On March 14, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2023 (Press release, In8bio, MAR 14, 2024, View Source [SID1234641166]).

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"IN8bio entered 2024 with significant momentum behind the company," said William Ho, CEO and co-founder of IN8bio. "Despite the difficult environment in 2023, the IN8bio team executed operationally and successfully advanced our programs. We presented positive data across our major clinical programs in leukemia and GBM, broadened our clinical portfolio, and strengthened our financial position by securing funding into 1Q 2025. We presented updated data from our INB-100 study at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which was the first time any allogeneic cellular therapy has reported sustained efficacy and long-term cell persistence through 365 days. This showcases the potential of gamma-delta T cells to provide long-term durable remissions for patients with leukemia. We believe that IN8bio is well-positioned for significant near- and long-term catalysts as we advance our pipeline of gamma-delta T cell therapies to potentially extend survival in some of the most aggressive forms of cancer."

Business Highlights and Recent Developments

Announced positive INB-100 data at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition demonstrating that 100% of evaluable leukemia patients (n=10) treated remained alive, progression-free, and in durable complete remission (CR) as of November 3, 2023. The data showed long-term in-vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration of INB-100. The study demonstrated the first-ever durable persistence of an allogeneic cellular therapy.
Reported positive data on INB-200 at the 28th SNO Annual Meeting. All patients who completed mandated doses surpassed a median PFS of seven months, exceeded the standard-of-care median PFS of four to seven months, with one patient in Cohort 2 remaining alive and progression free past 28.5 months as of October 20, 2023. In addition, most patients exceeded the expected PFS based on their age and methylguanine-DNA methyltransferase (MGMT) status of their tumors.
Announced a private placement totaling up to $46.9 million in potential gross proceeds. The initial closing of $14.4 million is expected to support operational execution and extended the Company’s cash runway into 1Q 2025 with the potential for up to $32.5 million in additional capital at increasing valuations, subject to certain conditions.
Initiated enrollment for the Phase 2 study of INB-400 in newly diagnosed GBM.
Announced publication in Frontiers in Immunology on IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) as a rational therapeutic approach to newly diagnosed glioblastoma titled, "Adoptive Cell Therapy for High Grade Gliomas using Simultaneous Temozolomide and Intracranial MGMT-Modified γδ T cells Following Standard Post-Resection Chemotherapy and Radiotherapy: Current Strategy and Future Directions."
Appointed Dr. Corinne Epperly, M.D., M.P.H., an internationally recognized immuno-oncology and cell therapy executive with 20 years of experience, to the Board of Directors.
Upcoming Anticipated Pipeline Milestones and Events

INB-100: Enroll an additional 10 patients in an expansion cohort at the recommended Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results at multiple medical meetings throughout 2024; potentially submit investigational new drug (IND) application for Phase 3 randomized control trial in 2024.
INB-200: Report Phase 1 long-term follow up results at multiple medical meetings in 2024.
INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024.
INB-400: Dose first patient and treat up to 15 patients at multiple sites across the United States in the Phase 2 trial in newly diagnosed GBM; potentially submit IND for Phase 1b allogeneic gamma-delta T cell study in relapsed GBM in 2024.
Fourth Quarter and Full Year 2023 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $4.5 million for the three months ended December 31, 2023, compared to $4.0 million for the comparable prior year period. R&D expenses were $16.8 million for the year ended December 31, 2023, compared to $14.1 million in the prior year. The increase in R&D expenses was primarily due to increased personnel-related costs, including salaries, benefits, and non-cash stock-based compensation due to increased headcount, as well as increased third-party clinical trial-related activities for the INB-100 and INB-200 programs. The increase was partially offset by a reduction in contract research organization expenses for INB-400 related to the IND filing in the prior year.
General and administrative (G&A) expenses: G&A expenses were $3.1 million for the three months ended December 31, 2023, compared to $3.9 million for the comparable prior year period. G&A expenses were $13.5 million for the year ended December 31, 2023, compared to $14.5 million in the prior year. The decrease in G&A expenses was primarily due to cost savings related to D&O insurance premiums and reductions in professional services.
Net loss: The company reported a net loss of $7.6 million, or $0.22 per basic and diluted common share, for the three months ended December 31, 2023, compared to a net loss of $7.8 million, or $0.32 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2023, net loss was $30.0 million, or $1.00 per basic and diluted common share, compared to a net loss of $28.5 million, or $1.36 per basic and diluted common share, for the prior year.
Cash position: As of December 31, 2023, the Company had cash of $21.3 million, compared to $18.2 million as of December 31, 2022.

On March 14, 2024 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO and Dr Tim Franklin, COO, will be attending BIO-Europe Spring (Press release, ImmuPharma, MAR 14, 2024, View Source [SID1234641165]). The event will be held between 18-20 March 2024, in Barcelona.

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BIO-Europe Spring is the premier springtime partnering event, designed to provide biotechnology companies with the opportunity to present to and connect with investors together with the global biopharma community.

