On March 30, 2023 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the fourth quarter and full-year ended December 31, 2022, and provided a corporate update (Press release, Theriva Biologics, MAR 30, 2023, View Source [SID1234629621]).

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"In 2022, we delivered on key milestones that further validate the value of Theriva’s oncology-focused platform, advanced our systemically administered lead oncolytic adenovirus, VCN-01, and with cash runway into the third quarter of 2024, we believe we are well positioned to propel our clinical development program forward," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "The dosing of the first patient in VIRAGE, our Phase 2b trial of VCN-01 in patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), as well as the Phase 1 trial of VCN-01 in patients with brain tumors, represent important steps in our pursuit to address unmet needs for difficult-to-treat cancers. Now, a key priority is to build on our compelling Phase 1 outcomes and generate clinical data that establish VCN-01’s differentiated mechanism of action, and potential synergistic clinical benefit in combination with chemotherapy and immunotherapy in a range of clinical indications. We will also leverage our discovery platform to identify the next generation of potent OV products."

Recent Program Highlights and Anticipated Milestones:

VCN-01:

In January 2023, the first patient was dosed in VIRAGE, the randomized, controlled, multicenter, open-label Phase 2b trial of VCN-01 in combination with standard-of-care chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy in newly diagnosed metastatic PDAC patients. The first patient was dosed in Spain and the trial is expected to enroll 92 adults at sites across the US and EU.
In January 2023, the first patient was dosed in the investigator sponsored clinical trial of VCN-01 in patients with high-grade brain tumors who are scheduled for surgical resection. The trial is being conducted at St. James’s University Hospital, United Kingdom, in collaboration with the University of Leeds. If the results show that intravenous VCN-01 gains entry to brain tumors that are otherwise only accessible through surgery, this could be transformative for patients by providing a potential systemic line of treatment that may minimize or eliminate complicated brain surgery.
Anticipated milestones:
Hold a pre-IND meeting with the FDA (H2 2023) to discuss the clinical development and potential registration pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma.
Present additional data from the study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (H2 2023).
SYN-004 (ribaxamase):

In February 2023, presented blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). SYN-004 appeared to be well tolerated in HCT patients treated with IV meropenem and SYN-004 was not detected in blood samples from the majority of the evaluable patients. These data were presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.
In November 2022, announced the first patient was dosed in the second cohort of the SYN-004 study in allo-HCT patients.
Anticipated milestones:
Complete the second cohort of our Phase 1b/2a clinical study of SYN-004 for the prevention of acute graft-versus-host-disease in bone marrow transplant patients (Q1 2024).
Fourth Quarter and Full-Year Ended December 31, 2022 Financial Results

General and administrative expenses increased to $9.9 million for the year ended December 31, 2022, from $6.5 million for the year ended December 31, 2021. This increase of 50.8% is primarily comprised of increased expense related to the fair value of the contingent consideration, higher insurance costs, additional salary and benefits related to new headcount, public relations expenses, and VCN administrative expenses not included in the prior year, offset by a decrease in consulting and legal costs related to the VCN acquisition. The charge relating to stock-based compensation expense was $0.4 million for the year ended December 31, 2022, compared to $0.3 million for the year ended December 31, 2021. In addition, we expect general and administrative expenses to increase as we increase headcount and related overhead due to the VCN acquisition.

Research and development expenses increased to $11.7 million for the year ended December 31, 2022, from $7.8 million for the year ended December 31, 2021. This increase of 50% is primarily the result of increased clinical trial expenses related to VCN-01 not incurred in the prior year, offset by lower clinical and manufacturing expenses related to our Phase 1a clinical trial of SYN-020 and expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. We anticipate research and development expense to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $112,000 for the year ended December 31, 2022, compared to $76,000 for the year ended December 31, 2021. In addition, we expect research and development expenses to increase as we incur higher clinical program costs for our VCN product candidates.

Other income was $471,000 for the year ended December 31, 2022, compared to other income of $6,000 for the year ended December 31, 2021. Other income for the year ended December 31, 2022 and is primarily comprised of interest income of $512,000 offset by an exchange loss of $41,000. Other income for the year ended December 2021 was primarily comprised of interest income.

Cash and cash equivalents totaled $41.8 million as of December 31, 2022, compared to $67.3 million as of December 31, 2021.

Conference Call

Theriva Biologics will host a conference call on Thursday, March 30, 2022, at 8:30 a.m. ET to review the full-year 2022 operational highlights and financial results. Individuals may participate in the live call via telephone by dialing 1-877-451-6152 (domestic) or 1-201-389-0879 (international) and using the conference ID: 13736047. Participants are asked to dial in 15 minutes before the start of the call to register. Investors and the public can access the live and archived webcast of this call via the "Investors" section of the company’s website, View Source, under "Events" or by clicking here, for 90 days after the call.

