On March 24, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported that research led by Roswell Park Comprehensive Cancer Center medical oncologist Shipra Gandhi, MD, has been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held April 8-13, 2022, in New Orleans, Louisiana (Press release, AIM ImmunoTech, MAR 24, 2022, View Source [SID1234610864]).

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Details of the poster presentation are as follows:

Title: Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Presenting Author: Shipra Gandhi, MD
Poster Number: 3127
Session: PO.TB06.05 – Secreted Soluble Factors and Exosomes in the Microenvironment
Presentation Type: E-Poster presentation
Session Date and Time: Tuesday, April 12, 2022, from 1:30 to 5:00 p.m. CDT

"Paclitaxel is known to have both immunostimulatory and immunosuppressive effects, but its impact on the chemokine system within the tumor microenvironment remains unclear," commented Dr. Gandhi, who is undertaking these studies in collaboration with senior author Pawel Kalinski, MD, PhD, Chair of Immunology at Roswell Park. "High levels of the cytotoxic T cell attractants CXCL9, CXCL10 and their common receptor CXCR3 in the breast tumor microenvironment predict higher probability of pathological complete response and improved long-term outcomes in patients treated with neoadjuvant taxanes, but are seen only in a limited portion of patients. Our current data highlight the potential for the chemokine modulatory regimen to enhance the effectiveness of taxane-based chemotherapy of breast cancer and potentially other diseases."

The accepted abstract detailed data gathered from evaluating paclitaxel’s impact on chemokine production in the human breast tumor microenvironment (TME) and the ability of a chemokine modulatory regimen (CKM) of Ampligen and Interferon-α to mitigate potentially undesirable aspects of taxane chemotherapy.

For the study, fresh breast cancer tissues obtained during routine surgeries, breast cancer cell lines BT-549 and MDA-MD-231 and peripheral blood monocyte-derived macrophages were analyzed immediately or cultured ex vivo for 24 hours in the absence or presence of paclitaxel and/or CKM components. The expression of chemokine genes and secretion of chemokines by freshly harvested and ex vivo-treated tumor explants, cancer cell lines and macrophages were analyzed by quantitative PCR (Taqman) and ELISA. Paired Student t-test was used for statistical analyses.

Breast cancer explants spontaneously expressed high levels of MDSC/Treg-attractants CXCL12 and CCL22, but only marginal levels of cytotoxic T cell (CTL) and natural killer (NK) cell attractants CXCL9, CXCL10, CXCL11 and CCL5. Unexpectedly, paclitaxel treatment resulted in further elevation of granulocyte/MDSC-attractant CXCL8 and CCL22, which was reversed by the combination of paclitaxel with the CKM including Ampligen. At the same time, while paclitaxel alone did not induce any of the CTL attractants tested, its combination with a CKM regimen of Ampligen and Interferon-α was highly effective in inducing CXCL9, CXCL10, CXCL11 and CCL5.

"Building off of a previously developed chemokine modulatory regimen combining interferon-α with TLR3 agonist Ampligen, Roswell Park set out to further evaluate paclitaxel’s impact on chemokine production. Based on the results, we believe that the combination chemokine modulatory regimen including Ampligen has the potential to mitigate undesirable aspects of taxane chemotherapy. We look forward to further evaluation," added Thomas Equels, Chief Executive Officer of AIM.

The results of the study identify an undesirable aspect of paclitaxel’s impact on breast cancer. The ability of CKM to enhance the expression of CTL/NK cell attractants and suppress the production of Treg/MDSC attractants produced by paclitaxel provides a strong rationale for further study of the combined use of CKM in taxane-based chemo-immunotherapy of breast cancer and potentially other diseases.

On March 24, 2022 MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), reported an update after a recent meeting with the U.S. Food Drug Administration (FDA) to discuss the pursuit of a marketing authorization for zandelisib, a phosphatidylinositol-3-kinase ("PI3K") inhibitor drug candidate, via the accelerated approval pathway under 21 CFR Part 314.500, Subpart H, based on data generated by the single arm Phase 2 TIDAL study (Press release, Kyowa Hakko Kirin, MAR 24, 2022, View Source [SID1234610893]). In the meeting, the FDA informed the companies of its position that a randomized trial is now needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib. Based on this view, the agency discouraged a filing based on the Phase 2 TIDAL study data and emphasized that the companies continue efforts with the ongoing, randomized Phase 3 COASTAL study as planned. Accordingly, in line with the FDA’s recommendation, the companies do not plan to submit an FDA marketing application based on the single arm Phase 2 TIDAL study. In addition, while the FDA stated that safety on the 60 mg intermittent schedule appears reasonable, it recommended continued dose exploration to further support the current dose and regimen.

