On November 5, 2020 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the third quarter ended September 30, 2020, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, NOV 5, 2020, View Source [SID1234570084]).

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"Following our decision to conclude enrollment in the Elevage Study at the end of September, we look forward to announcing topline results from this phase 2 study of azeliragon in December," said Steve Holcombe, president and CEO. "In addition, we are planning a mechanistic study of TTP399 to start early in the new year to better understand its impact on diabetic ketoacidosis. Finally, we are planning a phase 1 study of our PDE4 inhibitor compound, HPP737, as an initial step towards a proof-of-concept study in psoriasis. We expect to report topline results from both the mechanistic study of TTP399 and the phase 1 study of HPP737 during the second quarter of 2021."

Recent Achievements and Outlook

Type 1 Diabetes

FDA Engagement and Pivotal Study Planning. vTv continued its dialogue with the FDA during the third quarter surrounding the design and endpoints of its planned pivotal studies of TTP399 as an adjunct to insulin therapy for type 1 diabetes. Based upon the FDA’s feedback, the Company plans to conduct a placebo-controlled six-month clinical trial in approximately 400 subjects, followed by a second placebo-controlled six-month clinical trial to be initiated nine to twelve months after initiation of the first pivotal trial. The FDA also confirmed that the effect size of TTP399 on events of hypoglycemia as demonstrated in the Phase 2 SimpliciT-1 Study are clinically meaningful and that a reduction in events of hypoglycemia would be an acceptable clinical endpoint for evaluation of a therapy for the treatment of type 1 diabetes.

Development of Mechanistic Study of Ketoacidosis. To further support the hypothesis that TTP399 may help reduce the incidence of ketoacidosis, vTv plans to conduct a mechanistic study in a small number of patients with type 1 diabetes to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal. The Company proposed the mechanistic study to the FDA, and the FDA recommended that the study be performed in support of the planned pivotal trials. vTv expects the mechanistic study to be initiated in the first quarter of 2021 and to report topline results in the second quarter of 2021.

Two Oral Presentations at EASD of SimpliciT-1 Study Results. Members of vTv’s TTP399 clinical development team, including Chief Scientific Officer Dr. Carmen Valcarce, presented additional data at the 56th Annual European Association for the Study of Diabetes on the effects of TTP399 on hypoglycemia and ketone body formation from the positive SimpliciT-1 Study.
Dementia with Diabetes

Enrollment concluded for Phase 2 Elevage Study of azeliragon. On September 30, vTv concluded enrollment of patients in the Elevage Study. Forty-three (43) patients with mild probable Alzheimer’s disease and type 2 diabetes were enrolled in the study. The study is designed to evaluate the effect of six-months of treatment with azeliragon on cognitive performance. The Company plans to report top-line results for substantially all of the enrolled patients during December 2020, earlier than previously expected. The objective of the Elevage Study is to replicate in a randomized double-blind, placebo controlled study the results observed in a post hoc analysis of the phase 3 STEADFAST trial A-Study in which a subgroup of forty-seven (47) patients with mild Alzheimer’s disease and type 2 diabetes treated with azeliragon demonstrated nominally statistically significant improvements in cognition on the ADAS-cog11 scale of 5.5 points (p=0.006) at month 18 compared to the same subgroup of patients treated with placebo. Azeliragon associated improvement was nominally significant as early as month 6 on the ADAS-cog11 scale (4.9 points, p<0.001).

Elevage Study Update to be Presented at CTAD. Dr. Ann Gooch presented an update on the Elevage Study focusing on the demographic and baseline characteristics data of enrolled subjects at the 13th Clinical Trials on Alzheimer’s Disease conference on November 4, 2020.
Psoriasis

Multiple Ascending Dose Study with HPP737. The Company is planning a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, a PDE4 inhibitor, in healthy volunteers. vTv expects to initiate the study in the first quarter of 2021 and to report topline results in the second quarter of 2021.
Third Quarter 2020 Financial Results

Cash Position: The Company’s cash position as of September 30, 2020, was $1.8 million compared to $6.4 million as of June 30, 2020.

Revenue: Revenues were insignificant for both the second and third quarters of 2020.

R&D Expenses: Research and development expenses were $1.8 million and $2.5 million for the three months ended September 30, 2020 and June 30, 2020, respectively. This decrease of $0.7 million was driven primarily by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.