On March 14, 2024 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA), an artificial intelligence-driven biotherapeutic research and technology company, reported financial results for its third quarter of the 2024 fiscal year ("FY24"), which ended January 31, 2024 (Press release, ImmunoPrecise Antibodies, MAR 14, 2024, View Source [SID1234641164]).

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"ImmunoPrecise Antibodies proudly reports a fourth consecutive quarter of record revenue, demonstrating our capability to fulfill the rising needs of both new and existing clients through our comprehensive antibody discovery and development services. These services are designed to effectively reduce the risk, cost, and time associated with advancing safe and effective therapies to clinical trials. Key contributors to this revenue growth include our B Cell Select platforms and the enhanced capacity of our manufacturing facility, with additional support from our VHH antibody discovery technologies," stated Dr. Jennifer Bath, CEO of IPA.

She added "Up to this point in the fiscal year 2024, our cash burn has markedly reduced. At the end of the third quarter of fiscal year 2023, it stood at $19.4 million. Now, for the same period in fiscal year 2024, it’s down to $3.1 million. This figure does not include the funds received from our equity offering in December 2023. This reduction in cash burn is a result of both our increased revenue and strategic cost management efforts, even as we continue to invest in AI technologies to better serve our clients.

BioStrand, one of our subsidiaries, has started generating revenue from projects powered by its LENSai technology, and is making progress towards the further development and launch of its LENSai portal and SaaS platforms. Meanwhile, Talem Therapeutics is focused on leveraging its strategic partnerships to drive revenue through out-licensing opportunities, which also enhances contract research revenue and is creating new opportunities for BioStrand.

Overall, our strategy’s successful implementation has led to consistent revenue growth, lower operational costs, and strategic progress. This underscores our commitment to operational excellence and dedication to client support."

Business Highlights and Corporate Update

The strategy of IPA to provide a comprehensive range of services for antibody discovery and development is consistently yielding tangible outcomes. In the recent quarter, the Company recorded record revenues of $6.2 million and $18.1 million for the three- and nine-months ending January 31, 2024, respectively. These figures mark increases of 20.3% and 20.0% compared to the $5.2 million and $15.0 million revenues during the same periods in fiscal 2023. This is the third consecutive quarter in which we have experienced a year-over-year increase in revenue of approximately $1 million. Specifically, year-to-date IPA Canada’s laboratory revenue rose by 27%, while our Utrecht, Netherlands manufacturing facility experienced 32% growth in revenue, reinforcing our expansion strategy to meet customer needs.

BioStrand is generating fee-for-service revenue through its LENSai platform and is progressing in the development of commercial products to meet the needs of IPA’s client base of over 600 companies. During FY24 Q3, BioStrand introduced a new in silico service called epitope binning, which can be accessed by existing clients, as well as for standalone programs. This advancement is a significant step towards the upcoming rollout of the LENSai portal to all IPA clients, followed by the public launch of BioStrand’s comprehensive SaaS platform.

The Company’s decrease in R&D spending reflects the previous investments to develop the internal therapeutic Talem assets, which are now in the next phase of revenue generation, and now primarily represent BioStrand R&D. Efforts are underway to pursue out-licensing opportunities for those internally developed Talem assets. Simultaneously, the Company’s marketing partnerships are enhancing revenue in contract research and creating new opportunities in BioStrand.

The Company recently entered into a Sales Agreement for an "at the market" offering program with Clear Street, as sales agent, for the Company to offer and sell from time-to-time common shares.

Third Quarter FY24 Financial Results

Revenue: Total revenue was $6.2 million, compared to revenue of $5.2 million in fiscal year 2023 ("FY23") Q2. Project revenue generated $5.8 million, including $0.2 million of work completed by BioStrand, and compared to $4.8 million in FY23 Q3. Product sales and cryostorage revenue were $0.4 million, compared to $0.4 million in FY23 Q3.
Research & Development (R&D) Expenses: R&D expenses were $1 million, compared to $1.6 million in FY23 Q3, with the decrease reflecting reduced expenditures related to the build of the Company’s internal therapeutic Talem assets.
Sales & Marketing (S&M) Expenses: S&M expenses were $0.6 million, compared to $0.8 million in FY23 Q3.
General & Administrative (G&A) Expenses: G&A expenses were $4.2 million, compared to $4.1 million in FY23 Q3.
Net Loss: Net loss of $2.9 million, or $(0.11) per share on a basic and diluted basis, compared to a net loss of $4.7 million or $(0.19) on a basic and diluted basis in FY23 Q3.
Liquidity: Unrestricted cash totaled $6.2 million as of January 31, 2024, compared to $6 million as of October 31, 2023.
*Expressed in Canadian dollars, unless otherwise indicated.

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Thursday, March 14, 2024, at 10:30AM ET.

The conference call will be webcast live and available for replay via a link provided in the Events section of the Company’s IR pages at View Source

On March 14, 2024 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, reported that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs) (Press release, Geron, MAR 14, 2024, View Source [SID1234641163]).

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"We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS. There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer," said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer. "We believe that imetelstat has the potential to be an important new medicine for patients and look forward to continuing our collaboration with the FDA as they complete their review of our New Drug Application."

