On March 31, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported financial results for the fourth quarter and full year of 2021 (Press release, Pulse Biosciences, MAR 31, 2022, View Source [SID1234611292]).

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Company Updates

Implemented changes to commercial leadership, salesforce and strategy, to focus on increasing commercial clinic utilization and over near-term reducing emphasis on new system sales.

Appointed two medical technology industry veterans to commercial leadership positions; Kevin Danahy to the newly created role of Chief Commercial Officer and Joe Talarico as Vice-President of North American Sales.

Initiated operating expense reduction programs, including workforce reductions, expected to lower costs by approximately 20% from the current run rate, resulting in expected 2022 operating expenses in line with 2021.

Achieved fourth quarter 2021 revenue of $844 thousand and full year 2021 revenue of $1.4 million.

Completed the first three commercial sales of CellFX Systems, two in the fourth quarter of 2021 and one in the first quarter of 2022.

Transitioned 17 Controlled Launch Program participants to commercial use in the fourth quarter and expect an additional 10 participants to transition in the first quarter, resulting in 39 total commercial conversions at the end of the first quarter.

20 clinics remain in the Controlled Launch program after a total of 11 clinics have opted out at the end of Q1.

FDA meeting expected in Q2 2022 to discuss Additional Information letter regarding the sebaceous hyperplasia 510(k).

"2021 included a number of milestones for Pulse Biosciences, including regulatory approvals in the U.S., Europe, Canada and Australia, onboarding 70 Controlled Launch Program participants, the transition of 29 clinics to commercial use, and sales of our first two commercial CellFX Systems," said Darrin Uecker, President and CEO of Pulse Biosciences. "In 2022, our focus is on increasing utilization at commercial clinics to develop CellFX reference centers for the benign lesion market under new commercial leadership. At the same time, we will remain focused on expanding the CellFX System’s indications for use in dermatology and beyond."

Fourth Quarter 2021 Results

Revenue for the three months ended December 31, 2021 was $844 thousand. System revenue for the three months ended December 31, 2021 was $699 thousand, with approximately $600 thousand recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the three months ended December 31, 2021 was $145 thousand resulting from the purchase of cycle units to be used with commercial systems.

Total GAAP gross loss* for the three months ended December 31, 2021 was ($0.4) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the three months ended December 31, 2021 was ($0.3) million. Following the transition to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.

Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the three months ended December 31, 2021 were $15.0 million, compared to $13.8 million for the prior year period. Non-GAAP operating expenses for the three months ended December 31, 2021 were $11.2 million, compared to $11.1 million for the same period in the prior year. The year-over-year increase in operating expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities offset by uncapitalized manufacturing operations costs now recorded in cost of revenue.

GAAP net loss for the three months ended December 31, 2021 was ($15.4) million compared to ($13.8) million for the three months ended December 31, 2020. Non-GAAP net loss for the three months ended December 31, 2021, was ($11.5) million compared to ($11.1) million for the three months ended December 31, 2020.

Full Year 2021 Results

Revenue for the full year of 2021 was $1.4 million. System revenue for the full year of 2021 was $1.2 million including $1.1 million recognized on a non-cash basis resulting from the Controlled Launch Participants opting to acquire CellFX Systems. Cycle units revenue for the full year of 2021 was $229 thousand resulting from the purchase of cycle units to be used with commercial systems.

Total GAAP gross loss* for the full year of 2021 was ($0.6) million. Excluding non-cash expenses for stock-based compensation and depreciation and amortization, non-GAAP gross loss for the full year of 2021 was ($0.4) million. Following the transition to commercial operations in the third quarter of 2021, all uncapitalized manufacturing operations costs are now recorded in cost of revenue. Prior to commercialization, these costs were recorded in research and development expenses.

Total GAAP operating expenses representing research and development, sales and marketing and general and administrative expenses for the full year of 2021 were $62.5 million, compared to $50.0 million for 2020. Non-GAAP operating expenses for the full year of 2021 were $46.9 million, compared to $38.8 million for the same period in 2020. The year-over-year increase in operating expenses was driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities and investments to expand use of the CellFX System outside dermatology.

GAAP net loss for the full year of 2021 was ($63.7) million compared to ($49.9) million for 2020. Non-GAAP net loss for the full year of 2021, was ($47.9) million compared to ($38.7) million for 2020.

Cash, cash equivalents and investments totaled $28.6 million as of December 31, 2021 compared to $20.5 million as of December 31, 2020 and $42.0 million as of September 30, 2021. Cash used in the fourth quarter of 2021 totaled $13.4 million compared to $9.2 million used in the same period in the prior year and $13.8 million used in the third quarter of 2021. Excluding net proceeds from equity offerings, cash used in the full year of 2021 totaled $52.9 compared to $34.9 million used in 2020.

