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Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update
https://finance.yahoo.com/news/fite-reports-third-quarter-2023-120000702.html
Advanced liver cancer patient in prior Phase II study remains cancer-free 6.9 years after starting treatment with Namodenoson
PETACH TIKVA, Israel, November 30, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.
Clinical & Development Milestones Achieved
Namodenoson Drug Candidate:
Complete Response and 6.9 Year Survival Reported in Patient with Advanced Liver Cancer Treated with Namodenoson
A patient who had participated in Can-Fite’s prior Phase II liver cancer study who continues to receive treatment with Namodenoson under a compassionate use program now has overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life, defined as a complete response. Enrollment is ongoing in Can-Fite’s pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer. During the third quarter, the American Society of Clinical Oncology (ASCO) selected Can-Fite for the prestigious Breakthrough Abstract Award from Conquer Cancer® for its abstract titled "A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)".
Pancreatic Carcinoma Phase IIa Study with Namodenoson is Underway
Namodenoson inhibited the growth of pancreatic carcinoma in a pre-clinical study through a mechanism that entails the Ras pathway. The Company continues to receive awards and recognition from leading cancer associations, and articles summarizing Namodenoson’s robust anti-cancer effect in pancreatic carcinoma have been published. The American Association of Cancer Research (AACR) accepted Can-Fite’s study titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/ß-catenin Signaling Pathway" for a poster presentation at the AACR Special Conference on Pancreatic Cancer. Biomolecules, a peer-reviewed scientific journal focused on the function and mechanism of bioactive molecules, published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of the Wnt/ß-catenin, NF-?B, and RAS Signaling Pathways".
Piclidenoson Drug Candidate:
Entered Rare Genetic Disease Market with Treatment for Lowe Syndrome
In preclinical studies, Piclidenoson has been found to be effective in Lowe Syndrome, a rare genetic disease with no treatment available, and an estimated $100 million treatment market in the U.S. alone. Lowe Syndrome usually develops in the first year of life, causing brain abnormalities associated with intellectual disabilities and a life span shortened to less than 40 years. The discovery of Piclidenoson’s efficacy in Lowe Syndrome was made by researchers at the University of Naples Federico II and The Telethon Institute of Genetics and Medicine in Italy after testing thousands of compounds in search of a treatment. Can-Fite and Fondazione Telethon signed an agreement outlining their collaboration for the development of Piclidenoson for the treatment of Lowe Syndrome. As a rare genetic disease in dire need of a treatment, Lowe Syndrome may qualify for an accelerated approval path, and Can-Fite plans to move into an advanced stage clinical study in this indication.
Harnessing Artificial Intelligence (AI) to Identify and Accelerate New Oncology Programs:
Through an agreement with Collaborations Pharmaceuticals, Can-Fite is utilizing AI and machine learning (ML) to develop and bring to market next-generation A3 adenosine receptor (A3AR) oncology drugs at a significantly reduced development time and cost. New molecules will be designed with high affinity and selectivity to A3AR, the target of Can-Fite’s platform technology.
"In addition to the several major value-driving milestones achieved during the third quarter, we continue to enroll and treat patients in our pivotal Phase III liver cancer study and Phase IIb study for NASH. Our pivotal Phase III study in psoriasis is expected to commence soon while we also prepare for a Phase IIa study in pancreatic cancer," stated Motti Farbstein, Can-Fite’s CEO and CFO. "We believe our advanced stage pipeline with multiple indications positions Can-Fite well for partnerships and for achieving regulatory and market success based on our robust portfolio."
Financial Results
Revenues for the nine months ended September 30, 2023 were $0.59 million compared to revenues of $0.61 million for the same period in 2022. Revenues for the nine months ended September 30, 2023 and September 30, 2022 comprised of recognition of a portion of advance payments received under distribution agreements with Gebro, CKD, Cipher and Ewopharma.
Research and development expenses for the nine months ended September 30, 2023 were $4.71 million compared with $5.30 million for the same period in 2022. Research and development expenses for the nine months ended September 30, 2023 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH.
General and administrative expenses were $2.23 million for the nine months ended September 30, 2023 compared to $2.31 million for the same period in 2022. The decrease is primarily due to the decrease in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2023.
Financial income, net for the nine months ended September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022. The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.
Net loss for the nine months ended September 30, 2023 was $5.98 million compared with a net loss of $7.15 million for the same period in 2022. The decrease in net loss for the nine months ended September 30, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.
As of September 30, 2023, Can-Fite had cash and cash equivalents and short term deposits of $7.94 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the nine months ended nine 30, 2023 is due to the ongoing operations of the Company which was offset by the Company’s fundraise during January 2023. During November 2023, Can-Fite raised approximately $3 million from the exercise of certain warrants.
The Company's consolidated financial results for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
September 30,
December 31,
2023
2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
3,383
$
2,978
Short term deposits
4,556
5,001
Prepaid expenses and other current assets
1,122
1,170
Short-term investment
3
8
Total current assets
9,064
9,157
NON-CURRENT ASSETS:
Operating lease right of use assets
72
84
Property, plant and equipment, net
33
42
Total non-current assets
105
126
Total assets
$
9,169
$
9,283
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
September 30,
December 31,
2023
2022
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
647
$
896
Current maturity of operating lease liability
34
48
Deferred revenues
783
783
Other accounts payable
746
775
Total current liabilities
2,210
2,502
NON-CURRENT LIABILITIES:
Long - term operating lease liability
17
14
Deferred revenues
1,707
2,295
Total long-term liabilities
1,724
2,309
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at September 30, 2023
and December 31, 2022; Issued and outstanding: 1,224,837,393 and 815,746,293 shares as
of September 30, 2023 and December 31, 2022
-
-
Additional paid-in capital
160,937
154,192
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(156,829
)
(150,847
)
Total shareholders’ equity
5,235
4,472
Total liabilities and shareholders’ equity
$
9,169
$
9,283
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Nine months ended
September 30,
2023
2022
Revenues
$
588
$
613
Research and development expenses
(4,716
)
(5,309
)
General and administrative expenses
(2,233
)
(2,317
)
Operating loss
(6,361
)
(7,013
)
Total financial income (expense), net
379
(141)
Net loss
(5,982
)
(7,154
)
Basic and diluted net loss per share
(0.00
)
(0.01
)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
1,209,797,279
815,746,293
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are "forward looking statements". Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to the COVID-19 pandemic and the Russian invasion of Ukraine; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the "Risk Factors" section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 30, 2023 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231130873648/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
2.7800+0.5000 (+21.9298%)
As of 10:13AM EST. Market open.
Pullback, lol
Can you imagine the impact on sp when further news is announced in regards this news item, eg an emergency stockpiling contract?:
RedHill Announces Additional U.S. Government Funding for Opaganib Nuclear Countermeasure Development
July 21 2023 - 07:00AM
https://www.prnewswire.com/news-releases/redhill-announces-additional-us-government-funding-for-opaganib-nuclear-countermeasure-development-301882889.html
Opaganib awarded a further $1.7 million in U.S. Government funding for development as a medical countermeasure for gastrointestinal acute radiation syndrome (ARS)
I am quite optimistic about this would be item:
RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study
https://finance.yahoo.com/news/redhill-u-army-announce-opaganibs-110000709.html
- Novel, oral opaganib, delivered a statistically significant increase in survival time (at 150 mg/kg BID) in a U.S. Army-funded in vivo Ebola virus study
- Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, having previously shown in vitro benefit in several strains of Ebola virus disease models
- Twice daily administered opaganib has previously demonstrated antiviral benefit in late-stage clinical studies of patients hospitalized with moderate to severe COVID-19; opaganib was also selected by the NIH Radiation and Nuclear Countermeasures Program (RNCP) for Acute Radiation Syndrome development
Hopefully RDHL can partner some BP to further
distribute the drug in additional regions.
Can you imagine the impact on sp when further news is announced in regards this news item, eg an emergency stockpiling contract?:
RedHill Announces Additional U.S. Government Funding for Opaganib Nuclear Countermeasure Development
July 21 2023 - 07:00AM
https://www.prnewswire.com/news-releases/redhill-announces-additional-us-government-funding-for-opaganib-nuclear-countermeasure-development-301882889.html
Opaganib awarded a further $1.7 million in U.S. Government funding for development as a medical countermeasure for gastrointestinal acute radiation syndrome (ARS)
The Small Business Innovation Research (SBIR) grant, given to RedHill's development partner, Apogee, is in addition and complementary to the multimillion dollar-valued U.S. Government Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development
This SBIR grant, and the earlier selection by the RNCP, follows FDA confirmation of Animal Rule regulatory pathway applicability for opaganib for ARS, utilizing pivotal animal model efficacy studies as the basis for FDA approval instead of human efficacy trials
Opaganib, a novel oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting potential central government stockpiling for use in mass casualty radiological or nuclear incidents, if approved by the FDA
Opaganib is being developed for multiple indications, including COVID-19, acute respiratory distress syndrome (ARDS), oncology and additional indications
TEL AVIV, Israel and RALEIGH, N.C., July 21, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that opaganib[1] has been awarded a further $1.7 million in U.S. Government funding, via a Small Business Innovation Research (SBIR) grant to the Company's development partner, Apogee Biotechnology Corporation ("Apogee"). This SBIR grant will support research to further the development of opaganib as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). This grant is in addition and complementary to the multimillion dollar-valued U.S. Government Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development.
1.1900 +0.1900 (+19.0000%)
Pre-Market: 8:13AM EST
Momentum continues.
1.3200 +0.3200 (+32.0000%)
Pre-Market
Gamida Cell to Host Virtual Thought Leader Fireside Chat on December 4, 2023
https://finance.yahoo.com/news/gamida-cell-host-virtual-thought-011100511.html
BOSTON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, is hosting a virtual fireside chat with thought leader Gary Schiller, MD, FACP, Professor of Medicine and Director of the Hematological Malignancy & Stem Cell Transplant Program at the David Geffen School of Medicine at University of California – Los Angeles.
Dr. Schiller will discuss his experience working with patients in need of allogeneic stem cell transplant, as well as the patient journey from diagnosis to transplant, the decision-making process for donor source selection, and his experience with Omisirge® (omidubicel-onlv) since its FDA approval.
A live question and answer session will follow the fireside chat.
Details are as follows:
Virtual Thought Leader Fireside Chat
Monday, December 4, 2023, at 4:30 – 5:15 p.m. ET
Click here to register.
A replay of the event may be accessed on the Events and Presentations page under the Investors section of the Gamida Cell website.
This event is intended for institutional investors, sell-side research analysts and business development professionals only.
About Gary Schiller, MD, FACP
Gary Schiller, MD, FACP is the Director of the Hematological Malignancy/Stem Cell Transplant Program at the David Geffen School of Medicine at UCLA, supervising 150-200 transplants per year. He has extensive clinical research experience, having conducted investigator-initiated and multicenter trials, mostly in hematologic malignancies and Blood and Marrow Transplantation. He is past Chair of the Faculty Executive Committee for the School of Medicine at UCLA. He is an author of over 225 publications and 450 abstracts and presented in more than 350 events. He has mentored residents, medical students, and fellows for more than 30 years. He served as a member and Chair of the Committee on Training for the American Society of Hematology, worked with its Trainee Council developing programs for the national meeting of the Society and curriculum for its Trainee Day, and is Chair of the ASH Foundation committee. Dr. Schiller has an outstanding track record in clinical research, teaching, and mentoring. He was co-investigator on Alternative Training grant for Bone Marrow Failure syndromes and developed the Sickle Hemoglobinopathy program at UCLA. He also has extensive experience outside of medicine with nonprofit, charitable institutions. He has served on the Board of Trustees of Wilshire Boulevard Temple, and was Chairman of the Los Angeles Museum of the Holocaust. Dr. Schiller has 30 years of experience in the diagnosis and management of adults with hematologic malignancies and those undergoing allogeneic stem cell transplantation for non-malignant disorders.
Omisirge® (omidubicel-onlv) Indication
Omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.
Important Safety Information for Omisirge
BOXED WARNING: INFUSION REACTIONS, GRAFT VERSUS HOST DISEASE, ENGRAFTMENT SYNDROME, AND GRAFT FAILURE
Infusion reactions may be fatal. Monitor patients during infusion and discontinue for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin or bovine material.
Graft-versus-Host Disease may be fatal. Administration of immunosuppressive therapy may decrease the risk of GvHD.
Engraftment syndrome may be fatal. Treat engraftment syndrome promptly with corticosteroids.
Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery.
Contraindications
OMISIRGE is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine products.
Warnings and Precautions
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of OMISIRGE. Reactions include bronchospasm, wheezing, angioedema, pruritis and hives. Serious hypersensitivity reactions, including anaphylaxis, may be due to DMSO, residual gentamicin, Dextran 40, human serum albumin (HSA) and bovine material in OMISIRGE. OMISIRGE may contain residual antibiotics if the cord blood donor was exposed to antibiotics in utero. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration.
Infusion Reactions
Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops.
Engraftment Syndrome
Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.
Graft Failure
Primary graft failure occurred in 3% (4/117) of patients in OMISIRGE clinical trials. Primary graft failure, which may be fatal, is defined as failure to achieve an absolute neutrophil count greater than 500 per microliter blood by Day 42 after transplantation. Immunologic rejection is the primary cause of graft failure. Monitor patients for laboratory evidence of hematopoietic recovery.
Malignancies of Donor Origin
Two patients treated with OMISIRGE developed post-transplant lymphoproliferative disorder (PTLD) in the second-year post-transplant. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. One patient treated with OMISIRGE developed a donor-cell derived myelodysplastic syndrome (MDS) during the fourth-year post-transplant. The natural history is presumed to be the same as that for de novo MDS. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Gamida Cell at (844) 477-7478.
Transmission of Serious Infections
Transmission of infectious disease may occur because OMISIRGE is derived from umbilical cord blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection, clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal and infant donor blood is tested for evidence of donor infection. See full Prescribing Information, Warnings and Precautions, Transmission of Serious Infections for list of testing performed. OMISIRGE is tested for sterility, endotoxin, and mycoplasma. There may be an effect on the reliability of the sterility test results if the cord blood donor was exposed to antibiotics in utero. Product manufacturing includes bovine-derived reagents. All animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Test results may be found on the container label and/or in accompanying records. If final sterility results are not available at the time of use, Quality Assurance will communicate any positive results from sterility testing to the physician. Report the occurrence of transmitted infection to Gamida Cell at (844) 477-7478.
Transmission of Rare Genetic Diseases
OMISIRGE may transmit rare genetic diseases involving the hematopoietic system because it is derived from umbilical cord blood. Cord blood donors have been screened to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time cord blood collection takes place, the ability to exclude rare genetic diseases is severely limited.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 20%) are infections, GvHD, and infusion reaction.
Please see full Prescribing Information, including Boxed Warning.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Facebook, Twitter and Instagram.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv). Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
Omisirge® is a registered trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved.
Investor Contacts:
Chuck Padala
LifeSci Advisors
chuck@lifesciadvisors.com
1-646-627-8390
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
Source: Gamida Cell, Ltd
At last. First sign of the resurrection
from the dead for RDHL!!!
I am pretty sure your timing is perfect.
GLTY
BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript
Published on November 21, 2023 at 3:45 pm by INSIDER MONKEY TRANSCRIPTS in News, Transcripts
BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript November 20, 2023
Operator: Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2023 Financial Results Conference Call. All participants are presently in a listen-only mode. Following management’s formal presentation, instructions will be given for the question-and-answer session. [Operator Instructions] I would now like to turn the call over to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.
John Lacey: Thank you, Johnny. Welcome, everyone. Thank you for joining us on our third quarter 2023 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. I’d like to remind you that certain statements we make during the call will be forward-looking. If have such statements due to future events and are subject to more risks and uncertainty actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainty, please review our annual report on Form 20-F and our quarterly report on Form 6-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin Chief Executive Officer of BioLineRx.
Phil Serlin: Thank you, John, and good morning, everyone, and thank you for joining us on today’s call. Joining me today are Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. I will begin with an overview of our Stem Cell Mobilization program, then Holly will provide an update on the effects to launch of activities and progress. I will then provide an update on our other clinical programs, notably the Motixafortide program in PDAC and Sickle Cell Disease. Finally, Mali will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. We have made substantial progress since our last quarterly update with our Stem Cell Mobilization program.
We were very pleased to announce in September the U.S. FDA approval of Motixafortide known commercially as APHEXDA in combination with G-CSF to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. The approval of APHEXDA is the culmination of tireless work by the entire BioLineRx team and transitions us to a commercial stage company that is bringing the patients, physicians and caregivers, the first true advancement in stem cell mobilization in more than a decade. And Holly will detail shortly, we have built out our U.S. commercial infrastructure, which has been engaging in pre-and post-launch activities to support a robust future for APHEXDA. Feedback from our initial outreach to top-tier transplant centers across the U.S. suggest that APHEXDA fills a significant unmet need for a more effective mobilization regimen, conferring benefits to centers, payers and patients alike.
This encouraging feedback gives us great optimism the long-term opportunity that is in front of us. There are many factors driving the need for improved stem cell mobilization regimen several of which we have covered in our prior calls. The population of multiple myeloma patients undergoing autologous Stem Cell Mobilization has expanded to include older patients over the past decade, with 36% of patients aged 65 or over in 2021, older age has been shown to impair Stem Cell Mobilization as stem cell counts decreased with age. In addition, the introduction of stronger induction therapies has further impaired mobilization, including drugs such as lenalidomide and natalizumab (ph), which are often given in combination. As a result, many patients may require multiple apheresis sessions.
Recall that the approval of APHEXDA was based on results from the highly successful GENESIS Phase 3 clinical trial and in this contemporary trial, most patients received lenalidomide containing induction regimen and the median age in the Motixafortide treatment arm was approximately 64 years old. Particularly relevant to the transplant centers in the GENESIS trial affect the plus G-CSF enabled almost 90% of patients who proceed to transplantation after only one apheresis session. Also, as a reminder, multiple myeloma is the second most common hematologic malignancy and autologous stem cell transplantation remains the standard of care treatment and has been shown to prolong the lives of patients with this cancer type. And historically, depending on treatment regimens, up to 47% of patients have faced challenges mobilizing the target number of stem cell after one session.
