On March 6, 2023 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update (Press release, Adaptimmune, MAR 6, 2023, View Source [SID1234628208]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "The last twelve months have seen immense progress in autologous cell therapies for people with cancer. CAR-T therapies have established autologous T-cell therapy as viable businesses within the broader cell and gene therapy market, which has annual sales exceeding three billion dollars. Our progress with T-cell therapies in solid tumors is truly exciting, as solid tumors account for nearly 90% of all adult cancers. I think 2023 will be a breakout year for T-cell therapies to address the broader cancer market, with Adaptimmune at the forefront."

Adaptimmune’s first potential commercial product, afami-cel, for the treatment of synovial sarcoma

Adaptimmune initiated its BLA submission to the U.S. Food and Drug Administration (FDA) in the fourth-quarter 2022 and is on track to complete the BLA in mid-2023. This BLA is supported by data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy. The Company has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for afami-cel for the treatment of synovial sarcoma.

As reported in November 2022, data presented at the Connective Tissue Oncology Society (CTOS) annual meeting indicate continued clinical responses with an acceptable safety profile in heavily pre-treated patients with late-stage synovial sarcoma after a single dose of afami-cel.

Overall response rate was 39% in heavily pre-treated patients with synovial sarcoma, with a median duration of response of ~12 months

Afami-cel shown to drive tumor infiltration of activated and proliferative cytotoxic ("killer") T-cells into tumors – which likely contributes to antitumor responses.

Benefit:risk profile of afami-cel has been favorable, to date

Potential of next-gen MAGE-A4 TCR T-cell therapy (ADP-A2M4CD8) in multiple solid tumors

The following results were reported from 43 evaluable patients the Phase 1 SURPASS trial at the beginning of the year in heavily pre-treated patients with late-stage cancers after a single dose of ADP-A2M4CD8

37% overall response rate across multiple solid tumors

52% response rate in the focus indications of ovarian, bladder and head & neck cancers

75% response rate in these focus indications amongst patients who received ≤ 3 prior lines of therapy

The Company is initiating a Phase 2 trial, SURPASS-3, in 1H 2023 for people with ovarian cancer.

SURPASS-3 will be conducted in patients with platinum resistant ovarian cancer who have received ≤ 4 prior lines of therapy; ADP-A2M4CD8 will be investigated as monotherapy and also combined with the checkpoint inhibitor nivolumab.

SURPASS-3, which could become registrational, is supported by RMAT designation from the FDA and is being developed in collaboration with The GOG Foundation, Inc.

Adaptimmune is initiating two new cohorts in the Phase 1 SURPASS trial, combining ADP-A2M4CD8 with the checkpoint inhibitor pembrolizumab in 1) the second line treatment setting for bladder cancer and 2) in the first line treatment setting for head & neck cancer.

As announced last year, the Company has closed the SURPASS-2 trial in gastroesophageal cancers to further enrollment

Preclinical pipeline update

Last year, the Company announced that it will gain full control of the late-stage preclinical optimized PRAME TCR as well as the NY-ESO cell therapy program; discussions with GSK to finalize termination and transfer terms remain ongoing

The Company aims for the PRAME program to be IND-ready in 2023

Adaptimmune will continue to focus on its MAGE-A4 franchise while determining the optimal development path for complementary PRAME and NY-ESO programs

Partnered programs with Genentech continue with the allogeneic pipeline and the Company is also advancing its own wholly owned allogeneic programs

Last year, the Company took the decision to change the cell line being used to develop its MAGE-A4 allogeneic cell therapy. This change was due to the presence of a chromosomal abnormality in the original cell line and will delay the timing of the first allogeneic IND submission to 2025. This original cell line is not used in any of the Company’s partnered programs.

Corporate and other news

Adaptimmune announced a strategic combination with TCR² Therapeutics Inc. earlier today (please refer to separate press release dated March 6, 2023). As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into early 2026.

Adaptimmune and Universal Cells have agreed to terminate the Collaboration and License Agreement dated January 13, 2020 under which the parties agreed to co-develop certain allogeneic cell therapies. Termination is effective as of March 6, 2023. Termination does not impact the development of our allogeneic cell lines for our internal allogeneic programs or for our collaboration with Genentech Inc.

Completed the majority of the expenditure on two capital projects to prepare manufacturing network for the next phase of growth.

Additional cleanroom space in the manufacturing facility at the Navy Yard in Philadelphia, PA for future commercial launch of afami-cel

Construction of a dedicated allogeneic manufacturing facility in the United Kingdom (co-located with its UK research headquarters) to supply future allogeneic products.