On March 30, 2023 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported financial results for the year ended December 31, 2022 and business highlights (Press release, Aptevo Therapeutics, MAR 30, 2023, View Source [SID1234629620]).

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2022 Highlights

APVO436 (Acute Myeloid Leukemia)

In December 2022 we announced that APVO436, in combination with venetoclax and azacitidine, demonstrated substantial clinical activity and a favorable safety and tolerability profile in adult venetoclax treatment naïve AML patients. More specifically:

The combination of venetoclax and azacitidine with APVO436 in venetoclax treatment naïve response-evaluable patients in Cohort 2 of the Phase 1b study outperformed a composite benchmark across all clinical benefit categories (Benchmark Composite References:
Aldoss 2019 , Maiti 2021 , Morsia 2020 , Garciaz 2022 , Feld 2021)
The data, which was presented in a poster session at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) in New Orleans, also showed that APVO436, when given in combination with venetoclax and azacitidine was observed to be generally safe and well tolerated
Based on Phase 1b outcomes, we plan to initiate a Phase 2 trial in the second half of 2023 to further evaluate APVO436 in combination with venetoclax and azacitidine in venetoclax treatment naïve patients
ALG.APV-527 (solid tumors)

In September 2022, we received a "may proceed" notification from the U.S. Food and Drug Administration (FDA), allowing us and our partner, Alligator Bioscience, to initiate clinical trials evaluating the compound for the treatment of 5T4-expressing tumors in multiple solid tumor types. A first-in-human study was initiated in the first quarter of 2023.

The first patient in this trial was dosed in February 2023. Patient recruitment is ongoing. ALG.APV-527 targets 4-1BB co-stimulatory receptor (on T lymphocytes and NK cells) and 5T4 (solid tumor antigen) and is designed to promote anti-tumor immunity.
The Preclinical Pipeline

On January 9, 2023, Aptevo filed a provisional patent with the U.S. Patent and Trademark Office (USPTO) pertaining to an anti-PD-L1 and anti-CD40 compound, APVO711, with the potential to fight a range of solid malignancies such as head and neck squamous cell carcinoma, melanoma, and carcinomas of the lung, gastrointestinal tract and colon. Aptevo initiated preclinical studies for APV0711 in the first quarter of 2023.

"2022 was a year of progress and momentum for Aptevo. As a Company we remained focused on our work, and the outcomes were both significant and impactful, while we, along with the industry, faced continued market challenges. As promised earlier in the year, we announced positive results from our Phase 1b trial evaluating APVO436 in adult patients with AML at ASH (Free ASH Whitepaper), successfully ushered our second candidate, ALG.APV-527, for evaluation in the treatment of solid tumors expressing the tumor-associated antigen 5T4, through the IND process and announced that we dosed the first patient in a Phase 1 trial in February 2023. We also announced a new pipeline molecule, APV0711, very early this year, the result of a focused and successful effort of our scientific team in 2022."

Mr. White concluded, "I am very pleased with our slate of accomplishments in 2022. Together, they demonstrate continued progress both in the clinic and across the pipeline and set us up for another successful year in 2023."

"In 2023 we are working to leverage the successes of 2022 to ensure we continue to progress in the clinic. For example, we are currently planning a Phase 2 trial evaluating APVO436 in adults with AML who are venetoclax treatment naïve. This process is informed by results reported in the fourth quarter 2022 showing substantial clinical activity, that outperformed a composite benchmark of similar patients, and a favorable safety and tolerability profile in every patient category we assessed. Retaining optionality for APVO436 development is critical to the planning process as we move toward trial initiation in the second half of the year," said Dirk Huebner, MD, Chief Medical Officer at Aptevo.

Dr. Huebner continued, "Our second clinical candidate, ALG.APV-527, is a bispecific antibody with a tumor-directed 4-1BB agonistic effect and the ability to specifically stimulate antitumor-specific T cells and NK cells involved in tumor control and we are excited about its potential.

The Phase 1 trial, initiated with our first patient dosed in February this year, is a multi-center, multi-cohort, open-label study that will include six cohorts in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types likely to express the 5T4 antigen, including (but not limited to) non-small cell lung cancer (NSCLC), gastric/gastro-esophageal cancer and head and neck cancer. Recruitment for the trial is ongoing and we anticipate preliminary results from the study later this year."

