VistaGen Therapeutics Reports Fiscal 2021 First Quarter Financial Results and Highlights CNS Pipeline and Business Progress

On August 13, 2020 VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a biopharmaceutical company developing new generation medicines for anxiety, depression and other central nervous system (CNS) disorders, reported financial results for its fiscal 2021 first quarter ended June 30, 2020 (Press release, VistaGen Therapeutics, AUG 13, 2020, View Source [SID1234563610]).

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"We accomplished several meaningful milestones thus far this fiscal year that positively impact our clinical development programs, including our PH94B Phase 3 program in social anxiety disorder. We reached consensus with the FDA on the key aspects of the design of our pivotal Phase 3 clinical studies of PH94B for acute treatment of anxiety in adults with social anxiety disorder. This design is similar to the design of the highly statistically significant Phase 2 study of PH94B in social anxiety disorder," said Shawn Singh, Chief Executive Officer of VistaGen. "Additionally, we received the $5 million upfront license payment from our partnering arrangement with EverInsight Therapeutics for Phase 3 development and commercialization of PH94B in key markets in Asia. We also completed a successful public offering of our common stock, resulting in gross proceeds to us of $14.29 million. These accomplishments significantly strengthen our go-forward development plans. We believe now more than ever; the global society needs new, safe, fast-acting treatments for anxiety and depression and we remain committed to achieving that goal."

Financial Highlights During and Subsequent to the Fiscal 2021 First Quarter:

VistaGen received a $5 million non-dilutive upfront license payment from EverInsight Therapeutics, the Company’s strategic partner for Phase 3 development and commercialization of PH94B for anxiety-related disorders in multiple key markets in Asia.
VistaGen completed an underwritten public offering of common stock resulting in gross proceeds of $14.29 million to the Company, before underwriting discounts and commissions and offering expenses.
CNS Pipeline Highlights:

VistaGen reached consensus with the FDA on key aspects regarding the Company’s initial pivotal Phase 3 study of PH94B for acute treatment of anxiety in adults with social anxiety disorder (SAD) that, among other details, may provide significant time- and cost-efficiencies for its Phase 3 program.
As in the highly statistically significant (p=0.002) Phase 2 study of PH94B in SAD, VistaGen’s Phase 3 study will involve a single laboratory-simulated anxiety-provoking public speaking challenge.
The Phase 3 study will be a randomized, double-blind, placebo-controlled, parallel comparison study conducted at approximately 12 to 15 sites in North America.
The Subjective Units of Distress Scale (SUDS) will be used to assess the primary efficacy endpoint in the study.
Dr. Michael Liebowitz, Professor of Clinical Psychiatry at Columbia University, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), will be the Principal Investigator of the study.
Target enrollment (completed patients) will be approximately 182 adult patients with SAD.
Through the FDA’s Coronavirus Treatment Acceleration Program (CTAP), VistaGen submitted its preliminary protocol and development plan for an exploratory, open-label Phase 2A study of PH94B for acute treatment of adjustment disorder with anxiety (AjDA), including, but not limited to, anxiety-provoking stressors related to the diverse impact of the COVID-19 pandemic (e.g., fear and anxiety regarding health and safety, economic loss, unemployment, social isolation, distance-learning, etc.) and civil unrest.
The Company is currently working closely with the FDA on plans for the Phase 2A study in AjDA, which, when study preparations are completed, will be conducted in New York City by Dr. Michael Liebowitz.
Financial Results for the Fiscal Quarter Ended June 30, 2020:

Net loss: Net loss attributable to common stockholders for the fiscal quarter ended June 30, 2020 decreased to approximately $3.5 million compared to $6.5 million for the fiscal quarter ended June 30, 2019.

Research and development (R&D) expense: R&D expense decreased to approximately $1.7 million from $4.3 million for the quarters ended June 30, 2020 and 2019, respectively, primarily due to the completion of our Phase 2 study of AV-101 in major depressive disorder in the fourth calendar quarter of 2019. Expenses related to that study and other AV-101 related nonclinical activities decreased by $2.5 million in the quarter ended June 30, 2020 compared to expense in the quarter ended June 30, 2019. Noncash research and development expenses, primarily stock-based compensation, and depreciation in both periods, accounted for approximately $249,000 and $416,000 in the quarters ended June 30, 2020 and 2019, respectively.