With APHEXDA as a potential backbone of a new mobilization paradigm, we are optimistic that many more multiple myeloma patients will be candidates for this life extending procedure and will benefit from what we are calling an A-plus transplantation experience. And at this point, I’d like to turn the call over to Holly May, President of BioLineRx USA for a review of our launch activities. Holly, please go ahead.
Holly May: Thank you, Phil. As Phil indicated, the approval of APHEXDA for stem cell mobilization in multiple myeloma patients represents the first true advancement in stems mobilization in over a decade. Our decision to commercialize effects to independently in the U.S. is key to our efforts to make this new mobilization agent available to transplant centers and patients as quickly as possible. I would now like to provide a brief update on our recent and ongoing activity supporting the commercial launch, which we initiated immediately after APHEXDA approval. First, it may be helpful to provide some statistics that support the significant opportunity that is in front of us, not just in terms of potential sales, but also an ability to help thousands of patients who today are having great difficulty mobilizing enough stem cells for transplantation.
As a reminder, there are approximately 35,000 patients diagnosed with multiple myeloma each year in the U.S. And of those, we estimate that about 18,000 are eligible for autologous stem cell transportation. On these eligible patients, approximately 8,000 procedures per annually, a figure that has nearly doubled since 2010. Autologous stem cell transportation remains the preferred first-line treatment for patients with multiple myeloma. However, due to a number of factors, including an aging patient population and the increased use of three and four drug induction therapies, as Phil indicated, up to 47% of patients have had challenges collecting the target number of stem cells in one apheresis session. As we will cover in more detail shortly, the requirements for multiple apheresis session leads to potentially more adverse events, higher costs and tremendous inconvenience and mental hardship for patients.
With the efficacy demonstrated in Phase 3 GENESIS trial, which supported the approval of effects to indecent indication, we believe we can overcome these challenges. We believe we are highly differentiated as a novel second-generation mobilization agent and that we have a significant value proposition for all stakeholders, that includes centers, patients and payers. Staying on the topic of differentiation for a moment, we have done extensive research on the market and have deep appreciation of the evolving landscape. Since our last earnings call and as expected, multiple abbreviated new drug applications or ANDA have been approved for generic [indiscernible] leading to rapid and significant price erosion for the first-generation mobilization agent.
This is something that we anticipated and what we have incorporated into our model. And why we consider, plerixafor to be in the same overall market basket at APHEXDA, it is not the same as APHEXDA. We have a highly differentiated product profile based on our stronger and more consistent mobilization outcomes. And our early discussions with customers support that the centers appreciate the innovation as we look to address their need for a better mobilizer. As such, we have indicated previously that we have price effects at [indiscernible] per vial. We believe this price adequately reflects the value that APHEXDA adds to the autologous stem cell transplant treatment landscape. Further, notwithstanding the existence of lower-priced generic plerixafor.
We believe the differentiated clinical attributes APHEXDA will drive long-term adoption and allow it to evolve into the new standard of care for mobilization. Over time, we strongly believe that differentiation will outweigh drug price as centers adopt the best treatment paradigm for their patients. As we indicated previously, our first priority has been to educate transplant centers on the unmet need of roughly 8,000 patients who progress to autologous stem cell transplant each year. We estimate the top 80 centers out of the band 212 nationally perform approximately 85% of all stem cell transplant procedures. Since approval, we have established initial contact with all of our top-tier centers and root activity has been extremely high. Increases shares can be in short supply at many transplant center and the potential for APHEXDA to allow for the collection of the targeted number of stem cells quite often in a single apheresis session should allow for the more efficient scheduling and utilization of those tiers.
This is of significant value to transplant centers, particularly those that perform a high number of procedures. We are in ongoing discussions with pharmacy and therapeutics committees at those centers that require positive PMP formulary decision prior to trialing the product and including APHEXDA in their protocols. We are making consistent and steady progress. We believe an important factor driving the future success of APHEXDA is inclusion in clinical treatment guidelines. Shortly after approval, APHEXDA was included in the national clinical practice guidelines in oncology otherwise known as NCCN, for stem cell mobilization broadly, including multiple myeloma. The American Society for transplantation in cellular therapy or ASTCT is also working on updated guidelines, which we anticipate next year.
Currently, ASTCT to [indiscernible] recommendations call for a recommended collection target of 3 million to 5 million cells per program and double that target with multiple transplants are planned. Recall that in the GENESIS trial, the median number of CD34 stem cells collected on the first day of apheresis was $8.5 million in the treatment arm versus $1.5 million in the control arm. As Phil indicated earlier, the addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session compared to 10.8% in the G-CSF, given the demonstrated performance of APHEXDA relative to the current treatment guidelines, we are confident that we will ultimately gain inclusion. Turning now to payers. The success of any new therapeutic launch is contingent upon establishing broad, affordable access from a coverage and reimbursement perspective.
This includes not only national and regional commercial health plans, but also the centers for Medicare and Medicaid services since a significant number of multiple myeloma patients are older and therefore, receive their health care through Medicare. The immediate upfront cost of stem cell collection independent of drug costs is 13,850 per patient and can range from 6,300 (ph) to $48,500 and the cost of one apheresis session is 6,200 to 6,600 again independent of drug costs. For the ability to more predictably and reliably achieve the target number of stem cells required for transplantation and fewer apheresis sessions can result in significant savings to payers over time. Payers view the effects of clinical data very favorably. And as a result, we have already established unrestricted access to over 90% of covered lives.
This represents a mix of both commercial and government payers, and we continue to work to increase this number so that APHEXDA is as broadly accessible to patients as possible. In summary, I am very pleased with our launch progress to date. Both our commercial and medical affairs teams, which include many individuals with decades of experience in both stem cell mobilization and multiple myeloma are generating results in the early stages of this launch as we continue to engage with top transplant centers, physician leaders and payers on this exciting new treatment option. At this point, I’ll turn the call back to Phil to provide an update on our other programs.
Phil Serlin: Thank you, Holly. At this point, I would like to provide an update on opportunities that we are pursuing in Stem Cell Mobilization for multiple myeloma outside of the United States. Just a few weeks ago, we closed an exclusive license agreement with the development commercialization of Motixafortide in Asia across multiple indications. As part of the agreement in Stem Cell Mobilization cell mobilization, our partner, Gloria Biosciences plans to execute a 30 to 50 patient bridging study in China to support approval and commercialization of APHEXDA for Stem Cell Mobilization in multiple myeloma. And we’ll also seek approval in other Asian countries. In prior clinical trials, Gloria Biosciences has demonstrated an ability to enroll patients quickly, and we believe they will be able to complete this trial with similar efficiency.
In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma, the largest number of multiple myeloma cases globally. So this is an area of great unmet need in those territories as well. And in China, autologous stem cell translocation for multiple myeloma is already included in medical insurance reimbursement. We continue to evaluate additional commercialization partnership opportunities in significant markets for APHEXDA in stem cell mobilization. Turning now to our second development indication for Motixafortide pancreatic cancer, our license agreement with Gloria Biosciences covers this indication as well. Gloria Biosciences is a leader in the development of cancer immunotherapies in Greater China having developed and commercially launched the anti-PD-1 monoclonal antibody, zimberelimab, which is approved in the region for relapsed or refractory classical Hodgkin lymphoma into a recurrent or metastatic cervical cancer.
Gloria Biosciences went from IND to commercialization of zimberelimab in its first indication in China in only four years. So we believe they are uniquely positioned to explore the potential utility of Motixafortide in combination trials against this difficult to treat cancer. Recapping the terms of the agreement, we received $15 million upfront and are eligible to receive up to approximately $50 million in development milestones based on the achievement of specific development milestones in China and Japan. Additionally, we are eligible to receive up to approximately $200 million in potential commercial milestones and royalties ranging from 10% to 20% of net sales following the approval of Motixafortide in any indication in the Asia region.
In addition, the transaction included an equity investment of $14.6 million in BioLineRx, with the purchase of newly issued American depositary shares and of price at $2.14 per ADS. No warrants were issued in the transaction. In other PDAC developments in July, we announced the initiation of a randomized Phase 2 combination clinical trial of Motixafortide first-line pancreatic cancer. The trial known as CheMo4METPANC is sponsored by Columbia University, and it was recommended to precede the randomized phase of the study based on the very compelling preliminary data in the single-arm pilot phase of the study. Recall that the original pilot study was to enroll approximately 10 patients and was to be expanded to 30 patients if data from the first 10 patients were encouraging which was defined as three or more patients showing the partial response per the RECIST criteria.
As we recently presented at the AACR Special Conference on Pancreatic Cancer in September, seven of 11 patients were 64% experienced a partial response, of which five were confirmed PRs with one patient even experiencing resolution of the metastatic lesion in the liver. Along with the three patients were 27% experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare very favorably to historic partial response and disease control rate of 23% and 48%, respectively, reported with the current standard of care. Based on these compelling data, the original trial design was amended from a single-arm study with a target enrollment of 30 patients is mentioned to a much larger randomized study of 108 patients.
The trial’s primary endpoint is progression-free survival PFS. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit and overall survival. Enrollment in the study is expected to begin in the next few months. As is well known, PDAC is a tumor type in dire need of new effective treatment options. Neuro immunotherapies have shown promise in other tumor types with limited efficacy in PDAC due to immunosuppressive pathways. On our more optimism for this trial is also based on the success of our COMBAT/KEYNOTE-202 triple combination Phase 2a study for which we announced results in December 2020. Recall that the COMBAT/KEYNOTE study evaluated the combination of motixafortide, KEYTRUDA and chemotherapy as a second-line therapy.
Substantial improvement was observed across all study end points including overall survival, progression fee survival and overall response in the most challenging PDAC patients, those initially diagnosed with stage four cancer. The combination also appeared to be well tolerated with a low incidence of neutropenia and infections in treated patients. Needless to say, we are excited about the potential of Motixafortide to form the backbone of new PDAC treatment regimens giving new hope to patients suffering from this very difficult to treat tumor type, while demonstrating the versatility of Motixafortide across both hematological and solid tumor cancers. It is also worth mentioning that based on the promising data to date in PDAC, we see opportunities to explore Motixafortide as part of exciting new combination therapies to treat other solid tumor types.
This only adds to our optimism for the long-term potential of this molecule. Another area where we are exploring the potential utility of Motixafortide in autologous hematopoietic stem cell-based gene therapy for patients suffering from sickle cell disease one of the most common genetic diseases globally. To that end, in March, we announced the clinical trial collaboration with Washington University School of Medicine to evaluate Motixafortide in this indication. Unlike multiple myeloma patients, the current standard of care mobilization G-CSF carries significant risks and potential severe side effects for patients suffering from sickle cell disease. Furthermore, in many cases, current mobilization treatments fail to reliably yield optimal number of stem cells to facilitate gene therapy.
As such, this patient population is in need of an effective new mobilization regimen. Through this collaboration, we are conducting a proof-of-concept trial to study Motixafortide as both a single agent and in combination with the immunomodulator, natalizumab. The study is evaluating the safety and tolerability of the two regimens as mobilization agents of CD34+ in motixafortide stem cells in patients with sickle cell disease. Study enrollment has recently begun, and we anticipate data in the second half of 2024. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our main financial results. Mali, please go ahead.
Mali Zeevi: Thank you, Phil. As is our practice in our financial discussion on this call, we will only go over the most significant items in our financial statements. Sales and marketing expenses, research and development expenses, non-operating expenses, net loss and cash. Therefore, let me invite you to review the filings we made this morning, which contain our financials, 20-F and press release for additional information. Sales and marketing expenses for the three months ended September 30, 2023 were $8.1 million, an increase of $6.8 million or 517.4% compared to $1.3 million for the corresponding period last year. The increase resulted from the significant launch-related activities for Motixafortide in the U.S. Research and development expenses for the three months ended September 30, 2023 were $2.7 million, a decrease of $1.6 million or 37.6% compared to $4.3 million for the corresponding period last year.
The decrease resulted primarily from lower expenses for NDA supporting activities related to Motixafortide as well as lower expenses associated with the completed AGI-134 clinical trials. Non-operating expenses for the three months ended September 30, 2023 were $3.1 million, an increase of $3.5 million compared to nonoperating income of $0.4 million for the corresponding period last year. The increase relates primarily to a non-cash expense from revaluation of outstanding warrants due to an increase in the company’s share price during the 2023 period. Let me now turn to net loss. Net loss for the three months ended September 30, 2023, was $16 million compared to $6.8 million for the corresponding period last year. Net loss for the nine months ended September 30, 2023, amounted to $46.7 million compared to $19.2 million for the corresponding period last year.
The increases in net loss for both the three and the nine months period in 2023 were primarily due to the significant nonoperating expenses related to revaluation of outstanding warrants as well as the significant increases in sales and marketing expenses related to launch activities which were partially offset by a decrease in research and development expenses. The company emphasizes the non-cash expenses associated with the warrant revaluation did not impact its cash position as of September 30, 2023, note that they affect the company’s projected cash runway going forward. Turning to cash. The company held $26 million of cash, cash equivalents and short-term bank deposits as of September 30, 2023. This does not include the roughly $30 million consideration from the license agreement and the equity investment in the deal with Gloria Biosciences nor does it include the $30 million available to us under our debt agreement with Kreos Capital, which is tied to the attainment of certain milestones.
We believe we are well financed to fund our operations as currently planned into 2025. And with that, I’ll turn the call back over to Phil.
Phil Serlin: Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones. Commercial ramp-up of effects to U.S. sales and an ongoing evaluation of commercial partnership opportunities for APHEXDA in additional markets. Recruitment in the chemo for met Phase 2 randomized clinical trial in first-line PDAC sponsored by Columbia University. Recruitment in the Phase I pilot study of Motixafortide Hematopoietic Stem Cell Mobilization for gene therapies in sickle cell disease led by Washington University School of Medicine with initial data expected in the second half of 2024. Initiation by Gloria Biosciences of a 30 to 50 patient bridging study in 2024 to support approval of APHEXDA and Stem Cell Mobilization for multiple myeloma in China in preparation activities with Gloria Biosciences on a randomized Phase II/III clinical trial, evaluating ixaportid in combination with the PD-1 inhibitor zimberelimab and standard of care combination chemotherapy in first-line pancreatic cancer.
With that, we have now concluded the formal part of our presentation. Operator, we will now open the call to questions.
Operator: Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question is from Joe Pantginis of H.C. Wainright. Please go ahead.
Joe Pantginis: Hi, everybody. Good morning. Thank for taking the questions. And first, I just wanted to extend my well wishes to everybody, not only for these difficult and turbulent times, but also for the holidays. So we have all of our best — so I’d like to focus on two things for stem cell transplantation and then one on PANC (ph), if you don’t mind. So first, Holly, I really appreciate all the details that it definitely is encouraging to hear all the details that you shared about the launch. So hopefully, I’m not getting too much into the weeds because it is early. I guess, when you’re early in the launch, I’m just considering what places or areas that you feel the company has had nimble in according to the plans that you had and saying, okay, we learned we might need more emphasis in a particular geography or anything of that such of those details. Yeah.
Phil Serlin: Holly, go ahead.
Holly May: Yeah. Sure. Thanks, Joe. So much of what we’re doing right now is as expected as planned. We have said this previously, I spoke again in my comments this morning about the fact that transplant centers make up about 85% of all of the transplantations in the U.S. And therefore, we are — we have a deployment plan with field individuals, both sales account type people as well as medical affairs type people. And I think we kind of got that one right. The deployment plans and our ability to reach and hit the right frequency with in those institutions is spot on. I think one of the things that’s been interesting for us, I don’t know if it’s a huge shift, but it’s been interesting to speak to some of these decision makers within the centers about the — what we would — we have three pillars of value — and the one I think that maybe not surprising, but we’re finding a lot of interest in is that the efficiency of this product.
And that has to do really around the planning and logistics asset centers as well as the pharmacokinetics. So that’s an area I think that we are spending perhaps a little bit more time than maybe we had originally the strong clinical data, which is our efficacy pillar the Phase 3 GENESIS data is resonating quite well. But I think the thing that we’re spending some more time on is probably the efficiency and what that means. I do want to add, though, you didn’t ask this, but the third, I’ve spoken about the efficacy and the efficiency of the other really important part of our value proposition is the experience that patient experience as well. So we are out there with all of that messaging, but the one I think that we’re really finding to resonate for maybe a few more questions than we initially thought was that efficiency color.
Joe Pantginis: That’s really, really helpful. Thank you for that. And I guess the thing that I’m curious about is because it’s pretty intriguing is the fact that it’s huge that you’re on the NCCN guidelines. And you said for SCM broadly, so I wanted to get a sense of how that impacts your potential development plan. And I know you can’t really talk to off-label use in other indications, but I think this could help drive, I guess, how you develop for other indications. I don’t know if you have any comments on that.
Phil Serlin: Holly, do you want to take that?
Holly May: I can. Yes. So we are very much staying the course on thinking about what we want to do for add-on indications, either things that would be driven within our own clinical planning. We do have an active IS independent sponsored studies that is open and available for various institutions or physicians that have an area of interest [indiscernible] in stem cell mobilization. We are constantly looking at the data that required for making sure that we shore up our label and that. But I’m certainly not going to speak at all to any kind of off-label utilization that the guidelines may or may not afford. Did that answer your question?
Joe Pantginis: It does. I’d like to add something.
Phil Serlin: Joe, I’d like to add something — I just I’m sorry, I sorry to interrupt you. I just wanted to add, first of all, hi, good to speak to you. But I do want to add, we mentioned the gene therapy in the sickle cell disease area. And obviously, that’s an area that we’re putting a lot of focus on in a big way. And so we see that as a very key life cycle management upside for the company.
