On August 10, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies against difficult-to-treat cancers, reported the final topline results of the DeCidE1 Phase 2 clinical trial evaluating maveropepimut-S (MVP-S, formerly known as DPX-Survivac) in subjects with advanced recurrent ovarian cancer (Press release, IMV, AUG 10, 2021, View Source [SID1234586217]).

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"The overall results obtained from the DeCidE1 trial are very promising," said Dr. Oliver Dorigo, Principal Investigator of the DeCidE1 study and Director of the Gynecologic Oncology Service at Stanford University. "Treatment was well-tolerated with an overall survival rate of 44.9% at 23.8 months of follow up and a median overall survival of 19.9 months. These results are particularly encouraging because many subjects in the trial had been heavily pre-treated and 57.9% were platinum resistant. We believe that these results support the further clinical study of maveropepimut-S in ovarian cancer." Secondary endpoints in the DeCidE1 clinical study included an extensive analysis of collected biological samples. Dr Jeremy Graff, Chief Scientific Officer of IMV commented, "The translational analyses provide strong evidence that maveropepimut-S successfully elicits the generation of tumor antigen-specific T cells. Importantly, these analyses affirm the molecular and cellular mechanism of MVP-S based therapy. This data will also inform the discussion and design of a Phase 2 clinical study to be submitted to the FDA." The details of these translational analyses have been submitted to upcoming scientific meetings for presentation.

About the DeCidE1 Study

"DeCidE1" was a Phase 1b/2 multicenter, randomized, open-label study to evaluate the safety and effectiveness of maveropepimut-S (MVP-S, formerly named DPX-Survivac) with intermittent low dose cyclophosphamide (CPA). This Phase 2 trial enrolled 22 subjects with recurrent, advanced platinum-sensitive and resistant ovarian cancer. Subjects received 2 subcutaneous injections of MVP-S three weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off until end of treatment. Tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study were overall response rate, disease control rate and safety. Secondary endpoints included cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival, and biomarker analyses. More information on the DeCidE1 study can be found here.

On August 10, 2021 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the second quarter ended June 30, 2021 (Press release, Verrica Pharmaceuticals, AUG 10, 2021, View Source [SID1234586203]).

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"This quarter, we continued to ramp up commercial preparations for the potential FDA approval of VP-102, our lead product candidate for the treatment of molluscum contagiosum, including strengthening our senior leadership team and ensuring patient access to VP-102 through productive dialogue with medical providers and payors," said Ted White, Verrica’s President and Chief Executive Officer. "With a strong financial position, and a PDUFA goal date of September 23, 2021, we continue to invest in our commercial capabilities and, if approved, we look forward to the opportunity to launch VP-102 in the fourth quarter of 2021."

Business Highlights and Recent Developments

In May 2021, the Company announced that the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution) for the treatment of molluscum contagiosum by three months to September 23, 2021 to allow the Agency additional time to review information requested and submitted regarding the Company’s training program and distribution model.
The Company continued to expand its U.S. commercial operations during the quarter in preparation for the potential FDA approval of VP-102, and has made key hires in marketing, sales and payor functions to support product launch and commercialization. The Company will be focusing its sales efforts in Dermatology, Pediatric Dermatology and key academic centers and health systems.
The Company strengthened its management team in anticipation of the potential commercial launch of VP-102 with the appointment of Terry Kohler as Chief Financial Officer, effective July 16, 2021. Mr. Kohler is a strategic and operational finance leader with over 20 years of commercial business experience, most recently at a global pharmaceutical company with annual revenues over $2 billion.
The Company continues to prepare to submit an Investigational New Drug Application for LTX-315 in the second half of 2021 for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic merkel cell carcinoma.
Financial Results

Second Quarter 2021 Financial Results

Research and development expenses were $3.4 million in the second quarter of 2021, compared to $3.5 million for the same period in 2020. The decrease was primarily attributable to lower clinical costs related to Verrica’s development of VP-102 for external genital warts and common warts.
General and administrative expenses were $7.3 million in the second quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by increased headcount and other expenses related to pre-commercial activities for VP-102, as well as an increase in insurance, professional fees and other operating expenses.
For the second quarter of 2021, net loss on a GAAP basis was $11.8 million, or $0.43 per share, compared to a net loss of $9.4 million, or $0.38 per share, for the same period in 2020.
For the second quarter of 2021, non-GAAP net loss was $9.6 million, or $0.35 per share, compared to a non-GAAP net loss of $7.9 million, or $0.32 per share, for the same period in 2020.
Year-to-Date June 2021 Financial Results

