On May 15, 2024 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and upcoming business highlights and announced its financial results for the first quarter ended March 31, 2024 (Press release, Cullinan Oncology, MAY 15, 2024, View Source [SID1234643357]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have already made significant progress in the first quarter of 2024, continuing the momentum we demonstrated in 2023," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "With our recently announced strategic expansion into immunology, we will develop our CD19xCD3 T cell engager (TCE), CLN-978, in autoimmune diseases starting with SLE as our first indication. We are further encouraged by recent clinical data validating the CD19-directed TCE approach, which is significantly differentiated from CAR T based approaches, while we actively evaluate additional autoimmune indications for CLN-978. We also remain keenly focused on advancing our deep pipeline of clinical-stage oncology programs, with multiple data catalysts through this year and early 2025. With the gross proceeds of $280 million from our recently completed private placement, we believe we are well positioned to execute on our near- and long-term strategic and operational objectives. Additionally, we are pleased to welcome David Meek as a new director to Cullinan’s Board. David brings notable experience in scaling organizations towards successful commercialization. Thomas Ebeling has decided to resign from the Board at the end of his term. We appreciate Thomas’s contributions to Cullinan from the inception of the company to the clinical-stage organization we are today."

Portfolio Highlights

•
CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies
o
Cullinan will present initial data from the combination dose escalation module, as well as an update on the monotherapy dose escalation, during a poster session at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting on June 1, 2024.
o
Cullinan also remains on track to report initial data from disease specific dose expansion cohorts in the first half of 2025.

CLN-978 (CD19xCD3 T cell engager): systemic lupus erythematosus
o
In April 2024, Cullinan reported clinical observations from three patients treated in a Phase 1 dose escalation study of CLN-978 in relapsed / refractory B-cell non-Hodgkin lymphoma (B-NHL), which showed that CLN-978 is clinically active with a favorable safety profile at the initial dose of 30 μg administered subcutaneously once weekly.
o
Based on the potential of CLN-978 in autoimmune diseases, Cullinan has discontinued enrollment in the B-NHL study and will pursue development of CLN-978 in autoimmune diseases, with SLE as the initial indication. The Company plans to submit an IND application for SLE in the third quarter of 2024.
o
Recent publications in Nature Medicine and the European Journal of Cancer provide clinical validation of the CD19xCD3 TCE approach across multiple autoimmune diseases. Cullinan is actively evaluating additional autoimmune indications for CLN-978 and is committed to assessing its broad potential.
•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
Cullinan expects to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study in patients with EGFR ex20ins NSCLC who have progressed after prior systemic therapy, with or without exon 20 targeted therapy, by year-end 2024.
•
CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
o
Cullinan expects to provide a clinical data update from the ongoing Phase 1 multi-ascending dose study in r/r AML and MDS patients in the second half of 2024.
•
CLN-418 (B7H4x4-1BB bispecific immune activator): Solid tumors
o
Cullinan expects to provide a clinical data update from the ongoing Phase 1 dose escalation study in patients with advanced solid tumors in the second half of 2024.
•
CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.

Corporate Updates

•
David Meek has been appointed to the Board of Directors, effective May 15. Mr. Meek most recently served as CEO and board member of Mirati Therapeutics, Inc, and previously as CEO and board member of FerGene, Inc. and Ipsen. Thomas Ebeling will resign from Cullinan’s Board of Directors at the end of his term on June 26.
•
In April, the Company announced its strategic expansion into autoimmune diseases and, with it, changed its name to Cullinan Therapeutics.
•
Also in April, the Company completed an oversubscribed $280 million private placement sale of common stock. The financing includes new and existing leading life sciences institutional investors.
•
In April, the Company announced the appointment of Mary Kay Fenton as Chief Financial Officer.
First Quarter 2024 Financial Results