General and administrative (G&A) expense: G&A expense decreased to approximately $1.4 million from approximately $1.9 million for the quarters ended June 30, 2020 and 2019, respectively. Noncash G&A expense, $466,000 in the quarter ended June 30, 2020, decreased from $772,000 in the quarter ended June 30, 2019, primarily due to decreases in stock-based compensation and the noncash components of investor and public relations expense attributable to the amortization of the fair value of common stock or warrants granted to service providers.

Cash Position: At June 30, 2020, VistaGen had cash and cash equivalents of $1.5 million, compared to $1.4 million at March 31, 2020. After June 30, 2020, the Company received net proceeds totaling approximately $17.5 million from (i) the $5.0 million gross non-dilutive upfront license fee payment from EverInsight Therapeutics, Inc. pursuant our PH94B strategic collaboration agreement for development and commercialization of PH94B in key markets in Asia, and (ii) the gross proceeds of approximately $14.29 million from the sale of shares of common stock in the underwritten public offering.

As of August 13, 2020, there were 77,998,057 shares of common stock outstanding.

About PH94B
PH94B is a rapid-onset (within approximately 15 minutes) synthetic neurosteroid nasal spray with therapeutic potential across a broad range of anxiety-related disorders. Easily self-administered in microgram-level doses, PH94B does not require systemic uptake and distribution to produce its rapid-onset anti-anxiety effects.

VistaGen is preparing for Phase 3 clinical development of PH94B as a potential new generation fast-acting, non-sedating, non-addictive acute treatment of anxiety in adults with social anxiety disorder (SAD). The FDA has granted Fast Track designation for development of PH94B for this indication, believed to be the first such designation by the FDA for a drug candidate for SAD.

With its rapid-onset pharmacology, lack of systemic exposure and excellent safety profile in earlier studies, PH94B has potential as a novel treatment for multiple additional anxiety-related disorders. VistaGen is also preparing for exploratory Phase 2A development of PH94B for acute treatment of adjustment disorder. View more background information on SAD and a video on PH94B’s mechanism of action.

About PH10
PH10 is an investigational synthetic neurosteroid with therapeutic potential in a wide range of neuropsychiatric indications involving depression and suicidal ideation. VistaGen is initially developing PH10 as a potential fast-acting, non-sedating, non-addictive new generation stand-alone treatment of major depressive disorder (MDD). Following successfully completed Phase 2A development for MDD, VistaGen is now preparing for Phase 2B clinical development of PH10 for MDD.

About AV-101
AV-101 (4-Cl-KYN) targets the NMDAR (N-methyl-D-aspartate receptor), an ionotropic glutamate receptor in the brain. Abnormal NMDAR function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), which is a potent and selective full antagonist of the glycine co-agonist site of the NMDAR that inhibits the function of the NMDAR. Unlike ketamine and other NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker. In all studies to date, AV-101 has exhibited no dissociative or hallucinogenic psychological side effects or safety concerns similar to those that may be caused by amantadine, esketamine and ketamine. With its exceptionally few side effects and excellent safety profile, AV-101 has potential to be an oral new generation treatment for multiple CNS indications. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.

BIOLASE Reports Second Quarter 2020 Financial Results

On August 13, 2020 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported its financial results for the second quarter ended June 30, 2020 and provided a business update (Press release, Biolase Technology, AUG 13, 2020, View Source [SID1234563609]).

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"Despite the ongoing challenges associated with the COVID-19 pandemic, the developments in the quarter and more recently position BIOLASE for success," commented Todd Norbe, President and Chief Executive Officer. "Our Epic Hygiene dental laser meets the Centers for Disease Control and Prevention (CDC) guidelines to minimize the risk of COVID-19, while our all-tissue Waterlase dental lasers already create 98% less aerosol than traditional dental handpieces, meeting the American Dental Association’s recommendation of reduced aerosol production to limit the spread of infectious pathogens, such as COVID-19. I believe these unique attributes will meet the rising needs of dentists and patients and will contribute significantly to our success as dental practices reopen and procedures return to pre-COVID-19 levels.

"I also believe the oversubscribed rights offering we recently completed and the registered direct offering in June demonstrate investor confidence in our growth strategy. We believe our current liquidity position and our cost containment efforts provide us with sufficient capital to effectively execute on our growth strategy."

