MALVERN, Pa., Aug. 18, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s second quarter 2023 financial results and provide a business update at 8:30 a.m. ET on Tuesday, August 22, 2023.
Ocugen will issue its 2Q23 financial results on Monday, August 21, 2023. Following the press release, the Company will hold the conference call on Tuesday, August 22 at 8:30 a.m. ET. Attendees are invited to participate in the call using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 6803433 Webcast: Available on the events section of the Ocugen investor site
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
MALVERN, Pa., Aug. 17, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (Nasdaq: BXRX), a biotechnology company focused on developing T cell receptor therapies utilizing human regulatory T cells, as well as a portfolio of clinical stage Neuromuscular Blocking Agents and an associated reversal agent, today announced that it has entered into definitive agreements for the purchase and sale of 2,006,544 shares of its common stock and 1,395,243 Series E pre-funded warrants at a purchase price of $0.56 per share of common stock (or $0.55 per prefunded warrant) in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered series A-7 common stock purchase warrants (the “warrants”) to purchase up to 3,401,787 shares of common stock. The warrants have an initial exercise price of $0.56 per share and are not exercisable until the shareholders of the Company approve the issuance of the underlying shares (the “Approval”). The warrants are exercisable for a period of five years commencing from the date the Approval is obtained. Additionally, the exercise price of the warrants will be adjusted upon the Company effecting a reverse stock split, if the post-reverse stock split exercise price of the warrants is higher than the lowest daily VWAP of the common stock during the five trading days following the reverse stock split (the “Adjustment”). If the Adjustment is applicable, the exercise price of the warrants will be reduced to the lowest daily VWAP of the common stock during the five trading days following such reverse stock split, and the number of shares issuable upon exercise of the warrants shall increase such that the aggregate exercise price payable as a result of such Adjustment shall be equal to the aggregate exercise price payable prior to such Adjustment. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about August 21, 2023, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offerings, before deducting offering expenses payable by the Company, are expected to be approximately $1.9 million. The Company intends to use the net proceeds from the offerings for pipeline development activities and general corporate purposes.
The shares of common stock, the prefunded warrants and the shares of common stock underlying the prefunded warrants described above (but not the series A-7 warrants issued in the concurrent private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-253117) previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on September 2, 2021. The offering in the registered direct offering of the shares of common stock, prefunded warrants and the shares of common stock issuable thereunder is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov.
The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
In addition, on August 16, 2023, the Company also amended its series A-5 warrants to purchase 3,478,262 shares of the Company’s common stock (the “Series A-5 Warrants”) and series A-6 warrants to purchase 3,478,262 shares of the Company’s common stock (the “Series A-6 Warrants” and, collectively, the “Amended Warrants”) to (i) adjust the exercise price per share of common stock of the Amended Warrants to $0.56 per share of common stock, (ii) extend the expiration date of the Series A-5 Warrants to August 21, 2028 and (iii) extend the expiration date of the Series A-6 Warrants to February 21, 2025.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be 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 other jurisdiction.
About Baudax Bio
Baudax Bio is a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent. Our TCR Treg programs primarily focus on immune modulating therapies for orphan diseases or complications associated with such diseases, as well as the treatment of autoimmune disorders. We believe that our TCR Treg programs have the potential to provide valuable therapeutic options to patients suffering from diseases for which there are limited treatment options and significant unmet need, as well as to prescribers and payers in these markets.
Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding market conditions, the closing of the offerings, the satisfaction of the closing conditions of the offerings, the approval of the warrants by the Company’s stockholders, and the use of net proceeds from the offerings. These forward-looking statements are based on information available to Baudax Bio as of the date of publication of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, whether Baudax Bio will be able to successfully integrate the TeraImmune operations; whether Baudax’s shareholders will approve the conversion of the Series X Non-Voting Convertible Preferred Stock; whether Baudax Bio’s cash resources will be sufficient to fund its continuing operations and the newly acquired TeraImmune operations, including the liabilities of TeraImmune incurred in connection with the completion of the transactions; risks related to market, economic and other conditions, Baudax Bio’s ability to advance its product candidate pipeline through pre-clinical studies and clinical trials, that interim results may not be indicative of final results in clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates, Baudax Bio’s ability to raise future financing for continued development of its product candidates, Baudax Bio’s ability to pay its debt and to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; Baudax Bio’s ability to maintain listing on the Nasdaq Capital Market; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.