•
Cash Position: Cash, cash equivalents, investments, and interest receivable were $434.8 million as of March 31, 2024. Combined with proceeds from the April 2024 private placement, Cullinan expects its cash resources to provide runway into 2028 based on its current operating plan.
•
R&D Expenses: Research and development (R&D) expenses were $30.6 million for the first quarter of 2024, compared to $52.1 million for the first quarter of 2023. R&D expenses for both the first quarter of 2024 and 2023 included $3.1 million of equity-based compensation expenses. The decrease in R&D expenses was primarily related to the one-time upfront in-licensing fee for CLN-418 in 2023 and decreased chemistry, manufacturing and controls costs, partially offset by increased clinical costs.
•
G&A Expenses: General and administrative (G&A) expenses were $12.3 million for the first quarter of 2024, compared to $10.7 million for the first quarter of 2023. G&A expenses in the first quarter of 2024 and 2023 included $5.1 million and $4.2 million of non-cash equity-based compensation expenses, respectively. The increase in G&A expenses was primarily driven by increases in personnel costs and non-cash equity-based compensation expenses, partially offset by decreases in legal fees.
•
Net Loss: Net loss (before items attributable to noncontrolling interest) for the first quarter of 2024 was $37.3 million, compared with net loss of $58.1 million for the first quarter of 2023. Net losses resulted from the expenses described above, partially offset by interest income of $5.7 million and $4.5 million in the first quarter of 2024 and 2023, respectively.
•
Shares Outstanding: As of May 8, 2024, Cullinan had 57,634,234 shares of common stock outstanding, plus pre-funded warrants outstanding that are convertible into 315,790 shares of common stock, and non-voting preferred stock outstanding that is convertible into 6,475,000 shares of common stock.

On May 15, 2024 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 quarter ended March 31, 2024 (Press release, VBI Vaccines, MAY 15, 2024, View Source [SID1234643353]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"To date in 2024, our focus has centered around pipeline execution, expanding access and increased uptake of PreHevbrio in targeted market segments, and execution of strategic partnerships to drive opportunity for our portfolio assets, create shareholder value, and strengthen our balance sheet," said Jeff Baxter, VBI’s President and CEO. "We remain committed to creating opportunities for our vaccines, candidates, and technologies to meaningfully impact public health and the lives of patients, providers, and families."

Recent Key Program Achievements and Projected Upcoming Milestones

PreHevbrio [Hepatitis B Vaccine (Recombinant)]

Product revenue, net increased 105% from Q1 2023, with $1.0 million earned in Q1 2024
US:
H1 2024 PreHevbrio U.S. sales continue to demonstrate substantial growth over 2023, with over 80% of the 2023 full-year volume being sold in the first five months of 2024
Commercial execution in Q1 2024 created new demand in the large Integrated Delivery Network (IDN) and hospital system space, and saw continued national and regional pharmacy uptake
Public sector momentum building with PreHevbrio now available for purchase under the CDC Adult Vaccine Contract
Ex-US – PreHevbri:
VBI partners with Valneva SE to make PreHevbri available in certain European countries
In 2023, through this partnership, PreHevbri was launched in the UK, Sweden, Netherlands, and Belgium – in early 2024, PreHevbri also became available in Denmark and Norway
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate – Glioblastoma (GBM)

VBI-1901 is being evaluated in an ongoing, randomized, controlled Phase 2b study in comparison to standard-of-care chemotherapy treatment in recurrent GBM patients
April 2024: Encouraging early tumor response data from Phase 2b study in recurrent GBM presented at World Vaccine Congress 2024:
VBI-1901 Arm: 2 stable disease (SD) observations among patients eligible for evaluation at week 12 (n=2/5), achieving a 40% disease control rate, consistent with 44% disease control rate observed in the Phase 1/2a portion of the study
Control Arm (carmustine or lomustine chemotherapy): No tumor responses have been observed to date (n=0/6; 0% disease control rate) – all evaluable patients experienced a 2-8x increase in tumor size by week 6 and have been taken off study protocol
Mid-Year 2024 and Year-End: Additional tumor response data from ongoing Phase 2b study expected mid-year 2024, with initial survival data from early-enrolled participants expected by year-end 2024, subject to speed of enrollment
Novel mRNA-Launched eVLP (MLE) Technology Platform

April 2024: Announced expansion of strategic partnership with the Canadian Government to advance the development of the MLE technology platform, supported by the CAD$28 million funding award remaining under the original agreement
Throughout 2024: MLE technology remains under active evaluation by potential partners
Other Achievements and Upcoming Milestones

February 2024: Announced a series of agreements with Brii Biosciences ("Brii Bio"), pursuant to which, subject to achievement of certain activities, VBI would receive up to $33 million in consideration for VBI’s manufacturing capabilities and certain related assets at Rehovot manufacturing facility, the intellectual property for VBI-2601, VBI’s hepatitis B immunotherapeutic candidate, and a license for VBI-1901 in the Asia Pacific region, excluding Japan
Following completion of the full transaction, target mid-year 2024, VBI expects its total debt principal to be significantly reduced to $17 million
2024: Additional data expected from Phase 1 study of VBI-2901, VBI’s multivalent pan-coronavirus vaccine candidate – initial data from which were reported in September 2023
Recent Peer-Reviewed Publications