Joe Pantginis: Great. And then just the last question. I mean, short question, but maybe more elaborate answer. Maybe. The Phase II pilot study being run with Colombia. Obviously, you’re having a nice expansion into a larger set of patients. I guess a question this way. To what extent do data from this study impact or serve as a rate-limiting step for potential business development?
Phil Serlin: Okay. So let me just make sure that I understand. So I mean, I mean I think I do understand. I think we are obviously looking to generate data I think that we’ve made it clear that we are looking to generate data to move this forward. We were — we entered into agreement with Gloria Biosciences. In Asia, part of that deal, a significant part of that deal is for them to generate Phase IIb data in a randomized study, Phase II, III data in a randomized study in PDAC and we’re running this trial or we’re cooperating or collaborating with Columbia University in this IST trial. Depending on the data, we are hoping to be able to take this data and move forward from a business development perspective and speaking with large pharma companies, that would be the idea.
Of course, I’m not ruling out us potentially taking this forward ourselves depending on the situation. but it’s likely in a very significant indication like this. And when we’re talking about PDAC, we’re not only talking about PDAC. We look at this as sort of as a proof of concept for other solid tumors as well. And so obviously, that would speak to a larger company conducting many studies, many Phase III studies across the board in order to get broad approval in a number of indications. So I hope that answered your question. I think that we’re looking at this as a potential launch launching pad, so to speak, for business development with larger companies in this particular area of solid tumors.
Joe Pantginis: It certainly answer the question. I appreciate the color and as usual what I’m hearing personally is that you continue to have a lot of optionality going forward. Thanks a lot guys.
Phil Serlin: Thank you.
Holly May: Thank you.
Operator: The next question is from John Vandermosten of Zacks. Please go ahead.
John Vandermosten: All right. Thank you and hello, Phil, Holly and Mali. As the previous — as Joe mentioned, APHEXDA was added to the NCCN guidelines, how quickly is a change like that incorporated into practice?
Phil Serlin: Holly, do you want to take that?
Holly May: Sure. I mean from a market access perspective, that’s what many of these payers will mean on it for decisions about the reimbursability, et cetera. So from an NCCN perspective, pretty much immediately.
John Vandermosten: That’s great. And then looking at gene therapy, I mean, personally, I think that’s one of the greater options that you guys have out there. You’ve got quite a few. But there was recently a sickle cell disease drug approved Vertex, I think, in the UK. And I think they’re also applied in the EU and the U.S. as well. Is that what are the bottlenecks there in terms of gene therapy for sickle cell disease is stem cell mobilization part of the bottleneck there. Is that approval and potentially two others and somewhere where you can get into as well? I mean you’re doing work there. Maybe you can help me understand kind of how that drug that just got approved in the UK might be something that you could take advantage of.
Phil Serlin: Holly, do you want to take that? I mean…
Holly May: Why don’t I begin and then you can add on if I set some gap. And I may be a good one to ask just because it’s a world I came from. So prior to this, I was the Chief Commercial Officer at a gene therapy company. So I certainly understand the challenges — we also know that both Vertex and Bluebird are looking at PDUFA dates in December here in the U.S., so that could be significant. I think that the thing that is that gene therapy company to these ex-vivo gene therapy customers are always looking to solve for is that entire patient journey and what kind of improvements can be made. And that can happen on several different fronts conditioning with one area that, of course, they’re always looking at, but also [indiscernible] is another area.
And I think this is especially true with sickle cell disease because the standard for mobilization. We see it with our multiple myeloma indication is G-CSF plus a mobilizer such as APHEXDA and with that, we know that sickle stop patients are unable to be unable to use G-CSF in sickle cell patients. So I think it produces a an appendage situation in sickle cell. That’s not to say that symptom mobilization isn’t also something that’s looked at for some of these other applications. And in the future as these come to market. We will — we could also be looking at those. But right now, of course, our efforts are focused on the high unmet need in sickle cell. And as has been announced, we do have the study at Wash, which is looking at some of that.
So did I forget into, was there anything you wanted to add to that?
Phil Serlin: I think I might want to add. I think we’ve mentioned this previously, but we look at this area as something that we can really, really find a real place for it. There is an unmet need. There’s a huge amount of cells that are required to be mobilized in — for gene therapy. We’re talking about 15 million to 20 million CD34+ positive cells per kilogram. And just for example, in multiple myeloma, our phase III, we’re talking about 6 million cells per kilogram. And so a significantly higher number of cells need to be mobilized in order to move forward in gene therapy. And in addition, as Holly mentioned, these patients cannot receive G-CSF and therefore, it’s that much more difficult to mobilize. So the current mobilization regimen require these patients to go through multiple cycles of after recessions and mobilization and collection with usually a 30-day period between each cycle.
So therefore, the collection of the cells could be something that takes two to three months or even longer in some circumstances. And therefore, we hope and we think that we may be able to show better mobilization and perhaps even reduce the number of mobilization cycles to a bare minimum and therefore, save a significant amount of time and discomfort for the sickle cell patients since that’s the idea behind our value proposition there.
Holly May: There’s one other thing that you were speaking that I thought I would add on that is very unique about these approaches to gene therapy that you mentioned, in particular, John, the Vertex product. And that is the manufacturing and the manufacturing of the cells that go into that. That’s one — another reason why a very high number of CD34+ themselves are required for these types of therapies just because there’s always the need for backup in case something this is personalized medicine and gene therapy, obviously, that is manufactured for the individual. And so there is always a need for back up through the manufacturing processes, which just, again, drives the need for a very, very high number of stem cells.
John Vandermosten: Okay. Great. Yeah. It will be exciting to see how this turns out with that product and maybe you guys will be involved. A couple of questions on — there’s been a lot of, I guess, cash flow movements and share movements recently. And I’m wondering if you can give me some kind of sense of where cash and share balance might be at the beginning of the — at the end of the year, beginning of the year, December 31. Can you help me with that?
Phil Serlin: Yes. So I mean, I think we discussed our cash. We including the almost $30 million that we received from the deals or the agreements, the license and the equity investment. We have in excess of $50 million in cash on a pro forma basis, which, as we mentioned, is enough to take us into 2025. We also, as Molly mentioned, we have a $30 million debt facility that’s available to us. And so we feel quite comfortable from a cash perspective that we can meet everything that we need to do from a launch perspective in the near future. from that. So as a — you also asked about the number of shares, is that what you asked? Do you want to?
John Vandermosten: Yes, yes, exactly.
Phil Serlin: I think what Molly. No, but in ADS, I think we have about 70. We have somewhere — the exact number is in front of me. I apologize. I think it’s somewhere around 70 million (ph) outstanding ADSs.
John Vandermosten: Okay. Great. And then last one for me is just any kind of revenue guidance that you can provide us for the fourth quarter?
Phil Serlin: Yes. I mean that’s the question. So listen, John, I mean, we’re happy, as Holly mentioned, we’re happy with the way things are progressing. And there’s a lot of activity that we’re doing on all fronts, hospitals KOLs. The committees, P&T committees, as you know, we also got on the NCCN guidelines, et cetera. But as I’m sure you’re aware, we can’t, of course, get into sales forecast and companies usually don’t give forecast on commercial launches. And so that’s about all we can say at this point.
John Vandermosten: Right. I mean, lots of [indiscernible] there. Well thank you. You guys are in a great place and I appreciate you taking my questions.
Phil Serlin: Thanks so much.
Operator: This concludes the question-and-answer session. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin 2 hours after the conference. In the U.S. please call 1 (888) 295-2634. In Israel, please call (03) 925-5904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make your concluding statements?
Phil Serlin: Yes. Thank you, operator. In closing, we are progressing through 2023 with significant momentum. We are launching our first therapy in stem cell mobilization and are making significant progress, raising awareness of the many benefits APHEXDA can bring to payers and transplant centers. We completed our first ex-U.S. partnership agreement for APHEXDA and are evaluating the potential of commercial partnerships in other significant markets. We have made important additional life cycle management steps through both our PDAC program as well as our program for stem cell mobilization for gene therapies. I am very pleased with our progress during the third quarter, and I’m excited about what we are in the process of achieving. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in March. Be safe, and have a great day.
Operator: Thank you. This concludes the BioLineRx third quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.
Can-Fite Announces Exercise of Warrants for Approximately $3.0 Million in Gross Proceeds
https://finance.yahoo.com/news/fite-announces-exercise-warrants-approximately-185300215.html
PETACH TIKVA, Israel, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,963,637 American Depositary Shares (ADSs), having exercise prices ranging from $6.00 to $5.50 per ADS, issued by Can-Fite in December 2021 and January 2023, at a reduced exercise price of $1.53 per share. The ADSs representing ordinary shares issuable upon exercise of the warrants are registered pursuant to effective registration statements on Form F-3 (File No. 333-262055) and Form F-1 (File No. 333-269485). The closing of the offering is expected to occur on or about November 24, 2023, subject to satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
In consideration for the immediate exercise of the warrants for cash, Can-Fite will issue new unregistered warrants to purchase up to 3,927,274 ADSs. The new warrants will have an exercise price of $1.75 per ADS, will be immediately exercisable and have a term of exercise equal to five years from the date of issuance. In addition, Can-Fite has agreed to reduce the exercise price of series B warrants to purchase 1,363,637 ADSs held by the warrant holder from $5.50 per ADS to $1.75 per ADS and extend the term of such series B warrants to twenty months from the closing date.
The gross proceeds to Can-Fite from the exercise of the warrants are expected to be approximately $3.0 million, prior to deducting placement agent fees and offering expenses. The Company intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.
Can-Fite: Complete Response and 6.9 Years Overall Survival in a Patient with Advanced Liver Cancer Treated with Namodenoson
https://finance.yahoo.com/news/fite-complete-response-6-9-120000052.html
PETACH TIKVA, Israel, November 21, 2023--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that a patient who participated in the Phase II Liver Cancer Study and was treated with namodenoson has a complete response and overall survival of 6.9 years (82.8 months).
Liver Cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B.
A patient with advanced HCC that was enrolled in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response.
Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase III clinical study which is now enrolling patients in Israel, Europe and the US. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.
The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.
An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective.
"We are currently enrolling patients for the pivotal Phase III clinical study and hope that if the interim analysis data will be positive, we will be able to get a conditional approval, and that patients who suffer from this devastating disease will enjoy our drug," stated Can-Fite CEO Motti Farbstein.
According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.
Still buying yes9?
Gamida Cell to Present Corporate Highlights at the Piper Sandler 35th Annual Healthcare Conference
https://finance.yahoo.com/news/gamida-cell-present-corporate-highlights-130000108.html
BOSTON, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that its management team will present corporate highlights at the upcoming Piper Sandler 35th Annual Healthcare Conference in New York, NY.
Presentation Details
Format:
Fireside Chat
Date/Time:
Tuesday, November 28, 2023 at 11:00 –11:25 AM ET
Webcast:
Click here.
The Gamida Cell management team will be available for one-on-one meetings during the conference. Interested investors should contact their Piper Sandler representative.
BioLineRx Reports Third Quarter 2023 Financial Results and Recent Corporate and Portfolio Updates
https://finance.yahoo.com/news/biolinerx-reports-third-quarter-2023-120000394.html
- Received FDA Approval of APHEXDA® (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma -
- Closed Exclusive License Agreement for Motixafortide in Asia Region with Concurrent Strategic Equity Investment -
- Presented Encouraging Data at AACR from Pilot Phase of Randomized Phase 2 Combination Trial with Motixafortide in Patients with First Line PDAC -
- Began Enrollment of Phase 1 Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease -
- Management to host conference call today, November 20, at 10:00 a.m. EST -
TEL AVIV, Israel, Nov. 20, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the third quarter ended September 30, 2023, and provided corporate and portfolio updates.
"FDA approval of APHEXDA® in September was a transformative event for the company, and our U.S. commercial team is now working with payers and providers to make this important innovation available to patients," said Philip Serlin, Chief Executive Officer of BioLineRx. "We were pleased that APHEXDA® was recently added to the NCCN guidelines, and we believe that as centers adjust their protocols to include and gain experience with APHEXDA®, transplant teams will gain a deep appreciation for the efficiencies that it can provide, and more importantly, the improved treatment journey patients experience as they navigate their essential transplant process.
"In addition, the company also closed its motixafortide licensing agreement covering the important Asia market. The agreement, which provided significant upfront funding, will first advance potential indications in the region for stem cell mobilization and pancreatic cancer, areas of high unmet need. We continue to evaluate additional commercial partnership opportunities in other markets.
"Lastly, exciting data were presented at AACR from the single-arm pilot phase of the randomized Phase 2 combination clinical trial with motixafortide in first-line pancreatic cancer by the study's lead investigator at Columbia University. The highly encouraging data triggered a change in the protocol, from a small, single-arm study to a much larger randomized study. This study, as well as the enrolling Phase 1 study evaluating motixafortide for stem cell mobilization in patients with sickle cell disease seeking gene therapy, highlight the potential versatility of motixafortide and the tremendous progress we are making to realize the full promise of this novel molecule for patients around the world," Mr. Serlin concluded.
Corporate Updates
Received U.S. Food and Drug Administration approval of APHEXDA® (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma
Closed exclusive license agreement to develop and commercialize motixafortide in Asia, alongside strategic equity investment:
License agreement included $15 million upfront payment, up to $50 million in potential development and regulatory milestones, up to $200 million in potential commercial milestones, and tiered double-digit royalties on sales
Straight common equity investment of $14.6 million in BioLineRx American Depository Shares (ADSs)
Gloria Biosciences expected to begin pivotal bridging study to support potential approval and commercialization of motixafortide in stem cell mobilization in China
Gloria Biosciences planning randomized Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor zimberelimab and standard of care combination chemotherapy
Clinical Portfolio Updates
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
Received inclusion of APHEXDA® in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation
Received acceptance of an abstract on combination premedication benefits in the Phase 3 GENESIS trial, further educating on the use of APHEXDA at transplant centers. The poster will be presented at the American Society of Hematology (ASH) 65th Annual Meeting on December 10, 2023, in San Diego, California
Initiated pivotal bridging study preparation activities with Gloria Biosciences to support potential approval and commercialization of motixafortide in stem cell mobilization in China
Pancreatic Ductal Adenocarcinoma
Presented data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial in first-line pancreatic cancer (PDAC) at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer. Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced a partial response (PR), of which 5 (45%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. Three patients (27%) experienced stable disease, resulting in a disease control rate of 91%. Based on these encouraging results, the study was substantially revised to a multi-institution, randomized trial of 108 patients
Initiated preparation activities with Gloria Biosciences to support the development of a randomized Phase 2/3 clinical trial evaluating motixafortide in combination with the PD-1 inhibitor zimberelimab and standard of care combination chemotherapy in first-line pancreatic cancer
Sickle Cell Disease & Gene Therapy
Began enrollment in investigator-initiated Phase 1 pilot study led by Washington University School of Medicine in St. Louis evaluating motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate data in 2H of 2024
AGI-134 (synthetic alpha-Gal glycolipid)
Solid Tumor Immunotherapy
Evaluating next development pathways for AGI-134 program. The Phase 1/2a first-in-human, single-agent study, results of which were announced in Q4 2022, met the primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers
Third Quarter 2023 Financial Results
Research and development expenses for the three months ended September 30, 2023 were $2.7 million, a decrease of $1.6 million, or 37.6%, compared to $4.3 million for the three months ended September 30, 2022. The decrease resulted primarily from lower expenses associated with NDA supporting activities related to motixafortide as well as lower expenses associated with the completed AGI-134 clinical trial
Sales and marketing expenses for the three months ended September 30, 2023 were $8.1 million, an increase of $6.8 million, or 517.4% compared to $1.3 million for the three months ended September 30, 2022. The increase resulted primarily from the ramp-up of pre-commercialization activities related to motixafortide
General and administrative expenses for the three months ended September 30, 2023 were $1.5 million, an increase of $0.1 million, or 7.7% compared to $1.4 million for the three months ended September 30, 2022. The increase resulted from small increases in a number of individual G&A expenses
Non-operating expenses for the three months ended September 30, 2023 were $3.1 million, an increase of $3.5 million, compared to non-operating income of $0.4 million for the three months ended September 30, 2022. The increase relates primarily to the revaluation of outstanding warrants resulting from an increase in the company's share price during the 2023 period
Net loss for the three months ended September 30, 2023 was $16.0 million, compared to $6.8 million for the three months ended September 30, 2022. Net loss for the nine months ended September 30, 2023 amounted to $46.7 million, compared to $19.2 million for the nine months ended September 30, 2022. The increases in net loss for both the three- and nine-month periods in 2023 were primarily due to the significant non-operating expenses (which were also non-cash) related to revaluation of outstanding warrants, as well as the significant increases in sales and marketing expenses related to pre-commercialization and commercialization activities, which were partially offset by a decrease in research and development expenses
As of September 30, 2023, we held $26.0 million of cash, cash equivalents and short-term bank deposits. We anticipate that this amount, as well as the consideration from the exclusive license agreement and the securities purchase agreement of $29.6 million that was received in October 2023, will be sufficient to fund operations, as currently planned, into 2025
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 22, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
Protalix BioTherapeutics, Inc. (NYSE:PLX) Expected to Earn FY2023 Earnings of $0.16 Per Share
https://www.defenseworld.net/2023/11/17/protalix-biotherapeutics-inc-nyseplx-expected-to-earn-fy2023-earnings-of-0-16-per-share.html
Posted by Defense World Staff on Nov 17th, 2023
Protalix BioTherapeutics, Inc. (NYSE:PLX – Free Report) – Analysts at HC Wainwright increased their FY2023 earnings per share (EPS) estimates for Protalix BioTherapeutics in a research note issued on Tuesday, November 14th. HC Wainwright analyst R. Selvaraju now forecasts that the company will earn $0.16 per share for the year, up from their previous forecast of $0.08. HC Wainwright currently has a “Buy” rating and a $10.00 target price on the stock. The consensus estimate for Protalix BioTherapeutics’ current full-year earnings is $0.06 per share. HC Wainwright also issued estimates for Protalix BioTherapeutics’ Q4 2023 earnings at ($0.03) EPS and FY2024 earnings at $0.08 EPS.