G&A Expenses: General and administrative expenses were $1.1 million for the third quarter of 2020 and $1.7 million for the second quarter, respectively. The decrease of $0.6 million was driven by the reversal of certain performance-based compensation accruals that are no longer expected to be paid.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $2.3 million for the third quarter of 2020 compared to $5.0 million for the second quarter of 2020.

Net Loss Per Share: GAAP net loss per share was $0.03 and $0.07 for the three months ended September 30, 2020 and June 30, 2020, respectively, based on weighted-average shares of 48.2 million and 45.7 million for the three-month periods ended September 30, 2020 and June 30, 2020, respectively. Non-GAAP net loss per fully exchanged share was $0.02 and $0.08 for the three months ended September 30, 2020 and June 30, 2020, respectively, based on non-GAAP fully exchanged weighted-average shares of 71.3 million and 68.8 million for the three months ended September 30, 2020 and June 30, 2020, respectively.

On November 5, 2020 CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the third quarter and nine months ended September 30, 2020 and provided an update on recent developments (Press release, CorMedix, NOV 5, 2020, View Source [SID1234570083]).

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Recent Corporate and Regulatory Highlights:

CorMedix continues its interactions with the FDA regarding the New Drug Application, or NDA, for Defencath for the prevention of catheter related blood stream infections, or CRBSIs, in patients undergoing hemodialysis via central venous catheter. The FDA has tentatively scheduled the previously announced meeting of the Antimicrobial Drugs Advisory Committee for January 14, 2021 to discuss the Defencath NDA.
Recent changes to the CorMedix Board of Directors include the addition of Paulo Costa and Greg Duncan. These individuals further augment the expertise at the Board level on commercial leadership as well as corporate strategy. Each of Paulo and Greg has had successful careers and leadership roles in the biopharma industry.
CorMedix has continued to expand its efforts to prepare for the commercial launch of Defencath. This includes ongoing dialogue with key payors and dialysis providers and ongoing market research. The interactions have been positive and clearly position CorMedix to ensure that, once Defencath is approved by the FDA, it will be in the best possible position to successfully launch in the US market.
Cash and short-term investments, excluding restricted cash, at September 30, 2020 amounted to $37.0 million. Pro forma cash, including cash on the balance sheet at September 30, 2020 and the net proceeds from recent ATM issuance, is approximately $41.8 million.
Khoso Baluch, CorMedix CEO, commented, "We have continued to make progress on our goal of bringing Defencath to the U.S. market as a catheter lock solution for hemodialysis. We look forward to discussing Defencath with the Antimicrobial Drugs Advisory Committee in January, ahead of the February 28, 2021 PDUFA date for the product. We also are making necessary preparations for the launch of Defencath in the U.S. hemodialysis market, following FDA approval. We believe we have the team, the focus, the resources, and a novel catheter lock solution that will meaningfully improve patient outcomes and are excited about the opportunities in front of us."

Third Quarter and Nine Month 2020 Financial Highlights

For the third quarter of 2020, CorMedix recorded a net loss attributable to common shareholders of $6.6 million, or $0.22 per share, compared with a net loss of $5.3 million, or $0.22 per share, in the third quarter of 2019, excluding the impact of deemed dividends recognized in September 2019 as the result of an exchange agreement and warrant modification.

For the nine months ended September 30, 2020, CorMedix recorded a net loss attributable to common shareholders of $15.9 million, or $0.58 per share, compared with a net loss of $11.1 million, or $0.47 per share, in the first nine months of 2019, excluding the impact of deemed dividends recognized in September 2019 as the result of an exchange agreement and warrant modification. The increase in net loss in the first nine months of 2020 was driven primarily by increased operating expenses.

Operating expenses during the third quarter of 2020 were $6.6 million, compared with $5.2 million in the third quarter of 2019, an increase of approximately 28%. This increase was due to a $0.4 million, or 16%, increase in R&D expense and $1.1 million, or 40%, increase in SG&A expense. Operating expenses during the nine-month period ended September 30, 2020 amounted to $21.2 million compared with $15.6 million during the comparable period in 2019, an increase of $5.6 million, or 36%, due to a 32% increase in R&D expense and 40% increase in SG&A for this period. R&D expense for the first nine months of 2020 included approximately $3.8 million in costs related to the purchase of raw materials and manufacturing of Defencath prior to its potential marketing approval and also included increased staffing costs. Higher SG&A costs were primarily driven by higher staffing costs as well as costs related to market research studies in preparation for the potential market approval of Defencath.