Langley, Gantt, et al., "An enveloped virus-like particle alum-adjuvanted cytomegalovirus vaccine is safe and immunogenic: A first-in-humans Canadian Immunization Research Network (CIRN) study" published in Vaccine – Link Here
Financial Results for the Three Months Ended March 2024

Cash Position: As of March 31, 2024 VBI had $12.6 million in cash as compared with $23.7 million in cash as of December 31, 2023. Cash position at March 31, 2024, does not include approximately $2.8 million gross proceeds from registered direct offering of common shares and warrants, warrant exercises, and sale of common shares through VBI’s at-the-market facility with Jefferies LLC, subsequent to March 31, 2024 and through early April 2024.
Revenues, net: Revenues, net for the first quarter 2024 were $1.2 million as compared to $0.5 million for the same period in 2023. The revenue increase was a result of an increase in product sales of PreHevbrio in the U.S.
Cost of Revenues: Cost of revenues was $2.7 million in the first quarter of 2024 as compared to $3.6 million in the first quarter of 2023. The decrease in the cost of revenues was a result of the April 2023 organizational changes and decreased inventory-related costs, offset by increased product sales.
Research and Development (R&D): R&D expenses for the first quarter of 2024 were $2.6 million as compared to $3.2 million for the same period in 2023. R&D expenses were offset by $0.7 million for the three months ended March 31, 2024, and $2.4 million for the three months ended March 31, 2023 due to government grants and funding arrangements. The decrease in R&D expenses is primarily a result of decreased development expenses for VBI’s pan-coronavirus and GBM candidates, VBI-2901 and VBI-1901, due to timing of ongoing clinical studies of each candidate.
Sales, General, and Administrative (SG&A): SG&A expenses for the first quarter of 2024 were $7.7 million as compared to $13.3 million in the first quarter of 2023. The decrease in SG&A expenses was mainly a result of the April 2023 organizational changes that reduced our internal workforce, commercial field teams, and operating expenses.
Net Cash Used in Operating Activities: Net cash used in operating activities for the first quarter of 2024 was $11.8 million compared to $21.7 million for the same period in 2023. The 46% decrease in cash outflows is largely due to a decrease in net loss as a result of the April 2023 organizational changes, in addition to the change in operating working capital, most notably in inventory, other current assets, accounts payable, and other current liabilities.
Net Loss and Net Loss Per Share: Net loss and net loss per share for the first quarter of 2024 were $17.9 million and $0.73, respectively, as compared to a net loss and net loss per share of $27.8 million and $3.22 for the first quarter of 2023, respectively.
Net Loss and Net Loss Per Share, Excluding Foreign Exchange Loss: Net loss and net loss per share, excluding foreign exchange loss, for the first quarter 2024 were $13.6 million and $0.55, respectively, compared to $20.9 million and $2.43 for the first quarter 2023, respectively. See "Use of Non-GAAP Financial Measures" below for additional information regarding this non-GAAP financial measure, and "GAAP to Non-GAAP Reconciliation" for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.
Foreign exchange loss for the first quarter of 2024 was $4.3 million as compared to $6.8 million for the first quarter of 2023. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The decrease in foreign exchange loss was a result of the changes in the foreign currency exchange rates (of the New Israeli Shekel and the Canadian Dollar) in which the foreign currency transactions were denominated for each of those periods, including the foreign exchange impact of intercompany loans that are translated at period end.
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 and are defined as Net Loss and Net Loss Per Share excluding the foreign exchange loss in both calculations. Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are not intended to replace Net Loss or Net Loss Per Share or other measures of financial performance reported in accordance with generally accepted accounting principles (GAAP). VBI’s management believes that the presentation of Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are 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, and is a non-recurring item, 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 to Net Loss Per Share, Excluding Foreign Exchange Loss. See "Non-GAAP Financial Information" below for additional information regarding this non-GAAP financial measure, and "GAAP to Non-GAAP Reconciliation" for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.