2020 Second Quarter Financial Results

Net revenue for the second quarter of 2020 was $2.9 million, a decrease of 66%, compared to net revenue of $8.6 million for the second quarter of 2019. U.S. laser revenue was $0.8 million for the second quarter of 2020, a 72% decrease compared to U.S. laser revenue of $2.9 million for the second quarter of 2019. U.S. consumables and other revenue for the second quarter of 2020, which consists of revenue from consumable products such as disposable tips, decreased 68% compared to the second quarter of 2019. Outside the U.S., laser revenue declined 86% to $0.3 million for the second quarter of 2020 compared to $2.0 million for the second quarter of 2019 and consumables and other revenue decreased 39% year over year.

Gross margin for the second quarter of 2020 was 32%, compared to 39% for the second quarter of 2019. The lower gross margin reflects the impact of the decline in revenues relative to our fixed costs. Total operating expenses were $4.9 million for the second quarter of 2020 compared to $6.7 million for the second quarter of 2019, a decrease of approximately 27%. Operating loss for the second quarter of 2020, was $4.0 million, compared to an operating loss of $3.3 million in the second quarter of 2019, an increase of 19% year over year. Net loss for the second quarter of 2020 was $4.7 million, or $0.12 per share, compared to a net loss of $3.9 million, or $0.18 per share, for the second quarter of 2019.

Cash, cash equivalents, and restricted cash totaled $5.7 million as of June 30, 2020 and included proceeds from the registered direct private placement completed in June.

On July 22, 2020, the Company completed its previously announced rights offering, resulting in net proceeds to the Company of approximately $15.8 million, after deducting expenses and fees, and excluding any proceeds received upon exercise of any warrants.

Use of Non-GAAP Measures

The Reconciliation of GAAP Net Loss to Adjusted EBITDA at the end of this news release provides the details of the Company’s non-GAAP disclosures and the reconciliation of GAAP net loss and net loss per share to the Company’s Adjusted EBITDA and Adjusted EBITDA per share.

Adjusted EBITDA loss for the second quarter of 2020 was $2.9 million, or $0.08 per share, compared with Adjusted EBITDA loss of $2.8 million, or $0.13 per share, for the second quarter of 2019.

Conference Call Information

BIOLASE, Inc. will host a conference call today at 4:30 p.m. Eastern Time to discuss its operating results for the second quarter ended June 30, 2020, and to answer questions. For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 800-367-2403. For international participants outside the U.S./Canada, the dial-in number is 334-777-6978. For all callers, refer to the Conference ID 9516164. To access the live webcast, visit the Investor Relations section of the BIOLASE website at www.biolase.com and see "Investor Events".

An audio archive of the webcast will be available for 30 days on the Investor Relations section of the BIOLASE website.

Amgen Announces Pricing Terms For Senior Notes Exchange Offers, Increases The Maximum Notes Exchange Cap And Accepts Tendered Notes

On August 13, 2020 Amgen Inc. (NASDAQ:AMGN) reported the pricing terms of its previously announced nine separate private offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") certain specified series of its outstanding senior notes (collectively, the "Old Notes") for a combination of a cash payment and new Senior Notes due 2053 (the "New Notes") (Press release, Amgen, AUG 13, 2020, View Source [SID1234563607]). In addition, Amgen announced that it has increased the cap on the aggregate principal amount of New Notes to be issued in the Exchange Offers from $800,000,000 to $940,000,000 (such increased amount, the "Maximum Notes Exchange Cap"). Except for the increase in the Maximum Notes Exchange Cap described above, all other terms and conditions of the Exchange Offers remain unchanged.

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The Exchange Offers consist of the following:

(a) an offer to exchange the 6.90% Senior Notes due 2038;

(b) an offer to exchange the 6.375% Senior Notes due 2037;

(c) an offer to exchange the 6.40% Senior Notes due 2039;

(d) an offer to exchange the 5.75% Senior Notes due 2040;

(e) an offer to exchange the 5.65% Senior Notes due 2042;

(f) an offer to exchange the 5.375% Senior Notes due 2043;

(g) an offer to exchange the 5.15% Senior Notes due 2041;

(h) an offer to exchange the 4.95% Senior Notes due 2041; and

(i) an offer to exchange the 4.40% Senior Notes due 2045;

in each case, for a combination of a cash payment and New Notes, provided that the aggregate principal amount of New Notes to be issued in the Exchange Offers shall not exceed the Maximum Notes Exchange Cap and/or the Maximum New Notes Premium Cap (as defined in the Confidential Offering Circular).

