On August 10, 2022 NightHawk Biosciences (NYSE American: NHWK), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported strategic, financial, and operational updates for the second quarter ended June 30, 2022 (Press release, NightHawk Biosciences, AUG 10, 2022, View Source [SID1234618042]).

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Jeff Wolf, Chief Executive Officer of NightHawk, commented, "We continue to advance our evolution towards becoming a fully-integrated biopharmaceutical company via our subsidiary ecosystem. Specifically, we are on track to open the Scorpion San Antonio biologics manufacturing facility in Q3 and are actively progressing development efforts for our newly-announced commercial scale biomanufacturing facility in Manhattan, Kansas. We intend to provide a full suite of CDMO manufacturing and bioanalytic services to biopharmaceutical clients. I’m pleased to report that feedback from prospective customers has been positive, and we look forward to commercial announcements in the near-term."

"On the clinical front, we continue to evaluate a variety of strategic options for our HS-110 and PTX-35 programs moving forward. Our Elusys subsidiary recently executed a contract to deliver ANTHIM to Canada’s National Emergency Strategic Stockpile, our first sale of ANTHIM outside the United States. Finally, we continue to advance our research efforts and expand our pipeline through ongoing development at our Skunkworx subsidiary. Overall, we are extremely encouraged by the outlook for the business and look forward to providing further updates on our growing pipeline and commercial activities."

Second Quarter 2022 Financial Results

Recognized $0.05 million of contract revenue for the quarter ended June 30, 2022 compared to $0.5 million of grant and contract revenue for the quarter ended June 30, 2021. The decrease in grant revenue in the current-year period is due to the fact that we recognized all $15.2 million of grant revenue during 2021. As of June 30, 2022, we had a grants receivable balance of $1.5 million for CPRIT proceeds not yet received, but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
Research and development expenses were $4.7 million for the three months ended June 30, 2022 compared to $4.2 million for the three months ended June 30, 2021. The increase was primarily due to expenses associated with the ongoing Phase 1 clinical trial of PTX-35, integration costs associated with ANTHIM, as well as unallocated research expenses consisting of personnel costs, including stock-based compensation from stock awards, contractor expense and supplies purchased for discovery projects.
General and administrative expenses were $4.9 million and $2.9 million for the three months ended June 30, 2022 and 2021, respectively. The increase was due to increased labor and consulting costs, additional facility and office expenses and other professional services, and an increase in stock-based compensation expense.
Net loss attributable to NightHawk Biosciences was approximately $10.2 million, or ($0.40) per basic and diluted share for the three months ended June 30, 2022, compared to approximately $6.5 million, or ($0.26) per basic and diluted share for the three months ended June 30, 2021.
As of June 30, 2022, the Company had approximately $69.9 million in cash and cash equivalents.

On August 10, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the second quarter ended June 30, 2022 (Press release, Tracon Pharmaceuticals, AUG 10, 2022, View Source [SID1234618041]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We continue to have robust accrual in the ENVASARC pivotal trial as we have enrolled more than 36 patients and look forward to reporting the interim efficacy analysis on the initial 36 patients in the fourth quarter, after each patient has had two on-study scans." said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, we await the outcome of the binding arbitration relating to I-Mab’s alleged breaches of the TJ4309 and bispecific antibody agreements, and anticipate completing the TJ4309 Phase 1 trial that permits I-Mab the opportunity to terminate the license for a $9M payment to TRACON. We expect both the arbitration decision and the termination of the TJ4309 license to occur this year."

Recent Corporate Highlights

In June, we announced a registered direct financing of approximately $4.0 million in the aggregate with an accredited institutional healthcare-focused fund, which was completed at market price.

In July, we announced the enrollment of the 36th patient in the ENVASARC Phase 2 pivotal trial at the 600 mg dose of envafolimab.

In August, we announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

In August, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC trial proceed as planned following the review of more than three weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.
Expected Key 2022 Milestones

Report the interim safety analysis by the IDMC following the review of more than twelve weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Report the interim efficacy analysis by the IDMC following the review of more than twelve weeks of efficacy data from 36 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Initiate dosing in the Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy.

Report the International Chamber of Commerce (ICC) Arbitration Panel’s (the Tribunal) binding decision in the ongoing arbitration involving the TJ4309 and bispecific antibody agreements with I-Mab Biopharma where we are seeking to recover over $200 million in damages.

Complete the TJ4309 Phase 1 clinical trial permitting I-Mab the opportunity to terminate the TJ4309 license for a $9.0 million payment to TRACON.
Second Quarter 2022 Financial Results

Cash and cash equivalents were $13.6 million at June 30, 2022, compared to $24.1 million at December 31, 2021 and is expected to fund the company into 2023.

Research and development expenses for the second quarter of 2022 were $2.9 million, compared to $3.1 million for the second quarter of 2021.

General and administrative expenses for the second quarter of 2022 were $3.3 million, compared to $6.1 million for the second quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the second quarter of 2021 due to the now stayed lawsuit filed by I-Mab in the Delaware Court of Chancery involving the TJ4309 agreement.

