On August 15, 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 second quarter ended on June 30, 2022 (Press release, Scynexis, AUG 15, 2022, View Source [SID1234618308]).

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"We are pleased to see the improvements to the current sales trajectory, and we are well capitalized with a cash runway into the first quarter of 2024 to execute on the next important steps toward our goal of building a broad, long-lasting antifungal franchise," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "For the remainder of the year we will be focused on preparing for the approval of the recurrent VVC indication, while working to enroll invasive candidiasis patients into our MARIO study."

BREXAFEMME Commercial Update

BREXAFEMME delivered $1.3 million in net sales in Q2 2022. According to IQVIA data, there were approximately 5,141 total prescriptions for BREXAFEMME written in Q2 2022, a 29 percent increase of total prescriptions over Q1 2022.
BREXAFEMME was prescribed by over 2,200 individual healthcare professionals (HCPs) in the second quarter, an increase of 25% over Q1 2022.
Commercial insurance coverage of BREXAFEMME continues to expand. As of June 2022, BREXAFEMME was covered by plans representing more than 109 million or 60% of commercially-insured lives, a 17% increase over the 93 million covered lives as of Q1 2022.
Ibrexafungerp Clinical Updates

In August 2022, SCYNEXIS announced that the U.S. Food and Drug Administration (FDA) accepted the Company’s submission of a supplemental NDA for a labelling expansion for BREXAFEMME for the prevention of recurrent VVC. The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.
Initiated enrollment in MARIO, a global Phase 3 study to evaluate ibrexafungerp as an oral step-down treatment for invasive candidiasis (IC) in the hospital setting. SCYNEXIS anticipates study completion and results to enable regulatory filing and potential approval for IC, including candidemia, in 2024. If approved, oral ibrexafungerp would be the first non-azole oral therapy available for invasive candidiasis and would enable an IV-to-oral transition with a consistent mechanism of action. Like IV-only echinocandins, oral ibrexafungerp acts via glucan synthase inhibition, a mechanism which has been demonstrated to be the most effective for treating invasive Candida infections.
Initiated enrollment in a new Phase 3b, open-label, multicenter study (VANQUISH) to evaluate the efficacy, safety and tolerability of oral ibrexafungerp as a treatment for vulvovaginal candidiasis (VVC) in patients who have failed treatment with fluconazole, based on mycological and clinical outcomes. The VANQUISH study will enroll approximately 150 patients with complicated VVC who have failed fluconazole treatment and who will receive 600 mg of oral ibrexafungerp for one, three or seven consecutive days determined by their underlying complicating condition including immunocompromised state. Complicated patients include patients with recurrent VVC, those with VVC caused by non-albicans Candida species, and those with diabetes, immunocompromising conditions (e.g., HIV), or immunosuppressive therapy (e.g., corticosteroids).
Achieved target enrollment of 200 patients for its Phase 3 FURI study evaluating oral ibrexafungerp for the treatment of patients with severe fungal infections who are either intolerant to standard antifungal therapy or experience refractory fungal infections despite treatment, including those caused by Candida auris (C. auris). SCYNEXIS anticipates study closure activities to commence by the end of 2022 and also is on track to complete enrollment in the CARES trial during second half of 2022.
Following the positive Phase 1 data with the IV formulation reported previously, SCYNEXIS is preparing for discussions with FDA regarding the next stage of development.
Ibrexafungerp Scientific Presentations and Publications