Investor Relations Contact:
Mike Moyer LifeSci Advisors mmoyer@lifesciadvisors.com
Transformative Period Led by Acquisition of TeraImmune
Company to Prioritize Development of New TI-168 Treg Asset for Hemophilia A
Continuing to Advance Neuromuscular Blockade (NMB) Portfolio at Modest Pace
Announcement of Positive Top-Line Results from Phase 2 BX1000 Trial
MALVERN, Pa., Aug. 16, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (Nasdaq:BXRX) (“Baudax Bio” or the “Company”), is a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced results for the three and six months ended June 30, 2023 and provided a business update.
“Our second quarter was a transformative period for Baudax Bio, during which we announced positive top-line results from our Phase 2 BX1000 trial and capped off with our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “The transaction with TeraImmune adds the promising TI-168 clinical stage asset to our portfolio. TI-68 is a next-generation, autologous FVIII TCR-Treg cell therapy candidate to eliminate clotting factor VIII (FVIII) inhibitors in Hemophilia A patients — a rare genetic bleeding disorder that is caused by a lack of FVIII. We believe this is an attractive therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in Hemophilia A with inhibitors, animal models, and with an Investigational New Drug (IND) application already FDA-cleared. We believe we can, with a modest initial budget, activate the Phase 1/2a Clinical Trial of TI-168 for Treatment of hemophilia A with inhibitors. More broadly, we believe that this platform has potential for clinical applications, alone and in combination of, multiple other autoimmune disorders and therapeutic areas. By combining TeraImmune’s world class scientific team with Baudax Bio’s proven ability to execute clinical development programs, we believe we are well positioned to pursue development of TI-168 and realize its clinical potential, for one-time treatment, and further providing proof of concept for this TCR Treg approach.
“As noted above, we announced positive top-line data from our Phase 2 trial of BX1000 showing all patients in three BX1000 study cohorts were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds, and that study treatments were generally well tolerated with no occurrence of severe or serious adverse events,” continued Ms. Henwood. “Based on the strength of data from this program, which were highlighted in the Key Opinion Webinar we hosted, we continue to believe that when combined with our reversal agent BX3000, our NMB regimen may provide improved control of neuromuscular paralysis for surgical patients and deliver the first innovation in NMB in decades.”
“We believe the actions we’ve taken during our second quarter and recent weeks are a win for shareholders of both TeraImmune and Baudax Bio, and we look forward to working with our new colleagues to develop these assets to their full potential,” concluded Ms. Henwood.
Second Quarter 2023 and Recent Business Highlights
Acquisition of TeraImmune
The acquisition of TeraImmune was structured as a stock-for-stock transaction whereby all TeraImmune outstanding equity interests were exchanged for a combination of shares of Baudax common stock and shares of newly designated convertible Series X Non-Voting Convertible Preferred Stock. Subject to shareholder approval of the conversion, each share of Series X Non-Voting Convertible Preferred Stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. On a pro forma basis and based upon the number of shares of Baudax Bio common stock and preferred stock issued in the acquisition, Baudax Bio equity holders immediately prior to the acquisition will own approximately 18% of the combined Company (on an as-converted, fully-diluted basis and excluding certain out-of-the-money warrants held by Baudax Bio’s equity holders) immediately after these transactions. The acquisition was unanimously approved by the Board of Directors of Baudax Bio and the Board of Directors of TeraImmune. The closing of the transaction was not subject to the approval of Baudax Bio shareholders.
Gerri Henwood, President and Chief Executive Officer of Baudax Bio, will continue as CEO of the combined entity. In conjunction with the transaction, Yong Chan Kim, PhD, former Chief Executive Officer of TeraImmune, was appointed to the Board of Directors of Baudax Bio in July.
Nobel Capital provided a fairness opinion to the Baudax Bio Board of Directors.
