APYX Sees 3-30% Revenue Growth, AVDL Awaits FDA Decision, KZR To Report MISSION Data In Q2…

The following are some of the companies that reported fourth-quarter results and provided corporate updates on Thursday.

1. Aadi Bioscience Inc. (AADI), a biopharmaceutical company focused on developing precision therapies for genetically-defined cancers, said “it is well-positioned in 2022 with a strong team, a solid balance sheet, and a highly promising recently approved drug.”

The company received FDA approval for FYARRO, its first proprietary product, on November 22, 2021, for advanced malignant PEComa in adults. The drug was launched on February 23, 2022.

A phase II tumor-agnostic registrational trial evaluating Nab-sirolimus in adult and adolescent patients 12 years and older with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes, dubbed PRECISION 1, is underway. The trial consists of two separate arms for TSC1 or TSC2 alterations. Initial clinical data from PRECISION 1 are expected in the first half of 2023.

AADI closed Thursday’s trading at $19.49, up 8.40%.

2. 111 Inc. (YI), a tech-enabled healthcare platform company digitally connecting patients with medicine and healthcare services in China, reported a narrower loss for the fourth quarter ended Dec.31, 2021, as revenues jumped nearly 31%.

The company’s non-GAAP net loss attributable to ordinary shareholders was RMB83.5 million (US$13.1 million) compared to RMB98.2 million in the same quarter of last year. Net revenues for the fourth quarter of 2021 were RMB3.46 billion (US$543.1 million), representing an increase of 30.9% year-over-year.

The company ended the year 2021 with cash, cash equivalents, restricted cash and short-term investments of RMB 943.2 million (US$148.0 million).

YI closed Thursday’s trading at $2.37, up 7.73%.

3. Acurx Pharmaceuticals Inc. (ACXP), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, expects enrollment in a phase IIb clinical trial of its lead antibiotic candidate Ibezapolstat to be completed in the second half of 2022.

The trial is comparing the efficacy of oral Ibezapolstat to oral Vancomycin, the current standard of care for C. difficile infection.

A laboratory study comparing the impact of Ibezapolstat on the microbiome as compared with other commonly used antibiotics to treat patients with C. difficile infection, namely, Fidaxomicin, Vancomycin, and Metronidazole is underway and is expected to be completed in the second half of 2022.

ACXP closed Thursday’s trading at $3.77, up 1.34%.

4. Alpine Immune Sciences Inc. (ALPN), a clinical-stage immunotherapy company, expects 2022 to be a transformative year with several important readouts anticipated across its programs.

The lead drug candidate is Davoceticept (ALPN-202), which is under a phase I open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.

Davoceticept monotherapy dose escalation data (NEON-1) will be presented in an oral presentation at the 2022 American Association for Cancer Research (AACR) Annual Meeting on April 12, 2022. Initial findings of Davoceticept’s tolerability and clinical activity were previously reported in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Another wholly-owned compound is ALPN-303, being developed for inflammatory diseases.

A phase I study of ALPN-303 in healthy volunteers is ongoing, with initial safety, pharmacokinetic, and pharmacodynamic findings anticipated by mid-2022.

The company’s partnered program Acazicolcept (ALPN-101), is under a phase II trial in patients with systemic lupus erythematosus, dubbed Synergy. This compound is being developed in partnership with AbbVie Inc. (ABBV).

Cash position:

As of December 31, 2021, the company had cash, cash equivalents, and investments totaling $215.4 million.

ALPN closed Thursday’s trading at $8.64, up 4.85%.

5. Apyx Medical Corp. (APYX), which had impressive revenue growth and financial performance in 2021, expects total revenue growth of 3% to 30%, along with continued improvements in its profitability profile this year.

Formerly known as Bovie Medical Corp, Apyx is a medical technology company, operating in two segments – Advanced Energy and Original Equipment Manufacturing.

The Advanced Energy segment commercializes Helium Plasma Technology, marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market. The OEM segment is primarily development and manufacturing contract and product driven.

Net loss attributable to stockholders was $2.0 million or $0.06 per share on total revenue of $16.8 million. This compared with a net loss attributable to stockholders of $1.53 million or $0.04 per share and total revenue of $11.5 million in the year-ago quarter.

Looking ahead to 2022, the company expects total revenue to be in the range of $50.0 million to $63.0 million, representing growth of 3% to 30% year-over-year, compared to total revenue of $48.5 million for the year ended December 31, 2021.

APYX closed Thursday’s trading at $7.91, up 13.98%.

6. Avadel Pharmaceuticals plc (AVDL) is yet to be notified of the FDA decision related to FT218, the company’s once-nightly investigational sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy for people living with narcolepsy.

The FDA decision date was originally due on Oct.15, 2021.

Yesterday, the company revealed that it has been informed very recently by the FDA that they are actively working on the New Drug Application for FT218A and that it intends to respond in the near future.

AVDL closed Thursday’s trading at $7.32, up 4.13%.

7. AVROBIO Inc. (AVRO), a clinical-stage gene therapy company, is expected to share new data on the three patients dosed to date in its ongoing phase 1/2 clinical trial of AVR-RD-04 for cystinosis this year.

