On March 29, 2022 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a late clinical stage biopharmaceutical company focused on helping patients fight cancer with oncolytic viral immunotherapies, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Candel Therapeutics, MAR 29, 2022, View Source [SID1234611131]).

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"2021 was a year of significant progress for Candel, filled with important accomplishments in development of our late-stage pipeline of novel oncolytic viral immunotherapies for cancer treatment. We strengthened our organization for future growth with our successful initial public offering, by meeting key clinical trial accrual milestones and by enhancing our talent pool," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Today, we are well positioned for major catalysts over the next 12 months, namely, multiple data readouts across our product candidates and advancement of our pipeline of promising therapeutics with potential to treat various solid tumors, including lung, brain, pancreatic and prostate cancer. We look forward to delivering on our mission to develop oncolytic viral immunotherapies aimed at tipping the balance in favor of the patient’s immune system to fight cancer."

Fourth Quarter 2021 & Recent Highlights

Presented Candel’s novel oncolytic viral immunotherapies at several preeminent industry conferences:
October 2021: Cambridge Healthtech Institute’s 9th Annual Immuno-Oncology Summit
October 2021: Hanson Wade 6th Annual Oncolytic Virotherapy Summit
October 2021: 28th Annual Prostate Cancer Foundation Scientific Retreat
November 2021: 13th International Oncolytic Virus Conference Meeting
November 2021: Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting
Patrick Y. Wen, MD, principal investigator, presented initial safety data on CAN-2409 in combination with nivolumab from Candel’s Phase 1 clinical trial in high-grade glioma at the 26th Annual Meeting of the Society for Neuro-Oncology in November 2021.
Established a collaboration with Partnership for Accelerating Cancer Therapies and the Cancer Immune Monitoring and Analysis Centers – Cancer Immunologic Data Commons to profile the biomarker response to a combination of CAN-2409 and valacyclovir, in combination with anti-PD-1 and PD-L1 immune checkpoint inhibitors in patients with non-small cell lung cancer (NSCLC) in December 2021.
Enhanced executive leadership with the promotion of Francesca Barone, MD, PhD to Chief Scientific Officer and appointment of Seshu Tyagarajan, PhD, RAC as Chief Technical and Development Officer in 2022.
Strengthened cash position with non-dilutive debt financing with Silicon Valley Bank (SVB) in February 2022.
Appointed Mace Rothenberg, MD, prior Chief Medical Officer of Pfizer, as Senior Advisor to the CEO.
Key Upcoming Milestones

The Company expects to present initial data from an ongoing Phase 2 clinical trial of CAN-2409 and valacyclovir combined with PD-1 or PD-L1 targeting agents in patients with NSCLC in June 2022.
In the fourth quarter of 2022, the Company expects to present data from two high grade glioma clinical trials – a Phase 1b clinical trial of CAN-2409 in combination with nivolumab (Opdivo) combined with standard of care first line treatment and a Phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma.
Financial Results for the Year and Fourth Quarter Ended December 31, 2021

Cash Position: Cash and cash equivalents as of December 31, 2021 were $82.6 million, compared to $35.1 million as of December 31, 2020. The increase was due to receipt of $71.3 million of net proceeds from the Company’s successful initial public offering (IPO) of common stock in August 2021. In addition, the Company utilized $22.2 million in the year ended December 31, 2021 to fund operating activities. Subsequent to December 31, 2021, the Company entered into a term loan agreement with SVB and borrowed $20.0 million. Based on current plans and assumptions, the Company expects that its existing cash and cash equivalents, including the $20 million in term loan proceeds, will be sufficient to fund its operations into the fourth quarter of 2023.

Research & Development Expenses: Research and development expenses were $3.9 million and $15.2 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to $3.5 million and $8.8 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount to support the ongoing clinical trials for Candel’s product candidates as well as increased clinical development costs related to our clinical trial sites and the cost of treatment and follow-up on patients. Excluding stock-based compensation expense of ($810,000) and $1.2 million for the three- and twelve-month periods ended December 31, 2021, respectively, research and development expenses for the three- and twelve-month periods ended December 31, 2021, were $4.7 million and $14.0 million, respectively.

