On April 4, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported financial results for the year ended December 31, 2022 and highlighted recent business updates (Press release, Carisma Therapeutics, APR 4, 2023, View Source [SID1234629817]).

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"2022 was a transformational year for Carisma as we made meaningful progress across all areas of our business, including entering a development collaboration with Moderna, advancing our lead program CT-0508 in HER2+ solid tumors, and announcing our merger with Sesen Bio," said Steven Kelly, President and Chief Executive Officer of Carisma. "The successful close of the merger and concurrent financing has further strengthened our foundation, enabling us to continue to advance our pipeline of important therapies. We look forward to the multiple potential value inflection points over the next 18 months, including the completion of our Phase 1 study of CT-0508, as well as data from clinical trial sub-study of CT-0508 in combination with pembrolizumab."

Recent Business Highlights

Completed merger transaction with Sesen Bio in March 2023. Carisma Therapeutics and Sesen Bio closed the previously announced merger, pursuant to which the combined company changed its name to "Carisma Therapeutics Inc." and commenced trading on The Nasdaq Global Market under the symbol "CARM." The combined company will focus on the development of Carisma’s chimeric antigen receptor macrophage (CAR-M) therapies, which are believed to be the only therapies of their kind with demonstrated proof of mechanism and safety data in clinical trials. At the closing of the merger, taking into account the reverse stock split of shares of common stock of Sesen Bio prior to the closing, the combined company had approximately 40.3 million outstanding shares of common stock.
Received $105.3 million of proceeds as a result of completing the merger transaction, which includes $74.7 million from Sesen Bio and $30.6 million from a concurrent financing. The $30.6 million financing was from a syndicate of investors, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio.

Expanded Scientific Advisory Board (SAB) with additional expertise in solid tumor immunotherapy development capabilities. The Company appointed leading solid tumor immunotherapy expert Padmanee Sharma, MD, PhD to Carisma’s SAB in January 2023. Dr. Sharma is a nationally regarded cancer immunologist and professor in the departments of Genitourinary Medical Oncology and Immunology, Associate VP of Immunobiology and the T.C. and Jeanette D. Hsu Endowed Chair in Cell Biology at The University of Texas MD Anderson Cancer Center. Additionally, the Company appointed Moderna CSO of External Research Ventures, Lin Guey, PhD to Carisma’s SAB in February 2023. Dr. Guey is a leading expert in mRNA therapeutics and oversees Moderna’s partnership with Carisma to develop in vivo CAR-M therapies.

Presented new data from Phase 1 clinical trial of CT-0508 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2022. Additional findings from the CT-0508 CAR-M clinical trial for patients with advanced metastatic human epidermal growth factor receptor 2 (HER2) overexpressing solid tumors, supported a favorable safety profile and demonstrate that CT-0508 has been successfully manufactured using macrophages obtained from heavily pre-treated, advanced solid tumor patients and has shown high CAR expression, viability, and purity.
Anticipated Upcoming Milestones

Additional data from Group 2 of Carisma’s Phase 1 CT-0508 study expected in the second half of 2023
Initial data from clinical trial sub-study of CT-0508 in combination with KEYTRUDA (pembrolizumab) expected in the second half of 2023
Submission of IND application to the FDA for CT-0525, Carisma’s first anti-HER2 CAR-Mono product candidate, expected in the second half of 2023
Nomination of additional targets(s) under the Moderna development collaboration expected in 2023
Fiscal 2022 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2022 were $52.0 million, compared to $28.6 million as of December 31, 2021, and is not inclusive of proceeds from the merger transaction with Sesen Bio and concurrent financing, which were completed in March of 2023.
Moderna collaboration revenues were $9.8 million for the year ended December 31, 2022. The Company began its collaboration with Moderna in January 2022 and deferred $47.5 million in revenue from the Moderna collaboration agreement, which will be recognized in future periods.
Research & development expenses were $56.6 million for the year ended December 31, 2022, compared to $34.4 million in 2021. The increase was primarily due to costs associated with growth and expansion of Carisma’s clinical and pre-clinical activities to support advancing CT-0508 in clinical development and expand research for the Company’s Moderna in vivo research.
General & administrative expenses were $9.4 million for the year ended December 31, 2022, compared to $6.4 million in 2021, primarily due to costs associated with the expanded patent portfolio and preparing to operate as a public company.
Net loss was $61.2 million for the year ended December 31, 2022, compared to net loss of $40.8 million in 2021, primarily due to increased research and development expenses, which was partially offset by Moderna collaboration revenue.
Outlook