TI-168 and other Potential Product Candidates
The most advanced of the TeraImmune TCR Tregs is TI-168, intended for one time treatment of Hemophilia A with inhibitors. An IND for a Phase 1/2a study of TI-168 in patients with Hemophilia A with inhibitors has been cleared by FDA. The Company is now in the process of speaking with prospective investigators and assessing the readiness of potential study site staff and logistics for support of the clinical trial. The Company intends to select study sites and file for IRB (Investigational Review Board) approval at those study institutions. Hemophilia A with inhibitors is an Orphan Condition (in terms of numbers of patients) and the Company estimates that the trial would be ready to open one or more initial study sites and begin to enroll patients in approximately Q1 of 2024.
In addition to the TI-168 clinical stage product candidate, the Company has begun research work on other potential candidates for the TCR Treg platform in conditions such as Myasthenia Gravis, which it believes can be advanced to IND stage by approximately the end of 2024/early 2025, as well as other earlier stage potential product candidates.
NMB Portfolio
BX1000 Top-Line Data – The Company announced positive top-line results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery. Results of the study showed that BX1000 met the primary endpoint of readiness for intubation (evaluated as “Good” or “Excellent”) at all dose levels assessed. No severe adverse events were observed in any dose regimen.
Results showed that all patients in three BX1000 study cohorts were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds. There was evidence of a dose-response across the three doses of BX1000, and the degree of blockade for the highest dose group appears comparable to that of the “standard” dose of rocuronium (0.6 mg/kg) employed in the study. Study treatments were generally well tolerated, with no occurrence of severe or serious adverse events. The frequency and severity of adverse events was similar across all four dose groups, and no notable events were aggregated in any one dose group.
A further patient safety follow-up at 28 days after surgery, as well as additional analyses of EMG neuromuscular blockade data, showed a clear dose response for BX1000 on maximum T1 suppression with comparable results for the 1.5x ED95 dose of BX1000 and the 2X ED95 dose of rocuronium. An equivalent “time to 80% NMB” was also observed between the highest dose level for BX1000 (0.35 mg/kg) and rocuronium (0.66 mg/kg). Recovery measures showed equivalent time for “full recovery” for the highest dose of BX1000 (0.35 mg/kg) and rocuronium (0.60 mg/kg), but with tighter, thus more predictable, margins for BX1000.
The Company intends to continue development of its NMB portfolio at a prudent pace while prioritizing development of TI-168.
Financial Results for the Three Months Ended June 30, 2023
As of June 30, 2023, Baudax Bio had cash and cash equivalents of $1.4 million.
Research and development expenses from continuing operations for the three months ended June 30, 2023 were $1.8 million compared to $0.9 million for the three months ended June 30, 2022. The increase of $0.9 million was primarily the result of an increase in clinical and preclinical trials costs associated with our NMB program.
General and administrative expenses from continuing operations for the three months ended June 30, 2023 were $2.3 million compared to $2.9 million for the same prior year period. The decrease of $0.6 million was primarily a result of a reduction in personnel costs of $0.6 million and a decrease in consulting expenses of $0.3 million, partially offset by an increase in public company costs of $0.3 million.
Baudax Bio reported net loss from continuing operations of $(7.3) million, or $(1.49) per share, for the three months ended June 30, 2023. Net loss from continuing operations for the three months ended June 30, 2022 was $(4.3) million, or $(24.20) per share.
Financial Results for the Six Months Ended June 30, 2023
Research and development expenses from continuing operations for the six months ended June 30, 2023 were $4.7 million compared to $1.6 million for the six months ended June 30, 2022. The increase of $3.1 million was primarily due to an increase in operational expenses associated with our NMB program, including clinical and preclinical trials costs, of $2.8 million and an increase in general expenses, including consulting and other outside service expenses, of $0.3 million.
General and administrative expenses from continuing operations for the six months ended June 30, 2023 were $4.0 million compared to $9.8 million for the same prior year period. The decrease of $5.8 million was primarily a result of a reduction in personnel costs of $4.1 million, a decrease in consulting expenses of $0.9 million, a decrease in public company costs of $0.4 million, a decrease of $0.2 million in patent legal expenses and a decrease of $0.2 million in other costs.
Baudax Bio reported net loss from continuing operations of $(14.7) million, or $(4.08) per share, for the six months ended June 30, 2023. Net loss from continuing operations for the six months ended June 30, 2022 was $(12.5) million, or $(89.40) per share.