Verrica recognized license revenues of $12.0 million for the six months ended June 30, 2021 related to the Collaboration and License Agreement (the "Torii Agreement") with Torii Pharmaceutical Co., Ltd ("Torii"). There were no license revenues recognized in 2020.
Research and development expenses were $8.8 million for the six months ended June 30, 2021, compared to $8.4 million for the same period in 2020. The increase was primarily attributable to a one-time $2.3 million milestone payment to Lytix Biopharma AS upon the achievement of a regulatory milestone for LTX-315, partially offset by decreased Chemistry, Manufacturing and Controls ("CMC") and clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts.
General and administrative expenses were $13.9 million for the six months ended June 30, 2021, compared to $10.1 million for the same period in 2020. The increase was primarily driven by increased headcount and other expenses related to pre-commercial activities for VP-102, as well as an increase in insurance, professional fees and other operating expenses.
For six months ended June 30, 2021, net loss on a GAAP basis was $12.7 million, or $0.46 per share, compared to a net loss of $19.2 million, or $0.77 per share, for the same period in 2020.
For the six months ended June 30, 2021, non-GAAP net loss was $8.8 million, or $0.32 per share, compared to a non-GAAP net loss of $16.7 million, or $0.67 per share, for the same period in 2020.
As of June 30, 2021, Verrica had aggregate cash, cash equivalents, and marketable securities of $90.1 million. The Company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2021 will be sufficient to support planned operations at least into the first quarter of 2023.
Non-GAAP Financial Measures

In evaluating the operating performance of its business, Verrica’s management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.

About VP-102

Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review, with a PDUFA goal date of September 23, 2021, and could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.

About Molluscum Contagiosum (Molluscum)

There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.

On August 10, 2021 NuCana plc, a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported the appointment of Jeffrey D. Bloss, M.D. as Chief Medical Officer. Dr. Bloss will be based in NuCana’s US offices located outside Boston, MA (Press release, Nucana BioPharmaceuticals, AUG 10, 2021, View Source [SID1234586202]).

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"We are delighted to welcome Jeff to the executive team at NuCana," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Jeff brings over two decades of experience leading clinical development and medical affairs at several biotechnology and pharmaceutical companies. His achievements include leading the development, approval and commercialization of numerous blockbuster oncology drugs, which will be invaluable to NuCana as we continue to advance our ProTide pipeline through the clinic and, if approved, towards commercialization."

Dr. Bloss said, "I am excited to join NuCana and look forward to furthering its mission of improving treatment outcomes for patients with cancer by developing more effective and safer medicines. The Company’s phosphoramidate chemistry approach has the potential to positively impact the lives of millions of patients with cancer. With an ongoing Phase III clinical study of Acelarin plus cisplatin in patients with biliary tract cancer, the upcoming initiation of a Phase III clinical study of NUC-3373 in combination with other agents in patients with colorectal cancer and an ongoing Phase I clinical study of NUC-7738 in patients with solid tumors, I could not be joining NuCana at a more exciting time."

Jeffrey Bloss, M.D. brings over 25 years of leadership experience in oncology at multiple biopharmaceutical companies including Astellas, GlaxoSmithKline, Xencor, Onyx, Genentech and Eli Lilly. During his career Dr. Bloss has been a key member of the teams responsible for the development, approval and commercialization of more than ten successful oncology drugs, including Gemzar, Tarceva, Sorafenib, Tykerb and Xtandi. Immediately prior to joining NuCana, Dr. Bloss served as Chief Medical Officer of Tarveda Therapeutics, a venture-backed clinical-stage oncology company. Prior to Tarveda, Dr. Bloss was Chief Medical Officer and Senior Vice President, Medical Affairs at Aegerion. Before his work within industry, Dr. Bloss held a series of roles of increasing responsibility at the University of Missouri, Ellis Fischel Cancer Center and in the United States Air Force Medical Corps. Dr. Bloss completed his Residency in Obstetrics & Gynecology at Wilford Hall USAF Medical Center and his Fellowship in Gynecologic Oncology at the University of California, Irvine. He received his M.D. from Thomas Jefferson University Medical College and B.S. from Juniata College.