Carisma believes that its cash, cash equivalents and marketable securities of $52.0 million as of December 31, 2022, in combination with the net proceeds of $105.3 million from the completion of the merger with Sesen Bio and concurrent financing, are sufficient to sustain Carisma’s planned operations through the end of 2024.

About CT-0508

CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. We are selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.

On April 4, 2023 PathAI, a global leader in AI-powered pathology, reported the launch of PathExplore, the world’s first structured, standardized and scalable panel of human interpretable features (HIFs) offering unprecedented resolution of the tumor microenvironment (TME) from H&E whole-slide images (Press release, PathAI, APR 4, 2023, View Source [SID1234629816]). Powered by artificial intelligence, PathExplore1 spatially characterizes the TME with single-cell resolution, giving oncology drug developers the ability to unlock insights to inform the next phase of targeted oncology drug development.

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The last decade has seen significant strides in oncology therapeutic development, but challenges remain – many cancer patients do not respond to available treatment, and many aren’t eligible for potentially transformative therapies because of a lack of actionable insight into their disease. Researchers are looking to the tumor microenvironment, one of the most promising areas of oncology research, for answers and insights that will impact patient outcomes.

"PathExplore will enable researchers to identify novel spatial signatures predictive of outcomes," said Andy Beck, M.D., Ph.D., chief executive officer and co-founder of PathAI. "We’re hopeful that by giving oncology drug developers access to this level of detail and data from routine H&E samples, this next generation of pathology will drive advances in cancer therapy development."

Current technologies to measure and analyze the TME force researchers to make tradeoffs between resolution and scalability. Now with PathExplore, drug developers will have the ability to analyze the TME with deep resolution using a scalable platform that can be deployed on massive numbers of patient samples. PathExplore produces a panel of more than 600 quantitative HIFs: standardized and reproducible measures of counts, densities, areas and spatial relationships across cell types and tissue regions. PathExplore also generates overlay visualizations of cell types and tissue regions, delivered on PathAI’s AISight Translational Research platform.

PathExplore has been trained using over 6.5 million pathologist annotations on 66,000 slides. It is currently available for breast cancer, colorectal cancer, gastric cancer, melanoma, non-small cell lung cancer, pancreatic cancer, prostate cancer, and renal cell carcinoma, with more indications planned to launch later this year, including ovarian and bladder cancers. The standardized, structured quantification of the TME across disease areas will enable reproducible, comparable, and scalable analysis across drug programs.

"PathExplore will shift the research paradigm, bypassing long standing constraints we experience with some of the existing multi-omics modalities and allowing for more open exploration and discovery of relationships that were not identifiable by human analysis alone," said Mike Montalto, PhD, chief scientific officer at PathAI. "The degree of granularity, speed, efficiency and scale delivers unmatched insights that will change the way we view the tumor microenvironment."

PathAI’s HIFs have been used in over 15 scientific abstracts, presentations, and publications. To learn more about PathExplore, visit www.PathExplore.com or visit us at booth 315 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) April 14th-19th in Orlando, FL.

On April 4, 2023 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for the first quarter 2023 following the close of market on Tuesday, April 25, 2023 (Press release, Illumina, APR 4, 2023, View Source [SID1234629815]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, Chief Executive Officer, and Joydeep Goswami, Chief Financial Officer and Chief Strategy and Corporate Development Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 25, 2023. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website at investor.illumina.com. Alternatively, individuals can access the call by dialing 877.502.9276 or +1.313.209.4906 outside North America, both with Conference ID 1539055. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On April 4, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that enrollment is complete for MANIFEST-2, the ongoing Phase 3 study exploring the efficacy and safety of pelabresib, an investigational BET inhibitor, in combination with ruxolitinib versus ruxolitinib alone in patients with myelofibrosis who have not previously been treated with a JAK inhibitor (JAK inhibitor-naïve) (Press release, MorphoSys, APR 4, 2023, View Source [SID1234629812]). The topline data are now expected by the end of 2023, earlier than previously anticipated.