Net loss for the second quarter of 2022 was $6.2 million, compared to $8.9 million for the second quarter of 2021.
Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About TRC102

TRC102 (methoxyamine) is a novel small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On August 10, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2022 (Press release, ChromaDex, AUG 10, 2022, View Source [SID1234618040]).

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Second Quarter 2022 and Recent Highlights

Total net sales were $16.7 million, with $14.5 million from Tru Niagen, down 5% and 6% from the prior year period, respectively.
Total net sales and Tru Niagen net sales remained relatively flat year over year excluding the initial shelf stocking sales to Wal-Mart in the second quarter of 2021. Sales were also impacted by the timing of shipments to Watson’s due to COVID-19 ($1.5 million versus $2.9 million in the prior year period).
Strong gross margin of 60% despite lower sales and inflationary pressures in global supply chains.
General and administrative expense decreased $2.0 million from the prior year quarter driven by lower legal expense.
Announced agreement to launch commercial joint venture in Mainland China, marking an expansion milestone for the brand in a strategic market. Signed agreement with Sinopharm Xingsha to accelerate cross-border sales of Tru Niagen.
Partnered with Juvenis for cross-border sales of Tru Niagen into South Korea, furthering Asia expansion strategy.
In May 2022, the ChromaDex External Research Program (CERP) was honored in the "Nutrition Research Project" category for pioneering research behind Niagen.
"Our team is doing great work in a challenging environment," said CEO Rob Fried. "The e-commerce business continues to grow, and we are excited about our new partnerships in China and South Korea. We are placing greater emphasis on operating efficiency and profitable growth in the second half of the year."

Results of operations for the three months ended June 30, 2022 compared to the prior year quarter

For the three months ended June 30, 2022 ("Q2 2022"), ChromaDex reported net sales of $16.7 million, a decrease $1.0 million or (5)% compared to the second quarter of 2021 ("Q2 2021"). The decline in Q2 2022 revenues compared to Q2 2021 was related to the initial shelf stocking in Wal-Mart to support our launch in the prior quarter driving increased sales in Q2 2021, paired with lower sales to A.S. Watson, a related party, during Q2 2022, which was impacted by timing of shipments due to COVID-19. These declines were largely offset by growth in e-commerce sales of Tru Niagen.

Gross margin percentage declined to 60.0% in Q2 2022 compared to 61.1% in Q2 2021 primarily due to business mix and increases in supply chain headcount to scale the business.

Operating expense was flat at $16.4 million in Q2 2022, compared to $16.4 million in Q2 2021. For operating expense, there was a $2.0 million decrease in general and administrative expense which was largely offset by $1.8 million of higher selling and marketing expense. The increase in selling and marketing expense was related to brand building activities, including the new Tru Niagen television campaign. We expect to scale back our larger brand campaigns in the second half of 2022, as we shift our focus to more efficient distribution channels, primarily e-commerce, coupled with overall expense management.

The net loss for Q2 2022 was $6.4 million or $(0.09) per share compared to a net loss of $5.6 million or $(0.08) per share for Q2 2021. Adjusted EBITDA including legal expense, a non-GAAP measure, delivered a loss of $4.6 million for Q2 2022, a $1.1 million decline from Q2 2021. Adjusted EBITDA excluding legal expense, a non-GAAP measure, was a loss of $2.9 million for Q2 2022. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP measures to net loss, the most directly comparable GAAP measure.

For Q2 2022, net cash outflow from operating activities was $3.8 million, compared to $7.9 million in Q2 2021 largely due to changes in working capital including improvements in the collections of trade receivables.

2022 Full Year Outlook

Looking forward, for the full year, the Company expects high single digit revenue growth, driven by its global e-commerce business, offset by slower growth with new, and existing, partners. For the full year, the Company expects approximately 60% gross margin, selling and marketing expense will be down as a percentage of net sales, approximately $1 million increase in R&D, and approximately $6 to 7 million decrease in general and administrative expense, as reported, driven by lower legal expense. The Company expects to approach cash flow break-even in the third quarter and be cash flow break-even or better in the fourth quarter of 2022. The Company considers Adjusted EBITDA including legal expense, a non-GAAP metric, to be a proxy for cash flow before working capital investments, and is targeting cash flow break-even on that basis.

Investor Conference Call

A live webcast will be held Wednesday, August 10, 2022 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The toll-free dial-in information for this call is 1-888-330-2446 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on August 10, 2022 to 11:59 p.m. Eastern time on August 17, 2022. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

On August 10, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the second quarter ended June 30, 2022, and provided a business update (Press release, Ascendis Pharma, AUG 10, 2022, View Source [SID1234618039]).

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"Our anticipated launch of TransCon PTH in the U.S. next year, combined with our progress towards making SKYTROFA the leading product in a growing growth hormone market, moves us closer to fulfilling our Vision 3×3 and becoming a sustainable, profitable, leading biopharma company," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.

Company Highlights & Progress

TransCon hGH:
SKYTROFA revenue continued to double quarter-to-quarter, reaching €4.4 million in the second quarter.