2022 Summary Financial Results

Cash Position: Aptevo had cash and cash equivalents as of December 31, 2022 totaling $22.6 million.

Royalty Revenue: Royalty revenue for the period covered by this report reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR. As a result of the amendment, we ceased reporting as royalty revenue, royalties paid by Pfizer to HCR related to Pfizer’s sales of RUXIENCE (rituximab-pvvr). The last quarter for which we reported this royalty revenue was Q1 2022. The Amendment was effected to address a Nasdaq compliance matter and had the additional effect of eliminating the requirement to report all future Pfizer non-cash royalty revenue and extinguishing the liability that we recorded upon the initial sale of the royalties to HCR. RUXIENCE is a registered trademark of Pfizer.

Research and Development Expenses : Research and development expenses decreased by $1.1 million, to $17.9 million for the year ended December 31, 2022 from $19.0 million for the year ended December 31, 2021. The decrease was primarily due to lower spending on preclinical projects and employee costs. The decrease was partially offset by higher spending on our APVO436 Phase 1b clinical trial and getting ALG.APV-527 ready for entry into the clinic.

General and Administrative Expenses : For the year ended December 31, 2022, general and administrative expenses decreased by $0.8 million, to $13.9 million from $14.7 million for the year ended December 31, 2021. The decrease is primarily due to lower employee and consulting costs and no costs related to responding to stockholder activism matter.

Other Income (Expense): Other income (expense), net consists primarily of gain on extinguishment of liabilities, milestone income related to sale of royalties, costs related to debt extinguishment, accrued exit fees on debt, non-cash interest on financing agreements, and interest on debt.

Other Expense, Net

Other expense, net was $4.0 million for the year ended December 31, 2022 and $8.0 million for the year ended December 31, 2021. This decrease is primarily due to significant decrease of non-cash interest expenses recorded for the year ended December 31, 2022. We no longer record non-cash interest expense due to our Amendment to the Royalty Purchase Agreement in the second quarter of 2022, which eliminated the liability related to the sale of royalties. Additionally, interest expense on our MidCap Credit Agreement has decreased due to principal payments made in 2022.

Gain on Extinguishment of Liability Related to Royalties

We recorded $37.2 million in other income for the year ended December 31, 2022, due to our Amendment to Royalty Purchase Agreement. We did not have any such gain for the year ended December 31, 2021.

Milestone Income Related to Sale of Royalties

We recorded $2.5 million in other income for the year ended December 31, 2022, related to Pfizer’s net sales of RUXIENCE in fiscal year 2022. Due to our Amendment to Royalty Purchase Agreement, we record Milestone Amounts from HCR when they are earned. We received the 2021 milestone payment of $10 million, net of transaction costs, in the first quarter of 2022 and recorded the proceeds received as an additional liability related to sale of royalties under ASC 470-10-25, Debt – Sales of Future Revenues or Various Other Measures of Income.

Discontinued Operations: Income from discontinued operations was $1.0 million for the year ended December 31, 2022 and 2021. For the year ended December 31, 2022, we collected $1.0 million in deferred payments from Medexus related to IXINITY sales. For the year ended December 31, 2021, we collected $0.5 million related to the 2017 sale of the hyperimmune business to Saol International Limited, and deferred payments of $0.5 million from Medexus related to IXINITY sales.

Net Income (Loss) : Aptevo had net income of $8.0 million or $1.57 per share for the year ended December 31, 2022, compared to a net loss of $28.5 million or $6.07 per share for the corresponding period in 2021.

Aptevo Therapeutics Inc.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)

December 31, 2022 December 31, 2021
ASSETS

Current assets:

Cash and cash equivalents
$ 22,635 $ 45,044
Restricted cash
- 1,259
Royalty and milestone receivable
2,500 3,664
Prepaid expenses
1,571 1,823
Other current assets
744 780
Total current assets
27,450 52,570
Property and equipment, net
1,462 2,379
Operating lease right-of-use asset
5,303 1,584
Other assets
- 68
Total assets
$ 34,215 $ 56,601
LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and other accrued liabilities
$ 3,499 $ 3,462
Accrued compensation
2,105 2,077
Liability related to the sale of royalties, net – short-term
- 15,465
Current portion of long-term debt
2,000 11,667
Other current liabilities
1,102 2,086
Total current liabilities
8,706 34,757
Liability related to the sale of royalties, net – long-term
- 15,580
Long-term debt
1,456 3,707
Operating lease liability
6,079 1,341
Total liabilities
16,241 55,385

Stockholders’ equity:

Preferred stock: $0.001 par value; 15,000,000 shares authorized, zero
shares issued or outstanding
- -
Common stock: $0.001 par value; 500,000,000 shares authorized;
6,466,294 and 4,898,143 shares issued and outstanding at December
31, 2022 and December 31, 2021, respectively
48 47
Additional paid-in capital
223,962 215,232
Accumulated deficit
(206,036 ) (214,063 )
Total stockholders’ equity
17,974 1,216
Total liabilities and stockholders’ equity
$ 34,215 $ 56,601
Aptevo Therapeutics Inc.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)

For the Year Ended December 31,

2022 2021
Royalty revenue
3,114 12,292
Operating expenses:

Research and development
(17,882 ) (18,994 )
General and administrative
(13,873 ) (14,698 )
Loss from operations
(28,641 ) (21,400 )
Other income (expense):

Other expense from continuing operations, net
(4,027 ) (8,008 )
Gain on extinguishment of liability related to
sale of royalties
37,182 -
Milestone income related to sale of royalties
2,500 -
Net income (loss) from continuing operations
7,014 (29,408 )
Discontinued operations:

Income from discontinued operations
1,013 951
Net income (loss)
$ 8,027 $ (28,457 )

Net income (loss) per share:

Basic
$ 1.57 $ (6.07 )
Diluted
$ 1.57 $ (6.07 )
Shares used in calculation:

Basic
5,100,310 4,687,952
Diluted
5,102,914 4,687,952

On March 30, 2023 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported unaudited financial results for the fourth quarter and full-year 2022 and announced a change in its leadership, effective May 1, 2023 (Press release, EDAP TMS, MAR 30, 2023, View Source [SID1234629619]).

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In line with EDAP’s Global Group Strategy, and its focus on expansion in the United States and rest of world markets, the Board of Directors has decided to embark on a new era of leadership for the Company. The Board has therefore unanimously appointed Ryan Rhodes Chief Executive Officer of EDAP TMS effective May 1, 2023 to lead, strengthen and accelerate the Company’s development. Marc Oczachowski will continue to serve as Chairman of the Board of the Company.

Mr. Rhodes has over 30 years of leadership experience in market development in the medical device industry, including 20 years dedicated to medical robotics. Prior to joining EDAP, he served as Chief Executive Officer of Restoration Robotics, where he led the company to a successful merger with Venus Concept Inc. in 2019. He also held leadership positions at Intuitive Surgical, and Ethicon Inc., a Johnson & Johnson Company.

Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "In 2022, EDAP delivered another strong year of financial and operational performance, achieving record revenue and more than doubling worldwide Focal One sales compared to 2021. With EDAP experiencing strong positive HIFU momentum, particularly in the U.S., we have now reached a key inflection point to make this transition and to further accelerate our global expansion. I have enjoyed working with Ryan for almost two years. His leadership and knowledge of the industry, combined with his acute understanding of global commercial market development, are excellent assets for EDAP. I have complete confidence in Ryan’s ability to continue to accelerate the growth and development of the Company in support of its ongoing strategic objectives."

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, "During the fourth quarter, we achieved a record of nine Focal One transactions in the U.S., reflecting the growing appreciation for the clinical value of Focal One by both large academic healthcare institutions as well as local community hospitals. 2022 was a critical year in the adoption of Focal One robotic HIFU and the growth of this therapeutic option as part of the comprehensive management of prostate cancer. The number of U.S. sites selecting Focal One doubled over the previous year, and we saw positive momentum in the advancement of U.S. society guidelines with focal ablation. Our team and capacity have grown to be well positioned to drive even greater clinical and market expansion in 2023."

Ryan Rhodes added: "I am very pleased to be appointed Chief Executive Officer of the EDAP TMS group, and I am grateful to both Marc and the EDAP Board for their continued confidence in my abilities. I am excited to lead EDAP’s global strategy to a new era of growth as we continue to build and expand our winning organization across the U.S. and international markets."

Full-Year 2022 Results

Total revenue for the full year 2022 was EUR 55.1 million ($58.0 million), representing an increase of 25.1% over full-year 2021 total revenue of EUR 44.1 million ($51.9 million).

Total revenue in the HIFU business for the full year 2022 was EUR 15.6 million (USD 16.4 million), an increase of 57.7% as compared to EUR 9.9 million (USD 11.7 million) for the full year 2021.

Total revenue in the LITHO business for the full year 2022 was EUR 11.6 million (USD 12.2 million), an increase of 5.0% from EUR 11.0 million (USD 13.0 million) for the full year 2021.

Total revenue in the Distribution business for the full year 2022 was EUR 27.9 million (USD 29.4 million), a 20.6% increase compared to EUR 23.1 million (USD 27.3 million) for the full year 2021.