* Gross loss is calculated as total revenues less cost of revenues.

Reconciliations of GAAP to non-GAAP operating expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, March 31, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source

On March 31, 2022 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, reported financial results for the year ended December 31, 2021 and provided an update on recent corporate highlights (Press release, Mereo BioPharma, MAR 31, 2022, View Source [SID1234611291]).

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"During 2021, we continued to execute on all fronts and made substantial progress across our pipeline. We further advanced our etigilimab anti-TIGIT program, reporting highly promising interim data from the ongoing ACTIVATE Phase 1b/2 study and expanded our research to include clear-cell ovarian cancer through our partnership with Cancer Focus Fund and MD Anderson," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "In addition, we reported positive data from multiple studies of alvelestat, which also received orphan drug designation for the treatment of AATD. We ended the year well positioned for further success in 2022, with a strong balance sheet supported by the proceeds of our public offering early last year. Following our accomplishments in 2021, we look forward to our upcoming catalysts in 2022."

Highlights from 2021 and Recent Developments

Etigilimab (MPH-313)

Reported interim data in Q4 2021 from ACTIVATE Phase 1b/2 open label study of etigilimab anti-TIGIT antibody in combination with nivolumab in solid tumors
Based on analysis of 15 patients in the efficacy analysis set with a minimum of one scan to-date or clinical progression, those receiving the etigilimab / nivolumab combination have achieved one complete response in cervical cancer, one partial response in ovarian cancer and four instances of stable disease in ovarian cancer, cervical and uveal melanoma
Well tolerated with a favorable safety profile
Ongoing Phase 1b/2 basket combination study continues to enroll well
Update on additional patients and durability of initial responses expected in Q2 2022
Alvelestat (MPH-966)

Received orphan designation from the FDA for the treatment of AATD
Held an R&D Day update on the alvelestat programs in Q1 2022, including in the ongoing Phase 2 trial which enrolled 99 patients with AATD
Data expected in early Q2 2022
Reported positive bio-marker data from investigator-sponsored Phase 1b/2 study of alvelestat in patients with BOS following hematopoietic stem cell transplantation
Reported positive top-line results from Phase 1b/2 trial in hospitalized patients with COVID-19 respiratory disease; Alvelestat, on top of standard of care, resulted in a more rapid time to improvement in WHO Disease Severity score in the first 5-7 days compared to placebo plus standard of care.
Corporate Updates

Partnerships

Announced partnership with the Cancer Focus Fund supporting a Phase 1b/2 clinical study of etigilimab in combination with nivolumab in clear cell ovarian cancer to be conducted at The University of Texas MD Anderson Cancer Center
Ultragenyx expects to enroll the first patient in the Phase 2/3 study of setrusumab in 5–25 year-olds with osteogenesis imperfecta in 1H 2022
Public Offering of American Depositary Shares

Public offering gross proceeds of $115.1 million in Q1 2021
Strengthened Board of Directors

Pierre Jacquet, M.D., Ph.D. appointed to Board of Directors, September 2021
Anne Hyland appointed to Board of Directors, March 2022
Full Year 2021 Financial Results
Revenue was £36.5 million in 2021, representing the upfront payment under the licensing and collaboration agreement with Ultragenyx in January 2021 for the development and commercialization of setrusumab for OI.

Full year 2021 research and development expenses were £23.6 million, compared to £16.3 million in 2020, an increase of £7.2 million, or 44%. R&D expenses relating to etigilimab increased by £12.5 million. The increase was due to the costs associated with commencement of the open label Phase 1b/2 basket study in combination with nivolumab in a range of tumor types. R&D expenses relating to alvelestat increased £0.6 million, or 13%, primarily related to the ongoing Phase 2 proof-of-concept study. Partially offsetting the increases, R&D expenses relating to setrusumab and navicixizumab decreased by £4.1 million and £1.7 million, respectively. The decrease related to setrusumab was primarily driven by the licensing and collaboration agreement with Ultragenyx, under which Ultragenyx will fund global development of the program, and the decrease related to navicixizumab was driven by the global out-licensing agreement with OncXerna for the development and commercialization of navicixizumab.

Administrative expenses decreased by £5.3 million, or 25%, from £21.2 million in 2020 to £15.9 million in 2021. The decrease was primarily driven by a £4.0 million reduction in legal and professional fees in 2021, reflecting lower activity and related transaction costs in 2021 compared to 2020. Premises-related costs decreased by £1.3 million in 2021 primarily due to one-off transaction costs in 2020 associated with renegotiation of our office lease in Redwood City.

Net profit attributable to equity holders for the year 2021 was a net profit of £12.7 million, compared to a net loss of £163.6 million in 2020, reflecting an operating loss of £20.9 million and a gain of £40.0 million, due to changes in the fair value of financial instruments resulting from an unrealized gain on warrants.

