On March 13, 2023 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported a business update and announced financial results for the year ended December 31, 2022 (Press release, VBI Vaccines, MAR 13, 2023, View Source [SID1234628590]).

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Jeff Baxter, VBI’s President and CEO commented: "The achievements of 2022, across our pipeline, set 2023 up for a strong start, and I am encouraged by the building momentum for PreHevbrio as well as for our development-stage candidates targeting chronic hepatitis B, glioblastoma, and broader protection against COVID-19. We remain intensely focused on three priorities: (i) making a difference in the fight against hepatitis B, (ii) advancing our pipeline candidates targeting additional significant medical and public health needs, and (iii) managing our operating expenses and capital to fuel sustainable growth and value for key stakeholders – patients, healthcare providers, and shareholders. The potential impact our programs can have on patients and public health grows each year, and I am excited for the continued evolution of VBI in 2023."

Notable Recent Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV): Working to Address Both Sides of the Fight Against HBV – Prevention and Treatment

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

Net product sales of $0.9 million in 2022, following the U.S. launch at the end of Q1 2022
In Q1 2023, product access agreements were put in place with six retail pharmacy chains, including three of the top 10 national retail chains and three of the top 10 regional retail pharmacy networks
Reimbursement coverage is now estimated to be in place for 75% of Medicare-insured lives, 75% of commercially insured lives, and more than 60% of lives under state Medicaid plans
Momentum for PreHevbrio continues to build, with customer acquisition rate more than doubling since the beginning of Q4 2022
Outside of the U.S.:

Now approved in the United Kingdom, European Union/European Economic Area (brand name PreHevbri), and in Canada (brand name PreHevbrio)
H1 2023: As part of our partnership with Valneva, announced in September 2022, we expect PreHevbri will be available in certain European markets beginning in the first half of 2023
2023: We expect to make PreHevbrio available in Canada beginning in 2023
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

Initial Phase 2 data, announced in February 2023, suggest VBI-2601 in combination with BRII-835, an HBV-targeting siRNA, induced stronger anti-hepatitis B surface antigen (HBsAg)-specific T-cell and antibody responses compared to the siRNA alone; to date, two patients who received the combination regimen achieved maximum reductions in HBsAg at or below the lower limit of quantification (LLOQ) by Week 40
Represents strong HBV-specific immunomodulator data and suggests that VBI-2601 has the potential to be part of a functional cure regimen
Later in 2023: Additional data from this combination study expected to be announced
Q3 2023: Interim topline data expected from part one of the two-part Phase 2a/2b combination study evaluating VBI-2601 (BRII-179) as an add-on to existing pegylated interferon (PEG-IFN-α) and nucleos(t)ide reverse transcriptase inhibitor (Nrtl) therapy in non-cirrhotic chronic HBV patients
Glioblastoma (GBM): Survival Benefit and Tumor Responses Observed – Moving to Next Phase of Development

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

Program has now received both U.S. FDA Orphan Drug Designation (announced in June 2022) and FDA Fast Track Designation (announced in June 2021) for the treatment of GBM
Data from the Phase II study, as presented throughout 2022, demonstrated improvement in 6-, 12-, and 18-month overall survival compared to historical controls, two partial tumor responses (with one patient on protocol for more than two years achieving a maximum tumor reduction of 93%), and 10 stable disease observations
Based on the data seen to-date, we anticipate assessing VBI-1901 in randomized, controlled studies in both the primary and recurrent GBM settings
Q2 2023: Expected initiation of next phase of development in recurrent GBM setting
Mid-Year 2023: Expected initiation of VBI-1901 study arm, as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus’ anti-PD-1, balstilimab, in the primary GBM setting
COVID-19 & Coronaviruses: Targeting Broader Immunity – Clinical Data Expected Mid-Year 2023

VBI-2901: Multivalent Coronavirus Vaccine Candidate

Partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) expanded to advance the development of multivalent coronavirus vaccines that could be deployed against COVID-19 as well as future "Coronavirus X" (announced in December 2022)
Mid-year 2023: Interim data expected from Phase 1 study of VBI-2901, VBI’s vaccine candidate that expresses the SARS-CoV-2 (COVID-19), SARS-CoV-1 (SARS), and MERS-CoV (MERS) spike proteins
Additional Corporate Updates

Debt Financing: In September 2022, VBI closed a refinanced and upsized debt facility of up to $100 million with existing lender, K2 HealthVentures (K2HV), adding $20 million of non-dilutive funding to the balance sheet
Financial Results for the Twelve Months Ended December 2022