Gross profit for the twelve months ended December 31, 2022, was EUR 24.2 million (USD 25.4 million), compared to EUR 18.4 million (USD 21.7 million) for the year-ago period. Gross profit margin on net sales was 43.9% for the twelve months ended December 31, 2022, compared to 41.8% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 28.5 million (USD 29.90 million) for the twelve months ended December 31, 2022, compared to EUR 20.0 million (USD 23.6 million) for the same period in 2021.

Operating loss for the twelve months ended December 31, 2022, was EUR 4.3 million (USD 4.5 million), compared to an operating loss of EUR 1.6 million (USD 1.9 million) for the twelve months ended December 31, 2021.

Net loss for the twelve months ended December 31, 2022, was EUR 2.9 million (USD 3.1 million), or EUR (0.09) per diluted share, as compared to net income of EUR 0.7 million (USD 0.8 million), or EUR 0.02 per diluted share in the year-ago period.

As of December 31, 2022, the company held cash, cash equivalents and short-term investments of EUR 63.1 million ($67.5 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Fourth Quarter 2022 Results

Total revenue for the fourth quarter 2022 was EUR 15.7 million (USD 16.2 million), a 12.8% increase as compared to total revenue of EUR 14.0 million (USD 15.9 million) for the same period in 2021.

Total revenue in the HIFU business for the fourth quarter 2022 was EUR 5.4 million (USD 5.5 million), an increase of 27.9% as compared to EUR 4.2 million (USD 4.8 million) for the fourth quarter of 2021.

Total revenue in the LITHO business for the fourth quarter 2022 was EUR 3.6 million (USD 3.7 million), an increase of 7.5% as compared to EUR 3.3 million (USD 3.8 million) for the fourth quarter of 2021.

Total revenue in the Distribution business for the fourth quarter 2022 was EUR 6.7 million (USD 7.0 million), a 5.0% increase compared to EUR 6.4 million (USD 7.3 million) for the fourth quarter of 2021.

Gross profit for the fourth quarter 2022 was EUR 7.2 million (USD 7.4 million), compared to EUR 6.2 million (USD 7.1 million) for the year-ago period. Gross profit margin on net sales was 45.9% in the fourth quarter of 2022, compared to 44.5% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

Operating expenses were EUR 8.8 million (USD 9.1 million) for the fourth quarter of 2022, compared to EUR 5.8 million (USD 6.5 million) for the same period in 2021.

Operating loss for the fourth quarter of 2022 was EUR 1.6 million (USD 1.6 million), compared to an operating profit of EUR 0.5 million (USD 0.5 million) in the fourth quarter of 2021.

Net loss for the fourth quarter of 2022 was EUR 5.1 million (USD 5.3 million), or EUR (0.14) per diluted share, as compared to net income of EUR 1.4 million (USD 1.6 million), or EUR 0.04 per diluted share in the year-ago period.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30 a.m. ET today, March 30th, 2023. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Thursday, March 30th, 2023 @ 8:30 a.m. ET
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13736071
Webcast link: Here

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On March 30, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the fourth quarter and full year 2022 (Press release, Y-mAbs Therapeutics, MAR 30, 2023, View Source [SID1234629617]).

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"The fourth quarter of 2022 marked another period of significant progress for DANYELZA and set up 2023 to be a very productive year," said Thomas Gad, President and Interim Chief Executive Officer. "We are thrilled to report record DANYELZA net revenues of $16.4 million in the fourth quarter of 2022, a 31% sequential increase compared to the previous quarter. In addition, DANYELZA was conditionally approved in China, with a planned launch in the first half of 2023. We look forward to our partners’ continued efforts to expand DANYELZA globally to offer much-needed treatment for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow."

Mr. Gad continued, "We recently implemented a restructuring plan to prioritize resources on the DANYELZA franchise and development of our SADA technology in the fight against cancer. With a 35% reduction in force and an anticipated 28% reduction in annual operating expenses for 2023, we emerge leaner and supported by a robust balance sheet with $105.8 million in cash and cash equivalents as of December 31, 2022, which we estimate should support our business operations as currently planned into the first quarter of 2026. We achieved a major milestone of getting our first unique SADA IND cleared by the FDA and opening up our first ever SADA Phase I trial late in 2022. We are actively screening patients initially for Small Cell Lung Cancer, Sarcoma and Melanoma and are eventually planning to screen more broadly for GD2 positive solid tumors."