Presented positive outcomes from its global Phase 3 CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (RVVC), also known as vaginal yeast infection. The results were presented during the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting held in Boston August 4-6, 2022. The study met its primary endpoint, with 65.4% of patients who received monthly single-day ibrexafungerp treatment achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected, through Week 24. In addition, ibrexafungerp demonstrated superiority over placebo in preventing mycologically proven recurrence of RVVC through Week 24, a key secondary endpoint. No mycologically proven recurrence was detected in 70.8% of patients receiving ibrexafungerp. The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant in both primary and secondary endpoints (p=0.034 and 0.029, respectively). In the study, 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 adverse events, headaches and gastrointestinal in nature (i.e., diarrhea, nausea), were mostly mild and generally consistent with the current approved product label.
Presented positive outcomes from the CANDLE nested sub-study investigating oral ibrexafungerp in patients with recurrent vulvovaginal candidiasis (RVVC) who failed fluconazole treatment. The results were presented during the International Society for the Study of Vulvovaginal Diseases (ISSVD) XXVI World Congress and International Vulvovaginal Disease Update 2022 held in Dublin, Ireland, July 15-20, 2022. Data show that 71% of 24 patients with recurrent vulvovaginal candidiasis (RVVC) who failed to respond to a three-day regimen of fluconazole achieved a substantial reduction or complete elimination of signs and symptoms after receiving a one-day treatment with ibrexafungerp.
Reported new positive outcomes in patients with refractory vulvovaginal candidiasis (VVC) treated with oral ibrexafungerp from the ongoing Phase 3 FURI study. The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting held in San Diego May 6-8, 2022. Ibrexafungerp showed positive results in difficult-to-treat VVC patients with severe fungal infections who were either intolerant to standard antifungal therapy or experienced refractory infections despite treatment. Of the 14 patients in the FURI study with refractory or relapsed cases of VVC treated with ibrexafungerp, 10 (71.4%) had successful clinical outcomes as judged by an independent Data Review Committee. Patients with VVC received 750 mg of oral ibrexafungerp (375 mg twice a day) every 72 hours for a total of three dosing days (Day 1, Day 4 and Day 7). In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing product label.
Presented positive interim analyses of data from its ongoing Phase 3 FURI and CARES studies at the 32nd Annual European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held in Lisbon, Portugal April 23-26, 2022. In an interim analysis of the CARES study of 18 enrolled patients with candidemia and other infections caused by Candida auris (C. auris) treated for a mean duration of 18 days, 78% of patients showed complete or partial response and 11% had stable disease. An interim analysis was conducted with combined data of 49 patients with invasive candidiasis and candidemia from the ongoing Phase 3 FURI (n=39) and CARES (n=10) studies. Aggregate data from the two studies showed that of the patients treated with ibrexafungerp, 68% had complete or partial response and 14% had stable disease.
Additional preclinical data presented at ECCMID from an in vivo mouse model of pulmonary mucormycosis support ibrexafungerp as an effective potential treatment for mucormycosis. The study also demonstrated in vivo efficacy of ibrexafungerp monotherapy in treating both Rhizopus delemar and Mucor circinelloides infections in mice, consistent with other antifungals currently used against mucormycosis. Additionally, the study found that when ibrexafungerp was combined with liposomal amphotericin B or posaconazole, synergistic benefits were observed with a significant enhancement in median survival time and overall survival when compared to any one therapy alone (p<0.05).
Corporate Developments

SCYNEXIS raised gross proceeds of $45 million ($42 million net) in an April 2022 public offering of common stock, pre-funded warrants, and warrants.
Second Quarter 2022 Financial Results

BREXAFEMME increased its net product revenues from $0.7 million in Q1 2022 to $1.3 million in Q2 2022.

Research and development expense for Q2 2022 increased to $7.1 million from $4.7 million for Q2 2021.

Selling, general & administrative (SG&A) expense for Q2 2022 increased to $15.8 million from $12.8 million for Q2 2021. The increase was primarily driven by an increase in costs recognized to support the ongoing commercialization of BREXAFEMME.

Total other income was $8.4 million for Q2 2022, versus total other income of $15.0 million for Q2 2021. During Q2 2022 and Q2 2021, SCYNEXIS recognized non-cash gains of $9.7 million and $15.3 million, respectively, on the fair value adjustment of the warrant liabilities and non-cash gains of $0.2 million and $0.5 million, respectively, on the fair value adjustment of derivative liabilities.

Net loss for Q2 2022 was $13.3 million, or $0.31 basic loss per share, compared to a net gain of $1.7 million, or $0.06 basic income per share for Q2 2021.

Cash Balance

Cash and cash equivalents totaled $118.7 million on June 30, 2022, compared to $104.5 million in cash and cash equivalents on December 31, 2021. Based upon its current operating plan, SCYNEXIS believes that its existing cash and cash equivalents, and the anticipated sales of BREXAFEMME, will enable SCYNEXIS to fund its operating requirements into Q1 2024.

Conference call and webcast details

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

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.

On August 15, 2022 Vivesto AB, an oncology-focused specialty pharmaceutical company, reported to note the announcement this morning by Inceptua AB, that it has launched Apealea (paclitaxel micellar) in Germany (Press release, Vivesto, AUG 15, 2022, View Source [SID1234618299]).

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Vivesto signed a global strategic partnership with US-based Elevar Therapeutics ("Elevar") for the commercialization of Apealea in March 2020 which is now being launched in Germany through Elevar’s European partner Inceptua AB ("Inceptua").