The Exchange Offers are being conducted by Amgen upon the terms and subject to the conditions set forth in a confidential offering circular, dated July 30, 2020 (the "Confidential Offering Circular"). The Exchange Offers are only intended for, and copies of the offering documents will only be made available to, holders of outstanding Old Notes that have certified their status as (1) a "Qualified Institutional Buyer" as defined in Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), in a private transaction in reliance upon the exemption from the registration requirements of the Securities Act provided by Section 4(a)(2) thereof, or (2) (A) a person other than a "U.S. person" (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non-U.S. Qualified Offeree (as described in the Confidential Offering Circular) (each such holder, an "Exchange Eligible Holder" and, collectively, the "Exchange Eligible Holders"). Documents relating to the Exchange Offers have been and will be distributed only to holders of the outstanding Old Notes that have completed or will complete and have returned or will return the letter of eligibility confirming that they are Exchange Eligible Holders. Holders of the outstanding Old Notes that desire to review the eligibility letter may visit the website for this purpose at View Source or contact D.F. King & Co., Inc., the exchange agent and information agent for the Exchange Offers, by calling toll-free (800) 814-8954 or at (212) 269-5550 (banks and brokerage firms) or by email at [email protected].

Per $1,000 principal amount of Old Notes.
Does not reflect any accrued and unpaid interest. Amgen will pay accrued and unpaid interest on the Old Notes to, but not including, the Early Settlement Date (as defined herein) in cash.
The figures in this table reflect any optional adjustments of the principal amount of New Notes exchangeable for each $1,000 principal amount of the applicable series of Old Notes tendered and accepted for exchange, as permitted under the terms and conditions in the Confidential Offering Circular.
The table below indicates the interest rate (the "New Notes Coupon") for the New Notes to be issued by Amgen pursuant to the Exchange Offers, as calculated at the Price Determination Date in accordance with the Confidential Offering Circular:

In accordance with the Acceptance Priority Levels and proration procedures described in the Confidential Offering Circular, Amgen will accept $676,157,000 in aggregate principal amount of the Old Notes that were tendered for exchange at or prior to the Early Participation Date. Amgen expects to deliver an aggregate principal amount of $940,000,000 of New Notes and will pay an aggregate of $85,382,998.17 cash consideration, excluding accrued and unpaid interest, for the Old Notes accepted for exchange on the Early Settlement Date. Since Old Notes have been validly tendered as of the Early Participation Date so that the maximum amount of New Notes to be issued in exchange for such tendered Old Notes would exceed the Maximum Notes Exchange Cap, no additional Old Notes will be accepted for exchange after the Early Participation Date.

The table below indicates, among other things, the principal amount of each series of Old Notes validly tendered as of the Early Participation Date, the principal amount of Old Notes to be accepted for exchange as of the Early Participation Date and the percentage of the principal amount of Old Notes to be accepted for exchange pursuant to the Exchange Offers:

The withdrawal date (5:00 p.m., New York City time, on August 12, 2020) for the Exchange Offers has now passed. In accordance with the terms of the Exchange Offers, tendered Old Notes may no longer be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law. The Exchange Offers will expire at 12:00 Midnight, New York City time, at the end of August 26, 2020, unless extended by Amgen (such date and time, as it may be extended, the "Expiration Date").

Exchange Eligible Holders that validly tendered and did not validly withdraw their Old Notes at or prior to the Early Participation Date will be eligible to receive the applicable Total Exchange Price set forth in the first table above (each, a "Total Exchange Price"), which includes an early exchange premium equal to $30.00 in principal amount of New Notes for each $1,000 principal amount of the applicable series of Old Notes validly tendered and not validly withdrawn at or prior to the Early Participation Date and accepted for exchange (the "Early Exchange Premium").

In addition to the applicable Total Exchange Price, Exchange Eligible Holders whose Old Notes are accepted for exchange will be paid accrued and unpaid interest on such Old Notes to, but not including, the Early Settlement Date in cash.

Amgen has elected to conduct an early settlement for Old Notes tendered at or prior to the Early Participation Date and accepted by Amgen. Such early settlement is expected to occur on August 17, 2020 (the "Early Settlement Date"), subject to all the conditions to the Exchange Offers having been satisfied or waived by Amgen.