General and Administrative Expenses: General and administrative expenses were $3.9 million and $10.7 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to $2.6 million and $5.2 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021 and costs associated with operating as a public company. Excluding stock-based compensation expense of $364,000 and $1.7 million for the three- and twelve-month periods ended December 31, 2021, respectively, general and administrative expenses for the three- and twelve-month periods ended December 31, 2021, were $3.5 million and $9.0 million, respectively.

Total Operating Expenses: Total operating expenses were $7.8 million and $25.9 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to $6.2 million and $13.9 million for the comparable periods of 2020. The increases were primarily due to increased personnel-related costs, including stock-based compensation, for additional headcount required to support the growth of the Company and the transition to a public company, an increase in professional fees associated with Candel’s preparation for the IPO completed in August 2021, an increase in costs associated with operating as a public company and increased clinical development costs. Excluding stock-based compensation expense of ($446,000) and $2.9 million for the three- and twelve-month periods ended December 31, 2021, respectively, total operating expenses for the three- and twelve-month periods ended December 31, 2021, were $8.2 million and $23.0 million, respectively.

Net Loss: Net (income) loss was ($1.6 million) and $36.1 million for the three- and twelve-month periods ended December 31, 2021, respectively, as compared to a net loss of $10.5 million and $17.7 million for the comparable periods of 2020. The net (income) loss for the three- and twelve-month periods ended December 31, 2021, includes a noncash credit and charge of ($9.2 million) and $11.4 million, respectively, for the change in the fair value of the Company’s warrant liability and stock-based compensation expense of ($446,000) and $3.0 million, respectively. Excluding the noncash charges for the change in the warrant liability and the stock-based compensation, the net loss for the three- and twelve-month periods ended December 31, 2021, was $8.0 million and $21.7 million, respectively.

On March 29, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that management will participate in three upcoming investor conferences (Press release, Autolus, MAR 29, 2022, View Source [SID1234611130]). An audio webcast of any presentations will be available live. You can access the webcasts via the Events section of the Autolus website. An archived version will also be available through the Company’s website for a limited time following the conference.

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On March 29, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported the appointment of Reshma Rangwala, MD, PhD, as the Company’s Chief Medical Officer (Press release, Karyopharm, MAR 29, 2022, View Source,-MBA-and-Michael-Kauffman,-MD,-PhD-and-appointment-of-Reshma-Rangwala,-MD,-PhD-as-Chief-Medical-Officer [SID1234611124]). Dr. Rangwala will join the Company in mid-April 2022 and will be responsible for leading the Company’s clinical development programs and strategy.

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"We are delighted to have Dr. Rangwala join our team at this transformative point in our Company’s evolution," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Her extensive experience developing and executing clinical strategies for novel oncology therapeutics, as well as engaging regulators and the medical community at all stages of development, will be of immeasurable value as we accelerate our four core programs in clinical development."

"I am thrilled to join the Karyopharm team at this exciting and pivotal time in the company’s growth," said Dr. Rangwala. "Given their unique mechanism of action, both XPOVIO (selinexor) and eltanexor have significant potential for patients battling an array of cancer types and I look forward to leading the future clinical development and advancing both assets through the clinic. I am impressed with both the team and the science of XPO1 inhibition and I am excited to realize the potential of these important therapies."

Dr. Rangwala brings to Karyopharm more than a decade of experience in oncology and drug development. She was most recently the Chief Medical Officer at Aravive where she led the clinical development of batiraxcept across multiple tumor types. Prior to Aravive, she served as Vice President, Medical, at Genmab where she led the clinical development program for a first-in-class antibody drug conjugate and managed clinical strategy, protocol development, data monitoring, data analysis, study report authoring, and biologic licensing application preparations. Prior to Genmab, she served as Executive Clinical Director at Merck & Co., where she was involved in the clinical development of KEYTRUDA in non-small cell lung cancer and gynecologic malignancies. She received her B.S. in Biology from Duke University and her M.D./Ph.D. from the University of Cincinnati College of Medicine. Dr. Rangwala completed her internal medicine residency at Barnes Jewish Hospital in St. Louis, MO and her medical oncology fellowship at the Hospital of the University of Pennsylvania.

Further Transition of Co-Founders

Karyopharm also announced today that co-founders Sharon Shacham, PhD, MBA, and Michael Kauffman, MD, PhD will step down from their respective roles as Chief Scientific Officer and Senior Clinical Advisor as of May 31, 2022. Dr. Kauffman has stepped down from his role as a member of the Board of Directors. Dr. Shacham will continue to serve on Karyopharm’s Scientific Advisory Board and will serve in an advisory capacity.