On On August 14, 2022, Athenex, Inc. (the "Company") reported that entered into a Limited Waiver (the "Waiver") under the Revenue Interest Purchase Agreement (the "RIPA") with affiliates of Sagard Healthcare Partners and funds managed by Oaktree Capital Management (together, the "Purchasers"), pursuant to which the Purchasers waived the obligation of the Company to wire the $7,500,000 held in a segregated account (the "Segregated Funds") to Oaktree Fund Administration, LLC, as administrative agent (in such capacity, the "Administrative Agent") for the lenders (the "Lenders") under that certain Credit Agreement and Guaranty, dated as of June 19, 2020 by and among the Company, as borrower, the guarantors from time to time party thereto, the Administrative Agent and the Lenders (as amended, amended and restated, supplemented or otherwise modified from time to time, the "Credit Agreement") to be applied to the indebtedness under the Credit Agreement in accordance with the Credit Agreement. Accordingly, the Company has the right to use the Segregated Funds for its general corporate purposes (Filing, 8-K, Athenex, AUG 14, 2022, View Source [SID1234618478]).

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Also on August 14, 2022, the Company entered into the Sixth Amendment to the Credit and Guaranty Agreement (the "Sixth Amendment") with the Administrative Agent and the Lenders. Under the Sixth Amendment, the Lenders waived the Company’s obligation, if certain conditions in the RIPA and Credit Agreement had not been satisfied, to make an additional mandatory prepayment of the indebtedness under the Credit Agreement in the principal amount equal to $7,500,000, plus accrued and unpaid interest in respect of the principal amount being repaid and fees equal to 5% of the principal amount repaid, allocated as a 2.0% Exit Fee and 3.0% Prepayment Fee (each as defined in the Credit Agreement).

In addition, under the Sixth Amendment the Company agreed to, on or before September 30, 2022, make a mandatory prepayment in a principal amount equal to the amount by which $6,875,000 exceeds any mandatory prepayments made by the Company on or prior to September 30, 2022 from the proceeds of the sale of the Company’s China API business to TiHe Capital (Beijing) Co., Ltd. ("TiHe") in accordance with the Equity Purchase Agreement, dated as of July 7, 2022, by and between the Company and TiHe. If the sale to TiHe is not completed after September 30, 2022, the Company must make a mandatory prepayment of principal equal to $6,875,000 on September 30, 2022. However, any such mandatory prepayment shall be credited against any mandatory prepayments otherwise required in respect of the sale to TiHe. In addition to the mandatory prepayment of principal described in this paragraph, the Company must pay accrued and unpaid interest in respect of the principal amount being repaid plus fees equal to 5% of the principal amount being repaid, allocated as a 2.0% Exit Fee and 3.0% Prepayment Fee (each as defined in the Credit Agreement).

The foregoing summary of the Waiver and the Sixth Amendment do not purport to be complete and are qualified in their entirety by reference to the full text of the Waiver and the Sixth Amendment, copies of which are filed hereto as Exhibit 10.1 and Exhibit 10.2 and are incorporated herein by reference.

On August 13, 2022 UnogenBio reported the company has completed the angel financing of RMB 50 million in early January 2022. Invested exclusively by Lapam Capital headquartered in Beijing, the financing aims to support the technology layout of UnogenBio in multiple fields of innovative cancer treatment (Press release, Unogen Biotech, AUG 13, 2022, View Source [SID1234643978]).

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Established in 2021, UnogenBio is committed to developing anti-tumor drugs of world-class technology in order to satisfy unmet treatment needs. The entrepreneurial team of UnogenBio has full-chain and all-round success experiences from drug research and development to clinic. Ms. Fiona Yu, graduated from MIT, is the CEO of UnogenBio. With years of experience in business management and deep research in the development strategy of biotechnology, her book, The Success Code of Pharmaceutical Giants, is highly praised in the industry. With a passion for biotechnology, Fiona has co-founded UnogenBio with several senior scientific partners. Both CSO and CMO of the company served as executives at multinational pharmaceutical companies or the FDA. They have worked in the pharmaceutical industry for decades, and made innumerable achievements. At the present stage, the core assets of UnogenBio include two small molecule drugs of CD3 redirected multi antibodies (in study) and two small molecule drugs that turn cold tumors into hot tumors. Besides, the company is building a wholly new R&D platform and expanding its business lines actively. It will lay emphasis on the gamma-delta T cells and some innovative targets and technologies that are not available for producing drugs.