In July 2020, CorMedix completed an underwritten public offering of its common stock, which yielded net proceeds of approximately $21.3 million. The public offering was made pursuant to an underwriting agreement relating to the issuance and sale of an aggregate of 5,111,110 shares of common stock, including 666,666 shares of common stock pursuant to the full exercise of the underwriters’ option, at a public offering price of $4.50 per share. During October 2020, CorMedix issued shares under its at-the-market ("ATM") program and realized net proceeds of approximately $4.6 million.

Total cash on hand and short-term investments as of September 30, 2020 amounted to $37.0 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2020, and including the net proceeds received in October 2020 from ATM issuance, it has sufficient resources to fund operations for at least the coming 12 months, including the costs related to the initial preparations for the commercial launch of Defencath.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 5, 2020, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

On November 5, 2020 Pfizer Inc. (NYSE: PFE) reported further details regarding the proposed spin-off of its Upjohn Business and the subsequent combination of Mylan and the Upjohn Business to form Viatris Inc. As previously announced, Pfizer has set the close of business on November 13, 2020 as the record date for the spin-off, and the combination of Mylan and the Upjohn Business is expected to close on November 16, 2020.

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No action is required by Pfizer common stockholders to receive the distributed shares of Viatris common stock. Pfizer stockholders who hold Pfizer common stock on the record date and do not sell those shares "regular-way" prior to the distribution date will receive a book-entry account statement reflecting their ownership of Viatris common stock or their brokerage account will be credited with Viatris common stock. In addition, Pfizer stockholders will retain those shares of Pfizer common stock.

Pfizer has been advised by Nasdaq that a "when-issued" market for Viatris common stock will exist beginning on November 12, 2020, the date that is the business day immediately prior to the record date for the spin-off, and continuing until the close of business on the expected closing date of November 16, 2020. During this time, a Pfizer stockholder will have the option of selling the right to receive shares of Viatris common stock in the spin-off while retaining shares of Pfizer common stock. This option will be available under the temporary Nasdaq symbol "VTRSV".

In addition, Pfizer has been advised by the New York Stock Exchange that the following markets will exist in shares of Pfizer common stock in connection with the closing of the transaction:

Pfizer common stock "regular way" market (NYSE: PFE): If a Pfizer stockholder sells shares of Pfizer common stock in the "regular way" market beginning on November 12, 2020, the date that is the business day immediately prior to the record date for the spin-off, and continuing until the close of business on the expected closing date of November 16, 2020, that Pfizer stockholder will be selling both his or her shares of Pfizer common stock and the right (represented by a "due-bill") to receive shares of Viatris common stock in the distribution. Pfizer stockholders should consult their brokers before selling

their shares of Pfizer common stock in the "regular way" market during this time period to be sure they understand the effect of the NYSE "due-bill" procedures. The NYSE "due-bill" process is not managed, operated or controlled by Pfizer, Viatris or Mylan.

Pfizer common stock "ex-distribution" market (NYSE: PFE WI): If a Pfizer stockholder sells shares of Pfizer common stock in the "ex-distribution" market, which will begin on the record date for the spin-off, November 13, 2020, and continue until the close of business on the expected closing date of November 16, 2020, that Pfizer stockholder will be selling only his or her shares of Pfizer stock, and will retain the right to receive shares of Viatris common stock in the distribution.

Trades under the symbols "VTRSV" and "PFE WI" will settle after the closing date of the combination, which is expected to occur on November 16, 2020. If the combination is not completed, all trades under these temporary symbols will be cancelled.

If the combination is completed on the expected closing date of November 16, 2020, then beginning on November 17, 2020 (the first trading day after the closing), shares of Pfizer common stock will no longer trade in the "ex-distribution" market, shares of Pfizer common stock that are sold in the "regular way" market will no longer reflect the right to receive shares of Viatris common stock and shares of Viatris common stock will no longer trade in the "when-issued" market.