The complete terms of the Exchange Offers are described in the Confidential Offering Circular. Amgen reserves the right, subject to applicable law, to extend, terminate or otherwise amend the terms of any or all of the Exchange Offers.

If and when issued, the New Notes will not be registered under the Securities Act or any state securities laws. Therefore, the New Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws. Amgen will enter into a registration rights agreement with respect to the New Notes providing for certain registration rights with respect to the New Notes as described in the Confidential Offering Circular.

This press release is not an offer to sell or a solicitation of an offer to buy any security. The Exchange Offers are being made solely by the Confidential Offering Circular and only to such persons and in such jurisdictions as is permitted under applicable law.

In particular, this communication is only addressed to and directed at: (A) in any Member State of the European Economic Area or the United Kingdom that has implemented the Prospectus Directive, qualified investors in that Member State within the meaning of the Prospectus Directive and (B) (i) persons that are outside the United Kingdom or (ii) persons in the United Kingdom who are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or fall within Article 43 of the Order, or any other person to whom it may otherwise lawfully be communicated under the Order (all such persons together being referred to as "relevant persons"). The New Notes are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such New Notes will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

Seoul Viosys to Develop a Cancer Diagnosis Technology for Companion Animals with Violeds Technology

On August 13, 2020 Seoul Viosys (KOSDAQ: 092190), a leading compound semiconductor solution provider, reported that it has developed an advanced concept technology for early diagnosis of cancer in companion animals with its ultraviolet LED Violeds technology through clinical testing conducted by scientists at the University of Ulsan, based in South Korea (Press release, Seoul Viosys Co, AUG 13, 2020, View Source [SID1234563606]).

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According to Seoul Viosys’ research team, companion animals have a high incidence of cancer as humans, but it has difficulty in early diagnosis of cancer. So Seoul Viosys is in the process of developing a technology that can be applied not only in animals but also in human cancer diagnosis. The early cancer diagnosis method using Violeds light provides a profound study results to show significantly higher sensitivity in detecting cancer than the conventional diagnosis methods and enable to detect all incident cancers.

Seoul Viosys conducted comparative experiments with blood from healthy dogs and from cancer diseased dogs using a biomarker that can be easily collected in this clinical test. As a result, it’s confirmed that cancer diagnosis is possible by only one drop of blood. Seoul Viosys already applied for number of related patents.

Reactive Oxygen Species, ROS caused by various exogenous and endogenous factors damaged to DNA in cells and it can be pathological basis for cancer when this DNA is not repaired in a timely manner. Even though level of DNA damage on cancer cells due to oxidative stress is higher than healthy cells, the difference between the two results is small and it’s difficult to distinguish perfectly. However, Violeds technology provides the advantage that can be able to detect this delicate difference.

"Through the results of the pre-clinical testing with comet assay, an uncomplicated and sensitive technique for the detection of DNA damage at the level of the individual mononuclear cell, by research group of Ulsan University, Seoul Viosys demonstrates that Violeds technology has the performance for significantly high level of 95% sensitivity in detecting cancer for companion animals, but improvement for specificity is needed," said research team at Seoul Viosys.

"If we achieve the improved level of specificity in the future, we will be able to make a positive contribution to a quantum jump in medical technology by enabling early cancer diagnosis with about a tenth price compared to conventional test kits. Seoul Viosys also expects this technology to be used for human cancer diagnosis in the future and looks for relevant and suitable research partners to achieve significant specificity," added the team.

*Light and Violeds

Circadian rhythms as an internal clock that governs the body’s hormone levels and other biological processes such as sleep, wake, and eliminating waste from the body are based on a 24-hour cycle. It is based on natural sunlight, under which all animals and plants on the earth have evolved over 3.9 billion years, being with the beginning of the Earth 4.6 billion years ago. Seoul Viosys has recently launched air purifiers with Violeds light technology proven to sterilize various harmful bacteria and variants of coronavirus. Tracking traces of light is difficult, but if you can bend the light around the Earth, it will orbit 7.5 times per second. Also, it takes 8 minutes for light to reach Earth from the Sun, and hundreds of millions of years from distant galaxies. It is unprecedented that this light may also be used in cancer diagnosis.

BiomX Reports Second Quarter 2020 Financial Results and Provides Business Update

On August 13, 2020 BiomX Inc. (NYSE: PHGE), a clinical stage company developing natural and engineered phage therapies that target specific pathogenic bacteria, reported financial results and provided a business update for the second quarter ended June 30, 2020 (Press release, BiomX, AUG 13, 2020, View Source [SID1234563605]).

