On November 10, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D) reported financial results for the third quarter ended September 30, 2022, and provided an update on recent corporate developments (Press release, vTv Therapeutics, NOV 10, 2022, View Source [SID1234623829]).

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"During the third quarter, we continued working diligently toward the commencement of TTP399 Phase 3 clinical trials, which we expect to initiate in 1Q2023," said Paul Sekhri, Chief Executive Officer of vTv. "We intend to submit final protocols to the US Food and Drug Administration (FDA) in the coming weeks, with site-specific startup activities and patient enrollment starting the first quarter of 2023. Through our recently signed partnerships with CinRx and G42, I believe that we are well equipped to further advance the clinical development of TTP399 and move closer to realizing our goal of improving care and quality of life for patients with T1D."

Recent Achievements

Leadership. On July 27, 2022, the Company appointed Paul Sekhri as President, Chief Executive Officer (CEO) effective August 1, 2022, and was confirmed as a member of the board of directors on August 9, 2022. Mr. Sekhri brings nearly 30 years of healthcare industry experience, including serving as President and CEO of several healthcare companies, experience in several senior business development and strategy roles and he has been a director on more than 30 private, public company and non-profit boards.

Partnership. On July 25, 2022, the Company entered into agreements with CinRx Pharma and its subsidiary, CinPax. CinPax agreed to acquire $10.0 million in vTv Class A common stock at approximately $2.41 per share with $6 million paid at closing and the remaining $4.0 million payable on November 22, 2022. vTv will issue warrants to CinRx to acquire 1.2 million additional shares of Class A common stock at an exercise price of approximately $0.72 per share that become exercisable upon agreed vesting triggers. In addition, the agreements set forth terms under which vTv will leverage the CinRx team’s industry experience to collaborate on the oversight of the clinical trials for pharmaceutical products that contain TTP399.
Upcoming Milestones and Events

Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with T1D and has engaged with the FDA on the optimal clinical trial designs for these studies. The studies will recruit a total of approximately 1,000 patients and at least one of the studies will be one year of treatment. The FDA and the Company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemic events. These pivotal studies are expected to start in the first quarter of 2023.
Third Quarter 2022 Financial Results

Cash Position: The Company’s cash position as of September 30, 2022, was $15.3 million compared to $13.4 million as of December 31, 2021.

Research & Development (R&D) Expenses: R&D expenses were $3.1 million and $2.4 million in each of the three months ended September 30, 2022, and 2021, respectively. The increase of $0.7 million is attributable to a decrease in clinical trial costs for azeliragon, which was mainly driven by discontinuance of its development as a potential treatment of Alzheimer’s disease in patients with type 2 diabetes and a decrease in spending related to a multiple ascending dose study for HPP737, due to its completion in 2021, offset by higher spending on TTP399 due to drug product related costs and trial preparation costs.
General & Administrative (G&A) Expenses: G&A expenses were $2.6 million and $2.2 million for each of the three months ended September 30, 2022, and 2021, respectively. The increase was due to higher legal expense and higher other G&A costs offset by lower payroll costs.
Other (Expense)/Income: Other expense for the three months ended September 30, 2022, was $0.1 million and was driven by an unrealized gain related to the investment in Reneo as well as the losses related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party ("Related Party Warrants"). Other income for the three months ended September 30, 2021, was $0.2 million and was related to the unrealized loss recognized related to the investment in Reneo as well as gains related to the change in the fair value of the outstanding warrants in our own stock held by a related party.
Net Loss: Net loss attributable to vTv shareholders for the three months ended September 30, 2022, was $4.3 million or $0.05 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $1.1 million or $0.02 per basic share.

On November 10, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the third quarter ended September 30, 2022 and provided an overview of recent developments (Press release, Atreca, NOV 10, 2022, View Source [SID1234623828]).

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"The third quarter was a productive period, as we continue to enroll patients in the Phase 1b trial of ATRC-101," said John Orwin, Chief Executive Officer of Atreca. "We remain encouraged by the association we see between clinical activity and target expression, the durability of the clinical activity observed and the tolerability demonstrated in the study. We are making progress toward accelerating enrollment and are now planning to present data in early 2023, once we’ve treated enough participants to provide a meaningful update."

"An NHP toxicity study to evaluate ATRC-301, an ADC candidate in our anti-EphA2 program, revealed safety signals, including bleeding, and as a result, we are discontinuing the development of ATRC-301; however, we continue to evaluate our anti-EphA2 antibodies in multiple weaponized formats," said Stephen Gould, Ph.D., Chief Scientific Officer of Atreca. "While this will delay the timing of our next IND in oncology, our preclinical pipeline is otherwise progressing well, and in early 2023 we expect to provide updates on both an ADC targeting a novel tumor glycan and a bispecific T-cell engager targeting another RNA-binding protein."