Cash Position: As of December 31, 2022 VBI had $62.6 million in cash compared with $121.7 million in cash as of December 31, 2021.
Revenues, net: Revenues, net for the full year 2022 were $1.1 million, compared to $0.6 million for the same period in 2021. The increase was due to an increase in U.S. product revenue related to the launch of PreHevbrio in the U.S.
Cost of Revenues: Cost of revenues was $11.3 million for the full year 2022 as compared to $10.8 million in 2021. The increase was due to increased outsourced testing costs, direct labor costs, and increased inventory related costs for our 3-antigen HBV vaccine.
Research and Development (R&D): R&D expenses for the year ended December 2022 were $15.5 million compared to $19.6 million in 2021. R&D expenses were offset by $8.9 million and $14.9 million in government grants and funding arrangements, in 2022 and 2021, respectively. The decrease in R&D expenses related to a refund of $2.9 million received from the FDA related to the Prescription Drug User Fee Act program fee for PreHevbrio and a decrease in costs for our coronavirus vaccine program, offset by an increase in R&D expenses for VBI-1901 as we prepare for clinical studies in primary and recurrent GBM patients.
Sales, General, and Administrative (G&A): SG&A expenses for the full year 2022 were $56.1 million compared to $38.3 million for the full year 2021. The increase in SG&A expenses, partially offset by government grants and funding arrangements, was a result of the increased commercial activities related to PreHevbrio in the U.S., most notably the deployment of our U.S. promotional field team and development of our distribution infrastructure. Additional increased costs include increased insurance costs, increased professional costs, and increased labor costs.
Net Cash Used in Operating Activities: Net cash used in operating activities for the full year 2022 was $73.7 million, compared to $39.9 million for the same period in 2021. The increase in cash outflows was largely due to commercial expenses for the launch of PreHevbrio in the U.S, increased usage of cash as we build inventory for continued commercialization, less funding received from CEPI, and changes in other operating working capital balances. Additionally, there was $1.0 million cash advanced from CEPI pursuant to the CEPI Funding Agreement during 2022 compared to $18.4 million cash advanced from the CEPI Funding Agreement in 2021.
Net Loss and Net Loss Per Share: Net loss and net loss per share for the full year 2022 were $113.3 million and $0.44, respectively, compared to a net loss of $69.8 million and a net loss per share of $0.27 for the full year 2021.
Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the full year 2022 were $85.8 million and $0.33, respectively, compared to a net loss and a net loss per share, excluding foreign exchange loss, of $72.8 million and $0.29 for the full year 2021. Foreign exchange loss for the full year 2022 was $27.5 million as compared to a gain of $3.0 million for the full year 2021. Certain intercompany loans between VBI Vaccines Inc. and our subsidiaries are denominated in a currency other than the functional currency of each entity. The primary driver of the increase in foreign exchange loss was the impact of the relative strengthening of the U.S. and Canadian Dollars against the New Israeli Shekel upon translation of these intercompany loans.
Use of Non-GAAP Financial Measures

Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss are non-GAAP financial measures. VBI’s management believes that the presentation of Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss is useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below.

The following represents a reconciliation of Net Loss to Net Loss Excluding Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss.

About PreHevbrio [Hepatitis B Vaccine (Recombinant)]

PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised of the three surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the U.S., European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio (US/Canada), PreHevbri (EU/EEA/UK), and Sci-B-Vac (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see Full Prescribing Information.

On March 13, 2023 Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, reported recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2022, which include (Press release, Omeros, MAR 13, 2023, View Source [SID1234628589]).

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● Net income in the fourth quarter of 2022 was $128.7 million, or $2.05 per share, compared to a net loss in the third quarter of 2022 of $17.5 million, or $0.28 per share; our fourth quarter’s net loss from continuing operations was $46.0 million, or $0.73 per share, compared to $54.8 million, or $0.87 per share, in the third quarter of 2022. Cash burn for the fourth quarter of 2022 was $26.0 million.

● For the year ended December 31, 2022, net income was $47.4 million, or $0.76 per share. This compares to net income of $194.2 million or $3.12 per share for the year ended December 31, 2021.

● The milestone event specified in the asset purchase agreement by which we sold our former ophthalmology product OMIDRIA to Rayner Surgical, Inc. ("Rayner") occurred in December 2022, resulting in us recording as a receivable the $200.0 million milestone payment from Rayner in December 2022 and receiving the cash payment in February 2023.