Gamida Cell (NASDAQ:GMDA) Price Target Cut to $2.00
https://www.defenseworld.net/2023/11/19/gamida-cell-nasdaqgmda-price-target-cut-to-2-00.html
Posted by Defense World Staff on Nov 19th, 2023
Gamida Cell Ltd. logoGamida Cell (NASDAQ:GMDA – Free Report) had its price objective reduced by Piper Sandler from $5.00 to $2.00 in a research report sent to investors on Wednesday, Benzinga reports. They currently have an overweight rating on the stock.
GMDA has been the topic of a number of other reports. JMP Securities restated a market outperform rating and issued a $6.00 price target on shares of Gamida Cell in a research report on Thursday, September 28th. Needham & Company LLC reiterated a buy rating and set a $6.00 target price on shares of Gamida Cell in a research report on Tuesday, August 15th. Finally, HC Wainwright reduced their target price on shares of Gamida Cell from $11.00 to $5.00 and set a buy rating on the stock in a research report on Wednesday. Five equities research analysts have rated the stock with a buy rating, According to MarketBeat.com, the company presently has an average rating of Buy and a consensus price target of $5.40.
FWIW
Orion's Contest Turkey 2023 Pick BIVI $4.05
Orion's Contest Turkey 2023 Pick BIVI - $4.05
Protalix BioTherapeutics: Fiscal Challenges And Gout Therapy Prospects
Nov. 17, 2023 4:16 PM ET
Protalix BioTherapeutics, Inc. (PLX) 8 Comments
Summary
Protalix shows mixed financials with declining revenue, yet improved operating loss, indicating increasing operational efficiency.
PRX-115, in Phase I trials for refractory gout, is crucial in a competitive market with high efficacy and safety standards.
Despite financial resilience with a moderate cash burn rate, significant share dilution and debt raise long-term sustainability concerns.
Recommendation: Sell.
Protalix faces market positioning challenges and financial instability, warranting close monitoring and caution. Confidence score: 30/100.
At a Glance
Protalix BioTherapeutics (NYSE:PLX), navigating a complex biotech landscape, presents a nuanced picture marked by financial resilience and ambitious clinical endeavors. The company's recent financial performance shows a mix of declining total revenue, yet an improved operating loss and reduced net loss, hinting at operational efficiencies being realized. The significant share dilution, however, raises concerns about long-term financial sustainability. Clinically, the spotlight is on PRX-115, a novel candidate for refractory gout, currently in Phase I trials. Its success is pivotal, given the competitive and growing gout therapeutics market, where efficacy and safety benchmarks are high. While Protalix's modest cash burn rate and current ratio suggest short-term stability, the company's journey in advancing PRX-115 and navigating the complex market dynamics of gout treatment will be critical in shaping its future. The article, therefore, subtly prepares the reader for a cautious yet informed stance on Protalix's prospects, balancing clinical potential against financial and market realities.
Q3 Earnings
To begin my analysis, looking at Protalix BioTherapeutics' most recent earnings report, YoY for the three months ended September 30, 2023, reveals a mixed financial performance. Total revenue declined to $10.3M from $14.2M YoY, primarily due to a significant drop in revenues from license and R&D services, from $5.4M to $0.2M. However, revenues from selling goods increased from $8.8M to $10.2M. Operating loss improved, reducing to $1.9M from $3.1M. Notably, the net loss for the period decreased to $1.9M from $3.6M. Share dilution is evident, as the weighted average number of shares used in computing diluted earnings per share increased significantly from 49.5M to 83.8M. This suggests a substantial increase in outstanding shares, impacting shareholder value.
Financial Health
Turning to Protalix BioTherapeutics' balance sheet, their liquid assets, comprising cash and cash equivalents ($20.4M) and short-term bank deposits ($20.6M), total approximately $41M. The current ratio, calculated as current assets divided by current liabilities, is 1.68 ($72.6M/$43.4M), indicating a comfortable ability to cover short-term obligations. However, when comparing total assets ($87.6M) to total liabilities ($49.3M), there's a notable debt load, particularly considering the convertible notes under current ($20.2M) and long-term liabilities ($28.2M).
Over the last nine months, Protalix's net cash used in operating activities is approximately $4.9M, translating to a monthly cash burn rate of about $0.5M. The cash runway, calculated by dividing liquid assets by monthly cash burn, is approximately 82 months. This estimation, however, is based on past data and may not directly predict future performance. Looking into the future, Protalix estimates their cash runway extending into Q2 2025, per their most recent corporate presentation.
Given their current cash position and modest monthly burn rate, the odds of Protalix requiring additional financing within the next twelve months seem low, barring any significant increase in operating expenses or unforeseen financial obligations.
Market Sentiment
According to Seeking Alpha data, Protalix BioTherapeutics displays a mixed financial landscape. Its market capitalization of $102.86M, juxtaposed with a modest institutional ownership of 12.56%, suggests cautious market confidence. This is underscored by its short interest of 8.76%, indicating a moderate level of market skepticism or hedging against potential downside risks.
The company's growth prospects, evidenced by varied analyst projections, show a fluctuating trajectory with an anticipated rise in sales to $63.95M in 2023, followed by a slight decline in 2024, and a significant increase in 2025. This volatility in revenue forecasts reflects the inherent uncertainties and high stakes associated with biotech stock performance, particularly for companies like Protalix with critical drug candidates in early-stage trials.
Stock momentum, in comparison to SPY, reveals underperformance across multiple timeframes, with a notable decline of 29.50% over three months and 36.20% over six months, albeit with a positive uptick of 33.14% year-over-year.
The net insider activity over the past three and twelve months shows a positive trend, with 64,516 and 1,398,878 shares bought respectively, and no recorded sales. This could be interpreted as a vote of confidence from insiders in the company's future prospects.
Institutional holdings feature key players like BlackRock, State Street Corp, and Geode Capital Management, who have increased their positions, indicating some level of institutional trust in the company's future. The balance between new positions (9 holders, 777,017 shares) and sold-out positions (12 holders, 1,289,817 shares) further highlights a cautious but not entirely pessimistic institutional stance.
PRX-115: Protalix's Strategic Entry in Gout Therapeutics
Protalix BioTherapeutics is shifting its focus to gout therapeutics with its development of PRX-115 for refractory gout. This drug, a recombinant PEGylated uricase produced in plant cells, leverages the ProCellEx platform. Designed for prolonged half-life, it aims to reduce dosing frequency. PRX-115, administered intravenously, is in a Phase I clinical trial. This trial, a double-blind, placebo-controlled study with a single ascending dose approach, seeks to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of PRX-115 in a group of up to 56 patients. It involves up to seven cohorts, with a 3:1 randomization for either PRX-115 or placebo. A key focus of this trial is to monitor uric acid level reductions and evaluate dosing efficacy.
According to Grand View Research, the worldwide market for gout treatments, valued at $2.49 billion in 2022, is projected to expand at a CAGR of 6.25% from 2023 to 2030. The market's expansion is largely attributed to the growing number of gout cases and increased awareness of its treatments. Factors such as renal disorders, hypertension, diabetes, and obesity, which are common comorbidities of gout, further propel this market. Notably, approximately 26% of individuals with gout also have diabetes. The introduction of innovative treatments and a strong pipeline of drugs are additional catalysts for this growth. Nonetheless, the market's advancement is hindered by the delayed diagnosis of gout in less developed regions.
In the current gout treatment landscape, NSAIDs dominate the market. These drugs are widely used for the management of acute gout attacks due to benefits like lower costs and high effectiveness in combination therapy. However, the segment of urate-lowering agents, including xanthine oxidase inhibitors and uricosuric agents, is expected to grow significantly, driven by the introduction of novel drugs with enhanced efficacy and therapeutic value. The acute condition segment, primarily treated with NSAIDs, colchicine, and corticosteroids, held a revenue share over 60% in 2022, expected to maintain dominance during the forecast period??.
While PRX-115 presents a promising development in the treatment of severe gout, it faces significant challenges in terms of efficacy and safety. The drug must demonstrate a robust safety profile and superior efficacy compared to existing treatments to gain a foothold in the competitive gout therapeutics market. The high bar set by existing therapies, particularly in managing acute gout attacks and reducing uric acid levels, necessitates that PRX-115 not only matches but potentially exceeds these standards. Its success in ongoing clinical trials will be crucial in establishing its efficacy and safety, determining its potential role and impact in the evolving landscape of gout treatment.
My Analysis & Recommendation
In conclusion, Protalix BioTherapeutics confronts a complex and challenging landscape. Financially, the company demonstrates resilience with a moderate cash burn rate and a satisfactory current ratio, suggesting short-term financial stability. However, the significant share dilution and a notable debt load, particularly with convertible notes, raise concerns about long-term financial sustainability.
Elfabrio, developed by Protalix and FDA-approved for treating Fabry disease, faces a complex market environment. Its entry is constrained by established Enzyme Replacement Therapies (ERTs) such as Fabrazyme and targeted therapies like Galafold, and in my analysis, Elfabrio does not offer significant benefits over these existing treatments. Insurance and cost factors, as highlighted in the latest UpToDate guidelines, play a crucial role in therapy selection, potentially impeding Elfabrio's market adoption. While Chiesi will handle commercialization and related expenses, the financial returns for Protalix from Elfabrio manufacturing appear limited. Given these factors, Elfabrio's recent approval and its anticipated 2024 market entry seem to have a minimal impact on the market landscape.
The venture into gout treatment with PRX-115, though a strategic diversification, is high-risk and capital-intensive. Success hinges on PRX-115 demonstrating superior efficacy and safety in clinical trials, a formidable task given the established treatments in the gout market. The evolving gout therapeutics market, driven by increasing disease prevalence and rising awareness, offers potential but is fraught with competition and high entry barriers.
Investors should closely monitor Protalix's clinical trial outcomes, financial health, and market penetration strategies. A cautious approach with readiness to pivot based on emerging data and market responses is advisable. Diversifying investments and maintaining a vigilant stance on Protalix's operational and financial metrics can mitigate potential risks.
Given these considerations, my confidence score for Protalix BioTherapeutics is 30/100, leading to a "Sell" recommendation. The company faces significant challenges in market positioning and financial stability, necessitating careful scrutiny in the coming months.
Risks to Thesis
In reassessing Protalix BioTherapeutics, considering both my initial "Sell" recommendation and the specific risks associated with investing in microcap companies like Protalix is crucial.
Firstly, the improved operational efficiency indicated by the reduced operating loss might be a sign of better resource management and potential future profitability. This aspect, reflecting underlying strength, could have been underestimated in my analysis.
However, investing in microcap companies, such as Protalix, carries inherent risks. These include higher volatility, less liquidity, and often limited resources compared to larger firms. Such companies are more susceptible to market fluctuations and might face challenges in accessing capital markets efficiently. This risk might not have been fully addressed in my initial analysis.
Secondly, while share dilution is a concern for shareholder value, it might be necessary for funding R&D. The capital raised could lead to significant advancements, especially in their pipeline products. My initial analysis might have overemphasized the immediate negative impact of dilution, underestimating the potential long-term benefits of their R&D investments.
Thirdly, the positive net insider activity could be a bullish signal, indicating insider confidence in the company’s prospects. This aspect might not have been given due weight in my recommendation.
Lastly, although the competitive landscape for gout therapeutics is challenging, PRX-115 could capture a significant market share if it proves superior. The potential of PRX-115 might have been underrepresented in my assessment.
Moreover, microcap stocks like Protalix are often more responsive to company-specific news, such as clinical trial outcomes. This responsiveness can lead to significant price swings, adding to investment risk.
This article was written by
Stephen Ayers
This article aims to offer informational content and is not meant to be a comprehensive analysis of the company. It should not be interpreted as personalized investment advice with regard to "Buy/Sell/Hold/Short/Long" recommendations. The predictions and opinions expressed herein about clinical, regulatory, and market outcomes are those of the author and are rooted in probabilities rather than certainties. While efforts are made to ensure the accuracy of the information, there might be inadvertent errors. Therefore, readers are encouraged to independently verify the information. Investing in biotech comes with inherent volatility, risk, and speculation. Before making any investment decisions, readers should undertake their own research and evaluate their financial position. The author disclaims any liability for financial losses stemming from the use or reliance on the content of this article.
Comments (43)
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Stephen,
Thanks for your article.
Gout is early stage, cash draining, and the outcome is undefined. I would not put money into PLX based on the early stage Gout program. So we agree on that point.
OTH, contrary to your views, I believe Chiesi has stated they believe Elfabrio can capture 15% of the Fabry market. Could they be wrong?, of course. But they sell drugs for a living, AND, they put multiple $-millions behind this perspective-- they have skin in the game. Even 10% of the market is $200M, of which, nominally half would accrue to PLX. That's worth about $300M in valuation, especially w/o any material marketing expense. That's well over double the current MC. I'm willing to wait for 6 to 12-mos to see how the story unfolds. From these levels, the downside seems minimal, and if Chiesi's sales track anywhere near their estimates, the upside is considerable.
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J
jeremyjpj
Today, 12:02 AM
Comments (106)
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This guy has not done his DD.
1. Sales have just begun and you mention declining rev from a quarter that had a milestone lol. Laughable. It takes 3-4+ quarters of sales efforts to start judging how Chiesi is executing on getting this drug to patients and sales trajectories.
2. Elfabrio will have a large differentiation than Fabrazyme once approved for its once a month dose protocol since it has better half life profile. Dirty politics I think are what denied patients this much improved QOL option from the get go, but Chiesi is working hard to get the drug approved for once a month dosing. Then realistically this drug takes 35% of the ERT market conservatively imo. It also has a better AE profile even though cut over trials don’t really show it because all these patients were active on Fabryzme prior and able to handle that drug.
End of day let those in the Fabry community try the drug and learn about it and I feel confident Elfabrio will take its rightful place as a next gen. treatment option. Its not just another “me too” drug.
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Ralston Jones profile picture
Ralston Jones
Yesterday, 5:08 PM
Premium
Comments (8)
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This company's future rests on the successful commercialization of Elfabrio via Chiesi in my thinking, so I'm a bit surprised it seems to be such a minimal aspect of your thinking.If you're correct that Protalix sees very limited return via Elfabrio I think the company will be somewhat dead money - unless someone comes with an offer to scoop up the ProCellEx platform for cheap. Potential geopolitical risk is another concern. If however you're incorrect and Elfabrio takes significant share, you'll be wrong to the tune of potentially orders of magnitude.
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Stephen Ayers profile picture
Stephen Ayers
Yesterday, 5:11 PM
Analyst
Premium
Comments (2.14K)
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@Ralston Jones The article assumes Elfabrio is unlikely to have an impact and the to-the-point paragraph lays out a pretty good case. The article, therefore, focuses on their gout prospects, which the company, itself, highlights as a lead prospect. IMO PLX is very much a gout story now.
Thanks for the read,
Stephen
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john boy
Yesterday, 7:47 PM
Investing Group
Comments (16.48K)
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@Ralston Jones fabry desease was their ticket at 40% of 300,000 a year plus production revenue would lift them to 16.00 a share . I thoughttheir product was a prefferred method of treatment. does this guy know what he is talking about cause if he does your rightthis company may not make it.
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Stephen Ayers profile picture
Stephen Ayers
Yesterday, 7:51 PM
Analyst
Premium
Comments (2.14K)
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@john boy It's one of three ERTs (there's also Migalastat, an oral, targeted therapy) and there is no reason for patients to switch over to PLX's therapy (efficacy was "non-inferior", dosing frequency is the same)
I wish we had some idea, some info
in regards the the offer, one of them
which GMDA rejected.
Sometimes it pays to compromise.
I am more concerned about the fact that no
partner was hooked on.
Perhaps a miracle will happen, or else a R/S
will occur sooner than later.
Very disappointing.
Gamida Cell files for $150M mixed shelf
Nov. 15, 2023 5:31 PM ETGamida Cell Ltd. (GMDA)
By: Vansh Agarwal, SA News Editor
Gamida Cell (NASDAQ:GMDA) on Wednesday filed a prospectus for a
mixed securities shelf offering of up to $150M.
This prospectus is not an offer to sell these securities.
SEC Filing
1.7100+0.1700 (+11.0390%)
As of 01:26PM EST. Market open.
Nice
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) Director Departure
On November 14, 2023, Mr. Jeremy Blank submitted his resignation from the board of directors of Gamida Cell Ltd. (the “Company”), which resignation was effective immediately. Mr. Blank’s resignation was not the result of any disagreement with the Company. The Cooperation Agreement, dated as of August 11, 2023, by and among the Company, Jeremy Blank and Community Master Fund, LP, terminated pursuant to its terms upon Mr. Blank’s resignation.
Q3 2023 Gamida Cell Ltd Earnings Call
Participants
Mike Kuczkowski; Corporate Communications; Gamida Cell Ltd.
Abbey Jenkins; President and CEO; Gamida Cell Ltd.
Michele Korfin; COO and Chief Commercial Officer; Gamida Cell Ltd.
Ronit Simantov; Chief Medical Officer and Chief Scientific Officer; Gamida Cell Ltd.
Terry Coelho; CFO; Gamida Cell Ltd.
Gil Blum; Analyst; Needham & Company, LLC
Presentation
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's conference call for third-quarter 2023 financial results. My name is Chris and I'll be the operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request. I would now like to introduce your host for today's conference, Mike Kuczkowski of Gamida Cell Corporate Communications. Mike, please go ahead.
Mike Kuczkowski
Thank you, Chris, and good morning, everyone. Welcome to today's call during which we will provide an update on the company and review our financial results for the third quarter of 2023. Earlier this morning, we issued a press release summarizing our financial results and providing a business update, which is available on our website at www.gamidacell.com.