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"The FDA’s current position on the assessment of benefit and risk of PI3K inhibitors solely based on single arm studies appears to have evolved, as evidenced by the position the FDA communicated at the recent meeting on zandelisib, and the upcoming ODAC meeting scheduled for April 21, 2022 to discuss whether randomized data should be required for the class of PI3K inhibitors to demonstrate appropriate evidence of efficacy and safety," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Clearly, the outcome of our recent FDA meeting is a disappointing development. Nonetheless we will continue to focus on the ongoing Phase 3 COASTAL study as we consider options that provide the most expeditious approval pathway utilizing randomized data, and which we believe will demonstrate the potential of zandelisib to help patients. Today’s announcement in no way diminishes our conviction to the development of zandelisib and the promise of its emerging clinical profile. Based on current projections, MEI believes we have sufficient cash for operations to complete the COASTAL study enrollment in 2024."

Dr. Gold continued: "In partnership with Kyowa Kirin, we remain committed to the ultimate potential of zandelisib to address important medical needs as a single agent or in combination with other therapies providing physicians, and their patients, important new treatment options. We plan on completing evaluation of the Phase 2 TIDAL study, and look forward to sharing final data later this year to further advance an understanding of zandelisib’s clinical utility."

"Our dialogue with the FDA has updated our understanding of the evolving regulatory view of the PI3K inhibitor drug class. With this knowledge, we can focus our efforts to advance the COASTAL program," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D of Kyowa Kirin. "Our teams around the world have made steady progress to enroll patients and give us important momentum. Together with MEI Pharma, we will continue to work with the investigators, patients, and advocacy organizations to drive continued progress."

About 21 CFR Part 314.500, Subpart H
Under 21 CFR Part 314.500, Subpart H, a drug candidate may be eligible for accelerated approval if it is intended to treat a serious or life-threatening disease or condition, and the product would provide meaningful therapeutic benefit over existing treatments. Under accelerated approval, a product may be approved based on adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefits. As a condition of approval, the FDA may require that a sponsor receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies to verify the predicted clinical benefit.

The FDA historically granted accelerated approval to PI3K inhibitors under 21 CFR Part 314.500, Subpart H for relapsed or refractory follicular and marginal zone lymphomas. Such approvals were granted with the expectation that confirmatory Phase 3 studies producing randomized data would follow the approval. Generally the FDA has expressed a preference for randomized trials however, the recent meeting with the FDA was the first instance that the agency informed the companies that data from a single arm study, such as the Phase 2 TIDAL clinical study, would not be adequate to evaluate benefit and risk under 21 CFR Part 314.500, Subpart H and that a randomized study is required to support a potential accelerated approval.

About Zandelisib
Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. Clinical trials are investigating the efficacy and safety of zandelisib as a single agent and in combination with other modalities while administered on an Intermittent Dosing Regimen (IDT). The IDT leverages molecular and biologic properties specific to zandelisib.

In November 2021, MEI Pharma announced data from ongoing Phase 2 TIDAL study (NCT03768505) evaluating zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies. Zandelisib demonstrated a 70.3% objective response rate (ORR) as determined by Independent Review Committee (IRC) assessment in the primary efficacy population (n=91). In addition, 35.2% of patients achieved a complete response. At the time of the data cutoff, the data were insufficiently mature to accurately estimate duration of response (DOR). In line with previously reported data from the Phase 1B study, zandelisib was generally well tolerated. With 9.4 months (range: 0.8-24) median duration of follow-up in the total study population (n=121), interim data demonstrated a discontinuation rate due to any drug related adverse event of 9.9%. Patients enrolled in the study will continue to be followed for safety and DOR.

Ongoing zandelisib studies include the cohort in TIDAL evaluating patients with R/R marginal zone lymphoma (MZL) and continuing follow up in the cohort of the study evaluating patients with R/R FL. Also ongoing is the Phase 3 COASTAL study (NCT04745832) comparing zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with R/R FL or MZL who received more than one prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is intended to support marketing applications in the U.S. and globally.