About Baudax Bio
Baudax Bio/TeraImmune is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibition.
In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory T cells (Tregs) isolated from patients and induced Tregs converted from a patient’s T-effector (Teff) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: uses of proceeds; projected cash runways; future product development plans; and stockholder approval of the conversion rights of the Series X Preferred Stock, in each case, that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, and TeraImmune or its management, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. There are a number of important factors that could cause Baudax Bio’s actual results to differ materially from those indicated or implied by such forward-looking statements including, without limitation: whether Baudax Bio will be able to successfully integrate the TeraImmune operations and realize the anticipated benefits of the acquisition of TeraImmune; whether Baudax Bio’s shareholders approve the conversion of the Series X Preferred Stock and the required cash payment of the then-current fair value of the Series X Preferred Stock if such approval is not provided; whether Baudax Bio’s cash resources will be sufficient to fund Baudax Bio’s continuing operations and the newly acquired TeraImmune operations, including the liabilities of TeraImmune incurred in connection with the completion of the Merger; whether Baudax Bio’s collaborations will be successful; whether Baudax Bio will be able to advance its current product candidate pipeline through preclinical studies and clinical trials, that interim results may not be indicative of final results in clinical trials, that earlier-stage trials may not be indicative of later-stage trials, the approvability of product candidates; whether Baudax Bio will be able to comply with the financial and other covenants under its credit facility; and whether Baudax Bio will be able to maintain its listing on the Nasdaq Capital Market. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Baudax Bio may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.
Important Additional Information and Where to Find It
Baudax Bio, Inc., its directors and certain of its executive officers are deemed to be participants in the solicitation of proxies from Baudax Bio’s shareholders in connection with the matters to be considered at Baudax Bio’s 2023 Special Meeting of Shareholders. Information regarding the names of Baudax Bio’s directors and executive officers and their respective interests in Baudax Bio by security holdings or otherwise can be found in Baudax Bio’s proxy statement for its 2022 Annual Meeting of Shareholders, filed with the SEC on April 28, 2023. To the extent holdings of Baudax Bio’s securities have changed since the amounts set forth in Baudax Bio’s proxy statement for the 2023 Annual Meeting of Stockholders, such changes have been reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC. These documents are available free of charge at the SEC’s website at www.sec.gov. Baudax Bio intends to file a proxy statement and accompanying proxy card with the SEC in connection with the solicitation of proxies from Baudax Bio shareholders in connection with the matters to be considered at Baudax Bio’s 2023 Special Meeting of Shareholders. Additional information regarding the identity of participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in Baudax Bio’s proxy statement for its 2023 Special Meeting, including the schedules and appendices thereto. INVESTORS AND SHAREHOLDERS ARE STRONGLY ENCOURAGED TO READ ANY SUCH PROXY STATEMENT AND THE ACCOMPANYING PROXY CARD AND ANY AMENDMENTS AND SUPPLEMENTS THERETO AS WELL AS ANY OTHER DOCUMENTS FILED BY BAUDAX BIO WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION. Shareholders will be able to obtain copies of the proxy statement, any amendments or supplements to the proxy statement, the accompanying proxy card, and other documents filed by Baudax Bio with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Investor Relations section of Baudax Bio’s corporate website at https://www.baudaxbio.com/news-and-investors.com or by contacting Baudax Bio’s Investor Relations at Baudax Bio, Inc., 490 Lapp Road, Malvern, PA 19355 or by calling Baudax Bio’s Investor Relations at (484) 395-2440.