Completed restructuring with a reduction in headcount of approximately 25%.

In connection with the Company’s restructuring, Cintia Piccina separated from the Company as its Chief Commercial Officer effective March 5, 2023. Ms. Piccina remains engaged with Adaptimmune on a consultancy basis.

Financial Results for the fourth quarter and year ended December 31, 2022

Cash / liquidity position: As of December 31, 2022, Adaptimmune had cash and cash equivalents of $108.0 million and Total Liquidity1 of $204.6 million, compared to $149.9 million and $369.6 million, respectively, as of December 31, 2021.

Revenue: Revenue for the fourth quarter and year ended December 31, 2022 was $11.0 million and $27.1 million, respectively, compared to $1.4 million and $6.1 million for the same periods in 2021. Revenue has increased primarily due to an increase in development activities under our collaboration arrangements, in particular due to development activities under the Genentech Strategic Collaboration and License Agreement, which become effective in October 2021. Revenue also increased due to a $6 million payment receivable from GSK as a result of the termination and amendment to the GSK Collaboration and License Agreement.

Research and development (R&D) expenses: R&D expenses for the fourth quarter and year ended December 31, 2022 were $23.1 million and $127.7 million, respectively, compared to $29.5 million and $111.1 million for the same periods in 2021. R&D expenses increased due to an increase in the average number of employees engaged in research and development, increases in subcontracted expenditures and a decrease in offsetting reimbursements receivable for research and development tax and expenditure credits.

General and administrative (G&A) expenses: G&A expenses for the fourth quarter and year ended December 31, 2022 were $15.2 million and $63.4 million, respectively, compared to $14.8 million and $57.3 million for the same periods in 2021 due to increases in employee-related costs and other corporate costs and restructuring charges.

Net loss: Net loss attributable to holders of the Company’s ordinary shares for the fourth quarter and year ended December 31, 2022 was $29.3 million and $165.5 million, respectively ($(0.03) and $(0.17) per ordinary share), compared to $38.9 million and $158.1 million, respectively ($(0.04) and $(0.17) per ordinary share), for the same periods in 2021.

Financial Guidance

The Company believes that its existing cash, cash equivalents and marketable securities, together with the additional payments under the Strategic Collaboration and License Agreement with Genentech and reductions in the Company’s operating costs as a result of the restructuring of the Company that is expected to be completed in the first quarter of 2023, will fund the Company’s current operations into early 2025, as further detailed in the Company’s Quarterly Report on Form 10-K for the fourth quarter and year ended December 31, 2022, to be filed with the Securities and Exchange Commission following this earnings release.

On March 6, 2023 the Company announced entry into a merger agreement under which the Company will combine with TCR² Therapeutics Inc in an all-stock transaction. Following the closing of the transaction, we currently estimate that the cash runway of the combined company will extend into early 2026.

Webcast Information

The Company will host a live webcast to provide additional details at 8:00 a.m. EDT (1:00 p.m. GMT) today, March 6, 2023. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

On March 6, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will participate in a fireside chat at the Oppenheimer 33rd Annual Healthcare Conference on Monday, March 13, 2023, at 2:00 p.m. ET (Press release, ORIC Pharmaceuticals, MAR 6, 2023, View Source [SID1234628206]).

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The live webcast of the discussion will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the event.

On March 6, 2023 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and to support innovative cell-based research, reported preliminary revenue results for the fourth quarter and full year 2022 and provided initial 2023 revenue guidance (Press release, MaxCyte, MAR 6, 2023, View Source [SID1234628205]).

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Preliminary Unaudited Fourth Quarter and Full Year 2022 Revenue

Management expects total revenue for the fourth quarter of 2022 to be approximately $12.4 million, up from $10.2 million in the fourth quarter of 2021, reflecting growth of approximately 22% including approximately 4% growth in core business revenue. Revenue for the quarter ended December 31, 2022 includes approximately $1.9 million of Strategic Platform Licenses ("SPLs") program-related revenue, compared to immaterial program-related revenue in the fourth quarter of 2021.

Total revenue for the year ended December 31, 2022 is expected to be approximately $44.3 million, up from $33.9 million in full year 2021, reflecting growth of approximately 31% in total revenue and approximately 26% in core business revenue. Revenue for the year ended December 31, 2022 includes approximately $4.6 million of SPL program-related revenue, compared to $2.5 million of program-related revenue in 2021.

MaxCyte’s revenue is derived from its core business (sales and leases of instruments and sales of disposables to cell therapy and drug discovery customers), as well as program-related revenue from SPL agreements.