Interim data on the three patients from the phase 1/2 clinical trial reported last month were encouraging. The first three patients infused with AVR-RD-04 remain off oral cysteamine, and sustained engraftment has been observed in each of these patients, as demonstrated by stable vector copy number (VCN) levels.

A phase 1/2 trial of AVR-RD-02 in Gaucher disease type 1, dubbed GUARD1, is underway, with interim data expected this year.

As of Dec. 31, 2021, AVROBIO had $189.6 million in cash and cash equivalents.

AVRO closed Thursday’s trading at $1.56, up 8.33%.

8. BIOLASE Inc. (BIOL), a company dealing in dental lasers, reported strong fourth quarter and full year financial results, reflecting the rising demand for its dental lasers.

Net revenue for the fourth quarter of 2021 was $12.4 million, an increase of 46% year over year. Net loss for the fourth quarter of 2021 narrowed to $5.3 million or $0.03 per share from $6.1 million or $0.07 per share for the fourth quarter of 2020.

For the first quarter of 2022, the company expects net revenue to exceed $9.0 million, which would represent growth of at least 11% year over year. Looking ahead to full year 2022, the company expects net revenue to increase at least 10% from the 2021 revenue of $39.2 million.

At December 31, 2021, the company had cash and cash equivalents of approximately $30.0 million.

BIOL closed Thursday’s trading at $0.39, up 16.63%.

9. Black Diamond Therapeutics Inc. (BDTX), a clinical-stage precision oncology medicine company, has two compounds in clinical stage – BDTX-189 and BDTX-1535.

The company is actively enrolling patients in the safety expansion cohort of the Phase 1 study of BDTX-189.

A phase I study of BDTX-1535 for the treatment of glioblastoma multiforme (GBM) and non-small cell lung cancer (NSCLC) including those with central nervous system (CNS) metastases was initiated as recently as early this month. A clinical update on this trial is expected to be provided in the second half of 2023.

As of December 31, 2021, the company’s cash, cash equivalents, and investments totaled $209.8 million.

BDTX closed Thursday’s trading at $3.02, up 3.07%.

10. Cabaletta Bio Inc. (CABA), a clinical-stage biotechnology company developing targeted cell therapies for autoimmune diseases, has a couple of data readouts planned for this year.

The lead product candidate, DSG3-CAART, is being developed to treat mucosal pemphigus vulgaris, a blistering skin disease that affects mucous membrane. This compound is under a phase I trial, dubbed DesCAARTes, which has five dosing cohorts.

Cabaletta expects reporting clinical and translational data from cohorts A3 and A4 (500 million and 2.5 billion DSG3-CAART cells) as well as 28-day safety data for cohort A5 (5.0 to 7.5 billion DSG3-CAART cells) in the DesCAARTes trial at upcoming scientific meetings in mid-2022.

A phase I trial, dubbed MusCAARTes, evaluating MuSK-CAART as a potential treatment for patients with MuSK-associated myasthenia gravis, is expected to be initiated this year.

As of December 31, 2021, Cabaletta had cash and cash equivalents and investments of $122.2 million.

CABA closed Thursday’s trading at $1.71, unchanged from the previous day’s close.

11. Century Therapeutics Inc. (IPSC), a biotechnology company developing induced pluripotent stem cell- derived cell therapies in immuno-oncology, is all set to transition to a clinical stage company in 2022.

The company expects to file its Investigational New Drug (IND) application seeking FDA clearance to initiate a phase I trial of CNTY-101 in mid-2022. If all goes well as planned, the phase I trial, dubbed ELiPSE-1, will evaluate CNTY-101 in patients with relapsed/refractory aggressive lymphoma or indolent lymphoma after at least two prior lines of therapy, including patients who have received prior CAR T cell therapy.

An IND for CNTY-103 is expected to be submitted in 2023. CNTY-103 is Century’s first solid tumor candidate for glioblastoma.

The company’s cash, cash equivalents, and marketable securities were $358.8 million as of December 31, 2021.

IPSC closed Thursday’s trading at $13.06, down 0.99%.

12. Chinook Therapeutics Inc. (KDNY), a biopharmaceutical company developing precision medicines for kidney diseases, has a couple of data readouts planned for this year.

The lead drug candidate is Atrasentan, currently under a phase III trial in patients with IgA nephropathy, dubbed ALIGN. Chinook expects to report topline data from the six-month interim proteinuria endpoint analysis from this trial in 2023.

Atrasentan is also in a phase II basket trial in patients with proteinuric glomerular diseases, including IgA nephropathy, Focal segmental glomerulosclerosis, Alport syndrome and Diabetic kidney disease, dubbed AFFINITY. Data from the IgAN patient cohort of this study is expected to be presented at the ERA Congress in May 2022, with data from one or more additional cohorts expected in the second half of 2022.

Also in the pipeline are BION-1301 and CHK-336.