(amounts in thousands, except share and per share data)
June 30, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
1,416
$
5,259
Prepaid expenses and other current assets
444
303
Current assets of discontinued operation
—
785
Total current assets
1,860
6,347
Property and equipment, net
3,781
9
Right-of-use asset, net
2,939
854
Intangible asset, net
3,500
—
Goodwill
9,236
2,127
Non-current assets of discontinued operation
—
695
Total assets
$
21,316
$
10,032
Liabilities, Non-Voting Convertible Preferred Stock and Shareholders’ Deficit
Current liabilities:
Accounts payable
$
5,828
$
3,198
Accrued expenses and other current liabilities
2,648
2,133
Current portion of long-term debt, net
4,861
5,600
Current portion of operating lease liability
614
231
Current portion of contingent consideration
260
Convertible bond payable
1,000
—
Derivative instrument
5,246
—
Current liabilities of discontinued operation
—
10,298
Total current liabilities
20,457
21,460
Long-term debt, net
—
1,519
Long-term operating lease liability
2,296
585
Deferred tax liability
202
—
Other long-term liabilities
—
13
Non-current liabilities of discontinued operation
—
10,697
Total liabilities
22,955
34,274
Mezzanine equity:
Series X non-voting convertible preferred stock, $0.01 par value, Authorized, 27,090 shares; issued and outstanding 20,066 shares at June 30, 2023
9,040
—
Shareholders’ deficit:
Preferred stock, $0.01 par value. Authorized, 10,000,000 shares; issued and outstanding, 0 shares at June 30, 2023 and December 31, 2022
—
—
Common stock, $0.01 par value. Authorized, 190,000,000 shares; issued and outstanding, 6,961,867 shares at June 30, 2023 and 1,623,913 shares at December 31, 2022
70
16
Additional paid-in capital
176,126
166,646
Accumulated deficit
(186,875
)
(190,904
)
Total shareholders’ deficit
(10,679
)
(24,242
)
Total liabilities, non-voting convertible preferred stock and shareholders’ equity
$
21,316
$
10,032
Consolidated Statements of Operations (Unaudited)
For the Three Months Ended June 30,
For the Six Months Ended June 30,
(amounts in thousands, except share and per share data)
2023
2022
2023
2022
Operating expenses:
Research and development
$
1,779
$
879
$
4,696
$
1,573
General and administrative
2,254
2,898
4,025
9,832
Change in fair value of warrants and derivatives
2,870
(1
)
2,870
(6
)
Change in contingent consideration valuation
142
—
142
—
Total operating expenses
7,045
3,776
11,733
11,399
Operating loss from continuing operations
(7,045
)
(3,776
)
(11,733
)
(11,399
)
Other expense:
Other expense, net
(256
)
(569
)
(2,954
)
(1,140
)
Net loss from continuing operations
$
(7,301
)
$
(4,345
)
$
(14,687
)
$
(12,539
)
Income (loss) on discontinued operation
(74
)
(3,186
)
18,716
(7,801
)
Net income (loss)
$
(7,375
)
$
(7,531
)
$
4,029
$
(20,340
)
Per share information:
Net loss per share from continuing operations, basic and diluted
$
(1.49
)
$
(24.20
)
$
(4.08
)
$
(89.40
)
Net income (loss) per share from discontinued operation, basic and diluted
$
(0.02
)
$
(17.75
)
$
5.20
$
(55.62
)
Net income (loss) per share, basic and diluted
$
(1.51
)
$
(41.95
)
$
1.12
$
(145.03
)
Weighted average common shares outstanding, basic and diluted
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New Trials Expected To Begin In 2H23. Cocrystal reported a 2Q23 loss of $4.2 million or $(0.41) per share, ending the quarter with about $32.4 million in cash. During the quarter, the company selected its protease inhibitor CDI-988 for testing against norovirus. A clinical trial was previously planned to test CD1-988 against SARS-CoV-19, the virus that causes COVID-19. The company has received clearance to begin clinical testing for both indications in Australia. The Phase 2a clinical trial in influenza A is also expected to begin in 2H23.
CDI-988 Moves To Clinical Trials. CDI-988 is a novel 3CL protease inhibitor that targets an enzyme needed in the early steps of viral reproduction. It has been in development against SARS-CoV-2, the virus that causes COVID-19. Earlier this month, CDI-988 was also selected as the lead molecule to be tested against norovirus. A Phase 1 trial has been designed to test safety, tolerability, and pharmacokinetics in both indications. The trial will be conducted in Australia, where clinical testing was approved in May 2023. First data from the trial is expected in 2024.
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Successful submission of final clinical protocol and supporting CMC information to FDA to initiate Phase 3 VERSATILE-003 trial in the fourth quarter 2023
Biomarker data from VERSATILE-002 to be presented at ESMO 2023
Company to host conference call and webcast today at 8:00 AM EDT
PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, will discuss its financial results for the quarter ended June 30, 2023 and provide a business update on its conference call today.