Fourth Quarter 2022 and Recent Corporate Developments

● On February 2, 2023, Y-mAbs announced that the European Medicines Agency agreed to the Company’s Pediatric Investigational Plan for naxitamab

● On January 4, 2023, Y-mAbs announced a restructuring plan including a 35% reduction in workforce and an anticipated 28% reduction in annual operating expenses for 2023

● On December 21, 2022, Y-mAbs announced a partnership with WEP Clinical regarding early access program for DANYELZA (naxitamab-gqgk) in Europe

● On December 14, 2022, Y-mAbs announced a new SADA construct, CD38-SADA against non-Hodgkin’s Lymphoma

● On December 8, 2022, Y-mAbs announced that DANYELZA (naxitamab-gqgk) for the treatment of high-risk neuroblastoma was conditionally approved in China

On December 1, 2022, Y-mAbs announced that the Company had received a complete response letter for omburtamab BLA indicating that the FDA determined that it was unable to approve the BLA in its current form.

● On November 17, 2022, Y-mAbs activated its first ever SADA Phase I trial site and by March 11 Memorial Sloan Kettering was activated as the fourth clinical study site planned to enroll Small Cell Lung Cancer, Sarcoma and Melanoma patients

● On October 28, 2022, Y-mAbs announced the outcome of the FDA Oncologic Drugs Advisory Committee meeting, where the committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival

● On October 3, 2022 Y-mAbs announced pivotal data from Study 101 for omburtamab in CNS/LM metastasis from neuroblastoma at the International Society of Pediatric Oncology ("SIOP") annual congress

Financial Results

Revenues

Y-mAbs reported net revenues of $31.5 million and $65.3 million for the fourth quarter 2022 and year ended December 31, 2022, which represented increases of 228% and 87%, respectively, over $9.6 million and $34.9 million in the comparable periods of 2021. Net revenues in the quarter and year ended December 31, 2022 included license revenue of $15.0 million and $16.0 million, respectively, compared to no license revenue in the fourth quarter ended December 31, 2021, and license revenue of $2.0 million for the year ended December 31, 2021. During the three months and year ended December 31, 2022, we recognized a regulatory-based milestone payment received of $15.0 million from SciClone Pharmaceuticals International Ltd. for the conditional approval of DANYELZA in China.

DANYELZA net product revenue for the fourth quarter of 2022 and year ended December 31, 2022, was $16.4 million and $49.3 million, respectively, which represented increases of 71% and 50%, respectively, over the corresponding periods in 2021 and an increase of 31% compared to the third quarter 2022 DANYELZA net product revenues of $12.5 million. The increase was primarily driven by an increase in the number of new U.S. patients in treatment during the fourth quarter of 2022.

As of December 31, 2022, Y-mAbs has delivered DANYELZA to 48 centers across the United States, corresponding to an increase of 12% in the number of centers since the third quarter of 2022. During the fourth quarter of 2022, approximately 53% of the vials sold in the United States were sold outside Memorial Sloan Kettering ("MSK"), an increase from the prior quarter as a result of the growth of new patients at institutions outside MSK outpacing MSK’s growth of new patients.

Operating Expenses

Research and Development

Research and development expenses were $19.8 million for the three months ended December 31, 2022, compared to $28.7 million for the three months ended December 31, 2021. The $8.9 million decrease reflects decreased spending for clinical trials, outsourced research and supplies, and costs for outsourced manufacturing services due to decreased clinical trial activities in 2022. Having completed the resubmission of the BLA for omburtamab in the first quarter of 2022, we are now focused on pipeline development programs for potential DANYELZA label expansion and advancing SADA constructs into the clinic.

Research and development expenses decreased by $1.6 million to $91.6 million during the year ended December 31, 2022, compared to the prior year period. The decrease mainly reflects decreased clinical trial activities in 2022

Selling, General, and Administration

Selling, general, and administrative expenses decreased by $4.3 million to $10.8 million for the three months ended December 31, 2022, compared to $15.1 million for the three months ended December 31, 2021. The decrease in selling, general and administrative expenses was primarily the result of a $1.8 million decrease in costs related to the commercialization of DANYELZA as there were heavy launch costs in the fourth quarter of 2021.

Selling, general, and administrative expenses increased by $6.3 million to $60.9 million for the year ended December 31, 2022, compared to $54.6 million for the year ended December 31, 2021. The increase in selling, general, and administrative expenses was primarily attributable to a $7.8 million increase in severance and share-based compensation expense related to the termination of our former chief executive officer.

Net Loss

We reported net income for the fourth quarter ended December 31, 2022, of $1.2 million, or $0.03 per basic and diluted share, compared to a net loss of $36.9 million, or $0.85 per basic and diluted share, for the quarter ended December 31, 2021. The favorable change to net income in 2022 was primarily driven by the license revenues of $15.0 million, the positive gross profit impact from increased DANYELZA revenues and the decreased research and development expenses in 2022.