Other ongoing studies include a Phase 2 pivotal study in Japan (NCT04533581) in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) conducted by Kyowa Kirin.

In March 2020, the FDA granted zandelisib Fast Track designation for the treatment of adult patients with R/R follicular lymphoma who have received at least two prior systemic therapies. In November 2021, the FDA granted zandelisib Orphan Drug designation for the treatment of patients with follicular lymphoma.

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

Conference Call and Webcast
MEI Pharma will host a conference call and webcast on March 24, 2022 at 4:30pm Eastern Time. To access the live call, please dial 1-833-974-2378 (United States) or 1-412-317-5771 (International). Please ask to join the MEI Pharma call. The event is also available via a live audio webcast at this link, and on the Investors section of MEI’s website at View Source A replay of the webcast will be archived on MEI’s website for at least 30 days following the event.

On March 24, 2022 KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that Travis C. Mickle, Ph.D., President and CEO of KemPharm, will deliver a virtual presentation at Maxim’s 2022 Virtual Growth Conference being held March 28-30, 2022 (Press release, KemPharm, MAR 24, 2022, View Source [SID1234610924]).

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Registered investors will be able to view the pre-recorded presentation by Dr. Mickle highlighting KemPharm’s business and recent corporate achievements, as well as anticipated milestones. Members of the company’s management team will be available for one-on-one virtual meetings.

On March 24, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the fourth quarter and full year 2021 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAR 24, 2022, View Source [SID1234610865]).

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"Bellicum made great progress in the past year in the clinical development of our GoCAR-T cell therapies and in broadening the impact of our technology via licensing," said Rick Fair, President and Chief Executive Officer. "In 2021, we opened the BPX-601 trial in prostate cancer and reported a confirmed response in the first cohort treated, initiated the BPX-603 trial in HER2+ solid tumors, signed licensing agreements for our CaspaCIDe safety switch for use in six new CAR-T and CAR-NK programs, and raised additional capital expected to fund the company beyond our next data milestones for our GoCAR-T programs. The Omicron COVID-19 variant had a significant impact on our clinical trial sites and trial enrollment over the last two quarters, but we have recently seen an uptick in site activation and screening activity as cases decline. We believe we are well positioned to further demonstrate the value of GoCAR-T in the coming year."

Program Highlights and Current Updates

BPX-601 GoCAR-T

Enrollment in the Phase 1/2 dose escalation clinical trial in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) is ongoing. On December 6, 2021, Bellicum provided an interim data update and reported that one of the first three mCRPC patients treated in the study achieved a confirmed partial response by RECIST v1.1 criteria. Additionally, no dose-limiting toxicities were observed. The company expects to present a data update on BPX-601 in the first quarter of 2023.
BPX-603 GoCAR-T

Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate that incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. On December 6, 2021, the company reported initial Phase 1 data from this trial demonstrating a favorable safety profile in the first dose cohort of the study. The company expects to present a data update on BPX-603 in the first half of 2023.
Private Placement Completed

As previously reported, Bellicum entered into an agreement for a $35 million private placement of equity securities in December 2021 with two biotechnology specialist investment funds. Proceeds from the financing are expected to extend cash runway into the second quarter of 2023 and will be used to support ongoing clinical development of BPX-601 and BPX-603.
Regained Compliance with Nasdaq

On December 10, 2021, Nasdaq notified Bellicum that it had regained compliance with Listing Rule 5550(b)(1), which requires stockholders’ equity of at least $2.5 million for continued listing of the company’s common stock. Accordingly, the Company is now in compliance with the continued listing requirements of The Nasdaq Capital Market.
Charity Scripture Named Chief Development Officer

Dr. Scripture rejoined Bellicum in a full-time capacity effective December 1, 2021 after spending the previous year as VP, Business and Development Operations at ACELYRIN, a private biopharmaceutical company. Previously, Dr. Scripture was Vice President, Clinical & Medical Affairs at Bellicum. Prior to joining Bellicum, Dr. Scripture held clinical development leadership positions at AbbVie/Stemcentrx and Pharmacyclics, and spent almost a decade with Amgen in oncology clinical development and medical affairs.
Financial Results for the Fourth Quarter and Year Ended December 31, 2021

Revenues: Bellicum reported revenue of $0.5 million and $6.2 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $0.5 million during each of the comparable periods in 2020. The increase in revenues was due to agreements executed with external parties during the year. In the first quarter of 2021, Bellicum entered into a multi-year supply agreement with Takeda Development Center Americas, Inc. for the supply of rimiducid for potential use in clinical trials of TAK-007. Initial clinical trial supply was fulfilled in the second quarter of 2021 generating revenue of $0.7 million. Revenues from up-front and annual maintenance payments related to CaspaCIDe licensing agreements were $0.5 million and $5.5 million for the fourth quarter and full year 2021, compared to $0.5 million in 2020.