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Myelofibrosis – which belongs to a group of diseases called myeloproliferative disorders – is a difficult-to-treat form of blood cancer with limited treatment options. JAK inhibitors are a current standard of care treatment for myelofibrosis, which focus on relieving symptoms of the disease rather than treating its cause. But, with this treatment strategy, only about half of patients attain adequate disease control, and durability of response is often limited. Clinical data suggest synergistic effects between BET inhibition and JAK inhibition in myelofibrosis, supporting the potential of this combination therapy.

"With so many patients left behind by current treatment options for myelofibrosis, there is a critical need for regimens that elevate the standard of care for patients suffering from this debilitating disease," said Tim Demuth, M.D., Ph.D., Chief Research and Development Officer, MorphoSys. "Now that MANIFEST-2 has completed enrollment earlier than anticipated, we look forward to the coming insights into the therapeutic potential of pelabresib in combination with ruxolitinib for JAK inhibitor-naïve patients with myelofibrosis. MANIFEST-2 is the latest milestone in our efforts to improve outcomes for blood cancer patients and is a testament to our continued commitment to the myelofibrosis community."

MANIFEST-2 is a global, multicenter, double-blind, Phase 3 study of more than 400 patients who were naïve to JAK inhibitors. Patients were randomized 1:1 to pelabresib in combination with ruxolitinib or placebo plus ruxolitinib. The primary endpoint of the trial is the proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24 (known as SVR35). Reduction in spleen size is an important clinical endpoint in myelofibrosis because spleen enlargement reflects disease activity and can cause significant pain and discomfort.

The key secondary endpoint is the proportion of patients achieving a 50% or greater improvement in total symptom score, as measured by the Myelofibrosis Symptom Assessment Form v4.0, at week 24. Patients with myelofibrosis experience a severely diminished quality of life due to symptoms such as severe fatigue, fever and weight loss. The Myelofibrosis Symptom Assessment Form is a validated self-assessment tool designed specifically for myelofibrosis patients that can track changes in these symptoms.

The MANIFEST-2 trial is supported by findings from the Phase 2 MANIFEST trial of pelabresib in combination with ruxolitinib in patients with myelofibrosis, including those who were JAK inhibitor-naïve. Updated results from MANIFEST presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting and Exposition suggest that pelabresib in combination with ruxolitinib provided prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks.

Enrollment of the Phase 3 frontMIND study is also complete, with more than 880 patients enrolled in the trial. frontMIND is a global, multicenter, randomized, double-blind, placebo-controlled trial exploring tafasitamab, marketed in the U.S. as Monjuvi and outside the U.S. by Incyte as Minjuvi, plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP alone as a first-line treatment for high-intermediate and high-risk patients with diffuse large B-cell lymphoma. The topline data from this study are expected in the second half of 2025.

About Pelabresib

Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities.

About Myelofibrosis

Myelofibrosis – one of a group of diseases called myeloproliferative disorders – is a difficult-to-treat form of blood cancer that’s characterized by bone marrow fibrosis (a buildup of scar tissue in the bone marrow), spleen enlargement and anemia (low red blood cell counts) often requiring periodic blood transfusions. Patients with myelofibrosis can also suffer from a range of physical symptoms, including severe fatigue, night sweats, itching, increased bleeding and significant pain caused by their enlarged spleen. For many living with myelofibrosis, the combination of symptoms often severely impacts their quality of life. At diagnosis, several factors, such as age, genetics and bloodwork, help determine a patient’s long-term prognosis. About 90% of newly diagnosed patients have intermediate- to high-risk disease, which has a worse prognosis and a higher likelihood of disease-associated symptoms. Today, myelofibrosis treatments revolve around the use of medications called JAK inhibitors, which focus on relieving symptoms of myelofibrosis rather than treating its cause. But with this strategy, only about 50% of patients achieve adequate symptom control, and, unfortunately, that relief fades with time for many. Patients suffering from myelofibrosis are in critical need of treatment options that not only address their symptoms but also change the overall course of their disease.