● For the fourth quarter ended December 31, 2022, we earned OMIDRIA royalties of $17.9 million on Rayner’s U.S. net sales of $35.8 million, an all-time high for quarterly net sales of OMIDRIA. This compares to earned royalties of $16.5 million during the third quarter of 2022. For the year ended December 31, 2022, we earned royalties of $65.4 million on U.S. net sales of OMIDRIA.

● At December 31, 2022, we had $194.9 million of cash, cash equivalents and short-term investments. In addition, we had $213.2 million of accounts receivable, substantially all of which have been collected. We do not have any assets on deposit with Silicon Valley Bank nor do we have any other financial relationship with the bank or its affiliated entities.

● The Consolidated Appropriations Act of 2023 ("CAA") was signed into law in late December 2022 and expressly provides for separate payment of non-opioid pain management drugs, like OMIDRIA, in the outpatient surgery setting until January 1, 2028.

● We are preparing to resubmit our Biologics License Application ("BLA") for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy ("TA-TMA") and have requested a meeting with FDA, expected to be held next quarter, to confirm the additional information required by FDA to support approval.

● We have initiated two clinical trials evaluating OMS906, one enrolling patients with paroxysmal nocturnal hemoglobinuria ("PNH") who are treatment-naïve and the other enrolling PNH patients who have demonstrated an unsatisfactory response to ravulizumab; dosing is ongoing in the first and initiating in the second.

"With over $400 million available for operations and having secured our ongoing OMIDRIA royalty stream, Omeros now has the flexibility to retire our 2023 debt obligation while funding accelerated advancement across our portfolio of

cutting-edge platforms and programs well into 2025. Any additional revenue source – for which there are multiple opportunities – would only extend that runway, further driving shareholder value without the need for dilution," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "For narsoplimab, we are meeting with FDA to confirm the information required for approval of our resubmitted BLA for TA-TMA, we remain on track for third-quarter release of topline data from our pivotal ARTEMIS-IGAN trial, and there is mutual interest in working with the U.S. government in COVID-19 and ARDS. Our long-acting MASP-2 inhibitor OMS1029 looks promising in the clinic for quarterly IV or SC administration and, together with our orally available small-molecule inhibitors, complements narsoplimab and expands our control over the lectin pathway. OMS906, targeting the key activator of the alternative pathway MASP-3, we expect can also be dosed once quarterly and, given its significant biological advantages over potential competitors, pending efficacy data in PNH followed by C3G will go a long way in answering whether MASP-3 and OMS906 are the premier alternative-pathway target and therapeutic. We also are hoping for good news over the coming weeks on our PDE7 inhibitor OMS527 in both addiction and in Parkinson’s disease. And our novel molecular and cellular immuno-oncology platforms and programs continue to generate exciting data that consistently point to the same conclusion – the potential for transformative cancer therapies. All of our portfolio programs could well be successful, but the success of any one of them would deliver substantial shareholder value."

Fourth Quarter and Recent Clinical Developments

● Recent developments regarding narsoplimab, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 ("MASP-2") in advanced clinical programs for the treatment of TA-TMA and immunoglobulin A ("IgA") nephropathy, include:

o Preparations are underway for anticipated resubmission of our BLA for narsoplimab in TA-TMA following the late-2022 receipt of the decision by FDA’s Office of New Drugs regarding our appeal of FDA’s complete response letter previously issued on our original BLA. The decision denying our appeal proposed, as a path forward for BLA resubmission, the inclusion of additional analyses comparing response and survival in our completed pivotal trial to appropriate historical controls. We have requested a meeting with FDA’s Division of Nonmalignant Hematology to confirm the information required by FDA to support approval of narsoplimab in this indication. We expect that the Type B meeting will occur in the first half of the second quarter of 2023.

o Our Phase 3 ARTEMIS-IGAN trial evaluating narsoplimab for the treatment of IgA nephropathy continues to progress toward an anticipated readout of 9-month data on the proteinuria endpoint in the third quarter of 2023.

o An international group of leading transplanters recently published a systematic review of signs and symptoms of TA-TMA in Transplantation and Cellular Therapy, and a second manuscript on TA-TMA diagnosis and treatment has been accepted for publication by Bone Marrow Transplantation.

● Recent developments regarding OMS1029, our long-acting, next-generation MASP-2 inhibitor, include:

o Dosing of all cohorts in a single-ascending dose Phase 1 clinical trial of OMS1029 was successfully completed in early 2023. OMS1029 was well tolerated with no safety concerns identified. Preliminary pharmacokinetic ("PK") and pharmacodynamic ("PD") data show dose-proportional exposure and sustained lectin pathway inhibition, consistent with potentially quarterly intravenous or subcutaneous dosing.

o Preparations are underway to initiate, in summer 2023, a Phase 1 multiple-ascending-dose study of OMS1029 in healthy subjects.