You are encouraged to consult with your financial advisor regarding the specific implications of trading Pfizer common stock or Viatris common stock prior to or on the expected closing date of November 16, 2020. (Press release, Pfizer, NOV 5, 2020, View Source [SID1234570082])

On November 5, 2020 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, reported the appointment of Dr. Michael Cooreman, M.D., as Chief Medical Officer (CMO) (Press release, Inventiva Pharma, NOV 5, 2020, View Source [SID1234570081]). He joins Inventiva’s Executive Committee and succeeds Dr. Marie-Paule Richard, M.D., who has decided to take her retirement as of December 17, 2020.

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Dr. Michael Cooreman will oversee the Company’s medical and clinical activities and lead its medical development team, in particular with a view to the planned pivotal Phase III clinical trial evaluating Inventiva’s lead drug candidate lanifibranor for the treatment of NASH. Joining Dr. David Nikodem, Ph.D., Vice President of U.S. Operations, he will drive the establishment of Inventiva’s clinical team in the U.S. and manage the Company’s relationships with Key Opinion Leaders (KOL).

Dr. Cooreman joins Inventiva from Ferring Pharmaceuticals where he has been Vice President, Science and Medicine, in charge of Global Research and Development, Gastroenterology and Hepatology, since 2017. He will bring to Inventiva his extensive experience in translational medicine, clinical pharmacology and clinical product development, especially in the areas of liver diseases, including NASH, cirrhosis and viral hepatitis, metabolic and immune-mediated diseases and oncology. Over his career, Dr. Cooreman has worked for several companies in the United States of America (US) and been involved in numerous clinical trials. He has successfully led clinical and project teams developing a variety of investigational compounds, including small molecules and biologics, several of which have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other health authorities. His strong industry knowledge, established network and international profile, together with his deep expertise as an academic internist and gastroenterologist-hepatologist, will be important assets for Inventiva’s future development.

Dr. Cooreman’s arrival will facilitate a smooth transition with Dr. Marie-Paule Richard ahead of the Company’s next key milestones, including NASH-related meetings with the FDA and the EMA, planned for the fourth quarter of 2020, as well as the initiation of the pivotal Phase III clinical trial evaluating lanifibranor in patients with NASH, planned for the first half of 2021.

Frédéric Cren, Chairman, CEO and cofounder of Inventiva, commented: "I am delighted to welcome Michael in the role of CMO at this exciting stage of Inventiva’s development. His experience as both health practitioner and senior executive in leading pharmaceutical and biotech companies will be key to the deployment of our strategy going forward. As such, he will play a crucial role in the development of Inventiva in the US, especially with regards to the upcoming planned Phase III clinical trial of lanifibranor in NASH. I would like to take this opportunity to warmly thank Marie-Paule for her dedication, remarkable contribution and professionalism over the last two years and I wish her all the best in the future."

Biography – Dr. Michael Cooreman, M.D.

Prior to joining Inventiva, Dr. Michael Cooreman has been Vice President, Science and Medicine, in charge of Global Research and Development, Gastroenterology and Hepatology, at Ferring Pharmaceuticals in the U.S. since 2017. He previously held numerous U.S.-based positions as CMO and Executive Director in global roles at leading pharmaceutical and biotechnology companies, including Takeda Pharmaceuticals, Merck, Mitsubishi Tanabe, ImmusanT and Novartis, covering the four major regulatory regions U.S., EU, Japan and China. Over the years, Dr. Cooreman has developed a strong expertise in translational medicine, clinical pharmacology and clinical product development.

Of dual US and Belgian citizenship, Dr. Cooreman is trained as an internist and gastroenterologist-hepatologist, with a special interest in metabolic and immune-mediated liver and gastrointestinal diseases, as well as viral hepatitis, cirrhosis and oncology.

He holds a Doctor of Medicine degree from the University of Louvain, Belgium, and a doctorate from the Heinrich Heine University in Dusseldorf, Germany.

On November 5, 2020 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the third quarter 2020 and provided an operational update (Press release, Bellicum Pharmaceuticals, NOV 5, 2020, View Source [SID1234570080]).

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"Bellicum recently took significant steps to strengthen our balance sheet, restructure, and focus on our clinical development programs: BPX-601 in mCRPC and BPX-603 in HER2+ solid tumors," said Rick Fair, President and Chief Executive Officer of Bellicum. "We believe we are well positioned to explore the value of GoCAR in these two different solid tumor settings."