Here with me on our call today are Abbey Jenkins, President and Chief Executive Officer; Michele Korfin, Chief Operating Officer and Chief Commercial Officer; Ronit Simantov, Chief Medical Officer and Chief Scientific Officer; and Terry Coelho, our Chief Financial Officer.
Before we begin, I want to remind everyone that during this call, we may make forward-looking statements about our future expectations and plans, including with respect to the potentially life-saving or curative therapeutic potential of Omisirge, omidubicel-onlv; the company's cell therapy candidate, GDA-201; expectations regarding the commercial launch of Omisirge and potential to capture market share and generate revenue; Gamida Cell's plans for commercial or strategic partnerships to support the launch of Omisirge; Gamida Cell's financial runway; Gamida Cell's ability to keep its Israel facilities open, the state of its workforce, and future developments that may adversely impact Gamida Cell's Israel operations.
Our actual results may differ materially from what we project today due to a number of important factors, including those related to clinical, scientific, regulatory, and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around our product and product candidate, as well as those considerations described in the risk factors section of our most recent quarterly report on Form 10-Q and other filings that we may make with the SEC from time to time.
These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information or future events except as required by applicable law.
Now let me turn the call over to our President and Abbey Jenkins.
Abbey Jenkins
Thank you, Mike, and everyone joining us today. I want to begin by providing a brief corporate update. We've made strong progress this quarter, which I'll go into detail on in a moment. But I would be remiss if I didn't start this call by first acknowledging the courage and resilience of our Israeli team members, who have shown incredible dedication and commitment to patients as they continue operations to ensure we reliably deliver Omisirge to patients in need while living and working in a war zone. For patients with hematologic malignancies in need of an allogeneic stem cell transplant, Omisirge may represent their last or best hope for a cure, and we are proud to be able to continue to serve our patients under these challenging circumstances.
Our employees' safety is a key concern, and we are relieved to be able to say everyone remains safe. As you might imagine, the process of getting cells into Israel and delivering Omisirge back to transplant centers in the US could have been impacted when many airlines suspended flight service in Israel. Our team of dedicated employees did not hesitate to put patients first when their own lives were impacted, working diligently to maintain operations and adapting in real time as events unfolded. To see our team members demonstrate such resilience and strength in a challenging environment has been inspiring to witness.
Shifting gears and moving on to our corporate update. Our lean launch has continued to exceed our expectations across the two key metrics we defined for launch, transplant center onboarding and market access for patients. As of this morning, we have onboarded 17 transplant centers, exceeding the top end of our projected goal of 10 to 15 transplant centers for the year. Omisirge has confirmed coverage with US payers covering more than 90% of commercial lives, exceeding our full-year goal of 70%. This includes confirmed coverage with all of the top 20 US commercial payers. Omisirge has also confirmed coverage and reimbursement with Medicare for the Centers for Medicare and Medicaid Services. This means the vast majority of patients now have coverage in place for Omisirge.
The third quarter marks the moment Gamida Cell truly transitioned to a commercial stage company with our first revenue reported. We are so proud to provide Omisirge a potentially life-saving cell therapy for those in need of a transplant donor source. We are reporting revenue from the delivery of two Omisirge unit in the third quarter and are estimating revenue from the delivery of a total of four to six units of Omisirge for the full-year 2023.
The patient volume and Omisirge net ramp are aligned with all our expectations based on a lean launch model, a number of transplant centers onboarded, and consistent with other launches in the cell and gene space. We've received very strong feedback from transplant centers on the onboarding process on Gamida Cell Assist as a tool and resource. And most importantly, on Omisirge ability to fulfill an unmet need. Omisirge is the first and only true pharmaceutical transplant option approved on the basis of a global, randomized Phase 3 trial and transplanters see its value and potential.
As we end 2023 and prepare to enter 2024, we will continue to maintain our lean launch efforts due to resource constraints as we pursue additional funding. The early launch phase of Omisirge has confirmed our market research insights, there is an unmet need in the market that Omisirge can fulfill. Rapid transplant center onboarding has proven that transplant centers are interested in making Omisirge an option for patients with hematologic malignancies. Considering the need to thoughtfully invest based on our cash position, we will be prioritizing virtually all of our resources moving forward to expand patient access to Omisirge. Assuming our ability to extend our cash runway, we expect to have more than 40 transplant centers onboarded by the end of 2024, including at least half of the top 70 transplant centers in the US.
To reiterate, we remain committed to our two-pronged corporate strategy announced earlier this year, which involves, first, launching Omisirge in the US with a focus on expanding patient access by onboarding transplant centers and ensuring market access coverage and reimbursement; and second, pursuing a strategic partnership or transaction to fully -- to support fully resourced commercialization of Omisirge.
In terms of our business development activities, our efforts to identify a strategic partner are ongoing. We have received considerable interest from multiple potential partners during the process, which has been supported by the leading global independent investment bank, Moelis & Company, and has resulted in oral and written proposals. However at present, we have not identified a partnership that will adequately address our strategic needs and plans to continue the business development process in 2024. It will be critical for us to ensure we have sufficient capital to execute this two-pronged strategy.
A key step in the process was achieved at our recent annual general meeting of shareholders held in October. At this meeting, a majority of shareholders voted to approve six proposals relating to the company's business, including an increase in Gamida Cell's authorized share capital. This will provide us with the flexibility to continue to finance our operations and enable a potential transaction should one be available to us.
In summary, our lean launch is proceeding ahead of our expectations, and we expect to maintain our lean launch approach to expand the number of onboarded transplant centers and patients receiving Omisirge into 2024. We are proud to report our first Omisirge deliveries and official transition into being a commercial stage revenue reporting company expecting to deliver a total of four to six units for the full-year 2023. We are seeking the necessary funding to support expanded patient access to Omisirge and enable a strategic partnership to fully resource commercialization of Omisirge.
I will now turn the call over to Michele for a more in-depth update on the Omisirge launch. Michelle, over to you.
Michele Korfin
Thank you, Abbey, and good morning, everyone. As Abbey mentioned, Gamida Cell continues to advance efforts and prioritize resources across the organization to execute Omisirge's lean launch and ensure patients in need have access to the therapy. I will be sharing a few updates on how the launch is progressing, as well as a bit of context regarding the process of delivering Omisirge to a transplant center for use of a donor source for a patient in need of an allogeneic stem cell transplant.
The strong interest in Omisirge from transplant centers, including centers that were not part of the Phase 3 trial, has continued to grow since our last update. As of this morning, we have onboarded 17 transplant centers, exceeding our full-year target range of 10 to 15 centers. Overall, we're pleased with how onboarding is proceeding, having already exceeded our expectations for 2023, and considering the limited resources with which we launched.
In 2024, provided we obtain the necessary resources to support the ongoing commercialization of Omisirge, we anticipate continuing to onboard transplant centers at a robust pace. To support this onboarding, we have expanded our team of account managers since our last call. With our expanded team in place and subject to securing additional financial capital, we anticipate we could onboard more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the US. As a reminder, this is a targeted market, with about 70 of the top transplant centers performing 80% of the allogeneic stem cell transplants on an annual basis.
Transplant center onboarding is a key step to enable patients to access Omisirge. Our onboarding team works closely with transplant center personnel on the clinical training and administrative policies and procedures required to begin using Omisirge as a donor source. The Gamida team have the ability to be flexible with the timing of our onboarding approach. How quickly a transplant center is onboarded is determined by the needs of each individual transplant center and can include factors like staff availability to participate in the onboarding and the status of patients currently under evaluation who may be good candidates for Omisirge.
We have been able to onboard centers very quickly who have a patient already identified for Omisirge. Once Omisirge is selected as a donor source by the patient's transplanter and the allogeneic cells are received by Gamida Cell, we are ready to begin manufacturing. We have an experienced team in place and we are ready to reliably deliver Omisirge within 30 days from the start of manufacturing.
In terms of the number of Omisirge deliveries to date, we are tracking as we expected based on the number of transplant centers we anticipated having onboarded at this time and the time it typically takes for a patient to go from being identified as a candidate for transplant to the transplant taking place. Published data have shown that getting to transplant may take four to six months depending on the transplant center's preferred approach and the patient's diagnosis and clinical profile.
The evaluation process for a patient considered for Omisirge is consistent with other donor sources and is therefore very familiar to transplant center personnel. This is why it is so critical for us to focus our resources in the first month of launch on accelerating transplant center onboarding. By exceeding our initial target range of 10 to 15 centers, we are in a position to increase the number of patients receiving Omisirge. As more transplant centers are now onboarded, we are seeing an increasing number of patients enrolled in Gamida Cell Assist. Enrolling a patient in Gamida Cell Assist indicates a transplanter intends to use Omisirge as the patient's donor source.
As a result of our progress, in the third quarter, we reached a milestone of delivering Omisirge as a donor source for two patients. I could share that manufacturing is underway for additional units of Omisirge and we project delivering a total of four to six units of Omisirge for the full-year 2023. Given the pace of transplant center onboarding and the variability and time lines for preparing a patient for transplant, these numbers are in line with our expectations, and we are excited about the possibility that Omisirge will capture up to 20% market share peak, provided we are able to secure the necessary funding to support its fully resourced commercialization.
I also have to note that our Gamida Cell team has gone above and beyond to ensure manufacturing of Omisirge continues at our facility in Kiryat Gat, Israel, making truly heroic efforts to continue operations during the Israel-Hamas war. With the Omisirge launch ongoing and additional patients enrolled in Gamida Cell Assist, one of the foremost concerns for business continuity was ensuring that we could transport Omisirge out of our manufacturing facility and to patients. We were able to adapt and quickly overcome logistical challenges and our facilities remain operational, thanks to the dedication and resilience of our employees.
With that said, we continue to monitor the situation as it evolves, and we'll adjust our plans as needed. We are incredibly proud of the effort of all of our global employees as they have passionately worked with a lean launch team to ensure patients in need have access to Omisirge. Every team member is honored to play a role and bringing Omisirge to patients in need.
Now I'd like to turn the call over to Ronit Simantov, our Chief Medical and Chief Scientific Officer. Ronit?
Ronit Simantov
Thank you, Michele, and good morning, everyone. Today, I'll be sharing early feedback from transplant centers on Omisirge and some recent data on Omisirge and our NK cell therapy candidate, GDA-201.
As Michele stated earlier, we continue to see growing interest in Omisirge from transplant centers. My team and I are engaged in conversations with physicians and staff at transplant centers across the country and the feedback we hear reinforces our confidence in the value of Omisirge. Of note, we know from these discussions that a number of our onboard of transplant centers have identified multiple patients as candidates for Omisirge. The transplant teams we are engaged with be a clear need for an additional donor source option for their patients and are eager to make Omisirge available at their institution.
So far, the patients that have enrolled in Gamida Cell Assist we're seeing some progress Omisirge is the only option and who would otherwise go on transplanted. And some patients where transplanters are considering Omisirge over other options, including haplo.
We recently presented new data at the Society for Immunotherapy of Cancer or SITC Annual Meeting that further advanced our understanding on Omisirge's cellular makeup and potential mechanism of action. The data showed that the application of our NAM technology leads to a unique cellular composition enriched in myeloid populations and dendritic cells, providing a potential mechanism for the rapid engraftment and immune reconstitution observed in patients who were transplanted with Omisirge. This emphasizes how Omisirge is differentiated from other donor source options.
So that you can have the opportunity to hear from a transplant physician directly about his experiences on Omisirge, I'm pleased to share that we'll be holding a virtual fireside chat with Dr. Gary Schiller, professor of hematology/oncology and Director of hematological malignancies and stem cell transplantation at Ronald Reagan UCLA Medical Center. This event will take place on Monday, December 4 at 4:30 PM Eastern Time via webcast and will also be recorded. Dr. Schiller was an investigator in the Phase 3 study of omidubicel and UCLA Health is one of the 17 onboarded transplant centers where patients can access Omisirge. In addition to sharing his experience with Omisirge, Dr. Schiller will talk about the patient journey from diagnosis to transplant and the decision making around donor source selection.
I'd now like to take some time to share the recent news about our natural killer cell therapy candidate, GDA-201. We recently reported preliminary data from the ongoing multi-center Phase 1 study of cryopreserved GDA-201, designed to evaluate safety and determine maximum tolerated dose. The preliminary data from 10 patients with CD20 positive non-Hodgkin lymphoma in a Phase 1 study showed no dose-limiting toxicities in patients enrolled in the first three cohorts, treated with doses of up to 100 million cells per kilogram of GDA-201. Enrolled patients had relapsed or refractory lymphoma and were heavily pretreated with a median of six prior lines of therapy, including CAR T cell therapy in six patients and prior hematopoietic stem cell transplant in four patients.
We saw marked shrinkage of target lesions in 5 of the 10 patients and efficacy evaluation using Lugano criteria demonstrated two patients with complete response, two with partial response, and one with stable disease. Activity appeared to be dose-dependent with two of the three patients in cohort three responding. These results are consistent with previously reported data from the investigator-initiated study on the fresh formulation of GDA-201, which showed complete responses in patients with non-Hodgkin lymphoma. The fourth and final cohort of the current Phase 1 study is enrolling, and we are on track to report full data in the first quarter of 2024.
We're pleased to continue to work with transplant centers and academic institutions to further the availability of Omisirge and to add to the body of scientific evidence about the mechanism and potential of our innovative NAM technology.
I will now turn the call over to Terry Coelho, our Chief Financial Officer. Terry?
Terry Coelho
Thank you, Ronit, and good morning, everyone. I'm pleased to share that Gamida Cell is reporting revenue for the first time in its history. With the transition to a product revenue generating company, a number of changes have been incorporated into our financial reporting beginning with the third quarter of 2023 and I will point out some of those key changes as we walk through the financial results.
In the third quarter ended September 30, 2023, we are reporting net revenue of $673,000, resulting from the delivery of two units of Omisirge. The gross to net allowances and deductions were particularly low in the third quarter, given the confirmed insurance coverage and transplant status for those patients. Cost of sales, including cost of direct manufacturing and quality in addition to royalty expenses, was $626,000 in the quarter. Over time, we expect the cost of sales and therefore the gross margins to improve measurably as production volumes scale to capacity.
Beginning July 1, 2023, reporting of operating expenses has been modified to reflect the company's transition to commercial stage, with all operating expenses being reported as either research and development expenses or selling, general, and administrative or SG&A expenses. For 2022, and the first two quarters of 2023, previously reported commercial and general and administrative costs were combined into SG&A expenses. Additionally, certain expenses previously reported in research and development are now being reported in SG&A beginning in the third quarter of 2023, with no reclassification of prior periods.
Research and development expenses were $4.2 million in the third quarter of 2023 compared to $9.9 million in the same quarter of 2022. The $5.7 million decrease was primarily due to the aforementioned reporting transition, along with reduced omidubicel clinical spend relating to the Phase 3 clinical trial. Selling, general, and administrative expenses were $13.8 million in the third quarter of 2023, an increase of $6.6 million compared to $7.2 million in the third quarter of 2022.
The aforementioned financial reporting transition, which resulted in the inclusion of medical affairs and certain indirect supply chain and quality assurance expenses in SG&A reporting, contributed $4.4 million to the increase in the quarter. Additionally, excess capacity costs of $2.2 million associated with our manufacturing facility were recorded in SG&A in the third quarter.
Selling and marketing expenses increased by $1.3 million compared to the prior year quarter due to commercial launch activities. To further expand upon the excess capacity costs, these costs reflects the labor and manufacturing overhead costs incurred, but not absorbing cost of goods sold in the period, given that our facility is tasked to produce the anticipated demand over the course of the coming year.
Financial income and expenses net were $16.5 million of income in the third quarter of 2023 compared to $741,000 in expenses in the same period of 2022. The $17.2 million change in financial income was primarily due to $14 million of income related to the valuation of warrants liability and $3.2 million of income related to the valuation of the company's secured convertible senior notes issued in December 2022.
Our net loss in the third quarter was $1.5 million compared to a net loss of $17.8 million in the third quarter of 2022, driven primarily by the $17.2 million change in financial income as just discussed. As of September 30, 2023, Gamida Cell has total cash and cash equivalents of $60.4 million compared to $64.7 million as of December 31, 2022. The decrease of $4.3 million is due primarily to $59.2 million in net cash proceeds from financing activities, comprised of $21.1 million in net proceeds from the issuance of ordinary shares and warrants from the company's underwritten public offering in April 2023 and $39.4 million in net proceeds from the issuance of ordinary shares via the eight PM or at-the-market facility, offset by $1.1 million in principal payments of the company's 2022 convertible senior notes and $62.9 million of net cash used in operating activities.
The company expects its current cash and cash equivalents, including the funds raised subsequent to the close of the third quarter, to support its ongoing operating activities into the second quarter of 2024 based on Gamida Cell's current operational plans and excluding commercialization activities beyond the initial launch of Omisirge, as well as any additional financing activities that may be undertaken. The company raised $25.6 million in net proceeds from its ATM facility in the third quarter at an average price of $1.40 per share.
As of September 30, 2023, the company had reduced its principal balance on the 2022 secured convertible note by $16.7 million, from $25 million as of December 31, 2022, to $8.3 million at the end of the third quarter of 2023. The company also holds a 2021 convertible senior note with an aggregate principal amount of $75 million.
Earlier in the year, we embarked on a strategic restructuring process to prioritize the vast majority of our resources for the launch of Omisirge. And we have now mostly completed that process, including consolidating operations in Israel to a single location. As Abbey mentioned earlier, shareholders at our recent annual general meeting of shareholders voted to approve an increase in Gamida Cell's authorized share capital to 325 million ordinary shares. We believe this increase in authorized shares will provide us with the increased flexibility necessary to finance our operations.
With that, I'll turn the call back over to Abbey for some concluding remarks. Abbey?
Abbey Jenkins
Thank you, Terry. Before I turn the call over to the operator for questions, I want to bring us back around the beginning of the call and summarize the key points from our discussion today. We continue to make strong progress on the commercial launch of Omisirge, having exceeded our goals across both of the key metrics for launch of transplant center onboarding and market access. Additionally, we have reported revenue for two deliveries of Omisirge in the third quarter and project four to six deliveries of Omisirge units for the full-year 2023, which is in line with our initial launch assumptions based on our lean launch model and the transplant process for patients.