"In addition, the Bill & Melinda Gates Medical Research Institute continues to advance MAM01/ATRC-501, an antibody clinical candidate generated by the Atreca platform that is in development for the prevention of malaria, for which they expect to file an IND early next year," said John Orwin.

Recent Developments and Highlights

Atreca continued enrolling patients in its ongoing Phase 1b study of ATRC-101 based on ATRC-101 target expression in archival or newly obtained biopsies. To-date, 67 participants have been enrolled across the monotherapy and pembrolizumab combination cohorts of the study. The Company has taken steps to accelerate enrollment in the trial, including initiating additional trial sites and streamlining enrollment criteria. Atreca now expects to present updated monotherapy and combination data from the trial in the first quarter of 2023.

An non-human primate (NHP) toxicity study to evaluate ATRC-301, an antibody drug conjugate (ADC) candidate in our anti-EphA2 program, revealed safety signals, including bleeding, and as a result, Atreca is discontinuing the development of ATRC-301. The Company continues to evaluate its anti-EphA2 antibodies in multiple weaponized formats and advance its other lead-stage oncology programs, including APN-497444, an ADC against a novel tumor glycan target, and APN-346958, a CD3 bispecific T-cell engager against an RNA-binding protein target. Atreca is now targeting one additional Investigational New Drug (IND) application per year in oncology beginning in 2024.

A IND for MAM01/ATRC-501, an Atreca-discovered antibody clinical candidate licensed to the Bill & Melinda Gates Medical Research Institute ("Gates MRI") for the prevention of malaria, is expected to be filed by Gates MRI in the first quarter of 2023, and they expect to commence clinical development by the second half of 2023. Atreca retains commercial rights in the U.S., Europe and parts of Asia, and potential product development opportunities in those regions include prevention of malaria for those traveling to malaria endemic regions.

In October 2022, Atreca announced the presentation of two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, a trial-in-progress update on the Phase 1b clinical study of ATRC-101, and a poster on the discovery and preclinical development of its novel EphA2-targeted antibodies. Poster sessions began today, November 10th, at 9 a.m. ET.

Third Quarter 2022 Financial Results

As of September 30, 2022, cash and cash equivalents and investments totaled $85.7 million.
Research and development expenses for the quarter ended September 30, 2022, were $16.0 million, including non-cash share-based compensation expense of $1.9 million.
General and administrative expenses for the three months ended September 30, 2022, were $7.2 million, including non-cash share-based compensation expense of $2.0 million.
Atreca reported a net loss of $23.1 million, or basic and diluted net loss per share attributable to common stockholders of $0.60, for the three months ended September 30, 2022.

On November 10, 2022 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported it will release its unaudited financial results for the quarter ended September 30, 2022 on Tuesday, November 15, 2022, before the U.S. markets open (Press release, BioLineRx, NOV 10, 2022, View Source [SID1234623827]).

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The Company will host a conference call on Tuesday, November 15, 2022 at 10:00 a.m. EST featuring remarks by Philip Serlin, Chief Executive Officer.

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until November 17, 2022; please dial +1-888-295-2634 from the US or +972-3-925-5903 internationally.

On November 10, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics for orthopedic indications and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported financial results for the third quarter ended September 30, 2022 and provided an update on its clinical pipeline and other corporate developments (Press release, Conatus Pharmaceuticals, NOV 10, 2022, View Source [SID1234623826]).

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"We remain focused on the feasibility of developing emricasan as a potential treatment for bacterial skin infections including those related to methicillin resistant staphylococcus aureus ("MRSA") and evaluating our caspase-1 inhibitors that impact the inflammasome pathway," said Steven J. Mento, Ph.D., Interim President and Chief Executive Officer. "We also continue to make progress on the ongoing feasibility evaluation of our HST 003 study for cartilage regeneration in the knee, including implementation of protocol modifications, and other study resources given the continued recruitment challenges and expect to complete our evaluation in the fourth quarter of 2022."

Highlights from the Third Quarter 2022 and Business Updates

HST 003 – Our Phase 1/2 clinical study of HST 003 to evaluate the safety and efficacy of human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure is on-going. Our feasibility assessment for the HST 003 study continues to progress, and despite adding three additional clinical sites in the first quarter of 2022, and implementing protocol modifications in the third quarter of 2022, our recruitment challenges remain unresolved due to both the overall nature of the study and the impact of COVID-19 on the elective surgery environment. We expect to complete our feasibility evaluation in the fourth quarter of 2022.

HST 004 – Is a CCM solution intended to be administered through an intradiscal injection for spinal disc repair. In the second quarter of 2021, we initiated IND enabling activities for HST-004. However, due to pipeline program prioritization, we have made the decision to suspend all IND enabling activities for the HST-004 program.