Program Highlights and Current Updates

BPX-601 GoCAR-T

In October, Bellicum announced interim data from its BPX-601 Cohort 5C dose-escalation clinical trial in patients with relapsed/refractory metastatic pancreatic cancer. Consistent with previously reported findings of BPX-601 followed by single-dose rimiducid, BPX-601 followed by repeat rimiducid dosing was tolerated and exhibited evidence of rimiducid-mediated CAR-T cell activation in the first four patients treated. Clinically meaningful efficacy as measured by RECIST criteria was not observed.

Bellicum plans to explore the effects of BPX-601 in new tumor types and expects to begin enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) in the ongoing Phase 1/2 clinical trial before the end of the year. The company intends to review its plans in pancreatic cancer upon completion of the current safety cohort.
BPX-603 GoCAR-T

BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. The company plans to initiate enrollment in a Phase 1/2 basket trial in solid tumors that express HER2 later this year.
Corporate Updates

In November, the company completed a financing consisting of 1,040,000 shares of common stock, pre-funded warrants to purchase 3,109,378 shares of common stock and accompanying warrants to purchase 4,149,378 shares of common stock, that raised gross proceeds of approximately $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Bellicum, and excluding any proceeds that may be received upon exercise of the warrants.
In October, Bellicum implemented a restructuring program to focus on the clinical development of BPX-601 and BPX-603, pause the BCMA GoCAR-NK program, and discontinue discovery research and new product development. The company plans to reduce headcount by 79%, from 68 to 14 full-time employees by the end of 2020, which is expected to reduce operating expenses and extend its cash runway.
In October, Bellicum paid down all of its Oxford Finance debt obligations with payment of $27.4 million in principal plus applicable fees and accrued interest.
Third Quarter 2020 Financial Results

R&D Expenses: Research and development (R&D) expenses were $8.1 million and $30.3 million for the three and nine months ended September 30, 2020, respectively, compared to $14.3 million and $51.2 million for the three and nine months ended September 30, 2019, respectively. The reduction in expenses in the third quarter resulted primarily from reduced expenses related to reduced rivo-cel related activities, reduced expenses resulting from the manufacturing facility sale and the reduction in force implemented during the second half of 2019, partially offset by an increase in expenses related to the GoCAR programs.

G&A Expenses: General and administrative (G&A) expenses were $4.2 million and $12.1 million for the three and nine months ended September 30, 2020, respectively, compared to $9.2 million and $24.3 million for the three and nine months ended September 30, 2019, respectively. The reduction in expenses during the third quarter relative to the comparable period in 2019 was primarily due to the reduction in rivo-cel related commercialization activities as well as the effects of the reduction in force that reduced employee-related charges.

Loss from Operations: Bellicum reported a loss from operations of $12.3 million and $38.7 million for the three and nine months ended September 30, 2020, respectively, compared to a loss from operations of $23.4 million and $73.5 million for the three and nine months ended September 30, 2019, respectively. The results for the nine months ended September 30, 2020 included a net gain on dispositions of $3.8 million due to the manufacturing facility sale. Cash used in operating activities was $43.3 million for the nine months ended September 30, 2020, compared to cash used in operating activities of $64.8 million for the nine months ended September 30, 2019.

Net Loss: Bellicum reported net loss of $0.9 million and $26.5 million for the three and nine months ended September 30, 2020, respectively, compared to a net loss of $32.0 million and $83.5 million for the three and nine months ended September 30, 2019, respectively. The results included a non-cash gain of $12.1 million and $14.3 million related to the change in fair value of warrant and private placement option liability for the three and nine months ended September 30, 2020, respectively.

Shares Outstanding: As of October 30, 2020, Bellicum had 5,059,779 shares of common stock and 534,000 shares of preferred stock outstanding. Each share of preferred stock can be converted into 10 shares of common stock. In the November 2020 financing, the company issued 1,040,000 shares of common stock and pre-funded warrants to purchase 3,109,378 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $54.6 million as of September 30, 2020, compared to $93.8 million as of December 31, 2019. On a pro forma as adjusted basis to give effect to the net proceeds from the financing and the Oxford Finance payoff, cash and cash equivalents and restricted cash totaled $49.9 million as of September 30, 2020. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.