Total ordinary shares outstanding at December 31, 2021 were approximately 585 million. Total ADSs outstanding at December 31, 2021 were approximately 116.5 million, with each ADS representing five ordinary shares of the Company.

Cash and short-term deposits totaled £94.3 million at December 31, 2021.

On March 31, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the fourth quarter and year ended December 31, 2021 (Press release, Idera Pharmaceuticals, MAR 31, 2022, View Source [SID1234611290]).

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"We are actively identifying and evaluating new development or commercial-stage assets for Idera’s portfolio while we continue to preserve cash," stated Vincent Milano, Idera’s Chief Executive Officer. "In addition, we have asked JMP Securities, a Citizens Company, our current partner and advisor on business development activities, to expand their current scope of work beyond acquisition or in-licensing opportunities to include additional strategic alternatives for the Company."

Fourth Quarter Financial Results
Our cash position as of December 31, 2021 was $32.5 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the March 31, 2022 filing date of the Annual Report Form 10-K.

Research and development expenses for the three months ended December 31, 2021 totaled $2.1 million, compared to $5.1 million for the same period in 2020. General and administrative expense for the three months ended December 31, 2021 totaled $2.0 million, compared to $2.9 million for the same period in 2020.

Additionally, during the three months ended December 31, 2020, we recorded $3.2 million and $65.4 million non-cash warrant revaluation loss and non-cash future tranche right revaluation loss, respectively, related to the change in fair value of securities issued in connection with our December 2019 private placement transaction. No such non-cash losses were recognized in the three months ended December 31, 2021, as the warrants and future tranche rights were terminated in the first quarter of 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended December 31, 2021 was $4.1 million or $0.08 per basic and diluted share compared to net loss applicable to common stockholders of $76.7 million or $2.11 per basic and diluted share for the same period in 2020. Excluding the non-cash loss of approximately $68.6 million for the three months ended December 31, 2020 related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $8.1 million.

Full Year Results
Research and development expenses for the year ended December 31, 2021 totaled $16.4 million compared to $24.8 million for the same period in 2020. General and administrative expenses for the year ended December 31, 2021 totaled $10.0 million compared to $11.9 million for the same period in 2020. Restructuring costs for the year ended December 30, 2021 totaled approximately $1.3 million and relate to a reduction in force initiated in April 2021 to better align our workforce to our ongoing operational and business development activities. No such restructuring costs were incurred during 2020.

Additionally, during the year ended December 31, 2021 we recorded $7.0 million and $118.8 million non-cash warrant revaluation gain and non-cash future tranche right revaluation gain, respectively, related to the termination of securities issued in connection with our December 2019 private placement transaction in the first quarter of 2021. The losses of non-cash warrant revaluation and non-cash future tranche right revaluation were $3.7 million and $72.4 million, respectively, for the same period in 2020.

As a result of the factors above, net income applicable to common stockholders for the year ended December 31, 2021 was $96.9 million or $1.97 per basic share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per basic share for 2020. On a diluted basis, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million or $0.58 per diluted share compared to net loss applicable to common stockholders of $112.7 million or $3.33 per diluted share for 2020.

Excluding the non-cash gain of approximately $125.8 million related to the termination of securities issued in connection with the December 2019 private placement transaction in the first quarter of 2021, net loss applicable to common stockholders for the year ended December 31, 2021 was $28.8 million. Excluding the non-cash loss of approximately $76.1 million related to the change in fair value of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders for the year ended December 31, 2020 was $36.6 million.

On March 31, 2022 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has commenced an underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock (Press release, Sellas Life Sciences, MAR 31, 2022, View Source [SID1234611289]). All of the securities in the offering will be sold by SELLAS.

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SVB Leerink and Cantor are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-255318) that was previously filed with the Securities and Exchange Commission (the "SEC") on April 16, 2021 and declared effective on April 29, 2021. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected] or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 31, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, and GenFleet Therapeutics (Shanghai), Inc. ("GenFleet"), a clinical-stage biotechnology company developing cutting-edge therapeutics in oncology and immunology, reported that the companies have entered into an exclusive license agreement that grants rights to SELLAS for the development and commercialization of GFH009, a highly selective small molecule cyclin-dependent kinase 9 ("CDK9") inhibitor, across all therapeutic and diagnostic uses worldwide outside of Greater China (mainland China, Hong Kong, Macau and Taiwan) (Press release, Sellas Life Sciences, MAR 31, 2022, View Source [SID1234611288]).