With our expanded launch team in place and the securing of additional capital, we anticipate we could onboard a total of more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the Us. Operations in Israel continue and our team is adapting processes as necessary to ensure patient access to Omisirge continues during the ongoing Israel-Hamas war.
In terms of business development, we have not identified a partnership that will adequately address our strategic needs and plans to continue the business development process in 2024. We share promising preliminary data from the Phase 1 clinical trial for GDA-201 and are on track to share the full data readout in early 2024.
We are continuing to carefully manage our expenses and prioritizing virtually all of our resources towards the launch of Omisirge. We are thrilled to see increasing demand for Omisirge and are working to ensure that all patients in need have access to our NAM modified cell therapy. We believe our early launch success is a promising sign of Omisirge's long-term potential to increase access and address critical unmet needs in stem cell transplantation.
Now let's open the call for questions. Chris?
Question and Answer Session
Operator
(Operator Instructions) Gil Blum, Needham & Co.
Gil Blum
Hi. Good morning. Thank you for taking our questions. Just given the relatively small number of patients in the queue right now, could you give us some color on the individual patient types or anything that you know at this point?
Abbey Jenkins
Ronit and Michele, do you want to weigh in on this?
Michele Korfin
Sure, thank you.
Ronit Simantov
This is Ronit. I'm happy to weigh in and thanks, Gil, for the question. So yeah, there are patients who are enrolled in Gamida Cell Assist and we know some facts about these patients and what we also know is information that we're hearing directly from transplant physicians when we have conversations with them about potential patients. And the kinds of patients are different, depending on what the transplant center is like. Some are patients who really don't have any other transplant options, there are no other graft sources for them, no unrelated donor registry, no other related donor options and Omisirge is really seen as their only choice. And they would otherwise not receive a transplant, which is quite difficult for them.
There are other patients actually, who we've heard from physicians, who have more than one choice. And what physicians do is they really choose the best potential graft source for their patient of the available choices. And so there are some patients who have other choices, either mismatched or haplo or other potential donor sources for whom Omisirge is actually seen as the best choice. And so that's kind of how things are divided up. These are patients who need allogeneic stem cell transplants and may or may not have any other available donor sources.
Gil Blum
Thank you.
Michele Korfin
Thank you, Roni, and Gil, thank you. I'll just add on just going back to what we spoke about even before launch, we are generally seeing patients that are consistent with what we believe would meet the promise of Omisirge to both increase access and improve outcomes. So on the increasing side, we're seeing patients, as Ronit indicated, where Omisirge is their only donor source option. And that's consistent with the data that we had identified through our market insights that at least 1,700 patients are eligible each year for transplant but unfortunately, were not able to find a donor source before Omisirge approval.
And then on the improving outcome side, as Ronit indicated, we've heard examples where the transplant or has another option, and in one case, the other option was a haploidentical match, but the transplanter is choosing Omisirge for the patient. Although still in an early stage of the launch, we're very encouraged by what we are hearing.
Gil Blum
All right. Thank you for the answers. Maybe a bit about the dynamic with onboarded centers. Are there examples of where it was a bit of a reverse inquiry where the center reached out to you guys?
Michele Korfin
Yes. We have had multiple centers who have reached out to us and some part of the clinical studies, some that were not, that had a patient that was actively being evaluated for transplant and the transplanter felt Omisirge would be the most appropriate option. Certainly, those who were part of the clinical study, we've been in active dialogue with them. But in the case of one particular center who was in the clinical study, they asked if we could expedite the onboarding, which we were able to accommodate to address the patient need.
Gil Blum
Thank you. Very helpful. And maybe a last one. So outreach to physicians, I know you guys have a KOL event in December 4. Are you going to have presence at the upcoming ASH? I didn't see any specific presentation, but a booth for outreach to physicians. Thank you.
Michele Korfin
I'll start and then I'll turn to Ronit. So we will have a presence at ASH. I'll speak about the commercial presence, and then Ronit will talk about the medical, but we'll have our representatives from our launch team at ASH. We will have a commercial booth. So if you're there, please stop by. And we will have the opportunity to attend sessions and understand the dynamics of the scientific developments. But also, just as you alluded to, Gil, you'll have the chance to interact with individuals from the transplant centers that are either onboarded or in the queue to be onboarded. So we're looking forward to San Diego.
I'll turn to Ronit to discuss the medical side.
Ronit Simantov
Thanks, Michele. True, we don't have any academic presentations at ASH this year, but we do have a product theater presentation, as well as our medical folks engaging in small group and individual dialogues with physicians at ASH.
Operator
Does that answer your questions, Gil?
Gil Blum
Thank you. You've gotten all my questions.
Operator
(Operator Instructions) Ladies and gentlemen, we have reached the end of our question-and-answer session and I would like to turn the call back to President and CEO, Abigail Jenkins, for some closing remarks.
Abbey Jenkins
Thank you, Chris. Thank you all for joining us today. To recap, we remain confident in our team's ability to deliver Omisirge to an increasing volume of patients in need of a stem cell transplant in transplant centers across the US. We believe in Omisirge's ability to achieve its market potential and increase patient access to allogeneic stem cell transplant.
Thank you, everyone, for joining us on today's call, and we look forward to providing further updates on future calls. Thank you.
Operator
Thank you very much. Ladies and gentlemen, that concludes today's event and you may now disconnect your lines.
PR Newswire
RedHill Biopharma Announces the Transfer of its Listing to The Nasdaq Capital Market
Tue, November 14, 2023 at 3:00 PM GMT+2
Oy-Vey, Oy-Vey.
RedHill Biopharma receives approval to transfer its listing to the Nasdaq Capital Market
LOL, Big Deal. No.
Gamida Cell Reports Third Quarter 2023 Financial Results and Provides Company Update
https://finance.yahoo.com/news/gamida-cell-reports-third-quarter-120000319.html
Company continues to advance launch, reports initial revenue from Omisirge® (omidubicel-onlv)
Company to host conference call today at 8:30 a.m. ET
BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.
“The third quarter marked the first patients receiving Omisirge following FDA approval and the point at which Gamida Cell truly transitioned to a commercial-stage company with our first revenue reported,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. “Our lean launch prioritized two key performance indicators – transplant center onboarding and market access – both of which have surpassed our expectations, ahead of schedule. We anticipate continuing to onboard additional transplant centers, leading to a ramp-up of patients and Omisirge deliveries in the coming months.”
To date, a total of 17 transplant centers have been onboarded, exceeding the company’s 2023 target range of 10 to 15. Transplant center onboarding is a critical step in the process of making Omisirge available to patients, as it is required in order for transplant center teams to select Omisirge as a donor source. The company reported revenue for the delivery of two units of Omisirge in the third quarter of 2023 and projects revenue from a total of four to six units for full year 2023.
The company also provided an update on its market access efforts, reporting confirmed coverage with U.S. payers covering more than 90% of commercial lives, exceeding the full year goal of 70%. This includes confirmed coverage with all 20 of the top U.S. commercial payers. Omisirge also has confirmed coverage and reimbursement with Medicare from the Centers for Medicare and Medicaid Services (CMS).
Looking to 2024, the company will continue to maintain a lean launch effort due to resource constraints. Contingent on additional funding to extend its cash runway, the company anticipates onboarding more than 40 transplant centers by the end of 2024, including at least half of the top 70 transplant centers in the U.S.
Michele Korfin, Chief Operating and Chief Commercial Officer of Gamida Cell, said, “The strong interest for transplant centers to be onboarded and excellent feedback from transplanters as they are evaluating patients for Omisirge are encouraging indicators of its potential. We are excited about the opportunity for Omisirge to capture up to 20% market share at peak, provided we are able to secure the necessary funding to support fully resourced commercialization. We are proud of what our team has accomplished to date with limited resources to deliver Omisirge to patients in need of a donor source for allogenic stem cell transplant.”
Additionally, Jenkins provided an update on the company’s operations in Israel, noting that Gamida Cell’s manufacturing facility in Kiryat Gat has remained operational amid the ongoing Israel-Hamas war. “The dedication, courage and resilience demonstrated by our employees in Israel is an inspiration to us all. Despite the horror of terrorist attacks, they have continued to put patients first and have shown incredible strength and commitment to ensuring we can reliably deliver Omisirge to patients in need.”
Gamida Cell will hold a fireside chat with Gary Schiller, M.D., Professor, Department of Medicine, Hematology/Oncology and Director, Hematological Malignancies/Stem Cell Transplantation Unit at Ronald Reagan UCLA Medical Center, a part of UCLA Health. UCLA Health was a clinical trial site for the Phase 3 study of omidubicel in patients with hematologic malignancies and is one of the 17 transplant centers where patients can currently access Omisirge. Dr. Schiller will discuss his experience working with patients in need of allogeneic stem cell transplant, including the patient journey from diagnosis to transplant, decision making around donor source selection and his experience with Omisirge since approval. The virtual event will take place on Monday, December 4 from 4:30-5:15pm ET.
Third Quarter Highlights and Recent Developments
Corporate Developments
Annual shareholders meeting: Gamida Cell held its Annual General Meeting of Shareholders in New York City on October 19. At the meeting, shareholders approved six proposals relating to the company’s business, including:
The reappointment of Directors Ken Moch and Jeremy Blank
The reappointment of Kost, Forer, Gabbay & Kaiserer as the company’s independent auditors for the fiscal year ending December 31, 2023, until the 2024 Annual General Meeting of Shareholders
Amendments to the company’s compensation policy, and CEO and non-executive directors’ compensation
An increase in Gamida Cell’s authorized share capital to 325,000,000 ordinary shares
Corporate presentation and panel discussion at Cell & Gene Meeting on the Mesa: Abbey Jenkins, President and Chief Executive Officer, presented corporate highlights, including commercial launch updates for Omisirge and an overview of market opportunity at the annual Cell & Gene Meeting on the Mesa held October 10-12 in Carlsbad, CA and livestreamed globally. Jenkins also participated in a panel discussion titled “A record setting year for cell and gene therapies – how do we keep the momentum going?”
Strategic review: Efforts to identify a strategic partner are ongoing. The company reported it has received considerable interest from multiple potential partners during the process, which has been supported by the leading global independent investment bank, Moelis & Company LLC, and has resulted in oral and written proposals. However, according to the company, it has not identified a partnership that will adequately address strategic needs. Gamida Cell intends to continue the business development process in 2024.
Scientific Publications and Medical Meetings
Publication in Transplantation and Cellular Therapy: The company announced the publication of a secondary analysis of the Phase 3 clinical trial for Omisirge titled “Hospitalization and Healthcare Resource Utilization of Omidubicel-onlv Versus Umbilical Cord Blood Transplantation for Hematologic Malignancies: Secondary Analysis from a Pivotal Phase 3 Clinical Trial.” The publication is available online on the Transplantation and Cellular Therapy website.
Data presented at Society for Immunotherapy of Cancer's (SITC) Annual Meeting: Gamida Cell presented data further characterizing the mechanism of the company’s proprietary nicotinamide (NAM) technology on the expansion and enhancement of cells at SITC November 1-5 in San Diego, California. The full press release is available here.
Omidubicel: Researchers used immunophenotyping to evaluate and characterize the cellular populations in the cultured fraction (CF) and non-cultured fraction (NF) of omidubicel compared to standard umbilical cord blood (UCB). The data indicated that omidubicel is characterized by a significantly increased number of myeloid cells compared to UCB. The results provide a potential mechanism for the rapid engraftment and immune reconstitution observed in patients transplanted with omidubicel.
GDA-201: Researchers sought to better understand the impact of Gamida Cell’s NAM technology on natural killer (NK) cell kinetics. The data presented showed increased survival of feeder cells and prolonged support in NK cell expansion, resulting in higher fold expansion in NK cells expanded with NAM. In addition, NK cells expanded with NAM showed significantly higher cytotoxicity and an active phenotype. These data provide further evidence for the unique cell culture kinetics of NAM-NK cells.
Upcoming participation in the American Society of Hematology (ASH) Annual Meeting and Exposition: Members of the Gamida Cell team will attend the upcoming ASH Annual Meeting December 9-12 in San Diego, California. A product theater will be presented on Omisirge.
GDA-201
Preliminary data from Phase 1 study: On October 16, the company announced data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose. Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab. Activity appears to be dose dependent with two of the three patients in Cohort 3 responding. The fourth and final cohort of the study, at the target dose level of 2x108 cells/kg, is currently enrolling at six sites in the U.S. Full Phase 1 data are expected in the first quarter of 2024. Solely for financial reasons, we do not plan to conduct the Phase 2 portion of the GDA-201 Phase 1/2 study.
Third Quarter 2023 Financial Results
Net Revenue for the third quarter 2023 was $0.7 million, resulting from the delivery of two units of Omisirge. Cost of sales, including costs of direct manufacturing and quality in addition to royalty expenses, was $0.6 million in the quarter. Over time we expect the cost of sales, and therefore the company’s gross margin, to improve measurably if production volumes scale to capacity.
Beginning July 1, 2023, the company’s reporting of operating expenses was modified to reflect the company’s transition to the commercial stage, with all operating costs now being reported as either research and development expenses, or selling, general & administrative (SG&A) expenses. For 2022 and the first two quarters of 2023, previously reported commercial and general & administrative costs were combined into SG&A expenses. Additionally, certain expenses previously reported in research and development are being reported in SG&A beginning in the third quarter of 2023, with no reclassification of prior periods.
Research and development expenses were $4.2 million in the third quarter of 2023, compared to $9.9 million in the same quarter in 2022. The $5.7 million decrease was primarily due to the aforementioned reporting transition, along with reduced omidubicel clinical spend relating to the Phase 3 clinical trial.
SG&A expenses were $13.8 million in the third quarter of 2023, an increase of $6.6 million compared to $7.2 million in the third quarter of 2022. The aforementioned financial reporting transition, which resulted in the inclusion of medical affairs expenses and certain indirect supply chain and quality assurance expenses in SG&A reporting, contributed $4.4 million to the increase in the quarter. Additionally, excess capacity costs of $2.2 million associated with our manufacturing facility were recorded in SG&A in the third quarter. Selling and marketing expenses increased by $1.3 million compared to the prior year quarter, due to commercial launch activities.
Financial income/expenses, net, were $16.5 million of income in the third quarter of 2023, compared to $0.7 million of expenses in the same period of 2022. The $17.2 million change in financial income was primarily due to $14.0 million of income related to the valuation of warrants liability and $3.2 million of income related to the valuation of the Company’s secured convertible senior notes issued in December 2022.
Net loss was $1.5 million in the third quarter of 2023, compared to a net loss of $17.8 million in the third quarter of 2022, driven primarily by the $17.2 million change in financial income referenced in the financial income/expenses, net above.
Cash position: As of September 30, 2023, Gamida Cell had total cash and cash equivalents of $60.4 million compared to $64.7 million as of December 31, 2022. The decrease of $4.3 million is due primarily to $59.2 million in net cash proceeds from financing activities, comprised of $21.1 million in net proceeds from the issuance of ordinary shares and warrants from the company’s underwritten public offering in April 2023, and $39.4 million in net proceeds from the issuance of ordinary shares via the at-the-market (ATM) facility, offset by $1.1 million in principal payments of the Company’s 2022 convertible senior note, and $62.9 million of net cash used in operating activities. The company expects its current cash and cash equivalents, including the $0.5 million in funds raised through its ATM facility subsequent to the close of the third quarter, to support its ongoing operating activities into the second quarter of 2024, based on Gamida Cell’s current operational plans and excluding commercialization activities beyond the initial launch of Omisirge as well as any additional financing activities that may be undertaken.
Debt position: As of September 30, 2023, the company had reduced its principal balance on the December 2022 secured senior convertible note by $16.7 million, from $25.0 million as of December 31, 2022, to $8.3 million at the end of the third quarter of 2023. The company also has outstanding 2021 convertible senior notes with an aggregate principal amount of $75.0 million.
Conference Call Information
Gamida Cell will host a conference call today, November 14, at 8:30 a.m. ET to discuss these financial results and company updates. To access the conference call by phone, please register here or dial 1-877-425-9470 for domestic callers or 1-201-389-0878 for international callers and enter the conference ID 13741024. A live conference call webcast can be accessed here. A webcast replay will be available approximately two hours after the event for approximately 30 days.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic natural killer (NK) cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the potentially life-saving or curative therapeutic and commercial potential of Omisirge® (omidubicel-onlv), the Company’s cell therapy candidate, GDA-201, expectations regarding the commercial launch of Omisirge and potential to capture market share or generate revenue, Gamida Cell’s plans for commercial or strategic partnerships to support the launch of Omisirge, Gamida Cell’s financial runway, Gamida Cell’s ability to keep its Israel facilities open, the state of its workforce, and future developments that may adversely impact Gamida Cell’s Israel operations. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions including those related to clinical, scientific, regulatory and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 14, 2023, and other filings that Gamida Cell makes with the SEC from time to time (which are available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
OMISIRGE® is a registered trademark of Gamida Cell Inc. © 2023 Gamida Cell Inc. All Rights Reserved.