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"Following proof of concept clinical results for our phage therapy cocktail BX001 in acne-prone skin earlier this year, we continue to advance the development of multiple phage therapy candidates that have the potential to improve treatment in diverse disease areas," commented Jonathan Solomon, Chief Executive Officer of BiomX. "These candidates are designed with the ability to selectively reduce pathogenic bacterial strains without disrupting beneficial bacteria. Our BX002 program for the treatment of inflammatory bowel disease (IBD) is on track to begin clinical development in the third quarter, with the initial goal of demonstrating an ability to deliver viable phage to the lower gastrointestinal tract. We expect to report pharmacokinetics and safety data from the study by the end of 2020. This is an important step in our clinical development plans for both IBD and primary sclerosing cholangitis (PSC). The Phase 1a results are expected to inform the design of a Phase 1b/2a study aimed at evaluating the efficacy of BX002 in reduction of the target bacteria."

Recent Highlights and Key Upcoming Milestones

BX002 for the Treatment of Inflammatory Bowel Disease

BiomX has completed GMP manufacturing of phage in anticipation of a planned Phase 1a and the facility can now support multiple clinical trials simultaneously.
The first-in-human Phase 1a study of BX002 is expected to begin in the third quarter of 2020, with results expected by the end of 2020. The study is designed to provide pharmacokinetic measurements and safety data, including an assessment of delivery of viable phage to the gastrointestinal system as a key exploratory endpoint.
A Phase 1b/2a study aimed at evaluating the efficacy of BX002 in reduction of the target bacteria Klebsiella pneumoniae is expected to begin in 2021.
BX001 for the Cosmetic Market for the Appearance of Acne-Prone Skin

Following positive results from its Phase 1 cosmetic clinical study, BiomX is on track to initiate a Phase 2 cosmetic clinical study in the first quarter of 2021 with results expected in the second quarter of 2021.
BX003 for the Treatment of Primary Sclerosing Cholangitis

The Company’s program in the rare liver disease primary sclerosing cholangitis (PSC) shares the same bacterial target (Klebsiella pneumoniae) as the IBD program, BiomX plans to apply the Phase 1 study results in IBD to inform the PSC program, with the intention of progressing into Phase 2 development in 2022.
Phage Therapy for Tumor-Targeted Delivery in Cancer

BiomX is exploring phage mediated delivery of therapeutic payloads to Fusobacterium nucleatum bacteria residing in the tumors of patients with colorectal cancer. The results of a proof of concept in animal models are expected in the second quarter of 2021.
Second Quarter 2020 Financial Results

Cash balance and short-term deposits as of June 30, 2020, were $70.6 million, compared to $82.4 million as of December 31, 2019. The decrease was primarily due to net cash used in operating activities.
Research and development expenses were $4.1 million in the second quarter of 2020, compared to $2.9 million in the same period of 2019. The increase was primarily due to the manufacturing of BX001 and BX002, the Company’s product candidates for acne-prone skin and IBD/PSC, respectively.
General and administrative expenses were $2.3 million in the second quarter of 2020, compared to $1.2 million in the same period in 2019. The increase was primarily due to expenses associated with operating as a public company.
Net loss was $6.2 million in the second quarter of 2020, compared to $3.8 million in the same period of 2019.
Net cash used in operating activities was $11.4 million for the six months ended June 30, 2020, compared to $5.9 million in the same period of 2019.
Financial Expectations

Existing cash, cash equivalents and short-term deposits are expected to be sufficient to fund the Company’s current operating plan through mid-2022.
Conference Call Details

BiomX management will host a conference call and webcast today at 8:00 a.m. ET to report financial results for the second quarter of 2020 and provide business updates. To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (international). A live and archived webcast of the call will be available in the Investors section of the company’s website at www.biomx.com.

About Phage

Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Specific phage can target and kill specific bacterial species or strains without disrupting other bacteria or the healthy microbiota. All of BiomX’s phage-based product candidates derive from its proprietary platform, which is first used to discover and validate the association and biologic rationale of specific bacterial strains with human diseases or conditions, and is then used to develop rationally-designed phage combinations ("cocktails") of naturally occurring or synthetic phage to target pathogenic bacteria. The phage cocktails contain multiple phage with complementary functions optimized through in vitro and in vivo testing.