In June 2022, submitted a trial protocol to the FDA to evaluate TransCon hGH in Turner Syndrome.
The foresiGHt Trial in adult GHD on track to complete enrollment by the end of 2022.
Enrollment in the riGHt Trial, a Phase 3 trial in Japan for pediatric GHD, is expected to complete by the end of 2022.
Commercial launch of TransCon hGH planned for Europe in mid-2023.
TransCon PTH:
Following pre-NDA meeting with the FDA, on track to submit regulatory filing in the U.S. during the third quarter of 2022, with expected U.S. launch in mid-2023.
EU MAA submission planned during the fourth quarter of 2022.
After more than two years of treatment in the open-label extension portion of the Phase 2 PaTH Forward Trial, 57 out of 59 original subjects continue in the open label extension portion of the trial as of June 30, 2022.
In the Phase 3 PaTHway Trial, 79 out of 79 patients completed one-year follow-up; 78 out of 79 patients continue in the open-label extension portion of the trial as of June 30, 2022.
TransCon CNP:
Top-line data from the ACcomplisH Trial, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in North America, Europe, and Oceania in children ages 2-10 years with achondroplasia expected in the fourth quarter of 2022.
Planned fourth-quarter regulatory submissions for a new global randomized, double-blind, placebo-controlled Phase 2b trial of TransCon CNP in children down to 2 years of age with achondroplasia.
TransCon TLR7/8 Agonist:
Enrollment continues in transcendIT-101, a Phase 1/2 trial of TransCon TLR7/8 Agonist with or without a checkpoint inhibitor in patients with advanced or metastatic solid tumors who have failed prior lines of therapy.
transcendIT-101 monotherapy and combo-therapy dose escalation top-line data are expected during the third quarter of 2022.
TransCon IL-2 β/γ:
The Phase 1/2 IL-βelieγe Trial evaluating TransCon IL-2 β/γ monotherapy in patients with locally advanced or metastatic solid tumors continues to enroll patients. The Phase 1/2 IL-βelieγe Trial top-line data are expected in the fourth quarter of 2022.
During the second quarter of 2022, dosed first patient in combination checkpoint inhibitor and TransCon IL-2 β/γ dose-escalation arm of the IL-βelieγe Trial.
TransCon TLR7/8 Agonist and TransCon IL-2 β/γ Combination Therapy:
Plan to submit an IND or similar for Phase 2 cohort expansion for TransCon TLR7/8 Agonist and TransCon IL-2 β/γ during the fourth quarter of 2022.
Board of Directors to nominate Bill Fairey, and Siham Imani, both leaders in pharmaceutical commercialization, as new independent board members. The Board of Directors will call into an Extraordinary General Meeting to take place first half of September 2022.
Ended the second quarter of 2022 with cash, cash equivalents, and marketable securities totaling €995 million.
Second Quarter 2022 Financial Results

Total revenue for the second quarter was €6.2 million compared to €1.0 million in the same quarter of 2021. Revenue included U.S. revenue from SKYTROFA, as well as license, clinical supply and services provided to third parties, primarily VISEN Pharmaceuticals. The increase in revenue compared to the same period the prior year was primarily attributable to the €4.4 million commercial revenue from SKYTROFA (lonapegsomatropin-tcgd) in the second quarter following U.S. commercial launch in October 2021.

Research and development (R&D) costs for the second quarter were €90.4 million compared to €83.3 million during the same period in 2021, reflecting primarily higher employee costs resulting from an increase in the number of R&D related personnel.

Selling, general, and administrative (SG&A) expenses for the second quarter were €56.6 million compared to €35.3 million during the same period in 2021. Higher SG&A expenses were primarily due to an increase in commercial and administrative personnel following the launch of SKYTROFA.

Our share of net loss of associate was €1.2 million in the second quarter, compared to a net loss of €4.8 million during the same period in 2021.

Net finance income was €61.7 million in the second quarter compared to a net finance expense of €12.0 million in the same period in 2021.

For the second quarter of 2022, Ascendis Pharma reported a net loss of €81.3 million, or €1.46 per share (basic and diluted) compared to a net loss of €134.4 million, or €2.50 per share (basic and diluted) for the same period in 2021.

As of June 30, 2022, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €994.9 million compared to €789.6 million as of December 31, 2021. As of June 30, 2022, Ascendis Pharma had 56,965,058 ordinary shares outstanding.

Conference Call and Webcast Information

Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its second quarter 2022 financial results.

Those who would like to listen to the live webcast can access it through the following link. To access the live teleconference, register online here. Participants are encouraged to register at least 15 minutes prior to the call.

A replay of the webcast will be available on the Investors & News section of the Ascendis Pharma website at View Source shortly after conclusion of the event for 30 days.

On August 10, 2022 Athenex, Inc. ("Athenex") (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it intends to offer and sell, subject to market conditions, shares of its common stock, or pre-funded warrants to purchase common stock in lieu of common stock to certain investors, and accompanying warrants to purchase shares of its common stock, in an underwritten public offering (Press release, Athenex, AUG 10, 2022, View Source [SID1234618038]). All of the shares of common stock, warrants and pre-funded warrants are being offered by Athenex.

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SVB Securities is acting as sole book-running manager for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The offering is being made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from: SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

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