GAMIDA CELL LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
September 30,
December 31,
2023
2022
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
60,431
$
64,657
Short-term restricted deposit
2,723
-
Inventory
2,324
-
Accounts Receivable
676
-
Prepaid expenses and other current assets
2,355
1,889
Total current assets
68,509
66,546
NON-CURRENT ASSETS:
Restricted deposits
377
3,668
Property, plant and equipment, net
42,667
44,319
Operating lease right-of-use assets
3,706
7,024
Severance pay fund
1,288
1,703
Other long-term assets
1,201
1,513
Total non-current assets
49,239
58,227
Total assets
$
117,748
$
124,773
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Trade payables
$
1,664
$
6,384
Employees and payroll accruals
6,058
5,300
Operating lease liabilities
1,497
2,648
Accrued interest of convertible senior notes
710
1,652
Accrued expenses and other current liabilities
10,725
8,891
Total current liabilities
20,654
24,875
NON-CURRENT LIABILITIES:
Convertible senior notes, net
81,419
96,450
Warrants liability
11,610
-
Accrued severance pay
1,381
1,914
Long-term operating lease liabilities
2,302
4,867
Other long-term liabilities
-
4,690
Total non-current liabilities
96,712
107,921
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY (DEFICIT):
Ordinary shares of NIS 0.01 par value
357
211
Treasury ordinary shares of NIS 0.01 par value
*
*
Additional paid-in capital
471,012
408,598
Accumulated deficit
(470,987
)
(416,832
)
Total shareholders’ equity (deficit)
382
(8,023
)
Total liabilities and shareholders’ equity (deficit)
$
117,748
$
124,773
* Represents an amount lower than $1
GAMIDA CELL LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
(Unaudited)
Three months ended
September 30,
Nine months ended
September 30,
2023
2022
2023
2022
Net Revenue
$
673
-
$
673
-
Cost of Sales
626
-
626
-
Research and development expenses, net
$
4,248
$
9,864
$
21,776
$
31,732
Selling, general and administrative
13,837
7,197
34,691
22,698
Total operating expenses
18,085
17,061
56,467
54,430
Total operating loss
18,038
17,061
56,420
54,430
Financial (income) expenses, net
(16,519
)
741
(2,265
)
2,149
Net Loss
$
1,519
$
17,802
$
54,155
$
56,579
Net loss per share attributable to ordinary shareholders, basic and diluted
0.01
0.29
0.53
0.95
GAMIDA CELL LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
(Unaudited)
Nine months ended September 30,
2023
2022
Cash flows from operating activities:
Net Income (Loss)
$
(54,155
)
$
(56,579
)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation of property, plant and equipment
1,024
391
Financing expense (income), net
61
(2,461
)
Share-based compensation
4,297
3,829
Change in Fair Value of Warrants liability
(9,143
)
-
Change in Fair Value of convertible senior note
1,039
-
Warrants Issuance Costs
1,733
-
Amortization of loan issuance costs
625
582
Change in assets and liabilities:
Inventory
(92
)
-
Operating lease right-of-use assets
2,020
1,922
Operating lease liabilities
(2,417
)
(2,395
)
Increase in Accounts Receivable
(676
)
-
Increase (decrease) in accrued severance pay, net
(118
)
23
Increase (decrease) in prepaid expenses and other assets
(239
)
1,719
Decrease in trade payables
(4,720
)
(6,355
)
Increase (decrease) in accrued expenses and other liabilities
(2,096
)
5,079
Net cash used in operating activities
(62,857
)
(54,245
)
Cash flows from investing activities:
Purchase of property, plant and equipment
(833
)
(2,865
)
Purchase of marketable securities
-
(4,557
)
Proceeds from maturity of marketable securities
-
37,972
Proceeds from restricted deposits
294
500
Net cash provided by (used in) investing activities
$
(539
)
$
31,050
Cash flows from financing activities:
Proceeds from exercise of warrants liability
$
45
-
Proceeds from exercise of options
-
76
Principal payments of convertible senior note
(1,142
)
-
Proceeds from share issuance and warrants liability, net
60,267
22,298
Net cash provided by financing activities
59,170
22,374
Decrease in cash and cash equivalents
(4,226
)
(821
)
Cash and cash equivalents at beginning of period
64,657
55,892
Cash and cash equivalents at end of period
$
60,431
$
55,071
Kamada Reports Significant Increase in Sales and Profitability in the Third Quarter and Nine Month 2023; Reiterates 2023 Revenue and Profitability Guidance
https://finance.yahoo.com/news/kamada-reports-significant-increase-sales-120000929.html
Third Quarter 2023 Revenues were $37.9 Million Representing an 18% Increase Year-over-Year; Nine Month 2023 Revenues of $106.1 Million, Up 26% Year-over-Year
Third Quarter 2023 Adjusted EBITDA of $7.9 Million Representing a 31% Increase Year-over-Year; Nine Month 2023 Adjusted EBITDA of $17.7 Million, Up 67% Year-over-Year
Strong Third Quarter Results and Positive Outlook for Fourth Quarter Support Reiteration of Fiscal Year 2023 Revenue and Adjusted EBITDA Guidance
Multiple Recent Achievements with CYTOGAM®, including Availability of Product Manufactured by the Company for U.S. Commercial Sale and Presentation of New Clinical Data
Received Shareholder Approval and Subsequently Closed $60 Million Private Placement with FIMI Opportunity Funds
Conference Call and Live Webcast Today at 8:30 AM ET
REHOVOT, Israel and HOBOKEN, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced financial results for the three and nine months ended September 30, 2023.
“We are highly encouraged with our strong financial and operational momentum during the first nine months of the year,” said Amir London, Kamada’s Chief Executive Officer. “With total revenues of $106.1 million, which represent year-over-year growth of 26%, and adjusted EBITDA of $17.7 million, an increase of 67% as compared to the first nine months of 2022, we achieved the top- and bottom-line growth anticipated in our business in the first nine months of the year. We continue to effectively leverage our multiple growth drivers, including a significant increase in sales of our anti-rabies immunoglobulin product, KEDRAB® as well as the portfolio of the four FDA-approved immunoglobulins (CYTOGAM®, HEPAGAMB®, VARIZIG® and WINRHO® SDF), and our Israeli distribution business.”
“We expect the momentum from the first nine months of the year to extend through the fourth quarter of 2023, with annual profitability to be further meaningfully enhanced as compared to last year. As such, we are reiterating our full-year 2023 revenue guidance of $138 million to $146 million and adjusted EBITDA of $22 million to $26 million; the mid-point of the range would represent profitability growth of approximately 35% over 2022,” continued Mr. London.
“During the recent period we reported multiple achievements with CYTOGAM. Specifically, following recent FDA approval of the technology transfer process, CYTOGAM manufactured at our Israeli facility is now available for commercial sale in U.S., and new clinical data highlighting five-year real-world survival benefits of high risk CMV mismatch lung transplant patients receiving CYTOGAM were presented at IDWeek 2023. In addition, we continue to advance our pivotal phase 3 InnovAATe trial for Inhaled AAT and we recently received positive feedback from the independent Data and Safety Monitoring Board (DSMB) which recommended study continuation without modification for the sixth time since study initiation, based on encouraging safety data observed in the study to date,” added Mr. London.
“Our future prospects were also recently further buoyed by the recent closing of our $60 million private placement with FIMI Opportunity Funds. This strategic investment provides us with financial flexibility to pursue compelling business development opportunities, a process that we are currently engaged in,” concluded Mr. London.
Financial Highlights for the Three Months Ended September 30, 2023
Total revenues were $37.9 million in the third quarter of 2023, an 18% increase from the $32.2 million recorded in the third quarter of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased market share and demand for the product in the U.S. market.
Gross profit and gross margins were $14.8 million and 39%, respectively, in the third quarter of 2023, compared to $12.9 million and 40%, respectively, reported in the third quarter of 2022. Cost of goods sold in the Company’s Proprietary segment, for the third quarter of 2023 and 2022, included $1.3 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition.
Operating expenses, including R&D, Sales & Marketing (S&M), G&A and other expenses, totaled $10.4 million in the third quarter of 2023, as compared to $10.3 million in the third quarter of 2022. S&M costs, for the third quarter of 2023 and 2022, included $0.4 million of depreciation expenses of intangible assets generated through the IgG products acquisition.
Net income was $3.2 million, or $0.07 per share, in the third quarter of 2023, as compared to a net income of $0.5 million, or $0.01 per share, in the third quarter of 2022.
Adjusted EBITDA, as detailed in the tables below, was $7.9 million in the third quarter of 2023, a 31% increase as compared to $6.0 million in the third quarter of 2022.
Cash provided by operating activities was $0.9 million in the third quarter of 2023, as compared to cash provided by operating activities of $5.5 million in the third quarter of 2022. The change correlates to the changes in the Company’s working capital and supports overall growth.
Financial Highlights for the Nine Months Ended September 30, 2023
Total revenues for the first nine months of 2023 were $106.1 million, a 26% increase from the $83.9 million generated in the first nine months of 2022. The increase in revenues was primarily attributable to increased sales of KEDRAB to Kedrion due to increased market share and demand for the product in the U.S. market.
Gross profit and gross margins for the first nine months of 2023 were $41.1 million and 39%, respectively, compared to $31.4 million and 37%, respectively, in the first nine months of 2022. Cost of goods sold in the Company’s Proprietary segment, for the first nine months of 2023 and 2022, included $3.9 million of depreciation expenses associated with intangible assets generated through the IgG products acquisition.
Operating expenses, including R&D, S&M, G&A and other expenses, totaled $33.8 million in the first nine months of 2023, as compared to $30.9 million in the prior year period. S&M costs, for the first nine months of 2023 and 2022, included $1.2 million of depreciation expenses of intangible assets generated through the IgG products acquisition. The increase in operating expenses was attributable to an increase in S&M costs associated with the acquired portfolio commercial operation, as well as increased R&D costs, primarily due to advancing the pivotal Phase 3 InnovAATe trial for Inhaled AAT.
Net income for the first nine months of 2023 was $3.2 million, or $0.07 per share, as compared to net loss of $5.3 million, or $(0.12) per share, in the prior year period.
Adjusted EBITDA, as detailed in the tables below, was $17.7 million in the first nine months of 2023, a 67% increase as compared to $10.6 million in the first nine months of 2022.
Cash used in operating activities during the first nine months of 2023 was approximately $0.1 million, as compared to cash provided by operating activities of $21.8 million during the first nine months of 2022. The change correlates to the changes in the Company’s working capital and supports overall growth.
Balance Sheet Highlights
As of September 30, 2023, the Company had cash, cash equivalents, and short-term investments of $52.6 million, as compared to $34.3 million as of December 31, 2022. This includes the net proceeds of $58.2 million received from the $60 million financing closed during the third quarter. In addition, during the third quarter the Company made a $17.4 million pay-down in full the outstanding balance of a bank loan. The Company is currently debt free.
Recent Corporate Highlights
Received shareholder approval for and subsequently closed $60 million private placement with FIMI Opportunity Funds.
Announced multiple achievements with CYTOGAM, including the availability of product manufactured by Kamada for U.S. commercial sale, presented new clinical data highlighting five-year real-world survival benefits of high risk CMV mismatch lung transplant patients receiving CYTOGAM, and the establishment of a Scientific Advisory Board focused on U.S. clinical programs for CYTOGAM.
The Company continues to conduct its business operations in Israel with no effect on business continuity, and its global supply of products is not expected to be interrupted as a result of the recent events in Israel.
Fiscal Year 2023 Guidance
Kamada continues to expect to generate fiscal year 2023 total revenues in the range of $138 million to $146 million. The Company also continues to anticipate generating adjusted EBITDA during 2023 in the range of $22 million to $26 million, the mid-point of the range would represent profitability growth of approximately 35% over 2022.
Conference Call
Kamada management will host an investment community conference call on Monday, November 13, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-877-407-0792 (from within the U.S.), 1 809-406-247 (from Israel), or 1 201-689-8263 (International) and entering the conference identification number: 13741701. The call will also be webcast live on the Internet at: https://viavid.webcasts.com/starthere.jsp?ei=1637192&tp_key=fd85a910fe.
Non-IFRS financial measures
We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company’s core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain other costs.
MediWound Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients
https://finance.yahoo.com/news/mediwound-receives-positive-chmp-opinion-120000725.html
The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment for burn patients of all ages
YAVNE, Israel, Nov. 13, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently.
This positive opinion is based on the results of a global Phase 3 trial that evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients (CIDS study), funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid.
The Phase 3 study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in the time to achieve complete eschar removal and a significant reduction in the wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars as measured by MVSS. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and a reduction in the need for autograft in deep partial burns, as well as a favorable trend in the reduction of blood loss during the eschar removal process. In addition, the study confirmed NexoBrid to be safe and well-tolerated for all ages.
“This significant milestone advances our goal to redefine the standard of care for the treatment of severe burns. The current standard, surgery, is extremely traumatic to both patients and their families. NexoBrid offers a safe, fast, and highly effective debridement alternative to surgery, minimizing blood loss and reducing the time required for treatment,” said Ofer Gonen, CEO of MediWound. He added, “From a commercial perspective, pediatric burn victims comprise more than 30% of the total burn population making this new indication a significant addition to our addressable market.”
About NexoBrid
NexoBrid® is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including in United States, European Union and Japan, where it has been designated as an orphan biologic drug.
NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT) in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.
For more information visit www.mediwound.com and follow the Company on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, expectations and commercial potential of our products and product candidates, including NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated our expectations regarding future growth, market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
MediWound Contacts:
Hani Luxenburg
Daniel Ferry
Chief Financial Officer
Managing Director
MediWound Ltd.
LifeSci Advisors, LLC
ir@mediwound.com
daniel@lifesciadvisors.com
BioLineRx to Report Third Quarter 2023 Results on November 20, 2023
https://finance.yahoo.com/news/biolinerx-report-third-quarter-2023-120000735.html
- Management to Hold Conference Call at 10:00 a.m. EST -
TEL AVIV, Israel, Nov. 13, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced it will release its unaudited financial results for the quarter ended September 30, 2023 on Monday, November 20, 2023, before the U.S. markets open.
The Company will host a conference call at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until November 22, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
Protalix BioTherapeutics, Inc. (AMEX:PLX) Q3 2023 Earnings Call Transcript
Published on November 7, 2023 at 9:04 am by INSIDER MONKEY TRANSCRIPTS in
Protalix BioTherapeutics, Inc. (AMEX:PLX) Q3 2023 Earnings Call Transcript November 6, 2023
Protalix BioTherapeutics, Inc. beats earnings expectations. Reported EPS is $-0.04, expectations were $-0.07.
Operator: Good morning, ladies and gentlemen. And welcome to the Protalix Biotherapeutics Third Quarter 2023 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mr. Chuck Padala of LifeSci Advisors, Investor Relations for Protalix. You may begin the conference.
Chuck Padala: Thank you, operator and welcome to the Protalix Biotherapeutics Third Quarter 2023 Financial Results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Protalix; and Eyal Rubin, Senior Vice President and Chief Financial Officer. A press release announcing the results and the update was issued this morning and is now available on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release in this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in the Protalix’s filing with the U.S. Securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror?
Dror Bashan: Thank you, Chuck. And welcome everyone to our third quarter 2023 financial results and business update call. Before we begin, I would like to take a moment to acknowledge the situation here in Israel. We at Protalix are horrified by the devastating events that have been taking place in recent weeks. It is an extremely challenging time and we are heartbroken for the victims, families, friends and loved ones, many of us being personally impacted. Our hearts and prayers go out to all these those affected and we remain dedicated to the safety and wellbeing of our team. We are committed to provide our families, friends and colleagues any and all support they need at this time. At the same time, we want to reassure you that we are continuing to operate as usual.
There have been no disruptions to our facilities and we do not currently anticipate any interruption to the supply of our products Elfabrio and Elelyso. We appreciate all those who have been reached out to Protalix to express their concern and support and we thank you for joining us today. I will now review our recent progress and accomplishments. Following my remarks, Eyal will provide a more detailed review of our financial results and then of course, we will open the line for questions. Let me now turn to our accomplishments this quarter. Since receiving FDA and EMA approval for Elfabrio, our commercial partner, Chiesi has focused on commercial launch in both the United States and the European Union. We are also pleased that Elfabrio has been granted additional regulatory approvals outside the EU, like in Great Britain and Switzerland, and we look forward to continued global growth of Elfabrio.
Having now secured the approval of two drug products, Elfabrio and Elelyso, we are now focusing our attention to develop our pipeline assets with the potential to address high unmet needs for patients with limited therapeutic options. Our most advanced development candidate is PRX-115 for the potential treatment of severe gout. We are currently sponsoring a Phase 1 first in human clinical trial of PRX-115 to evaluate its safety, pharmacokinetics, pharmacodynamics and immunogenicity. It is a double-blind, placebo-controlled single ascending dose trial of up to 56 participants. 42 participants have been dosed today in this first in human trial. We expect to announce topline results from this study in mid-2024. We believe PRX-115 is potentially a good candidate to target this market.
Our next pipeline candidate is PRX-119 for the potential treatment of NETs-related diseases. NETs are web like structures released by activated neutrophils that trap and kill a variety of microorganisms. Excessive formation or ineffective clearance of NETs can result in different pathological effects and has been observed in various autoimmune inflammatory and fibrotic conditions. We look forward to providing with updates on these programs as they progress. There are currently several other preclinical programs and we will update regarding these programs once applicable. On the corporate side, we welcome Dr. Eliot Forster, as Chairman of our Board of Directors, succeeding Mr. Zeev Bronfeld, who retired from his position on our board. As an independent director, Dr. Forster was also appointed to our nominating committee.
Eliot’s reputation in management and leadership in the life science field speaks for itself, and he has a record of success in the United States, the European Union and Asia. We are grateful to Zeev for his dedication and leadership since the founding of Protalix many, many years ago, and we look forward to working with Eliot and leveraging his expertise as we enter this exciting phase of development for this company. Before turning the call to over to Eyal, I want to know that our strong balance sheet provides us with sufficient cash runway to maintain current operations without the need for near-term capital infusion. With that, it is now my pleasure to turn the call over to Eyal to review our financials. Eyal, please.
Eyal Rubin: Thank you, Dror. And thank you everyone for joining today’s call. Let me review our third quarter 2023 financials. We recorded revenues from selling goods of $10.2 million during the three months ended September 30th, 2023, an increase of $1.4 million or 16% compared to revenues of $8.8 million for the three months ended September 30th, 2022. The increase resulted primarily from an increase of $3 million in sales to Chiesi, following the approval by the FDA and the EMA, as Dror mentioned, of Elfabrio, and of $0.6 million in sales to Brazil, partially offset by $2.2 million decrease in sales to Pfizer. Recorded revenues from license and R&D services of $0.2 million for the three months ended September 30th, 2023, a decrease of $5.2 million, or 96%, compared to revenues of $5.4 million for the three months ended September 30, 2022.
Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Chiesi Agreements. As of March 1st, 2023, sponsorship of the extension studies was transferred to Chiesi, and Chiesi is now administering all open label extension studies. Cost of goods sold was $4.9 million for the three months ended September 30th, 2023, a decrease of $2.2 million, or 31%, from cost of goods sold of $7.1 million for the three months ended September 30th, 2022. The decrease in cost of goods sold was primarily the result of the decrease in sales to Pfizer, partially offset by an increase in sales of Elfabrio to Chiesi and of Elelyso to Brazil. For the three months ended September 30th, 2023, our total research and development expenses were approximately $3.7 million comprised of approximately $1 million of subcontractor-related expenses, approximately $1.9 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses.
For the three months ended September 30th, 2022, our total research and development expenses were approximately $7.4 million comprised of approximately $4.9 million in subcontractor-related expenses, approximately $1.7 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses. Total decrease in research and developments expenses was $3.7 million, or 50%, compared to the three months ended September 30th, 2022. The decrease in research and development expenses primarily resulted from the completion of our Fabry clinical program and the regulatory processes related to the BLA and MAA review of Elfabrio by the applicable regulatory agencies. Selling, general and administrative expenses were $3.7 million for the three months ended September 30, 2023, an increase of $0.9 million, or 32%, compared to $2.8 million for the three months ended September 30th, 2022.
The increase resulted primarily from an increase of approximately $0.6 million in salary and related expenses due to one-time cash bonuses and an increase in share-based compensation. Financial income, net was $0.2 million for the three months ended September 30, 2023, compared to financial expenses, net of $0.4 million for the three months ended September 30, 2022. The change resulted primarily from an increase of $0.3 million in interest income. In the three months ended September 30, 2023, we recorded income taxes of approximately $0.1 million which were primarily the result of the provision for current taxes in respect of Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted in December 2017. Cash, cash equivalents and short term bank deposits were approximately $41 million at September 30th, 2023.
Net loss for the three months ended September 30th, 2023 was approximately $1.9 million, or $0.03 per share, basic, and $0.04 per share diluted, compared to a net loss of $3.6 million, or $0.07 per share, basic and diluted, for the same period in 2022. I will now turn the call back to you, Dror.
Dror Bashan: Thank you, Eyal. In concluding this earnings call, I would like to know that we at Protalix are proud of our accomplishments. We have a proven platform technology with two approved therapeutics driving a rich and sustainable pipeline of assets. A worldclass team, a strong balance sheet supporting our strategic plans and a strategic vision to creating a long-term value for our stockholders. We look forward to updating you in the future in our progress. Before we start taking questions, I would like to note that we are praying for our friends and family during this challenging time. One that is filled with pain. I’m grateful for our entire Protalix team, their enduring commitment and resolve at this time as we develop a portfolio for patients with unmet medical needs is noteworthy. Now I would like to ask the operator to open the call for questions, please.
Operator: [Operator Instructions] The first question comes from the line of Boobalan Pachaiyappan with H.C. Wainwright
Boobalan Pachaiyappan: Hi, this Boobalan Sorry for the voice. I’m still recovering from sore throat. So thanks for taking our questions. Firstly, with respect to revenue from selling goods. I see that the revenue dropped from $15 million in second quarter to $10 million in the third quarter. Can you discuss the underlying factors for this drop in revenue and also what are your expectations for revenue in the fourth quarter?
Eyal Rubin: Thank you, Boobalan for the question. So in terms of the decrease, part of the decrease is decrease in sales to Pfizer and part of it is decrease in sales to Chiesi, mentioned in the previous call, the sales to Chiesi are basically their inventory buildup. At this point, the sales to Chiesi are not indicative of the penetration of sales in the market. So obviously, as they build the inventory, there’s going to be fluctuation in the next year and a half or even two years during the term that they’re building the inventory and so it materially also penetrating the market and building their presence in the markets. With respect to your second question, about guidance on the revenue for the fourth quarter, we usually don’t provide guidance for revenue, especially since the POs from Chiesi and from Brazilian Pfizer are dynamic, especially at this point, where Chiesi is the majority of the sales and they are building up their presence in the market.
So I guess that it’s going to take time until we’ll be able to share forecasts and feel comfortable giving those forwarding statements.
Boobalan Pachaiyappan: Okay, fair enough. And then, congrats on winning FDA, sorry, the regulatory approval in UK and Switzerland. So I was wondering if you could provide or maybe at a high level discuss the Fabry disease market opportunity in the UK and Switzerland, and also which countries can we expect to approve Elfabrio in the upcoming quarters?
Dror Bashan: So actually the drug was approved already in most of the, if I may say, western countries in Europe. So the United Kingdom is not part of the EU, but it’s certainly an important market. Also in Switzerland it was approved, and the idea is indeed to move on to other markets outside the EU, including Japan where Chiesi initiated the study in order to register the drug later on and other markets as well. As for the specific size of the Fabry market in the UK, I don’t have it in front of me. And also this is Chiesi, if I may say, a role right now. So once we will have more data or Chiesi will release more data, we will be able to share it with you. But it’s certainly the UK is a very important market in the Europe. Let’s put this way.
Boobalan Pachaiyappan: Okay, thanks for the color. Let’s switch gears and discuss your clinical programs, especially PRX-115, the ongoing Phase 1 study. So I’d like to get some additional color on some of the items that you’re listed in the exclusion criteria. So I was looking at the clinicaltrials.gov website. And so some of the criteria, especially the exclusion criteria, so it says you’re excluding patients with one or more Gaucher in the last one year and those with subcutaneous tophi or those with advanced renal diseases, they’re also excluded. So I’m trying to understand is the strategy to target mild or moderate forms of gout without the renal complication, if I may? So you can clarify more on that.
Dror Bashan: Yes, sure. Thank you for that. So actually it’s a Phase 1 study. It’s a single dose. So it’s the first time we actually infuse it to participants. The participants are actually volunteers with hyperuricemia. They are not and the idea is first to check safety, of course. And then to see if indeed we reduce the hyperuricemia to normal levels or acceptable levels and then take it further. So we measure multiple aspects in order to be able to move on, of course, subject to safety to multiple to like a multiple ascending dose later on in 2024. So it does not indicate right now. The idea is not to indicate for mild patients at all. Actually, it’s for severe gout patients.
Boobalan Pachaiyappan: Okay. Thank you for the color. One last question, if I may. So again, with respect to PRX-115. So I know you’re collecting immunogenicity data and blood uric acid levels as well. So I’m curious, what do you expect to see in these two data, especially Phase 1 study? What are your expectations?
Dror Bashan: So again, we would like to see safety for sure. And then we will analyze from a PKPD point of view additional measurements to see if we have indications for reduction, of course, of the hyperuricemia and other parameters in order, again, to see frequency of dosing and other signals. that will enable us, if I may say, to take further steps or more calculated steps for the next study.
Boobalan Pachaiyappan: Okay, thank you for taking all my questions.
Dror Bashan: Yes, and again, just to make sure, the intent at least is to enroll up to 56 subjects. So I think it’s enough of a number to, or we hope it’s enough of a number to get enough information to move on. I won’t say minimize the risk, but with less risk, of course. Safety for sure, but more than that.
Operator: Next question comes from the line of John Vandermosten with Zacks
John Vandermosten: All right, thank you, Dror and Eyal. Good day to you. Beyond cost how much of your expense structure is oriented towards the Elfabrio business?
Dror Bashan: Okay. Can you repeat the question? I can hardly hear you. I’m sorry.
John Vandermosten: Oh, I’m sorry. Beyond cost, how much of your expense structure is oriented towards the Elfabrio business now?
Eyal Rubin: In terms of cost structure, other than manufacturing, which takes something like three to four months a year, and the production of three to four months a year is sufficient to supply and provide half of the patient population worldwide, we’re not investing at present in Elfabrio.
John Vandermosten: Okay. And how do you see your capital structure changing now that you have two revenue generating products, and then also keeping in mind that there’s the convertible bet on the balance sheet.
Eyal Rubin: That’s a good question. A, we truly we have two revenue generating products out there. Since we are not doing anything in the equity capital markets, so obviously, I guess gradually, slowly, but surely when revenues are going to start to ramp up, the big boys are going to join the party and we’re going to see that we have a stable streamline of revenues and we are accumulating cash. So it’s a different company. It’s not a biotech, a typical biotech company in the development stage. At present, we don’t see this change. As we said, the company at this point is self-sustained. We don’t see any need to raise money in the foreseeable future for the ongoing operations. So I guess that’s going to take time. Over time, I guess that the capital structure is going to change.
John Vandermosten: Okay. And I think that are coming due next year in about a year. And then quarterly cash burn, can you give us some help on how to forecast that going forward? I noticed it was a little bit greater than net income for the quarter and I just wanted to see if you could help us understand how that might flow through for the next several quarters.
Eyal Rubin: Yes, so I think that I responded to this one previously too by Boobalan. And since we are just in a phase of revenue ramp up and Chiesi just starting to penetrate the market and building the presence, slowly but surely, I guess that that’s going to fluctuate. So we don’t feel comfortable at this point sharing the forecasts for the next couple quarters. Yes, I think it’s very, very, very fluctuating. They can decide that they are pulling two batches, one batch, for even technical reason delaying one. So I think at this point it’s going to be irresponsible to share forecasts for the short term. Long term, as I said in the next day, you’re going to have to, that’s going to be mostly an inventory buildup with a runway that will ramp up, I’m talking about sales obviously, we’ll ramp over time.
John Vandermosten: Okay, and then shifting to PRX-115 and assuming that topline comes out as expected or better in the middle of next year, what are the next steps there? Would that be P phase 2 or I guess I’m just wondering what we should expect to see from that development program.
Dror Bashan: So we intend to do a multiple dose following the single dose that we do now and then once we have, which is actually a Phase 2 and then we will continue from there.
John Vandermosten: Okay, and just one last one on 119. What are the next steps for that program?
Dror Bashan: So we, thank you for that. So we will gather information in the near future, if I may say, from the different preclinical studies and other data that we have. And we’ll go for, if I may say, kind of a portfolio go-no-go meeting. And if indeed we decide to go ahead, we will share and continue to toxicology in Phase 1.
Operator: Thank you. This concludes today’s question and answer session. I would now like to turn the floor over to Dror Bashan for closing comments.
Dror Bashan: So thank you everybody for your participation. And I appreciate the time. And we look forward speaking with you on our next call for 2023 results. And I hope with a more peaceful time for us here in Israel. Thank you all.
Operator: Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
Protalix BioTherapeutics GAAP EPS of -$0.04 beats by $0.03, revenue of $10.35M beats by $2.71M
Nov. 06, 2023 6:53 AM ETProtalix BioTherapeutics, Inc. (PLX)
By: Meghavi Singh, SA News Editor
Protalix BioTherapeutics press release (NYSE:PLX):
Q3 GAAP EPS of -$0.04 beats by $0.03.
Revenue of $10.35M (-27.0% Y/Y) beats by $2.71M.
Cash, cash equivalents and short term bank deposits were approximately $41.0 million at September 30, 2023.
Protalix BioTherapeutics Reports Third Quarter 2023 Financial and Business Results
https://finance.yahoo.com/news/protalix-biotherapeutics-reports-third-quarter-115000440.html
Company to host conference call and webcast today at 8:30 a.m. EST
CARMIEL, Israel, Nov. 6, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the third quarter ended September 30, 2023 and provided a business update on recent regulatory, clinical and corporate developments.
"We continued our efforts this quarter towards turning Protalix into a fully-sustainable biopharmaceutical company with a growing pipeline of differentiated proprietary assets. With the approval of Elfabrio® by the U.S. FDA and the European Medicines Agency earlier this year, we are pleased to see our commercial partner Chiesi Global Rare Diseases hit the ground, both in the United States and the European Union. Additionally, Chiesi is continuing to position Elfabrio for future growth with additional approvals worldwide," said Dror Bashan, Protalix's President and Chief Executive Officer. "Our strong balance sheet coupled with our growing revenue stream allows us to focus on the continued development of our growing pipeline of assets, including PRX-115, our recombinant PEGylated uricase in development for the potential treatment of severe gout. We are continuing to enroll patients in our Phase I clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115, and look forward to continuing to progress this product candidate forward, Mr. Bashan continued. "We are proud of our achievements and look forward to an exciting future as a company with a proven platform and two approved drugs, a rich pipeline of product candidates in lucrative markets, a world-class team of dedicated employees, strong financial support with a solid balance sheet and an increasing stream of revenues."
2023 Third Quarter and Recent Business Highlights
Regulatory Advancements
The Company, together with its development and commercialization partner, Chiesi Global Rare Diseases (Chiesi), a business unit of the Chiesi Group, continued to attain marketing authorizations around the world for Elfabrio (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease. Elfabrio, a PEGylated enzyme replacement therapy (ERT), is a recombinant human a-Galactosidase-A enzyme expressed in plant-cell culture that is designed to provide a long half-life.
On August 15, 2023, Chiesi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Elfabrio in Great Britain for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.
On September 11, 2023, Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland, announced the approval of Elfabrio in Switzerland for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease.
Clinical Developments
The Company continued to advance its First in Human (FIH) phase I clinical trial of PRX–115, a recombinant PEGylated uricase product candidate under development as a potential treatment for severe gout. To date, 32 patients have been dosed in the trial. The FIH trial is a double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of PRX–115 in up to 56 patients with elevated uric acid levels (>6.0 mg/dL) and no previous exposure to PEGylated uricase. The study is being conducted at New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines. We expect to announce top-line results from this study in mid-2024.
Corporate Developments
On September 14, 2023, Eliot Richard Forster, Ph.D. joined the Company's Board of Directors as its Chairman, replacing former Chairman Zeev Bronfeld, who retired for personal reasons. In addition to his role as Chairman, Dr. Forster is serving as an independent director on the Company's Nominating Committee.
Third Quarter 2023 Financial Highlights
The Company recorded revenues from selling goods of $10.2 million during the three months ended September 30, 2023, an increase of $1.4 million, or 16%, compared to revenues of $8.8 million for the three months ended September 30, 2022. The increase resulted primarily from an increase of $3.0 million in sales to Chiesi, following the approvals by the FDA and the EMA of Elfabrio, and of $0.6 million in sales to Brazil, partially offset by a $2.2 million decrease in sales to Pfizer.
The Company recorded revenues from license and R&D services of $0.2 million for the three months ended September 30, 2023, a decrease of $5.2 million, or 96%, compared to revenues of $5.4 million for the three months ended September 30, 2022. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Chiesi Agreements. As of March 1, 2023, sponsorship of the extension studies was transferred to Chiesi, and Chiesi is now administering all open label extension studies.
Cost of goods sold was $4.9 million for the three months ended September 30, 2023, a decrease of $2.2 million, or 31%, from cost of goods sold of $7.1 million for the three months ended September 30, 2022. The decrease in cost of goods sold was primarily the result of the decrease in sales to Pfizer, partially offset by an increase in sales of Elfabrio to Chiesi and of Elelyso to Brazil.
For the three months ended September 30, 2023, the Company's total research and development expenses were approximately $3.7 million comprised of approximately $1.0 million of subcontractor-related expenses, approximately $1.9 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses. For the three months ended September 30, 2022, our total research and development expenses were approximately $7.4 million comprised of approximately $4.9 million in subcontractor-related expenses, approximately $1.7 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses. Total decrease in research and developments expenses was $3.7 million, or 50%, compared to the three months ended September 30, 2022. The decrease in research and development expenses primarily resulted from the completion of our Fabry clinical program and the regulatory processes related to the Biologics License Application (BLA) and Marketing Authorization Application (MAA) review of Elfabrio by the applicable regulatory agencies.
Selling, general and administrative expenses were $3.7 million for the three months ended September 30, 2023, an increase of $0.9 million, or 32%, compared to $2.8 million for the three months ended September 30, 2022. The increase resulted primarily from an increase of approximately $0.6 million in salary and related expenses due to one-time cash bonuses and an increase in share-based compensation.
Financial income, net was $0.2 million for the three months ended September 30, 2023, compared to financial expenses, net of $0.4 million for the three months ended September 30, 2022. The change resulted primarily from an increase of $0.3 million in interest income.
In the three months ended September 30, 2023, the Company recorded income taxes of approximately $0.1 million which were primarily the result of the provision for current taxes in respect of Section 174 of the U.S. Tax Cuts and Jobs Act, which was enacted in December 2017.
Cash, cash equivalents and short term bank deposits were approximately $41.0 million at September 30, 2023.
Net loss for the three months ended September 30, 2023 was approximately $1.9 million, or $0.03 per share, basic, and $0.04 per share, diluted, compared to a net loss of $3.6 million, or $0.07 per share, basic and diluted, for the same period in 2022.
Conference Call and Webcast Information
The Company will host a conference call today, November 6, 2023, at 8:30 a.m. EST, to review the regulatory, clinical and corporate developments, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:
Conference Call Details:
Date:
Monday, November 6, 2023
Time:
8:30 a.m. Eastern Standard Time (EST)
Toll Free:
1-877-423-9813
Israeli Toll Free:
1-809-406 247
International:
1-201-689-8573
Conference ID:
13741587
Call me™:
https://tinyurl.com/2tsadwma
The Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away.
Webcast Details:
The conference will be webcast live from the Company's website and will be available via the following links:
Company Link: https://protalixbiotherapeutics.gcs-web.com/events0
Webcast Link: https://tinyurl.com/362f74wx
Conference ID: 13741587
Participants are requested to access the websites at least 15 minutes ahead of the conference call to register, download and install any necessary audio software.
A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Company's website, at the above link.