MaxCyte ended the year with 18 SPL partnerships, including 3 SPL partnerships added during 2022 with Intima Bioscience, LG Chem, and Curamys. MaxCyte signed an SPL partnership agreement with Catamaran Bio in January 2023, bringing the current total number of SPL partnerships to 19.

"We delivered strong growth across the business in 2022, giving us confidence as reflected in our initial 2023 revenue guidance," said Doug Doerfler, President and CEO of MaxCyte. "Our diverse and robust partnership portfolio continues to grow with three new partnerships added in 2022, in addition to the signing of a partnership with Vertex Pharmaceuticals following the transfer from CRISPR Therapeutics for the development of its CRISPR/Cas9-based gene-edited therapy (exa-cel, formerly known as CTX001). We were pleased to announce an additional partnership in January 2023 with Catamaran Bio to support their CAR-NK cell therapy programs for solid tumors. We look forward to further expansion of our partnerships based on a strong pipeline and the continued progression of our partners’ programs as they move into and through the clinic towards commercialization."

In addition to revenue, management regularly reviews key business metrics to evaluate MaxCyte’s business, measure performance, identify trends affecting its business, formulate financial projections and make strategic decisions. As of the dates presented, these key metrics were as follows:

As of December 31,

2022

2021

2020*

Installed base of instruments (sold or leased)

>600

>500

>400

Number of active SPL partnerships

18

15

12

Total number of licensed clinical programs (SPL partnerships only)

>125

>95

>75

Total number of active licensed clinical programs under SPL partnerships currently in the clinic**

16

15

7

Total potential pre-commercial milestones under SPL partnerships

>$1.55 billion

>$1.25 billion

>$950 million

* Amounts presented as of December 31, 2020, give effect to one SPL entered into and additional INDs cleared in January 2021.

** Number of licensed clinical programs under SPLs are by number of product candidates and not by indication.

MaxCyte’s fourth quarter and full year 2022 financial results presented in this release are preliminary and unaudited and are subject to revision based on the completion of MaxCyte’s normal quarter and year-end process and year-end audit. As a result, these preliminary results may differ from the audited actual results that will be reflected in MaxCyte’s consolidated financial statements for the year ended December 31, 2022, which we expect to issue on March 15, 2023.

2023 Revenue Guidance

Management is providing initial 2023 revenue guidance for total revenue, core business revenue and SPL program-related revenue.

Management expects full year 2023 total revenue growth between 21% and 26% over 2022, including core business revenue growth between 20% and 25% over 2022, and SPL program-related revenue of approximately $6 million.

Fourth Quarter and Full Year Financial Results

MaxCyte will report full 2022 financial results and host a conference call on March 15, 2023, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

On March 6, 2023 Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its fourth quarter and full year 2022 financial results and highlighted recent corporate achievements (Press release, Day One, MAR 6, 2023, View Source [SID1234628204]).

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"Day One made tremendous progress in 2022 on our mission of bringing novel targeted therapies to children with brain cancer and people of all ages with life-threatening diseases," said Jeremy Bender, Ph.D., chief executive officer of Day One. "With positive topline results from the FIREFLY-1 study and commercial launch planning well underway, we believe we are on track to submit our first New Drug Application in the first half of this year. Given the significant unmet need for new therapies in children with relapsed or progressive pediatric low-grade gliomas, our team is laser focused on executing on our mission."

Program Highlights

•
In March 2023, Day One dosed the first patient in the pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib as a frontline therapy for patients newly diagnosed with pLGG.
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The study is a randomized, monotherapy, open-label trial aiming to enroll approximately 400 patients aged 6 months to 25 years across approximately 100 sites globally, including in the United States, Europe and Asia.
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The primary endpoint will be the overall response rate (ORR) based upon Response Assessment for Neuro-Oncology (RANO) criteria as reported by Blinded Independent Central Review.
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Secondary endpoints will include safety, progression-free survival, overall survival, duration of response, functional outcomes and quality of life measures.

•
In January 2023, Day One announced positive topline results from the ongoing, open-label, pivotal Phase 2 FIREFLY-1 trial evaluating tovorafenib (DAY101) as a monotherapy in relapsed or progressive pLGG. The primary endpoint of the FIREFLY-1 trial is ORR by RANO criteria as assessed by Blinded Independent Central Review. Topline results as of September 28, 2022 include:
o
Among 69 RANO-evaluable patients:
▪
64% ORR and 91% clinical benefit rate (complete response + partial response/unconfirmed partial response + stable disease)
•
4% (n=3) confirmed complete responses
•
59% (n=41) partial responses (31 confirmed and 10 unconfirmed)
•
28% (n=19) patients with stable disease
▪
86% (n=59) of patients had a BRAF fusion alteration, for which there are no approved systemic therapies, while the remaining 14% (n=10) had a BRAF mutation

o
Safety data, based on 77 treated patients, indicated monotherapy tovorafenib (DAY101) to be generally well-tolerated. The most common side effects reported related to tovorafenib (DAY101) were change in hair color (75%), increased creatine phosphokinase (64%), anemia (46%), fatigue (42%), and maculopapular rash (42%).