The ODAC reviewed the results from the IMerge Phase 3 clinical trial. The primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat vs. placebo (p<0.001), with median RBC-TI duration approaching one year for imetelstat ≥8-week RBC-TI responders. In addition, 28% of imetelstat-treated patients compared to 3% on placebo obtained a statistically significant improvement in the key secondary endpoint of at least 24-week RBC-TI. For those patients achieving ≥24-week RBC-TI, the median duration was 80 weeks. Clinically meaningful RBC-TI was achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and International Prognostic Scoring (IPSS) risk category. Additionally, a sustained increase in mean hemoglobin levels in imetelstat-treated patients was observed over time compared to placebo patients. Consistent with prior imetelstat clinical experience, the most common Grade 3-4 adverse events were thrombocytopenia (62%) and neutropenia (68%) that were generally manageable and of short duration.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024 for Geron’s New Drug Application (NDA) for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for ESAs. The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding. Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval.

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 trial is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower-risk) transfusion-dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion-dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week RBC-TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week RBC-TI), the duration of RBC-TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, the Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed by Geron in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies, resulting in malignant cell apoptosis. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to Janus kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.

On March 14, 2024 Tubulis reported the successful completion of an upsized and oversubscribed €128 million ($138.8 million) Series B2 financing (Press release, Tubulis, MAR 14, 2024, View Source [SID1234641162]). The round was co-led by EQT Life Sciences and Nextech Invest Ltd, on behalf of one or more funds managed by it, with participation from new US-based funds, Frazier Life Sciences and Deep Track Capital as well as all existing investors, including Andera Partners, BioMedPartners, Fund+, Bayern Kapital (with ScaleUp-Fonds Bayern), Evotec, coparion, Seventure Partners, OCCIDENT and High-Tech Gründerfonds (HTGF). Tubulis is developing a pipeline of uniquely matched antibody drug conjugates (ADCs) with an indication-tailored targeting molecule and payload combination to develop novel ADCs with superior properties.

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The proceeds of the Series B2 will primarily support progress in Tubulis’ pipeline of next-generation ADCs toward clinical evaluation and help achieve clinical proof-of-concept for lead candidates, TUB-040 and TUB-030. TUB-040 addresses tumor-antigen Napi2b, a well-characterized target in ovarian and lung cancer and TUB-030 targets 5T4, an antigen often overexpressed in solid tumors. Preclinical proof-of-concept data for these two candidates will be presented at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April. The company expects to start its first Phase 1/2a clinical trial, including dose escalation and dose optimization cohorts in 2024. The capital will also fund the expansion of Tubulis’ suite of technology platforms to unlock novel payloads for the development of versatile and customizable ADCs. In line with the addition of new US investors, Tubulis plans to increase its corporate footprint by establishing a US subsidiary.

"This substantial financing from a syndicate of global specialist biotech investors recognizes Tubulis’ unique position in the ADC space. Our proprietary platform technologies and internal know-how are the foundation for our pipeline of truly differentiated protein-drug conjugates," said Dominik Schumacher, PhD, CEO and Co-founder of Tubulis. "Our goal is to establish Tubulis as a global ADC leader as we transition into a clinical-stage company and harness the full power of ADCs to bring their therapeutic value to patients with solid tumors."

In conjunction with the financing, Christoph Broja, Managing Director at EQT Life Sciences and Kanishka Pothula, Managing Partner at Nextech Invest will join Tubulis’ Supervisory Board. An overview of all members as well as their biographies can be found here.

Kanishka Pothula, Managing Partner at Nextech Invest commented: "Recent developments in oncology underscore the significant potential of ADCs for the treatment of solid tumors. We are convinced that Tubulis will be at the forefront of this next wave of ADC therapeutics. The team continuously pushes the boundaries of ADC design and has developed an impressive set of platform technologies that give the company the full flexibility to tailor each component of the ADC to a specific indication. The company is on the path towards providing new, high-quality treatment options for many hard-to-treat cancers and we are excited to join their journey by providing strategic support in the next phase of corporate growth."

"Dominik and the Tubulis team have developed highly differentiated ADC candidates that have the potential to significantly change the treatment paradigm in targeted solid tumor indications. We are looking forward to supporting the Tubulis team in realizing their vision of delivering the true value of ADCs by extending patient benefit and improving quality of life, said Christoph Broja, Managing Director at EQT Life Sciences. At EQT, we are focused on guiding the next global leaders in healthcare and Tubulis is well positioned to directly impact the future of oncology treatments," added John de Koning, Partner at EQT Life Sciences.

Tubulis was established with the goal of maximizing the overall performance of ADCs by addressing the main bottlenecks in the field through innovation in all aspects of ADC development. The company has created a unique suite of technologies that combine a diverse range of targeting molecules, innovative payloads, and proprietary conjugation technologies to deliver revolutionary ADCs with superior, indication-tailored properties. The company’s platforms allow it to move beyond traditional payload classes and expand antibody conjugation options through novel chemical groups, resulting in stable, high drug-to-antibody ratios.

¹Nextech Invest Ltd, on behalf of one or more funds managed by it.