"Through their unwavering dedication and passion, Drs. Shacham and Kauffman built Karyopharm from the ground up, bringing hope to countless cancer patients and their families. It has been an honor to work alongside them, and I’m truly grateful for their partnership over the last year. This executive transition has allowed us to glean as much knowledge and insight from our founders as possible, while also bolstering our leadership team in clinical and program management. We believe that we are well positioned for future success, with a promising and focused pipeline of assets as well as a strong commercial strategy," concluded Mr. Paulson.

"I want to thank all of my colleagues at Karyopharm for their partnership over the years as we built the XPOVIO and eltanexor franchises and advanced our development programs targeting both hematologic and solid tumor malignancies," said Dr. Shacham. "I’m confident the team will continue to achieve its objectives and deliver value to investors, healthcare providers and most importantly, to patients."

"It has been a pleasure working alongside the management team at Karyopharm as we grew the hypothesis about nuclear export and its role in cancer from an idea into a robust commercial enterprise with several programs in development that have significant potential for patients," said Dr. Kauffman. "As the Company enters this next stage of its evolution and growth, I believe Karyopharm is well-positioned to deliver on its mission to bring differentiated medicines to patients battling cancer."

On March 29, 2022 IGM Biosciences, Inc. (NASDAQ: IGMS) reported that it intends to offer and sell $200.0 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, non-voting common stock, in an underwritten public offering (Press release, IGM Biosciences, MAR 29, 2022, View Source [SID1234611123]). In addition, IGM intends to grant the underwriters a 30-day option to purchase up to an additional $30.0 million of shares at the public offering price, less underwriting discounts and commissions. All of the securities offered in the offering will be sold by IGM. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan, BofA Securities, Stifel, and Guggenheim Securities are acting as joint book-running managers for the offering.

The securities in the offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on August 9, 2021 and declared effective on August 19, 2021. IGM will file a preliminary prospectus supplement and accompanying prospectus relating to the proposed offering with the SEC, copies of which can be accessed for free through the SEC’s website at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. When available, copies of the preliminary prospectus supplement, the final prospectus supplement and the accompanying prospectuses relating to this offering may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255, or via email: [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On March 29, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the fourth quarter and full year ended on December 31, 2021 (Press release, Scynexis, MAR 29, 2022, View Source [SID1234611122]).

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"SCYNEXIS had an incredible year of accelerated growth and landmark accomplishments with the approval and launch of our first commercial product, BREXAFEMME (ibrexafungerp tablets), as well as significant scientific advancement toward our goal to build a broad antifungal franchise for ibrexafungerp across multiple indications," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "The coming year promises to be even more exciting as we continue our momentum by enlarging the prescriber base, expanding payer coverage, and growing BREXAFEMME revenues. Additionally, we plan to file a supplemental New Drug Application (sNDA) in recurrent vulvovaginal candidiasis (rVVC), and we anticipate receiving approval for this label expansion by the end of 2022."

BREXAFEMME Commercial Update

BREXAFEMME delivered $0.6 million in net sales in fourth quarter 2021 and $1.1 million in total net sales in 2021. According to IQVIA data, there were approximately 3,700 total prescriptions for BREXAFEMME written in Q4 2021, and more than 4,600 total prescriptions written in 2021.

BREXAFEMME was prescribed by over 1,600 healthcare providers (HCPs) in the fourth quarter, and 40% of these doctors expanded their use and prescribed the treatment to multiple patients during this period.

Commercial insurance coverage of BREXAFEMME continues to expand. As of the end of 2021, BREXAFEMME was covered by plans representing more than 81 million or 48% of commercially-insured lives.

Ibrexafungerp Clinical Updates

Reported positive results from the pivotal Phase 3 CANDLE study of oral ibrexafungerp for prevention of rVVC. In this international trial of 260 patients with rVVC, defined as three or more episodes of vulvovaginal candidiasis (VVC) in the previous 12 months, patients initially received a three day regimen of fluconazole to treat their current infection, and responders were randomized in the prevention phase to receive either 300 mg ibrexafungerp BID or matching placebo one day a month, for six months. The study showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed or suspected, through Week 24 compared to 53.1% of placebo-treated patients (p=0.02). The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant (p=0.034). Ibrexafungerp was generally safe and well-tolerated. There were no serious drug-related adverse events, and no patients treated with ibrexafungerp discontinued therapy due to adverse events. The most commonly reported events were headaches and gastrointestinal events, which were mostly mild and generally consistent with the current BREXAFEMME label. SCYNEXIS plans to submit the results in a supplemental NDA to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022 and anticipates receiving approval by year-end.