About MANIFEST-2

MANIFEST-2 (NCT04603495) is a global, double-blind, randomized Phase 3 clinical trial with pelabresib in combination with ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis. The primary endpoint of the study is a 35% or greater reduction in spleen volume (SVR35) from baseline at 24 weeks. The key secondary endpoint of the study is a 50% or greater improvement in total symptom score (TSS50) from baseline at 24 weeks. Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2 trial sponsor.

About MANIFEST 

MANIFEST (NCT02158858) is an open-label Phase 2 clinical trial of pelabresib in patients with myelofibrosis. The MANIFEST trial is evaluating pelabresib in combination with ruxolitinib in JAK-inhibitor-naïve myelofibrosis patients (Arm 3), with a primary endpoint of the proportion of patients with a ≥35% spleen volume reduction from baseline (SVR35) after 24 weeks of treatment. The trial is also evaluating pelabresib either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1) or as add-on therapy in combination with ruxolitinib in patients with a suboptimal response to ruxolitinib or myelofibrosis progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on transfusion-dependent (TD) status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a ≥35% spleen volume reduction from baseline after 24 weeks of treatment. Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST trial sponsor.

About Monjuvi (tafasitamab-cxix)

Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi and Minjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in Europe and Canada.

XmAb is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?
MONJUVI may cause serious side effects, including:

– Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, rash, flushing, headache, or shortness of breath during an infusion of MONJUVI.

– Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or any bruising or bleeding.

– Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4 F (38 C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

– Feeling tired or weak

– Diarrhea

– Cough

– Fever

– Swelling of lower legs or hands

– Respiratory tract infection

– Decreased appetite

These are not all the possible side effects of MONJUVI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

– Have an active infection or have had one recently.

– Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

– You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

– Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

– Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to MORPHOSYS US INC. at (844) 667-1992.

Please see the full Prescribing Information for MONJUVI, including Patient Information, for additional Important Safety Information.

About Diffuse Large B-cell Lymphoma (DLBCL)

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter, leading to a high medical need for new, effective therapies, especially for patients who are not eligible for an autologous stem cell transplant in this setting.

About frontMIND

The frontMIND (NCT04824092) trial is a randomized, double-blind, placebo-controlled, global Phase 3 clinical study in previously untreated high-intermediate and high-risk DLBCL patients that is conducted in partnership with the German Lymphoma Association (GLA), the Italian Lymphoma study group and the US Oncology Network. The study enrolled more than 880 DLBCL patients to receive either tafasitamab plus lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-CHOP alone. The primary endpoint is investigator-assessed progression-free survival, according to Lugano 2014 criteria, and key secondary endpoints include event-free survival by investigator, overall survival, metabolic complete response rate by a Blinded Independent Review Committee, and overall response rate.

On April 4, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the compensation committee of BioCryst’s board of directors granted six newly-hired employees stock options to purchase an aggregate of 124,300 shares, and restricted stock units (RSUs) covering an aggregate of 40,350 shares, of BioCryst common stock (Press release, BioCryst Pharmaceuticals, APR 4, 2023, https://ir.biocryst.com/news-releases/news-release-details/biocryst-reports-inducement-grants-under-nasdaq-listing-rule-38 [SID1234629811]). The options and RSUs were granted as of March 31, 2023, as inducements material to each employee entering into employment with BioCryst. The options and RSUs were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

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The options have an exercise price of $8.34 per share, which is equal to the closing price of BioCryst common stock on the grant date. The options and RSUs vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee’s continued service with the company. Each stock option has a 10-year term. The options and RSUs are subject to the terms and conditions of BioCryst’s Inducement Equity Incentive Plan and a stock option agreement or restricted stock unit agreement, as applicable, covering the grant.