o
Among a total of 77 treated patients:
▪
Participants were heavily pretreated, with a median of three prior lines of systemic therapy (range: 1-9)
▪
The median duration of tovorafenib (DAY101) treatment was 8.4 months, with 77% (n=59) of patients on treatment at the time of the data cutoff
▪
Nearly 60% (n=46) of patients had already received at least one prior MAPK inhibitor prior to study participation

•
Patient enrollment continues in the Phase 1b/2 FIRELIGHT-1 trial evaluating tovorafenib (DAY101) as a monotherapy and as a combination with the company’s investigational MEK inhibitor, pimasertib, in adults and adolescents with relapsed, progressive, or refractory solid tumors harboring MAPK pathway aberrations.

Upcoming Milestones

•
Additional follow-up data from the full FIREFLY-1 study population is planned for presentation at a medical meeting in the second quarter of 2023.

•
Anticipated submission of an NDA for tovorafenib (DAY101) to the United States Food and Drug Administration (FDA) in the first half of 2023.

Fourth Quarter and Full Year 2022 Financial Highlights

•
Cash Position: Cash, cash equivalents and short-term investments totaled $342.3 million on December 31, 2022. Based on Day One’s current operating plan, management believes it has sufficient capital resources to fund anticipated operations into 2025.

R&D Expenses: Research and development expenses were $26.0 million and $85.6 million for the fourth quarter and full year ended December 31, 2022, respectively, as compared to $11.2 million and $43.6 million for the same periods in 2021. The increase was primarily due to additional employee compensation costs, clinical trial and pre-commercial manufacturing activities related to Day One’s lead product candidate, tovorafenib (DAY101).

•
G&A Expenses: General and administrative expenses were $16.7 million and $61.3 million for the fourth quarter and full year ended December 31, 2022, respectively, as compared to $10.8 million and $29.2 million for the same periods in 2021. The increase was primarily due to additional employee compensation costs, an ongoing commercial buildout, and professional service expenses to support company growth.

•
Net Loss: Net loss totaled $40.1 million for the fourth quarter of 2022 with non-cash stock compensation expense of $6.8 million, compared to $21.9 million for the fourth quarter of 2021 with non-cash stock compensation expense of $5.1 million. Net loss was $142.2 million for the year ended December 31, 2022, with non-cash stock compensation expense of $27.2 million, compared to $72.8 million for the year ended December 31, 2021, with non-cash stock compensation expense of $13.3 million.

Upcoming Events

43rd Annual TD Cowen Health Care Conference
o
Management will participate in a fireside chat on March 7 at 9:10 a.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events & Presentations section of the Company’s website.

About Tovorafenib

Tovorafenib is an investigational, oral, brain-penetrant, highly-selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is being investigated in primary brain tumors or brain metastases of solid tumors. Tovorafenib has been studied in over 325 patients to date. Currently tovorafenib is under evaluation in a pivotal Phase 2 clinical trial (FIREFLY-1) among pediatric, adolescent and young adult patients with relapsed or progressive pLGG, which is an area of considerable unmet need with no approved therapies. Tovorafenib is also being evaluated alone or as a combination therapy for adolescent and adult patient populations with recurrent or progressive solid tumors with MAPK pathway aberrations (FIRELIGHT-1).

Tovorafenib (DAY101)has been granted Breakthrough Therapy and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pLGG harboring an activating RAF alteration. Tovorafenib (DAY101) has also received Orphan Drug designation from the FDA for the treatment of malignant glioma, and from the European Commission (EC) for the treatment of glioma.

On March 6, 2023 Verrica Pharmaceuticals Inc. ("Verrica" or "the Company") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Verrica Pharmaceuticals, MAR 6, 2023, View Source [SID1234628200]).

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"We continue to execute across all aspects of our business, highlighted by the FDA’s recent acceptance of the filing of the resubmission of our NDA for VP-102, which is being developed for the treatment of molluscum contagiosum," said Ted White, Verrica’s President and Chief Executive Officer. "Our potentially first-in-class oncolytic peptide immunotherapy, VP-315, for the treatment of basal cell carcinoma also continues to advance, and we remain on track to dose patients in Part 2 of our ongoing Phase 2 trial in the second quarter.