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GFH009, currently in Phase 1 clinical trials in the United States and China, is a highly selective next-generation CDK9 inhibitor. CDK9 activity has been shown to negatively correlate with overall survival in a number of cancer types, including hematologic cancers, such as acute myeloid leukemia ("AML") and lymphomas, as well as solid cancers, such as osteosarcoma, pediatric soft tissue sarcomas, and melanoma, and endometrial, lung, prostate, breast and ovarian cancer. As demonstrated in pre-clinical and clinical data, to date, GFH009’s high selectivity has the potential to reduce toxicity as compared to older CDK9 inhibitors and other next-generation CDK9 inhibitors currently in clinical development. The Company believes, based on the initial pharmacokinetic data of the ongoing Phase 1 dose-escalating clinical trial, that the administration of GFH009 leads to lower toxicity and more potent efficacy due to its unique mechanism of action. Thus far in the Phase 1 clinical trial, which is planned to enroll approximately 80 patients, including an expansion part 2 of the study, and which is at the fourth of six doses, stable disease has been observed in three patients and, in one AML patient, a bone marrow blast decrease from 40% to 20% was observed at 9 mg, which is the third of six dose levels.

"SELLAS’ license agreement with GenFleet marks a pivotal milestone for the Company as we expand and diversify our clinical pipeline with GFH009 and progress it toward commercialization," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO of SELLAS. "There is significant interest in CDK9 inhibitors in the industry, and we are extremely excited to have the opportunity to develop GFH009. Not only has GenFleet advanced the molecule to clinical trials, but the asset also has attributes that can potentially make it best-in-class. Working with GenFleet brings together two companies with complementary skill sets: GenFleet is a leader in cutting-edge drug discovery, and SELLAS’ focus and expertise is in clinical development and commercialization of oncology drugs for a range of indications, particularly hematological malignancies. In early 2023, we plan to initiate a Phase 2 clinical trial with GFH009 in combination with venetoclax in AML, a cancer we know quite well as it is the indication of our registrational study for galinpepimut-S ("GPS"), our lead asset. We also plan to initiate a Phase 1/2 basket study in pediatric soft tissue sarcomas in late 2022 or early 2023 where there is a pressing unmet medical need and where GFH009 could potentially contribute to extending the lives of the afflicted children."

Dr. Stergiou continued, "SELLAS and GenFleet both strive on a daily basis to meet the unmet medical needs of patients all over the world who are suffering from cancer, and this license agreement reflects our joint commitment to developing novel, more tolerable treatment options for these patients and their families/caregivers. Additionally, we believe GenFleet’s track record of success suggests that GFH009 has the potential to bring to SELLAS the ability to address many indications in a cost- and time-effective manner."

"SELLAS’ excellence in execution, as well as its expertise and capabilities in clinical development, especially in AML and other hematological and solid cancers, will help GenFleet to maximize the value of this asset," concluded Qiang Lu, PhD, Chairman of GenFleet Therapeutics. "We are pleased that GFH009, one of the leading assets in our first-in-class portfolio, will now be developed and commercialized on a worldwide basis, with numerous trials planned in 2023, thus potentially benefiting patients not only in China but also those throughout the world."

Following completion of the Phase 1 clinical trial and achievement of a maximum tolerated dose, SELLAS plans to commence a Phase 2 clinical trial of GFH009 in combination with venetoclax and azacitidine in AML patients with active disease. The current standard of care for the vast majority of AML patients, including older patients, is venetoclax in combination with a hypomethylating agent such as azacitidine. GFH009 has shown in preclinical models a strong synergy with venetoclax. The Company believes that GFH009 has the potential to improve response to venetoclax or possibly convert resistance to venetoclax into a response and that the program will not only be a synergistic, but also an integral complement to the Company’s program for GPS in AML patients. The Company also plans to commence a Phase 1/2 basket clinical trial of monotherapy GFH009 in pediatric soft tissue sarcomas, including Ewing’s sarcoma and rhabdomyosarcoma, in late 2022 or early 2023, which it expects to be completed by the end of 2023. Positive results from this program could ultimately provide the basis for a rare pediatric disease priority voucher. GenFleet plans to commence several Phase 2 studies in China for various hematological malignancies.

Under the financial terms of the agreement, SELLAS will pay to GenFleet (i) an initial payment of $10 million as an upfront license and technology transfer fee, a portion of which is payable within 30 days of the execution of the license agreement with the remainder due upon the completion of the technology transfer, (ii) development and regulatory milestone payments for up to three indications totaling up to $48 million in the aggregate, and (iii) milestone payments totaling up to $92 million in the aggregate upon the achievement of certain net sales thresholds of GFH009 in the United States and rest of the world other than Greater China in a given calendar year. SELLAS will also pay GenFleet tiered royalties based on a percentage of annual net sales of GFH009 ranging from the low to high single digits.

SELLAS plans to host a R&D Day for analysts, investors and media in the second quarter of 2022. More information will be provided soon.