 study with global key opinion leaders in oncology drug development at world-class oncology clinical trial sites in UK on this important pro-drug approach to improving the safety and efficacy of chemotherapies.

"If the study shows that the pre|CISION technology is effective in reducing systemic toxicity of Doxorubicin in humans, then that will open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION pro-drug chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 2027.

I look forward to further updating the market when key clinical development milestones are achieved."

Neil Bell, Chief Development Officer, Avacta Life Sciences commented:

"The initiation of this AVA6000 Phase I trial is a significant and transformational milestone for Avacta . AVA6000 offers an opportunity to improve upon the current doxorubicin treatment paradigm for patients, either as a monotherapy or in combination. We look forward to the results from our AVA6000 first-in-human clinical trial as we strive to improve therapeutic index of doxorubicin for patients."

AVA6000 Principal Investigator Professor Udai Banerji, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust commented:

"I am delighted that the first patient has now received AVA6000 in the first-in-human study. This drug harnesses our understanding of the tumour microenvironment to enhance drug delivery – targeting potent anticancer therapies to tumours and potentially sparing patients debilitating side effects. It is fantastic that efforts are being made to discover and develop smarter, kinder treatments."

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On August 11, 2021 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the appointment of Sijme Zeilemaker as Chief Executive Officer (Press release, ImmuneTune, AUG 11, 2021, View Source [SID1234586349]). With his experience in several oncology biotech companies ranging from preclinical to Phase II clinical development and skillset in business development and investor relations, he will be responsible for bringing Immunetune into the next phase of the company.

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"It is great to be joining a biotech working on truly differentiated technologies to bring a potentially best-in-class program into the clinic. Having seen the forefront of innovation in immuno-oncology the last few years, Immunetune has the right approach and results to make a difference. Gerben and his team have done an impressive amount of work and it is such an exciting phase to be joining them," stated Sijme Zeilemaker.

"We are thrilled bringing Sijme on board to strengthen our team at this pivotal point in time. With his experience with both big pharma partners and international life science investors, he knows exactly what data and technologies they will be looking for," says Gerben Zondag, founder of Immunetune, who will take on the role of Chief Operating Officer. "With the rest of the management team in place, we are confident to move our company and programs forward into the clinic."

Sijme Zeilemaker is joining Immunetune having previously acted as Chief Operating Officer, Director Business Development and Head of Investor Relations at Immunicum AB, a clinical-stage biotech developing cell therapies against cancer, publicly listed at the Nasdaq Stockholm. He joined Immunicum in 2017 as part of a small team and supported the growth of the company through a collaboration with Pfizer and Merck KGaA, three financing rounds, and the merger with DCprime. Before Immunicum, Sijme was Director Business Development at InteRNA Technologies, and held business development roles at to-BBB technologies and 2-BBB Medicines, transitioning these companies from preclinical to clinical-stage.

On August 11, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-184 Orphan Drug Designation for the treatment of pancreatic cancer (Press release, Lantern Pharma, AUG 11, 2021, View Source [SID1234586348]). LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including pancreatic cancer.

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Pancreatic cancer is the fourth leading cause of cancer deaths in the United States with a five-year survival rate of 7.9% and a 10-year survival rate of just 1%. GLOBOCAN estimates that for pancreatic cancer there are approximately 490,000 thousand new cases of pancreatic cancer globally, with over 62,000 occurring in North America annually. Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease. LP-184 is designed to target a specific subset of pancreatic cancer patients that are genetically defined, which has the potential to increase beneficial therapeutic options for patients and may ultimately improve survival for those with this cancer.

"Receipt of Orphan Drug Designation is an important accomplishment for the LP-184 program and for our company. This designation further validates our data-driven approach to oncology drug development as well as the groundbreaking collaborative R&D approach we are advancing with leading institutions such as Fox Chase Cancer Center," stated Panna Sharma, President & CEO of Lantern Pharma. "Orphan Drug Designation is designed to provide a number of benefits, including seven years of market exclusivity, which complements our growing portfolio of patents that provide us additional commercial and market protections."

"This orphan designation is one of many upcoming milestones that we expect to achieve for our LP-184 program in pancreatic cancer. We recently reported that LP-184 demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, within in-vivo mouse models over 8 weeks. In comparison, the tumors in the untreated mice grew by over eleven-fold in volume during the same 8-week period. We are excited to advance this groundbreaking research to help patients suffering from this devastating disease where the benefits of current treatment options are very limited."

Lantern has begun discussions on the design of first-in-human clinical studies for LP-184 in collaboration with Dr. Igor Astsaturov, an established, NCI -funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center, as well as other key opinion leaders in the pancreatic cancer treatment landscape.