"In parallel with our regulatory and clinical accomplishments, we continue to make progress in our pre-commercial activities as we prepare for a potential U.S. launch of what could potentially be the first FDA-approved therapy for molluscum – a condition afflicting millions of children each year in the U.S. Utilizing our innovative "Buy-and-Bill" commercial model, we believe shelf-stable products for in-office administration such as VP-102 can be efficiently distributed to reach this large and underserved patient population with minimal capital outlay for dermatology practices."

Business Highlights and Recent Developments

VP-102

On February 27, 2023, the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) of July 23, 2023 for Verrica’s New Drug Application (NDA) for VP-102, which is being developed for the treatment of molluscum contagiosum (molluscum). In January, the Company announced that it resubmitted the NDA for VP-102 for the treatment of molluscum to the FDA

Verrica is seeking conditional approval to market VP-102 in the United States under the brand name YCANTH. VP-102 is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. If approved, VP-102 would be the first product approved by the FDA to treat molluscum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children.

VP-315

Verrica expects to initiate Part 2 of its ongoing Phase 2 study in basal cell carcinoma in the second quarter of 2023. Part 2 is designed to confirm the exploratory dose from Part 1 and identify the recommended dosing regimen for Part 3 of the study. Cohorts will be expanded, and dosing evaluated based upon safety and efficacy results. VP-315 is a potentially first-in-class oncolytic peptide immunotherapy in development as a non-surgical treatment option for non-melanoma skin cancers. The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 66 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.

Financial Results

Fourth Quarter 2022 Financial Results

Verrica recognized collaboration revenues of $0.1 million for the three months ended December 31, 2022, which was related to the Collaboration and License Agreement (Torii Agreement) with Torii Pharmaceutical Col, Ltd (Torii). Verrica did not recognize any revenue for the same period in 2021

Verrica reported a net loss of $5.9 million for the fourth quarter of 2022, compared to a $9.5 million loss for the same period in 2021

Research and development expenses were $3.0 million in the fourth quarter of 2022, compared to $3.4 million for the same period in 2021. The decrease was primarily attributable to a decrease in CMC costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts and common warts in 2022

General and administrative expenses were $3.2 million in the fourth quarter of 2022, compared to $5.1 million for the same period in 2021. The decrease was primarily due to decreased headcount, a decrease in insurance, and other operating costs.

Full Year 2022 Financial Results

Verrica recognized collaboration revenues related to the Torii Agreement of $9.0 million for the year ended December 31, 2022 compared to $12.0 million for 2021. The current period collaboration revenue was related to an $8.0 million milestone payment and $1.0 million related to Torii’s purchase of supplies and reimbursement for development activities while the 2021 collaboration revenue was driven by the Torii upfront license milestone payment of $12.0 million

Research and development expenses were $12.2 million for the year ended December 31, 2022, compared to $15.9 million for 2021. The decrease was primarily attributable decreased CMC and clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts in 2022, as well as a decrease of 1.3 million related to payments made to Lytix Biopharma AS (Lytix) upon the achievement of regulatory milestones for VP-315, during 2022 compared to 2021

General and administrative expenses were $17.4 million for the year ended December 31, 2022, compared to $27.0 million for the same period in 2021. The decrease of $9.6 million was primarily a result of a decrease in expenses related to pre-commercial activities for VP-102 and decreases in headcount, insurance, professional fees, and other operating costs

Costs of collaboration revenue were $0.7 million for the year ended December 31, 2022, compared to no costs for the year ended December 31, 2021. The costs of collaboration revenue during 2022 consisted of payments for manufacturing supply to support development and testing services pursuant to the clinical supply agreement with Torii

For the year ended December 31, 2022, net loss on a GAAP basis was $24.5 million, or $0.72 per share, compared to a net loss of $35.1 million, or $1.30 per share, for the same period in 2021

For the year ended December 31, 2022, non-GAAP net loss was $17.4 million, or $0.51 per share, compared to a non-GAAP net loss of $27.6 million, or $1.02 per share, for the same period in 2021

As of December 31, 2022, Verrica had aggregate cash and cash equivalents of $34.3 million. In February 2023, the Company raised gross proceeds of approximately $32.5 million in an underwritten offering of its common stock and pre-funded warrants. Including the net proceeds received from this offering and the Company’s existing cash and cash equivalents as of December 31, 2022, Verrica believes it has sufficient cash and cash equivalents to support planned operations into the first quarter of 2024.

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, loss on debt extinguishment 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 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. Verrica is seeking conditional approval to market VP-102 in the United States under the 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.