Lapam Capital is a leading venture capital institution in biological medicine industry in China. Lapam Capital, with a total size greater than RMB 6 billion, has four RMB funds and one dollar fund under its management, and owns the only special fund for biological medicine funded by the Social Security Fund of the People’s Republic of China so far. Focusing on investing in quality projects in the segments of innovative drugs and medical devices, Lapam Capital mainly invests in projects at the start-up, early and middle stages. By now, Lapam Capital has invested in over 50 innovative drug companies and over 10 innovative medical device companies, incubated and supported a large number of well-known pharmaceutical companies, including Betta Pharmaceuticals, RemeGen, Clover Biopharmaceuticals, Asieris Pharmaceuticals, Stemirna Therapeutics, Binhui Biopharm, ImmuneOnco, Biostar, Eyebright, and other star enterprises Multiple partners of Lapam Capital have over two decades of experience in research, development and management of international/domestic biological medicine industry, and are qualified for providing comprehensive value-added services to the invested enterprises.

According to Ms. Fiona Yu, it is UnogenBio’s great honor to receive trust and support from Lapam Capital. The excellent investment performance of Lapam Capital would be the best endorsement for a technology company at the start-up. Lapam Capital is not just our financial investor, and the industry resources and human relations it provides will make our future development easier and faster. For now, the company has completed its arrangements in USA, and is planning its domestic research and development platform actively and vigorously. Domestic scientists with a passion for innovative technology are welcome to join us to work together for the future of innovative medicine in China. –

Mr. Yu Zhihua, Chairman of Lapam Capital, believes that UnogenBio is a unique company. Although it is a newly-established company, it has a relatively whole team of senior experts in drug discovery, preclinical and clinical stages, considering R&D and operation. The company’s projects have fully considered product differentiation and advanced technologies, and have abilities in technical innovation and external resource integration. UnogenBio shows its own particular potential in team comprehensiveness and balance, as well as in foundation and direction of scientific researches. So we are optimistic about the future of UnogenBio.

On On August 12, 2022, Propanc Biopharma, Inc. (the "Company") reported that entered into a securities purchase agreement (the "GS Capital Purchase Agreement") with GS Capital Partners, LLC ("GS Capital"), pursuant to which GS Capital purchased a convertible redeemable note (the "GS Capital Note") from the Company in the aggregate principal amount of $93,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of GS Capital (Filing, 8-K, Propanc, AUG 12, 2022, View Source [SID1234618484]). The transaction contemplated by the GS Capital Purchase Agreement closed on April 16, 2022. The GS Capital Note contains a $5,000 original issue discount. The Company intends to use the net proceeds ($88,000) from the GS Capital Note for general working capital purposes.

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The maturity date of the GS Capital Note is August 12, 2023 (the "Maturity Date"). The GS Capital Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to GS Capital in shares of common stock, but shall not be payable until the GS Capital Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment. The GS Capital Note is exchangeable for an equal aggregate principal amount of notes of different authorized denominations, as requested by GS Capital surrendering the same. GS Capital is entitled, at its option, at any time after cash payment, to convert all or any amount of the principal face amount of the GS Capital Note then outstanding into shares of the Company’s common stock (the "Common Stock") at a price for each share of Common Stock ("Conversion Price") of $0.0028 per share (the "Fixed Price"). However, in the event the Company’s Common Stock trades below $0.002 per share for more than five (5) consecutive trading days, then the Fixed Price shall be equal to $0.0013 per share. In the event of default, the Conversion Price shall be equal to 65% of the lowest trading price of the Common Stock as reported on the OTC Markets on which the Company’s shares are then traded or any exchange upon which the Common Stock may be traded in the future, for the ten prior trading days including the day upon which a Notice of Conversion is received by the Company. GS Capital is restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by GS Capital, exceeds 4.99% of the outstanding shares of the Company’s Common Stock.

The GS Capital Note may be prepaid until 180 days from the issuance date. If the GS Capital Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 91 days from the issuance date, then the prepayment premium shall be 115% of the face amount plus any accrued interest, if prepaid after 90 days from the issuance date, but less than 121 days from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, then the prepayment premium shall be 130% of the face amount plus any accrued interest. So long as the GS Capital Note is outstanding, the Company covenants not to, without prior written consent from GS Capital, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144.

Pursuant to the terms of the GS Purchase Agreement, the Company paid GS Capital’s legal fees of $5,500.

Other than as described above, the GS Capital Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the GS Capital Note.

Upon the occurrence and during the continuation of certain events of default, interest shall accrue at a default interest rate of 24% per annum or, if such rate is usurious or not permitted by current law, then at the highest rate of interest permitted by law.

In the event that the Company fails to deliver to GS Capital shares of Common Stock issuable upon conversion of principal or interest under the GS Capital Note, the penalty shall be $250 per day the shares are not issued beginning on the 4th day after the conversion notice was delivered to the Company. This penalty shall increase to $500 per day beginning on the 10th day.

The GS Note was issued, and any shares to be issued pursuant to any conversion of the note shall be issued in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.