Reached agreement with FDA on the regulatory path forward in invasive candidiasis (IC) infections in the hospital setting. The MARIO study, a global Phase 3 multi-center, prospective, randomized, double-blind study of two treatment regimens, will evaluate oral ibrexafungerp as an oral step-down treatment in patients suffering from IC compared to oral fluconazole. Eligible hospital patients with IC will receive treatment with IV echinocandin and will then be switched to either oral ibrexafungerp or oral fluconazole once step-down criteria are met. Approximately 220 patients will be enrolled and randomized in the study. The primary objective of the study is to determine whether treatment of IC with IV echinocandins followed by oral ibrexafungerp is as effective as treatment with IV echinocandins followed by oral fluconazole, the current standard of care. The primary end point of the study will be all-cause mortality at 30 days after initiation of antifungal therapy.

Received Orphan Medicinal Product Designation for ibrexafungerp by the European Medicines Agency (EMA) for the indication of invasive candidiasis. This designation will provide at least 10 years of market exclusivity in the EU for ibrexafungerp for invasive candidiasis. SCYNEXIS was also recently awarded a new patent in the U.S. and obtained allowance of an additional European patent application, expanding ibrexafungerp lifecycle protection to 2038.

Reported successful completion of a Phase 1 clinical study of liposomal IV formulation of ibrexafungerp. SCYNEXIS reported encouraging results and the successful completion of its Phase 1 randomized, double-blind, placebo-controlled single and multiple ascending dose study evaluating the safety, tolerability, and pharmacokinetics of the liposomal IV formulation of ibrexafungerp in healthy subjects. Dosing began in March 2021, and the last cohort completed in October 2021. Results from progressive ascending dosing to reach target exposure showed IV ibrexafungerp was generally well tolerated with no concerning safety findings, and SCYNEXIS is moving forward with next steps for this formulation.

Ibrexafungerp Scientific Presentations and Publications

Three presentations from an interim analysis of a Phase 3 open-label study (FURI) were presented at Virtual ID Week 2021 on September 29-October 3, 2021. These data support the favorable clinical activity of oral ibrexafungerp in severe hospital-based fungal infections across multiple indications, including refractory candidiasis, oropharyngeal and esophageal candidiasis, and in Candida bone and joint infections. Of the 74 patients treated with oral ibrexafungerp 62.1% achieved complete or partial response with another 24.3% showing stable disease.

Preclinical data supporting the potential of ibrexafungerp, to treat mucormycosis using an in vivo mouse model of mucormycosis, were presented at the 10th Trends in Medical Mycology (TIMM) meeting. On October 8-11, 2021, investigators presented findings, from an NIH-funded trial in which ibrexafungerp monotherapy demonstrated survival benefits equivalent to current standard of care treatments, including liposomal amphotericin B and posaconazole. Additionally, the study found when ibrexafungerp was combined with amphotericin B, synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone. Mucormycosis has an estimated 54% overall mortality rate.

Corporate Developments

Warrant exercises generated a combined $29.0 million in cash in the fourth quarter of 2021, further strengthening the balance sheet. On December 3, SCYNEXIS reported warrant exercises totaling $7.9 million and on December 22, the Company reported additional warrant exercises totaling $21.1 million.

SCYNEXIS received $4.7 million in non-dilutive proceeds in February 2022 from the sale of New Jersey State net operating losses to a third party.

SCYNEXIS received an additional $5.0 million in non-dilutive proceeds in March 2022 from the third tranche of the previously reported Term Loan Agreement with Hercules Capital/SVB upon achieving positive results from the Phase 3 CANDLE study of ibrexafungerp for the prevention of recurrent yeast infections.

Fourth Quarter 2021 Financial Results

BREXAFEMME generated net product revenue of $0.6 million in the fourth quarter of 2021. The product was approved for sale by the FDA in June 2021.

Cost of product revenue was $0.2 million in the fourth quarter of 2021.