GAAP to Non-GAAP Reconciliations

The following represents a reconciliation of Net Loss to Net Loss Excluding Impairment Charges and 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 – Pre-S1, Pre-S2, and S. 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 May 15, 2024 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), reported financial results for the first quarter ended March 31, 2024, and provided a corporate update on its key program for Alzheimer’s disease (Press release, Vaccinex, MAY 15, 2024, View Source [SID1234643352]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Treatment with pepinemab believed to halt or slow progression of neurodegenerative disease:

Vaccinex expects to complete the planned 12-months of treatment of the last patients enrolled in its randomized, double-blind, Phase 2a SIGNAL-AD trial of pepinemab anti-SEMA4D antibody for mild Alzheimer’s disease (NCT04381468) in early June 2024. Database lock will follow by early July to enable final analysis of the major study outcomes.

Of interest to investors:

Vaccinex’s lead product, pepinemab, is designed to block astrocyte activation that is otherwise triggered by SEMA4D upregulation on stressed or damaged neurons in the brain during progression of Alzheimer’s Disease (AD) and Huntington’s Disease (HD).
Astrocytes, which are key brain cells that support the health and function of neurons, express high affinity receptors for SEMA4D and undergo substantial changes in morphology and gene expression when SEMA4D binds to these receptors. As a result, they switch from normal supportive functions to neurotoxic inflammatory activity that is believed to accelerate and aggravate progression of neurodegenerative diseases.
The Company’s hypothesis, which is being tested in the SIGNAL-AD study, is that treating with pepinemab antibody can block signaling by SEMA4D and prevent some or all damaging consequences of astrocyte activation.
The Company has previously reported that antibody blockade of SEMA4D appears to protect and restore healthy astrocyte functions and, by some measures, also appears to slow or prevent cognitive decline in Huntington’s disease.
The Company believes that the prevalence of AD (6 million people diagnosed with AD in the US alone) and current concerns about the limitations of treatment with anti-Aβ amyloid antibodies could make pepinemab, if approved, attractive as a potential alternative treatment or possibly for use in combination with anti-Aβ to enhance the benefit to patients. Pepinemab has, to date, been well-tolerated in clinical trials that enrolled a total of more than 600 patients, with no evidence of amyloid-related imaging abnormalities (ARIA).
Of further interest to the medical and research communities:

Deposition of Aβ amyloid in the brain is recognized as the earliest event in the pathologic cascade for AD. However, the observation that many elderly, cognitively normal subjects also evidence deposition of Aβ amyloid in their brains suggests that this is not of itself sufficient for disease progression and that a sequence of subsequent events, including astrocyte activation and formation of toxic tau tangles in neurons, is required. Others have recently shown that Aβ deposition in combination with astrocyte activation is associated with increased plasma levels of phosphorylated tau peptide (p-tau 217).
Key outcomes of the SIGNAL-AD study will include impact of pepinemab treatment on brain metabolic activity, an important biomarker of clinical progression in AD, together with other biomarkers of disease progression including plasma levels of glial fibrillary acidic protein (GFAP) released by reactive astrocytes, and phosphorylated tau peptide. Exploratory evaluation of treatment effects on cognitive decline will employ several validated cognitive scales. Topline data will be presented at a major Alzheimer’s medical conference.
The SIGNAL-AD study was funded in part by two investments from the Alzheimer’s Drug Discovery Foundation (ADDF) for a total of $4.75 million, and by an $0.75 million grant from the Alzheimer’s Association.
Financial Results for the Quarter Ended March 31, 2024:

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2024, were $3.0 million, as compared to $1.5 million as of December 31, 2023.

On February 8, 2024, and March 28, 2024, the Company completed private placements of common stock with accompanying warrants to purchase common stock to certain investors, including entities controlled by Albert D. Friedberg, the chairman of the Company’s board of directors and Maurice Zauderer, the Company’s President and CEO, for gross proceeds of $4.94 million. On March 29, 2024 the Company raised an additional $1.50 million in a public offering and also received a $1.75 million investment from the ADDF in a private placement of preferred stock together with common warrants to purchase common stock. ADDF has been a leading and visionary supporter of research in AD for 25 years and this was the second such award received by Vaccinex from this distinguished foundation. Details of all these transactions are available in 8-K and other periodic reports filed with the Securities and Exchange Commission (SEC).

Research and Development Expenses. Research and development expenses for the quarter ended March 31, 2024, were $3.4 million as compared to $3.8 million for the comparable period in 2023.