● Recent developments regarding OMS906, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 ("MASP-3"), the key activator of the alternative pathway, include:
o Clinical data from our single-ascending-dose Phase 1 study evaluating both intravenous and subcutaneous administration of OMS906 in healthy subjects were presented in December at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). As previously announced, the drug was well tolerated, and there were
no safety signals of concern. Based on clinical data to date, we expect that OMS906 will be dosed quarterly, either intravenously or subcutaneously.

o In late 2022 we began enrolling in our Phase 1b clinical trial evaluating OMS906 in treatment-naïve patients with PNH. Dosing in this study began in early 2023.

o Enrollment has also begun in our Phase 1b clinical trial evaluating OMS906 in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab. The study enrolls PNH patients receiving ravulizumab, adds OMS906 to provide combination therapy with ravulizumab for 24 weeks, and then provides OMS906 monotherapy in patients who demonstrate a hemoglobin response with combination therapy. First dosing of OMS906 in this study is scheduled to begin later this month, once the ravulizumab monotherapy period has ended.

o A Phase 1b clinical trial evaluating OMS906 in patients with complement 3 glomerulopathy ("C3G") has also been initiated, with enrollment expected to commence next month.

● Recent developments regarding OMS527, our phosphodiesterase 7 ("PDE7") inhibitor program focused on addiction and movement disorders, include:

o We are engaged in discussions with third parties regarding external funding for development of our PDE7 inhibitors as a treatment for addictive disorders.

o OMS527 is also being evaluated as a potential treatment for levodopa-induced dyskinesias ("LID"), which are crippling, involuntary movements reportedly affecting 50 percent or more of levodopa-treated patients with Parkinson’s disease. LID is caused by prolonged treatment with levodopa, the most prescribed treatment for Parkinson’s. Collaborators at Emory University are evaluating our PDE7 inhibitor in a clinically predictive primate model of LID.
Financial Results

Net income for the fourth quarter of 2022 was $128.7 million, or $2.05 per share, which includes the $200.0 million milestone recognized as income in discontinued operations. This compares to a net loss of $17.5 million in the third quarter of 2022, or $0.28 per share. Net loss from continuing operations for the fourth quarter of 2022 was $46.0 million, or $0.73 cents per share. For the third quarter of 2022, net loss from continuing operations was $54.8 million, or $0.87 per share. Cash burn for the fourth quarter of 2022 was $26.0 million.

Net income for the full year 2022 was $47.4 million, or $0.76 per share, and our net loss from continuing operations was $182.0 million or $2.90 per share. This compares to the prior full year’s net income of $194.2 million, or $3.12 per share, and a loss from continuing operations of $191.5, or $3.07 per share.

In December 2022, the milestone event entitling us to a $200.0 million milestone payment from Rayner occurred. We recorded the $200.0 million milestone as revenue in discontinued operations and as a receivable in December 2022. We received the cash payment on February 3, 2023. Per the terms of the asset purchase agreement with Rayner, following the milestone event the applicable royalty rate was reduced to 30% of the net revenue from U.S. sales of OMIDRIA. Upon achieving the $200.0 million milestone, we conservatively revalued the OMIDRIA contract royalty asset using the reduced royalty rate of 30% on future OMIDRIA U.S. net sales while reflecting an increase in expected OMIDRIA U.S. net sales due to the CAA securing separate payment for drugs like OMIDRIA until at least January 1, 2028. This remeasurement resulted in a $26.2 million reduction in the OMIDRIA contract royalty asset and a corresponding loss being recorded in discontinued operations in the fourth quarter.

During the fourth quarter of 2022, we earned royalties of $17.9 million on $35.8 million of Rayner sales of OMIDRIA. This compares to earned royalties of $16.5 million in the third quarter of 2022. These royalties were recorded as a reduction of the OMIDRIA contract royalty asset.

Total costs and expenses for the fourth quarter of 2022 were $40.1 million compared to $50.8 million for the third quarter of 2022. The decrease was primarily due to the manufacturing of narsoplimab drug substance in the third quarter of 2022 for future commercial and clinical use. We expense commercial drug substance until approval is assured.