On August 10, 2021 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, reported its financial results for the second quarter ended June 30, 2021, and recent business highlights (Press release, Achilles Therapeutics, AUG 10, 2021, View Source [SID1234586201]).

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"Achilles continued to make significant progress in the second quarter of 2021. We presented data at AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) demonstrating that we can quantify the active clonal neoantigen-reactive T cell (cNeT) component and cNeT dose of our product. We were also able to track our cNeT post-dosing and describe phenotypic and functional characteristics. We believe that this critical capability will allow us to develop a potency assay which could be a crucial advancement in the TIL therapeutic space. We remain on target to report clinical and characterization data on ten patients that have received cNeT monotherapy across the CHIRON and THETIS trials in the fourth quarter," said Dr Iraj Ali, Chief Executive Officer of Achilles. "We continue to enroll and dose patients and have recruited our first US patient at the Moffitt Cancer Center. Also in the fourth quarter of 2021, we plan to begin enrolling patients using our Process 2 to deliver higher dose cNeT and to open a checkpoint combination cohort in our melanoma (THETIS) study to evaluate the addition of a PD-1 inhibitor to cNeT therapy."

Business Highlights

Closed an initial public offering of 9,750,000 ADRs at a public offering price of $18.00 per share for gross proceeds of $175.5 million.
Enrolled first US Patient in ongoing PI/IIa CHIRON study in non-small cell lung cancer at the Moffitt Cancer Center
Presented a poster at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting describing the ongoing phase I/IIa CHIRON clinical trial evaluating clonal cNeT in patients with advanced non-small cell lung cancer (NSCLC)
Presented data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting detailing the Company’s comprehensive translational research program and insights into the in vivo dynamics of cNeT post-dosing and the potential to develop a potency-based release assay
Strengthened the Board of Directors and Scientific Advisory Board with the additions of Julie O’Neill and Markwin Velders, Ph.D., respectively
Received a Horizon 2020 grant as part of the Neoantigen Consortium, to collaborate on the development of a tool to predict neoantigen immunogenicity
Financial Highlights

Cash and cash equivalents: Cash and cash equivalents were $299.3 million as of June 30, 2021, as compared to $177.8 million as of December 31, 2020. Current cash and cash equivalents include net proceeds of $160.6 million from an initial public offering that closed in the second quarter. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations into the second half of 2023, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.
Research and development (R&D) expenses: R&D expenses were $10.8 million for the second quarter ended June 30, 2021, an increase of $6.3 million compared to $4.5 million for the second quarter ended June 30, 2020. R&D expenses were $19.7 million for the six months ended June 30, 2021, an increase of $11.3 million compared to $8.4 million for the six months ended June 30, 2020. The increase was primarily driven by increased activity related to our ongoing clinical trials and overall R&D.
General and administrative (G&A) expenses: G&A expenses were $5.4 million for the second quarter ended June 30, 2021, an increase of $3.0 million compared to $2.4 million for the second quarter ended June 30, 2020. G&A expenses were $10.3 million for the six months ended June 30, 2021, an increase of $6.2 million compared to the $4.1 million for the six months ended June 30, 2020. The increase was primarily driven by fees associated with the Company’s IPO preparation, subsequent public company obligations, and an increase in headcount and related personnel costs.
Net loss: Net loss for the second quarter ended June 30, 2021 was $16.2 million or $0.45 per share compared to $6.9 million or $7.64 per share for the second quarter ended June 30, 2020. Net loss for the six months ended June 30, 2021 was $29.9 million or $1.60 per share compared to $12.1 million or $13.57 per share for the six months ended June 30, 2020. The decrease in loss per share is due in part to the increased number of shares following the conversion and issuance of shares from the IPO.
Upcoming Events
Dr Iraj Ali, Chief Executive Officer, will present at the following investor conferences in September 2021. Additional details will be available at View Source

Wells Fargo Virtual Healthcare Conference: Friday, September 10, 2021
H.C. Wainwright 23rd Annual Global Investment Conference: September 13-15, 2021
Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit: September 20-23, 2021

On August 10, 2021 Cullinan Oncology, Inc. (Nasdaq: CGEM), an oncology company seeking to drive shareholder returns by focusing on the patient, reported its financial results for the second quarter ended June 30, 2021 and reported on recent business highlights (Press release, Cullinan Oncology, AUG 10, 2021, View Source [SID1234586200]).