We reported a net loss for the year ended December 31, 2022, of $95.6 million, or $2.19 per basic and diluted share, compared to a net loss of $55.3 million, or $1.28 per basic and diluted share, for the year ended December 31, 2021. Net loss in the year ended December 31, 2021, included a $62.0 million net gain from the sale of our DANYELZA Priority Review Voucher, after sharing 40% of the net proceeds from the sale with MSK, pursuant to the terms of our license agreement with MSK. The increase in net loss for the year ended December 31, 2022, also reflects the impact of contractual severance-related benefits for our former chief executive officer, as noted above, partially offset by the gross profit impact of DANYELZA’s revenue growth and 2022 license revenues.

Cash and Cash Equivalents

We had approximately $105.8 million in cash and cash equivalents as of December 31, 2022, and we expect a full-year 2023 cash burn of $50-55 million. Our existing cash and cash equivalents, when combined with anticipated DANYELZA revenues, which are assumed to increase by 10% each year for the purpose of our analysis of runway, is expected to be sufficient to fund our operations into the first quarter of 2026. In terms of development activities, we have assumed that our prioritized programs will be advanced at our own expense and no new programs are assumed at this point. We assume no new partnerships or other new business development, and no further development of the omburtamab program.

This estimate reflects our current business plan that is supported by assumptions that may prove to be inaccurate, such that we could use our available capital resources sooner than we currently expect.

Financial Guidance

Management reiterated its 2023 financial guidance including:

● Anticipated DANYELZA net product revenues of $60-$65 million;

● Anticipated operating expenses of $115-120 million;

● Anticipated total annual cash burn of $50-55 million; and

● Cash and cash equivalents anticipated to support operations as currently planned into the first quarter of 2026

Webcast and Conference Call

Y-mAbs will host a conference call on Friday, March 31, 2023, at 9 a.m. Eastern Time. To participate in the call, please use the following dial-in information.

Investors (domestic): 877-407-0792
Investors (international): 201-689-8263
Conference ID: 13736579

To access a live webcast of the update, please use this link.

On March 30, 2023 Fresh Tracks Therapeutics, Inc. (the "Company" or "Fresh Tracks") (Nasdaq: FRTX), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update (Press release, Vical, MAR 30, 2023, View Source [SID1234629616]).

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"We are pleased with the progress made in advancing our development of FRTX-02 over the past year. The results from Part 1 of our first-in-human Phase 1 study demonstrate the potential of FRTX-02 as a generally safe and well-tolerated, once-daily oral treatment for a broad range of autoimmune and inflammatory diseases," commented Andrew Sklawer, President and Chief Executive Officer of Fresh Tracks. "We believe the Phase 1 topline results support the continued development of FRTX-02. As we plan out our path forward, we have initiated the comprehensive process previously disclosed, to explore and evaluate strategic options to progress the development of our novel pipeline of potential treatments for autoimmune, inflammatory, and other diseases, including FRTX-02, with the goal of maximizing shareholder value."
Research and Development Highlights
FRTX-02: a potential first-in-class DYRK1A inhibitor for the treatment of autoimmune and inflammatory diseases
•Announced in early March 2023 positive topline results from Part 1 of the Phase 1 clinical trial of FRTX-02, which is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of FRTX-02 capsules in healthy subjects, which included single and multiple ascending dose assessments of FRTX-02 or placebo in healthy adult subjects.
•Topline results support the continued development of FRTX-02 as a potential first-in-class, once-daily oral treatment for atopic dermatitis and/or other autoimmune diseases.
FRTX-10: a covalent Stimulator of Interferon Genes (STING) inhibitor candidate for the potential treatment of autoimmune, inflammatory, and rare genetic diseases
•Continued to progress the preclinical IND-enabling development activities of FRTX-10.
Recent Corporate Highlights
Evaluation of Strategic Options
As previously announced on March 7, 2023, the Company’s board of directors ("Board") and executive management team have approved and are conducting a comprehensive process to explore and evaluate strategic options to progress the development of its novel pipeline of potential treatments for autoimmune, inflammatory, and other diseases with the goal of maximizing shareholder value. Potential strategic options to be explored or evaluated as part of this process may include, but are not limited to, a financing, sale or licensing of assets, acquisition, merger, business combination, and/or other strategic transaction or series of related transactions involving the Company. Fresh Tracks does not expect to disclose developments with respect to this process until the evaluation of strategic options has been completed or until the Board has concluded disclosure is appropriate