Interest expense during the fourth quarter of 2022 was $7.9 million, an increase of $3.0 million from the third quarter of 2022. On September 30, 2022, we sold to DRI Healthcare Acquisitions LP an interest in a portion of our future OMIDRIA royalty receivables and received $125.0 million in cash proceeds. The transaction was recorded as debt for financial reporting purposes with an implied interest rate of 9.4%.

Net income from discontinued operations, net of tax was $174.8 million, or $2.78 per share, in the fourth quarter of 2022 compared to net income from discontinued operations, net of tax of $37.3 million, or $0.59 per share, in the prior quarter. The increase was primarily due to the $200.0 milestone we earned in the fourth quarter, partially offset by the milestone-driven revaluation of the OMIDRIA contract royalty asset.

As of December 31, 2022, we had $194.9 million of cash, cash equivalents and short-term investments. In addition, we had $213.2 million in accounts receivable, all of which have now been collected. We previously maintained a line of credit with Silicon Valley Bank, which we allowed to expire in August 2022. We do not have any assets on deposit with Silicon Valley Bank nor do we have any other financial relationship with the bank or its affiliated entities

Conference Call Details

To access the live conference call via phone, participants must register to receive a unique PIN at the following URL: https://register.vevent.com/register/BIb42f849906d44aaea742e6f375a5609e.

Once registered, you will have two options: (1) Dial in to the conference line provided at the registration site using the PIN provided to you, or (2) choose the "Call Me" option, which will instantly dial the phone number you provide. Should you lose your PIN or registration confirmation email, simply re-register to receive a new PIN.

For online access to the live or subsequently archived webcast of the conference call, go to the investor page of Omeros’ website at View Source

On March 13, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported that Jonathan P. Foster, Chief Financial Officer of Moleculin, will present at the virtual Oppenheimer 33rd Annual Healthcare Conference on Tuesday, March 14, 2023 at 12:40 PM ET (Press release, Moleculin, MAR 13, 2023, View Source [SID1234628588]).

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In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live video webcast of the presentation will be available on the Events page of the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On March 13, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that the Phase 1 trial of XMT-2056 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA) (Press release, Mersana Therapeutics, MAR 13, 2023, View Source [SID1234628587]). This action follows the company’s communication to FDA that Mersana was voluntarily suspending the trial due to a recent Grade 5 (fatal) serious adverse event (SAE) that was deemed to be related to XMT-2056. The SAE and its cause remain under investigation.

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XMT-2056 is Mersana’s first Immunosynthen STING-agonist ADC product candidate to enter the clinic, and the SAE occurred in the second patient who had been enrolled at the initial dose level in the dose escalation portion of the Phase 1 trial in previously treated patients with HER2+ recurrent or metastatic solid tumors. During the clinical hold, no patients will be enrolled or dosed in the trial.

"In line with our steadfast commitment to patient safety, we have been proactive in our response to this event. With the clinical hold in place, our efforts for XMT-2056 are now focused on undertaking the work required to fully analyze this SAE and consider potential next steps for development," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "At the same time, we continue to make progress with our UpRi and XMT-1660 clinical trials, which remain unaffected."

On March 13, 2023 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company’s Chief Manufacturing and Technology Officer, Hemant Kumar, Ph.D., will participate in the upcoming Bioprocessing Summit Europe Conference taking place March 14-16, 2023 in Barcelona, Spain (Press release, Genprex, MAR 13, 2023, https://www.genprex.com/news/genprex-to-present-at-bioprocessing-summit-conference/ [SID1234628585]).

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Dr. Kumar will deliver the following presentation:

Event: Bioprocessing Summit Europe

Conference Date: March 14-16, 2023

Location: InterContinental Barcelona- Fira Center, Barcelona, Spain

Speaker: Hemant Kumar, PhD, Chief Technology and Manufacturing Officer at Genprex

Speaker Topic: Managing Headwinds Due to CDMO’s M&A Activities and Its Impact on Gene Therapy Companies and Innovation

Speaking Date and Time: Wednesday, March 15 at 8:30 a.m. Central European Time

"Dramatic increase in mergers and acquisitions within the global CDMO market has changed the landscape for advancing the development of disruptive innovative gene therapies. This has encouraged CDMOs to provide integrated services to advance drug development but can be a financial burden on clinical stage companies due to potentially higher costs for services and licensing fees, and can add delays in timelines for regulatory submissions," noted Dr. Kumar. "Managing these headwinds through better partnership with CDMOs is key to overcoming these challenges as together we work to bring life-altering new gene therapy treatments to patients battling diseases of unmet medical need."