R&D Expenses: Research and development expenses were $4.0 million and $23.6 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $8.7 million and $39.1 million for the fourth quarter and year ended December 31, 2020, respectively. The decrease in R&D expenses for the fourth quarter and year ended December 31, 2021, compared to the prior year, was primarily due to reduced expenses related to rivo-cel related activities, the sale of the manufacturing facility, and the reduction in force that was implemented in the fourth quarter of 2020, partially offset by an increase in expenses related to Bellicum’s GoCAR-T programs. This resulted in $12.3 million reduction in employee-related expenses and a $3.2 million reduction in other R&D expenses.

G&A Expenses: General and administrative expenses were $1.6 million and $7.0 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $3.4 million and $15.5 million for the comparable periods in 2020. The decrease in G&A expenses for the fourth quarter and year ended December 31, 2021, compared to the year ended December 31, 2020, was primarily due to the reduction in force that reduced employee-related expenses by $6.8 million as well as the reduction in rivo-cel related commercialization activities that reduced expenses by $1.7 million.

Loss from Operations: Bellicum reported a loss from operations of $5.1 million and $24.9 million for the fourth quarter and year ended December 31, 2021, respectively, compared to $13.0 and $51.7 million for the comparable periods in 2020. The results for the year ended December 31, 2021 include loss on dispositions of $0.5 million whereas for the year ended December 31, 2020, a gain on dispositions of $3.7 million was recognized.

Net Income/Loss: Bellicum reported net income of $2.5 million and a net loss of $9.7 million for the fourth quarter and year ended December 31, 2021, respectively, compared to net income of $18.8 million and a net loss $7.7 million for the fourth quarter and year ended December 31, 2020, respectively. The results included gain from change in fair value of warrant derivative liabilities of $7.6 million and $15.1 million for the fourth quarter and year ended December 31, 2021, respectively.

Shares Outstanding: As of March 21, 2022, Bellicum had 8,552,207 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock is convertible into 10 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $47.7 million as of December 31, 2021, compared to $37.0 million as of December 31, 2020. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2023.

On March 24, 2022 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Werewolf Therapeutics, MAR 24, 2022, View Source [SID1234610895]).

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"This has been an exciting year for Werewolf as we executed our public offering and advanced our novel INDUKINE molecule pipeline. We expect to file the IND for our first candidate, WTX-124, in the second quarter of 2022, and the IND for our second candidate, WTX-330, early in the third quarter of 2022. The anticipated initiation of these clinical studies remains consistent with our previous expectations," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We are pleased with the progress that we made in our first year as a public company and expect that 2022 will be a pivotal year for the Company as we anticipate entering the clinic and continue to progress our pipeline."

2021 Highlights
Completed upsized Initial Public Offering: In May 2021, Werewolf completed its Initial Public Offering (IPO) of 7,500,000 shares of common stock at a public offering price of $16.00 per share. Gross proceeds from the IPO were $120 million and net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $109.2 million.
Entered clinical trial collaboration with Merck for Werewolf’s WTX-124 INDUKINE program: In August 2021, Werewolf announced that it entered into a clinical trial collaboration agreement with Merck, known as MSD outside the United States and Canada, to evaluate WTX-124, a systemically-delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, as a treatment for patients with solid tumors. The planned clinical trial will be conducted by Werewolf and is designed to evaluate the safety and preliminary efficacy of WTX-124 as a monotherapy and in combination with KEYTRUDA in patients with solid tumors.
Presented preclinical data on WTX-124, WTX-330, and WTX-613 at SITC (Free SITC Whitepaper) Annual Meeting: In November 2021, Werewolf presented preclinical data during the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) demonstrating the potential of INDUKINE molecules to drive targeted anti-tumor immune responses. Posters were presented for Werewolf’s three lead molecules : "WTX-124 is a novel IL-2 pro-drug that is conditionally activated in tumors and drives anti-tumor immunity in murine syngeneic cancer models;" "WTX-330, a conditionally activated IL-12 INDUKINE therapy, releases IL-12 selectively in the tumor microenvironment to activate anti-tumor immune responses and induce regressions in mouse tumor models" and; "WTX-613, a conditionally activated IFNα INDUKINE