or legally required. MTS Health Partners, LP has been retained as the Company’s exclusive financial advisor to assist in this review process.
Sales of Common Stock
In March 2023, the Company sold 2,887,535 shares of its common stock under an at-the-market equity offering program ("ATM") at a weighted-average price of $2.34 per share, for aggregate net proceeds of approximately $6.6 million.
Sofpironium Bromide
In the second quarter of 2022, Fresh Tracks entered into an asset purchase agreement ("APA") with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited ("Botanix"). Under the terms of the APA, Botanix acquired and assumed control of rights, title, and interests to assets primarily related to the proprietary compound sofpironium bromide that were owned and/or licensed by us or Brickell Subsidiary, Inc. in exchange for an upfront payment, near-term regulatory milestone payments, and sales-based milestone payments, as well as tiered earnout payments on net sales of sofpironium bromide gel. In connection with the sale of sofpironium bromide, Fresh Tracks and Botanix entered into a transition services agreement ("TSA") whereby Fresh Tracks provides consulting services as an independent contractor to Botanix in support of and through filing and approval of the U.S. new drug application ("NDA") for sofpironium bromide gel, 15%.
In December 2022, the U.S. Food and Drug Administration ("FDA") accepted the NDA submission by Botanix for sofpironium bromide gel, 15%, which was a milestone upon which Fresh Tracks received a milestone payment of $2.0 million from Botanix. In November 2022, Fresh Tracks paid its former licensor of sofpironium bromide $1.0 million in cash in lieu of issuing $1.0 million in shares of its common stock as originally provided for under a license agreement. In March 2023, Botanix reported that the FDA’s mid-cycle review is expected to be completed soon and that it expects the FDA’s decision on the NDA submission in the third quarter of 2023.
Fourth Quarter and Full Year 2022 Financial Results
The Company reported cash and cash equivalents of $8.7 million as of December 31, 2022, compared to $26.9 million as of December 31, 2021. The Company expects its cash and cash equivalents as of December 31, 2022, combined with $6.6 million in net proceeds received in March 2023 from sales of the Company’s common stock under its ATM program, will be sufficient to fund its operations for at least the next 12 months.
Revenue was $2.1 million for the fourth quarter of 2022, compared to $0.1 million for the fourth quarter of 2021. Revenue was $6.9 million for the year ended December 31, 2022, compared to $0.4 million for the year ended December 31, 2021. Revenue in 2022 primarily consisted of contract revenue recognized under the APA and TSA with Botanix, while revenue in 2021 was driven by royalty revenue earned on a percentage of net sales of ECCLOCK (sofpironium bromide gel, 5%) in Japan under a licensing agreement with Kaken Pharmaceutical Co., Ltd. Contract revenue in 2022 consisted of upfront payment of $3.0 million, a milestone payment of $2.0 million, fees for consulting services the Company provided to Botanix of $0.8 million, reimbursed development expenditures of $0.6 million, and sublicense income of $0.4 million.
Research and development expenses were $2.6 million for the fourth quarter of 2022, compared to $3.1 million for the fourth quarter of 2021. Research and development expenses were $14.0 million for the year ended December 31, 2022, compared to $28.2 million for the year ended December 31, 2021, which was driven primarily by lower clinical expenses of $16.6 million related to sofpironium bromide and lower personnel and other unallocated expenses of $0.5 million, partially offset by increased costs related to our STING inhibitor platform of $2.2 million and increased costs related to our DYRK1A inhibitor program of $0.7 million.
General and administrative expenses were $4.0 million for the fourth quarter of 2022, compared to $3.3 million for the fourth quarter of 2021. General and administrative expenses were $14.4 million for the year ended December 31, 2022, compared to $12.4 million for the year ended December 31, 2021. The annual increase of $2.0 million was primarily related to increased expenses in 2022 of $1.9 million in payments to a former licensor and higher legal and compliance fees of $0.4 million, partially offset by lower compensation-related expenses of $0.2 million and lower other general administrative expenses of $0.1 million.
The Company’s net loss was $4.5 million for the fourth quarter of 2022 compared to $6.1 million for the fourth quarter of 2021. Net loss was $21.1 million for the year ended December 31, 2022, compared to $39.5 million for the year ended December 31, 2021.

No Quarterly Conference Call
In consideration of the Board and management team’s ongoing process of exploring and evaluating strategic options to progress the development of the Company’s novel pipeline, Fresh Tracks’ management has decided not to host a conference call to discuss its fourth quarter and full year 2022 financial results. Additional details regarding the financial results for the full year 2022 and corporate update can be found in the Company’s Annual Report on Form 10-K.