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.

On August 11, 2021 IMV Inc. (the "Company" or "IMV") (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported its financial and operational results and provided an update for the second quarter ended June 30, 2021 (Press release, IMV, AUG 11, 2021, View Source [SID1234586346]).

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"IMV is undergoing a critical transformation and focusing on delivering tangible clinical and scientific data to support further development and commercialization of our unique programs and DPX platform technology," said Andrew Hall, interim Chief Executive Officer of IMV. "The recent results obtained with the translational analyses in ovarian cancer further validate our lead compound and DPX technology. We are also very excited by the overall expansion of our clinical pipeline across a range of tumor antigens and indications. Our recent financing has strengthened our balance sheet and provided us with the runway to deliver additional confirmatory data to investors and the scientific community."

"Based on clinical results and a continued deeper understanding of the mechanism of action of our distinctive delivery platform we believe we are in an exceptional position to deliver sustainable shareholder value supported by an enhanced financial position and our ability to attract quality talent at every level of the organization," concluded Mr. Hall.

Corporate Updates

Appointment of Andrew Hall as Interim Chief Executive Officer (CEO)

On August 4, 2021, the Corporation announced that Frederic Ors stepped down as Chief Executive Officer and that the IMV Board appointed Andrew Hall, formerly of Celgene, the Company’s Chief Business Officer, as Interim CEO. The Company’s Board is commencing a comprehensive search process to identify a permanent CEO.

Appointment of a Chief Scientific Officer (CSO)

Jeremy R. Graff, Ph.D., formerly of Lilly, was recently appointed Chief Scientific Officer of IMV and brings over 20 years of experience in preclinical and clinical research and translational analysis for novel immune-activating therapeutics in oncology.

Development of IMV’s Clinical Advisory Committee

Stanley Frankel, M.D, an industry veteran, was appointed clinical advisor to support development of MVP-S in diffuse large B-cell lymphoma (DLBCL) and the initiation of the Company’s next clinical trial in advanced ovarian cancer.

Dr. Frankel brings a wealth of experience and knowledge in hematology, cell therapy and immuno-oncology accumulated at Bristol-Myers Squibb (BMS) where he was Senior Vice President, Cellular Therapy Development, and responsible for late development portfolio of cellular therapy assets including Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel). Prior to this experience, Dr. Frankel was Corporate Vice President, Head, Immuno-Oncology & Cellular Therapy, Clinical Research and Development Head, Cell Therapy Clinical Center of Excellence at Celgene and served on joint steering and/or joint development committees for alliances with JW Therapeutics, Jounce Therapeutics, AstraZeneca/MedImmune, Juno Therapeutics, and BeiGene.

Jose Iglesias, M.D., another renowned expert in the Immuno-Oncology space, was recently appointed as Clinical Advisor. Dr. Iglesias brings decades of expertise in clinical development strategy, clinical trial design, biomarker-guided pharmacodynamics, proof of principle and proof of concept studies, drug approval strategies, studies to support commercialization, academic research collaborations and liaisons with worldwide centers of excellence and oncology cooperative groups. Dr. Iglesias served as Chief Medical Officer at Senti Biosciences, Biothera Pharmaceuticals, Bionomics Ltd., Abraxis Bioscience Inc. and as Vice President, Clinical Development at Celgene.

Operational Expansion in the USA

IMV has now established a U.S. subsidiary and an office in Cambridge, Massachusetts, a world-leading biotech research hub with a large geographical concentration of biotech and pharmaceutical companies, world-renowned universities, research centers, and a highly skilled talent pool.

This new corporate office will serve as a springboard to accelerate future business development and other initiatives.

Clinical Programs with Maveropepimut-S (MVP-S, Formerly Named DPX-Survivac)

Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

In the previous Phase 2 clinical study (SPiReL), MVP-S in combination with Merck’s KEYTRUDA and intermittent low dose cyclophosphamide (CPA) showed promising data with 50% Overall Response Rate (ORR) and 78.6% Disease Control Rate (DCR) in evaluable patients. Also, PD-L1 expression has been identified as a potential predictive biomarker of response, as PD-L1+ patients demonstrated 85.7% ORR and 85.7% DCR. Most commonly reported events are Grade 1 and 2 injection site reactions, 20.8% subjects reported Grade 3 or above adverse events.

The Company announced in April that it entered into an agreement with Merck (NYSE: MRK) to initiate a Phase 2B clinical trial to evaluate its lead compound, MVP-S, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 2B study r/r DLBCL.

The trial was initiated in June 2021, and the first sites have since been activated. PD-L1 will be assessed for every potential patient considered for enrollment.

Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer

IMV has recently completed the DeCidE1 clinical trial evaluating MVP-S in association with CPA in patients with advanced recurrent ovarian cancer. The final patient completed the study after more than 2 years of clinical benefit with MVP-S. In this study, many subjects have been through several lines of prior treatment and 57.9% patients were platinum resistant. Overall, the treatment was well tolerated with most adverse events being injection site reactions. At the 2-year cut-off, the overall survival rate in this cohort was 44.9% with a median overall survival of 19.9 months, results that support further clinical evaluation of this treatment.

Translational analyses from this trial confirm generation of tumor-antigen directed T cells by MVP-S. The details of these translational analyses have been submitted for presentation at upcoming scientific meetings. These data will also inform the discussion and design of a Phase 2B clinical study to be submitted to the FDA.

Recent Financing Strengthens IMV’s Financial Position

All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).

Public Offering

On July 20, 2021, IMV announced the closing of a public offering of 14,285,714 units at a price to the public of $1.75 per Unit, for aggregate gross proceeds to the Corporation of approximately $25 million (Estimated net proceeds are $23 million). Each unit is comprised of one common share and three-quarters of one common share purchase warrant. Each Warrant entitles the holder thereof to purchase one common share at a price of $2.10 per common share, subject to adjustment in certain events, for five years until July 20, 2026. If the warrants are fully exercised, they can represent approximately $22.5M of additional gross proceeds.

Overview of Second Quarter 2021 Financial Results

On June 30, 2021, the Company had cash and cash equivalents of $22.8 million and working capital of $24.6 million, compared with $36.3 million and $35.6 million, respectively at December 31, 2020. Subsequent to June 30, 2021, the Company completed the above-mentioned public offering of 14,285,714 units at $1.75 per unit for gross process of $25 million (estimated net proceeds of $23 million) resulting in pro-forma cash and cash equivalents of $45.8 million as of June 30, 2021. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations for more than 12 months.

Research and development expenses were $5.2 million for the three months ended June 30, 2021, compared with $3.8 million for the three months ended June 30, 2020. This increase of $1.4 million was mainly due to startup costs for the Phase 2B trial in DLBCL, the timing of manufacturing activities for MVP-S and DPX-SurMAGE, and an increase in headcount. These increases were partly offset by a decrease in costs for the pre-clinical development of DPX-COVID-19 and costs for the ongoing basket trial of MVP-S in several cancer indications.

General and administrative expenses were $3.4 million for the three months ended June 30, 2021, compared with $2.2 million for the three months ended June 30, 2020. This increase of $1.2 million was mainly attributable an increase in the Company’s Directors and Officers insurance premium as a result of rate increases in mid-2020, an increase in headcount and an increase in recruiting fees for new executives and board members.

Government assistance totaled $1.2 million for the three months ended June 30, 2021, compared with $1 million in Q2 2020. This increase in mainly driven by the revaluation of the Nova Scotia loan upon receipt of the 2-year deferral of repayments partly offset by a decrease in various government grants for the development of DPX-COVID-19, consistent with the decrease in development expenses described above.

The net loss and comprehensive loss of $7.4 million ($0.11 per share) for the three months ended June 30, 2021, was $2.6 million higher than the net loss and comprehensive loss of $4.8 million ($0.08 per share) for the three months ended June 30, 2020.

For the six-month period ended June 30, 2021, the net loss and comprehensive loss of $14.3 million ($0.21 per share) was $2.3 million higher than the net loss and comprehensive loss of $12.0 million ($0.24 per share) for the six-month period ended June 30, 2020. The higher net loss is primarily the result of a $1.1 million increase in R&D expenses and a $2 million increase in general and administrative expenses partly compensated by a $1 million increase in government assistance mainly towards COVID-19 vaccine development as well as the revaluation of the loan with the province of Nova Scotia upon receipt of the above-mentioned amendment.

As of August 10, 2021, the number of issued and outstanding common shares was 82,142,629 and a total of 15,705,452 stock options, warrants and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as the Company’s website at View Source

Selected Upcoming Milestones

Maveropepimut-S (MVP-S):

Q3 2021: Initiation of investigator-led study in breast cancer
H2 2021: Design of Phase 2 clinical study in ovarian cancer for FDA meeting
Q4 2021: Clinical update for the basket trial (Bladder & MSI-hi tumor cancers)
H1 2022: Clinical update for the breast trial
DPX-SurMAGE:

H2 2021: Initiation of a Phase 1 clinical study in bladder cancer
Conference Call and Webcast Information

Management will host a conference call and webcast today August 11, 2021, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 2877244

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.