— BION-1301 is currently in phase 1/2 development for patients with IgAN.
— CHK-336, being developed for the treatment of patients with primary hyperoxaluria (PH), secondary hyperoxaluria due to increased endogenous oxalate production and idiopathic stone formation, is expected to advance to a phase 1 clinical trial in healthy volunteers in the first half of 2022.

Cash, cash equivalents and marketable securities totaled $355.1 million at December 31, 2021.

KDNY closed Thursday’s trading at $13.85, up 0.73%.

13. CymaBay Therapeutics Inc. (CBAY) expects enrollment in its global, phase III registrational study evaluating the safety and efficacy of Seladelpar in patients with primary biliary cholangitis, dubbed RESPONSE, in the first half of 2022.

The RESPONSE study is designed to enroll 180 patients.

A long-term study of Seladelpar in patients with primary biliary cholangitis, intended to collect additional long-term safety data to support registration, dubbed ASSURE, is underway. To date the company has enrolled over 120 patients in the study.

The company had $194.6 million in cash, cash equivalents and short-term investments as of December 31, 2021.

CBAY closed Thursday’s trading at $3.18, up 4.26%.

14. Fusion Pharmaceuticals Inc. (FUSN), a clinical-stage oncology company developing next-generation radiopharmaceuticals as precision medicines, expects data from phase I trial of FPI-1434 in the second half of 2022.

The expected data includes safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing paradigm.

FPI-1434 is a radioimmunoconjugate designed to target and deliver alpha emitting medical isotopes to cancer cells expressing IGF-1R, a receptor that is overexpressed on many tumor types.

The company expects to dose the first patient in its phase I trial of FPI-1966 in patients with solid tumors expressing FGFR3 in the second quarter of 2022.

As of December 31, 2021, Fusion held cash, cash equivalents and investments of $220.8 million.

FUSN closed Thursday’s trading at $7.83, up 8.45%.

15. Kezar Life Sciences Inc (KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncologic disorders, has a couple of catalysts to watch in the coming months.

Topline data from its MISSION and PRESIDIO trials are expected in the second quarter of this year.

— MISSION is a phase II trial of KZR-616 in patients with lupus nephritis.
— PRESIDIO is a phase II clinical trial of KZR-616 in patients with active dermatomyositis or polymyositis.

Cash, cash equivalents and marketable securities totaled $208.4 million as of December 31, 2021.

KZR closed Thursday’s trading at $15.31, up 4.08%.

16. Marker Therapeutics Inc. (MRKR), a clinical-stage immuno-oncology company, is scheduled to report topline data from the Group 2 active disease group of its phase II trial of lead product candidate MT-401 in patients with Acute Myeloid Leukemia next quarter (Q2, 2022).

The company is in the process of developing a patient cell bank inventory and expects to dose the first patient with MT-401-OTS next year.

MRKR closed Thursday’s trading at $0.43, up 4.23%.

17. MediWound Ltd. (MDWD), a commercial-stage biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, reported a wider loss for the fourth quarter of 2021 on 18% drop in revenue.

Net loss widened to $4.2 million or $0.15 per share for the fourth quarter of 2021 from $1.7 million or $0.06 per share for the fourth quarter of 2020. Revenues for the fourth quarter of 2021 were $5.5 million, a decrease of 18% compared to $6.7 million in the year-ago period.

The company expects to resubmit the Biologics License Application for NexoBrid to the FDA in mid-year 2022.

NexoBrid is proposed for the removal of eschar (debridement) in adults with deep partial- and full-thickness thermal burns.

As of December 31, 2021, MediWound had $11.0 million in cash and short-term investments.

MDWD closed Thursday’s trading at $1.91, down 0.52%.

18. Nkarta Inc. (NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer cell therapies to treat cancer, has set itself a couple of milestones to achieve this year.

The company plans to present initial clinical data from its ongoing phase I clinical trial of NKX101 as monotherapy in patients with relapsed/refractory AML and higher-risk MDS in the first half of 2022.

A phase I clinical trial of NKX019 as monotherapy in patients with advanced B cell malignancies is underway, with initial results expected this year.

As of December 31, 2021, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $240.2 million.

NKTX closed Thursday’s trading at $11.47, up 10.71%.

19. Silence Therapeutics plc (SLN), a clinical-stage company developing a new generation of medicines by harnessing the body’s natural mechanism of RNA interference, has an important catalyst to keep an eye on in the coming months.

The company is evaluating SLN124 in a phase I study in thalassemia. The study is fully enrolled and topline data are anticipated in the third quarter of this year.

SLN closed Thursday’s trading at $16.71, down 1.71%.

20. Spectrum Pharmaceuticals Inc. (SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, has a regulatory catalyst to watch out for in the second half of this year.

The company’s investigational drug Poziotinib, proposed for the treatment of patients with non-small cell lung cancer harboring HER2 exon 20 insertion mutations, is under FDA review, with a decision expected on November 24, 2022. Currently, there are no FDA approved treatments for patients with NSCLC harboring HER2 exon 20 insertion mutations.

Spectrum had cash, cash equivalents, and marketable securities of approximately $100.6 million as of December 31, 2021.

SPPI closed Thursday’s trading at $0.84, up 10.35%.

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