Recent Business Highlights: PDS0101 Lead Drug Candidate
VERSATILE-003: Submitted the final Phase 3 clinical protocol and supporting Chemistry, Manufacturing and Controls (CMC) information to the U.S. Food and Drug Administration (FDA) to enable initiation of the VERSATILE-003 randomized, controlled multicenter study of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer in the fourth quarter 2023
VERSATILE-002: Phase 2 open-label, multicenter study of PDS0101 in combination with KEYTRUDA® in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer
Announced clinical immune response data to be presented at upcoming European Society for Medical Oncology (ESMO) Congress 2023
Biomarker data highlighting HPV16-specific killer and helper T cell responses will be presented
Presented interim data at the 2023 American Society of Clinical Oncology (ASCO) annual meeting, demonstrating a 12-month overall survival rate of 87%, with only 8% of patients experiencing Grade 3 treatment-related adverse events, and no reports of more severe Grade 4 or 5 adverse events
Achieved the efficacy threshold in Stage 2 of this clinical trial for the naïve patient arm
14 patients in the immune checkpoint inhibitor (ICI) naïve arm experienced either a complete response or partial response on two consecutive scans 9-12 weeks apart, constituting a confirmed objective response. This result suggests that PDS0101 has a statistically significant additive effect over published results of ICI monotherapy
Completed enrollment in the ICI naïve arm and expect final data readout in mid-2024
PDS0301 + docetaxel: Phase 2, open label, single-arm trial of PDS0301 in combination with docetaxel in metastatic castration sensitive and castration resistant prostate cancer, led by the National Cancer Institute (NCI)
Announced selection of abstract for oral presentation by the NCI at the upcoming Cytokines 2023 Annual Meeting on October 15-18, 2023
The Phase 2 clinical trial is investigating the safety, immune responses, and clinical activity of the combination in metastatic prostate cancer patients
First clinical trial of an immunocytokine with docetaxel in prostate cancer patients
Business Highlights
PDS Biotech was added to the broad-market Russell 2000® and Russell 3000® Indexes in June 2023
“We continue to make significant strides with our lead candidate, PDS0101, specifically with the regulatory and clinical activities necessary to initiate the VERSATILE-003 trial, as well as with progression of the Phase 2 VERSATILE-002 clinical trial,” stated Dr. Frank Bedu-Addo, CEO of PDS Biotech. “In the second quarter, at ASCO 2023, we presented interim data from VERSATILE-002 which revealed an impressive estimated 12-month overall survival rate of 87% and a progression-free survival of 10.4 months, while maintaining a favorable safety profile when PDS0101 is combined with KEYTRUDA®. The reported 12-month overall survival rate for immune checkpoint inhibitors is 30-50%. These encouraging findings fuel our enthusiasm as we prepare to initiate the Phase 3 VERSATILE-003 clinical trial in which patient overall survival will be the primary trial outcome in the fourth quarter of 2023.”
Dr. Bedu-Addo further commented, “In addition to our enthusiasm for PDS0101, we are thrilled about the prospects of PDS0301 which we believe may potentially overcome some of the key safety and efficacy limitations of current cytokines. We are excited about the NCI’s abstract acceptance at the upcoming Cytokines 2023 annual meeting. We anticipate these results have the potential to offer valuable insights into the use of PDS0301 in conjunction with chemotherapy for various solid tumors, presenting a promising avenue for future development and commercialization possibilities.”
Second Quarter 2023 Financial Results
Net loss for the three months ended June 30, 2023 was approximately $11.5 million, or ($0.37) per basic share and diluted share, compared to a net loss of approximately $5.8 million, or ($0.20) per basic share and diluted share, for the three months ended June 30, 2022. The higher net loss this quarter was primarily due to costs incurred in connection with our research and development programs.
Research and development expenses increased to $8.0 million for the three months ended June 30, 2023 from $3.8 million for the three months ended June 30, 2022. The increase of $4.2 million is primarily attributable to an increase of $1.4 million in clinical trials, $0.5 million in personnel costs, including $0.2 million in non-cash stock-based compensation, and $2.3 million in manufacturing expenses.