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molecule, induces anti-tumor immune responses resulting in strong tumor growth control in syngeneic mouse tumor models."
The results from the presented studies for WTX-124 and WTX-330 will be included in the investigational new drug (IND) applications.
Presented INDUKINE Data at ASH (Free ASH Whitepaper) Annual Meeting: In December 2021, Werewolf presented preclinical data during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating interleukin-12 (IL-12) and interferon-α (IFNα) INDUKINE molecules inhibited syngeneic lymphoma tumor growth in mice, induced anti-tumor immune responses and were tolerated in non-human primates.
The preclinical data for the IL-12 and IFNα INDUKINE molecules demonstrated anti-tumor activity in the A20 B cell lymphoma model and the EG7.OVA T lymphoblast model. Both treatments were well tolerated by the mice at active dose levels. The IL-12 and IFNα INDUKINE molecules also strongly activated key immune cell populations in treated tumors, confirming the immune mechanism of anti-tumor activity.
Strengthened Board of Directors with the Addition of Two Industry Leaders: In May 2021, Werewolf appointed Mike Sherman to the Company’s Board of Directors. Mr. Sherman brings over 30 years of experience in advancing therapeutics to commercial launch and driving successful operations and strategic transactions.
Additionally, in October 2021, the Company appointed Meeta Chatterjee, Ph.D., to its Board of Directors. With over 30 years of broad strategic and operational experience, Dr. Chatterjee brings deep and proven expertise across biopharmaceutical R&D, operations, corporate strategy, and business development.
Enhanced Management and Operations Teams: In June 2021, the Company appointed Chulani Karunatilake, Ph.D., as Chief Technology Officer. Dr. Karunatilake brings more than 30 years of experience in Chemistry and Manufacturing Controls (CMC) process and strategy development and will oversee manufacturing operations in the newly formed role.
Since joining Werewolf, Dr. Karunatilake has built a CMC team with expertise to complement the world-class clinical organization led by Dr. Randi Isaacs, Werewolf’s CMO.
Added to the Nasdaq Biotechnology Index: In December 2021, Werewolf announced that it had been added to the Nasdaq Biotechnology Index. The Nasdaq Biotechnology Index (NBI) is designed to measure the performance of a set of securities listed on The Nasdaq Stock Market that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The Nasdaq Biotechnology Index is calculated under a modified market capitalization-weighted methodology. Companies in the Nasdaq Biotechnology Index must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. Nasdaq selects constituents once annually in December.
Financial Results for the Fourth Quarter and Full Year 2021
•Cash position: As of December 31, 2021, cash and cash equivalents were $157.5 million, compared to $92.6 million as of December 31, 2020. The increase was primarily due to the receipt of $109.2 million in net proceeds from the initial public offering completed in May 2021, offset by operating expenses incurred during the period. Werewolf expects its existing cash and cash equivalents to enable the funding of its operating expenses and capital expenditure requirements through at least the second quarter of 2023.
•Research and development expenses: Research and development expenses were $13.4 million for the fourth quarter of 2021, compared to $5.3 million for the same period in 2020. Research

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and development expenses were $35.3 million for the full year 2021, compared to $16.6 million for the full year 2020. The increase in research and development expenses was primarily due to increased manufacturing, contract research organization, and personnel expenses incurred to advance the Company’s product candidates WTX-124, WTX-330 and WTX-613 and expand research and development activities.
•General and administrative expenses: General and administrative expenses were $4.5 million for the fourth quarter of 2021, compared to $2.1 million for the same period in 2020. General and administrative expenses were $14.8 million, compared to $5.8 million for the full year 2020. The increase in general and administrative expenses was primarily due to increased personnel, professional services, and other operating costs attributable to operating as a public company and the progression towards clinical development.
•Net loss: Net loss was $17.9 million for the fourth quarter of 2021, compared to $7.4 million for the same period in 2020. Net loss was $50.0 million for the full year 2021, compared to $15.0 million for the full year 2020.