Research and development expense for the fourth quarter of 2021 decreased to $7.7 million from $10.2 million versus the fourth quarter of 2020. The decrease of $2.5 million, or 25%, was primarily driven by a decrease of $1.5 million in chemistry, manufacturing, and controls (CMC) expense, a decrease of $0.4 million in clinical development expense, a net decrease in other research and development expense of $0.8 million, offset in part by an increase of $0.2 million in regulatory expense.

Selling, general & administrative (SG&A) expense for the fourth quarter of 2021 increased to $15.0 million from $5.2 million versus the fourth quarter of 2020. The increase of $9.8 million, or 188%, was primarily driven by a $7.2 million increase in commercial expense, an increase of $0.5 million in salary related costs, an increase of $0.2 million in costs associated with information technology costs, and increases of $0.7 million each in professional fees and medical affairs expenses, all primarily due to the costs recognized to support the ongoing commercialization of BREXAFEMME

Total other expense was $6.9 million for the fourth quarter of 2021, versus total other expense of $27.4 million for the fourth quarter of 2020. During the fourth quarters of 2021 and 2020, SCYNEXIS recognized non-cash losses of $5.0 million and $21.3 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash losses of $0.6 million and $4.4 million, respectively on the fair value adjustment of derivative liabilities.

Net loss for the fourth quarter of 2021, was $29.2 million, or $1.05 per share, compared to net loss of $42.7 million, or $3.43 per share for the fourth quarter of 2020.

Full Year 2021 Financial Results

BREXAFEMME generated net product revenue of $1.1 million for the full year 2021.

Earlier in 2021, SCYNEXIS recognized $12.1 million in licensing revenue from Hansoh Pharma pursuant to an Exclusive License and Collaboration agreement related to the research, development and commercialization of ibrexafungerp in the Greater China region.

Cost of product revenue was $0.3 million for for the full year 2021.

Research and development expense for the full year 2021 decreased to $23.8 million from $36.5 million versus the comparable prior year. The decrease of $12.7 million, or 34.9%, was primarily driven by a decrease of $5.5 million in CMC, a decrease of $5.2 million in clinical development expense, a decrease of $0.9 million in preclinical expense, a decrease of $0.5 million in regulatory expense, and a net decrease in other research and development expense of $0.5 million.

SG&A expense for the full year 2021 increased to $49.9 million from $14.6 million versus the comparable prior year. The increase of $35.3 million, or 241.3%, was primarily driven by a $23.1 million increase in commercial expense, a $3.5 million increase in salary and other compensation related costs, a $2.6 million increase in medical affairs expense, and a $2.2 million increase in information technology costs, all primarily due to the costs recognized to support the ongoing commercialization of BREXAFEMME. The increase for the full year 2021, was also driven by an increase of $1.7 million in certain professional fees, a $1.2 million increase in business development expense associated with the licensing agreement entered into with Hansoh in February 2021, and a net increase of $1.0 million in other selling, general and administrative expense.

Total other income was $24.9 million for the full year 2021, versus total other expense of $7.2 million for the comparable prior year. During the full years 2021 and 2020, SCYNEXIS recognized a non-cash gain of $30.4 million and a non-cash loss of $5.2 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash gains of $1.2 million and $2.3 million, respectively, on the fair value adjustment of derivative liabilities.

Net loss for the full year 2021, was $32.9 million, or $1.25 per share, compared to net loss of $55.2 million, or $5.15 per share for the comparable prior year.

Cash Balance

Cash and cash equivalents totaled $104.5 million on December 31, 2021, compared to $93.0 million in cash, and cash equivalents on December 31, 2020. Based upon its existing operating plan, the Company believes that its existing cash and cash equivalents, the funding of $5.0 million from the third tranche of the previously reported Term Loan Agreement with Hercules Capital/SVB for positive CANDLE study top-line data, and receipt of $4.7 million in conjunction with the sale of New Jersey Net Operating Losses will enable us to fund our operating requirements into the second quarter of 2023.

Conference call and webcast details

A conference call to discuss the results will be held at 8:30 a.m. EDT

Investors (domestic): (877) 705-6003
Investors (international): (201) 493-6725
Conference ID: 13727358

Webcast: View Source;tp_key=627476145d

About Ibrexafungerp

Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The U.S. Food and Drug Administration (FDA) granted ibrexafungerp Qualified Infectious Disease Product (QIDP) and Fast Track designations for the IV and oral formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia) and invasive aspergillosis (IA) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.