Emricasan MRSA – We continue to make progress on the feasibility of developing emricasan as a potential treatment for bacterial skin infections including those related to MRSA including testing emricasan in animal studies for MRSA. We expect to complete our feasibility assessment in the fourth quarter of 2022.

Nine Months Ended September 30, 2022 Financial Highlights

Product, License, and Grant Revenues

For the nine months ended September 30, 2022 and 2021, we recognized product revenues of $0 and $0.9 million, respectively. The revenue for the first nine months of 2021 was due to a one-time unanticipated sale of CCM to Allergan, unrelated to the Allergan Agreements. As of March 31, 2021, all obligations of the Company related to the additional supply of CCM to Allergan under the Allergan Agreements have been completed.

For the nine months ended September 30, 2022 and 2021, we recognized license revenue of $3.8 million and $22 thousand, respectively. The increase in the current period is due to a one-time payment of $3.75 million received in March 2022 as consideration for execution of the Allergan Letter Agreement.

For the nine months ended September 30, 2022 and 2021, we recognized grant revenue of $0 and $0.1 million, respectively. The related revenue is associated with a research and development grant awarded to the Company from the NSF. As of March 31, 2021, all work required by the Company under the grant has been completed.

Cost of revenues – for the nine months ended September 30, 2022 and 2021, we recognized $0 and $0.2 million, respectively, for cost of product sold to Allergan under the Allergan Agreements.

Research and development expenses – research and development expenses for the nine months ended September 30, 2022 and 2021 were $3.9 million and $6.9 million, respectively. The decrease of $3.0 million was primarily due to decreases in development costs of our clinical and pre-clinical product candidates, outside services, and personnel related expenses, partially offset by facility rent increases.

General and administrative expenses – general and administrative expenses for the nine months ended September 30, 2022 and 2021 were $7.5 million and $6.3 million, respectively. The increase of $1.2 million was primarily due to increases in royalty expenses, legal fees, outside services and rent expenses, offset by reductions in insurance and other administrative expenses.

Cash and cash equivalents – as of September 30, 2022, we had $14.6 million in cash and cash equivalents. Histogen believes that its existing cash and cash equivalents and cash inflow from operations will be sufficient to meet Histogen’s anticipated cash needs through December of 2023.

On November 10, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company and creator of the unique CellFX System which harnesses and effectively controls the application of Nano-Pulse Stimulation (NPS) to human cells and tissue for ablation in multiple therapeutic conditions, reported financial results for the third quarter ended September 30, 2022 (Press release, Pulse Biosciences, NOV 10, 2022, View Source [SID1234623825]).

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Company Updates

Tightened strategic corporate focus. Going forward the novel unique Pulse Biosciences CellFX system is being majorly focused on cardiac cellular/tissue ablation for the purpose of treating atrial fibrillation. The CellFX System is capable of rendering electrical pulse field stimulation ranging in duration of time from a millionth to up to a billionth of a second, defined as rendering Nano Pulse field stimulation.

Optimizing headcount relating to our strategic focus change.

Entered into a $65 million, 5% interest payable quarterly, March 20, 2024 expiration, term loan agreement with Mr. Duggan, majority shareholder and Executive Chairman, to support product development initiatives.

Anticipates quarterly cash burn rate of approximately $8 million, commencing in the first quarter of 2023, under current circumstances resulting from the tightened strategic corporate focus.

Appointed executives to the following roles:

Chairman of the Board, Robert Duggan, to Executive Chairman.

Kevin Danahy, to President and Chief Executive Officer.

Darrin Uecker, to the newly created role of Chief Technology Officer.

Joe Talarico, assumes role of Vice-President of Business Development.

Third Quarter 2022 Results

There was no revenue recognized in the third quarter of 2022. Total GAAP cost and expenses representing cost of revenues, research and development, sales and marketing, and general and administrative expenses for the three months ended September 30, 2022 were $18.0 million, compared to $14.8 million for the prior year period. Cost of revenues in the third quarter of 2022 includes a $7.2 million inventory reserve related to the dermatology business. Non-GAAP cost and expenses for the three months ended September 30, 2022 were $16.8 million, compared to $13.0 million for the prior year period.

GAAP net loss for the three months ended September 30, 2022 was ($18.0) million compared to ($14.3) million for the three months ended September 30, 2021. Non-GAAP net loss for the three months ended September 30, 2022 was ($16.8) million compared to ($12.4) million for the three months ended September 30, 2021.

Cash and cash equivalents totaled $69.2 million as of September 30, 2022 compared to $28.6 million as of December 31, 2021 and $14.8 million as of June 30, 2022. Cash used in the third quarter of 2022 totaled $10.6 million. This compares to $13.8 million used in the same period in the prior year and $12.8 million used in the second quarter of 2022.

Reconciliations of GAAP to non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, November 10, 2022, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source