General and Administrative Expenses. General and administrative expenses for the quarter ended March 31, 2024, were $1.8 million as compared to $1.7 million for the comparable period in 2023.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended March 31, 2024, were $3.9 million and $(2.94) compared to $5.0 million and $(20.89) for the comparable period in 2023.

Total Stockholders’ Equity. Stockholders’ Equity as of March 31, 2024, was $2.7 million on March 31, 2024, as compared to a deficit of $(2.3) million on December 31, 2023. The 2023 discrepancy between the stockholder’s equity balance and the Nasdaq listing requirement was largely due to a determination that the terms of warrants issued on October 3, 2023 did not meet all the requirements for classification as equity and were, therefore, classified as liabilities. The Company brought this matter to the attention of all Vaccinex warrant holders in March 2024, and the holders of 89% of all outstanding warrants agreed to modification of terms of their warrants resulting in the ability to classify the modified warrants as equity on our balance sheet as of March 31, 2024. On April 11, 2024, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market advising that based on the financial statements contained in its Form 10-K for the year-ended December 31, 2023, the Company no longer complied with the requirement to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on the Nasdaq Capital Market (the Equity Standard). The letter from Nasdaq was not a notice of delisting and had no immediate effect on the Company’s listing on the Nasdaq Capital Market. However, Nasdaq required the Company to submit a plan by May 13, 2024, describing how it would regain compliance with the Equity Standard. The Company has submitted the required plan, and while the Company is confident that its plan is promising and feasible, the Company cannot provide assurances that Nasdaq will accept the plan or that the Company will maintain compliance with the Equity Standard.

Financial tables are included below. The Company effected a 1-for-14 reverse stock split on February 20 2024. All share and share amounts have been retroactively restated to give effect to the reverse stock split. For further details on Vaccinex’s financials and the reverse stock split, please refer to its Form 10K filed April 1, 2024, with the SEC.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and other glial cells in the brain and dendritic cells in immune tissue. Over 600 patients have been treated or enrolled in clinical trials of pepinemab in different indications and pepinemab appears to be well-tolerated with a favorable safety profile.

On May 15, 2024 Sigyn Therapeutics, a development-stage medical technology company, reported financial results for the first quarter ended March 31, 2024 (Press release, Sigyn Therapeutics, MAY 15, 2024, View Source [SID1234643349]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During the quarter, the Company reported a loss from operations of $629,972, as compared to an operating loss of $521,258 for the comparable period in 2023. The Company’s net loss for Q1 2024 was $758,088 or $0.62 per share, as compared to a net loss of $1,341,036, or $1.39 per share, during Q1 2023.

During the first quarter, the Company completed a 1-for-40 reverse split of its common stock. As a result, 1,224,827 shares of Company’s common stock are currently issued and outstanding.

For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov, or access them on the Company’s website at www.SigynTherapeutics.com.

Subsequent to previously reported first quarter activities, the Company published a white paper on May 7th entitled: "Sigyn TherapyTM, an Emerging Candidate to Address Endotoxemia, Sepsis, and Drug-Resistant Viral & Bacterial Infections." The paper details the advancement of Sigyn TherapyTM to treat life-threatening conditions that are not addressed with drug therapies. It can be accessed through the following link:

View Source

On May 9th, the Company submitted a Patent Cooperation Treaty (PCT) application entitled: "DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES". WO Patent Application No.: PCT/US24/28579. The patent submission is associated with the Company’s ImmunePrepTM platform to improve the delivery of immunotherapeutic antibodies to treat cancer, which are among the most valued assets in global medicine. Regardless, this class of drugs are poorly delivered to cancer cell targets and as a result, many cancer patients don’t respond to therapy. The patent inventors are James A. Joyce and Annette M. Marleau, who previously collaborated on patent submissions underlying the Company’s ChemoPrepTM and ChemoPureTM devices to improve the delivery and reduce the toxicity of chemotherapy.

On May 15, 2024 Veracyte, Inc. (Nasdaq: VCYT) a leading cancer diagnostics company, reported it will participate in the following investor conferences (Press release, Veracyte, MAY 15, 2024, View Source [SID1234643334]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

-Leerink Partners 2024 Healthcare Crossroads Conference – Austin, TX
Fireside Chat on May 29th at 12:20 p.m. Eastern Time
-William Blair 44th Annual Growth Stock Conference – Chicago, IL
Presentation on June 4th at 5:40 p.m. Eastern Time
Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source A replay of the webcasts will be available following the conclusion of the live presentation broadcast.