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"Solid execution led to the advancement of our clinical pipeline this quarter," stated Owen Hughes, Chief Executive Officer of Cullinan Oncology. "We are pleased with the encouraging results of Cullinan Pearl (EGFR exon 20) showcased at ASCO (Free ASCO Whitepaper) as well as the recent IND clearance for the first two programs in our immuno-oncology pipeline, Cullinan MICA (MICA/B antibody) and Cullinan Florentine (FLT3 bispecific). With over $456 million of cash and investments on hand, we remain well capitalized to advance our broad pipeline through multiple clinical readouts. In the near term, we expect to provide updated preclinical data on Cullinan Amber at the Next-Gen Cytokine Therapeutics Summit in September as well as a Cullinan Pearl clinical and regulatory update in the fourth quarter."

Q2 2021 Portfolio Highlights

Cullinan Pearl: Presented interim data at ASCO (Free ASCO Whitepaper) 2021 from ongoing Phase 1/2a trial evaluating CLN-081 in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 mutations (press release).
Safety: CLN-081 continues to demonstrate promising overall safety and tolerability, with an encouraging GI toxicity profile.
Efficacy: As of the ASCO (Free ASCO Whitepaper) data cutoff, there were 5 pending partial responses (PR), 4 of which subsequently confirmed. In addition, follow-up data from patients in the 100mg Phase 1 cohort showed the DCR, defined as best response of PR + stable disease ≥6 months, increased to 92% (12 / 13 patients).
Phase 1/2a trial status: Cullinan recently completed enrollment of the Phase 2a 100mg expansion cohort (total n=36) and initiated expansion at 150mg (from 7 patients treated to date to 13 total). Cullinan intends to provide a clinical and regulatory update in Q4 2021.
Cullinan MICA: Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug application (IND) for CLN-619, a novel MICA/B-targeted antibody for the treatment of solid tumors (press release). CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with therapeutic potential for both solid and liquid tumor indications. Cullinan intends to initiate a first-in-human (FIH) trial of CLN-619 in 2H 2021, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy.
Cullinan Florentine: Received FDA clearance of IND for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML) (press release). CLN-049 is designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells, triggering the T cells to kill the targeted cancer cells via their intrinsic cytolytic mechanisms. Studies have shown that FLT3 is expressed on AML blasts in over 75% of AML patients, regardless of FLT3 mutational status. Cullinan intends to initiate a FIH trial of CLN-049 in 2H 2021.
Cullinan Amber: Continued progress towards final candidate selection for CLN-617, a fusion protein combining two potent antitumor cytokines, IL-2 and IL-12, in a single molecule with a collagen-binding tumor retention domain for the treatment of solid tumors. IND-enabling studies are planned to commence in the 2H 2021.
Cullinan NexGem: Continued to progress CLN-978, an internally developed half-life extended T cell engager designed to simultaneously engage CD19 and CD3, through IND-enabling development.
Q2 2021 Financial Results

Cash Position: Cash, cash equivalents and investments were $456.3 million as of June 30, 2021, compared to $473.0 million as of March 31, 2021. Net cash used in operating activities for the second quarter of 2021 was $16.4 million.
R&D Expenses: Research and development (R&D) expenses were $11.8 million for the second quarter of 2021, including $2.3 million of non-cash equity-based compensation expense, compared to $12.5 million for the second quarter of 2020. The decrease in R&D expenses is primarily related to a non-recurring non-cash charge related to the MICA acquisition in the second quarter of 2020, partially offset by increased expenses from headcount growth as well as expanded clinical and CMC activity from other portfolio programs.
G&A Expenses: General and administrative (G&A) expenses were $4.8 million for the second quarter of 2021, including $1.9 million of non-cash equity-based compensation expense, compared to $1.6 million for the second quarter of 2020. The increase in G&A expenses is primarily related to headcount growth as well as additional costs associated with operations as a public company.
Net loss: The Company’s net loss (before items attributable to noncontrolling interest) was $16.4 million for the second quarter of 2021, compared to $13.9 million for the second quarter of 2020, driven predominantly by increases in costs associated with public company operations and non-cash equity-based compensation expenses.