General and administrative expenses increased to $4.7 million for the three months ended June 30, 2023 from $3.3 million for the three months ended June 30, 2022. The increase of $1.4 million is primarily attributable to an increase of $0.5 million in personnel costs, including $0.4 million in non-cash stock-based compensation and $0.9 million in professional fees.
Cash and cash equivalents as of June 30, 2023, totaled approximately $60.6 million. Based on the company’s cash resources, PDS Biotech believes this amount is sufficient to fund operations and research and development programs for 12 months following the filing of the Company’s June 2023 Quarterly Report on Form 10-Q which will be filed as of the date of this press release.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT today, August 14, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13731437. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About Versamune® Versamune® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune® based investigational immunotherapies promote a potent targeted T cell attack against cancers expressing the protein. They are given by subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest that Versamune® based investigational immunotherapies, such as PDS0101, demonstrate meaningful disease control by reducing and shrinking tumors, delaying disease progression and/or prolonging survival. Versamune® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. We believe Versamune® based investigational immunotherapies represent a transformative treatment approach for cancer patients to provide improved efficacy, safety and tolerability.
About PDS0101 PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16 targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggests PDS0101 generates clinically effective immune responses and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression, and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.
About PDS0301 PDS0301 is a novel investigational tumor-targeting antibody-conjugated Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. PDS0301 is given by a subcutaneous injection. PDS0301 is designed to improve the safety profile of IL-12 and to enhance the anti-tumor response.
Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.
Common stock, $0.00033 par value, 75,000,000 shares authorized at June 30, 2023 and December 31, 2022, 30,868,188 shares and 30,170,317 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively
10,188
9,956
Additional paid-in capital
155,187,231
145,550,491
Accumulated deficit
(122,753,230
)
(101,558,417
)
Total stockholders’ equity
32,444,189
44,002,030
Total liabilities and stockholders’ equity
$
63,754,250
$
77,007,923
PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Operating expenses:
Research and development expenses
$
8,004,852
$
3,761,646
$
13,848,538
$
8,922,961
General and administrative expenses
4,691,321
3,331,006
8,270,049
6,648,913
Total operating expenses
12,696,173
7,092,652
22,118,587
15,571,874
Loss from operations
(12,696,173
)
(7,092,652
)
(22,118,587
)
(15,571,874
)
Interest income (expenses), net
Interest income
750,654
74,547
1,479,995
80,247
Interest expense
(995,397
)
–
(1,962,242
)
–
Interest income (expenses), net
(244,743
)
74,547
(482,247
)
80,247
Loss before income taxes
(12,940,916
)
(7,018,105
)
(22,600,834
)
(15,491,627
)
Benefit for income taxes
1,406,021
1,198,905
1,406,021
1,198,905
Net loss and comprehensive loss
(11,534,895
)
(5,819,200
)
(21,194,813
)
(14,292,722
)
Per share information:
Net loss per share, basic and diluted
$
(0.37
)
$
(0.20
)
$
(0.69
)
$
(0.50
)
Weighted average common shares outstanding, basic, and diluted
VERSATILE-003 will evaluate PDS0101 in combination with KEYTRUDA® in recurrent or metastatic HPV16-positive head and neck cancer
PDS Biotech anticipates initiating the VERSATILE-003 trial in the fourth quarter of 2023
PRINCETON, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced the submission to the U.S. Food and Drug Administration (FDA) of an updated Chemistry, Manufacturing and Controls (CMC) package and a Phase 3 multicenter registrational protocol to the company’s Investigational New Drug (IND) submission to evaluate the combination of PDS0101 and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of recurrent or metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC). The protocol was developed in accordance with guidance from the FDA on key elements of the Phase 3 program to support the eventual submission of a Biologics License Application (BLA).
The Phase 3 trial, named VERSATILE-003, is a randomized, active comparator-controlled study designed to investigate the safety and efficacy of PDS0101 combined with KEYTRUDA® compared to KEYTRUDA® monotherapy in immune checkpoint inhibitor (ICI)-naïve patients with recurrent or metastatic HPV16-positive HNSCC. The primary efficacy endpoint for VERSATILE-003, per the protocol, is overall survival (OS). The Phase 3 study is expected to involve approximately 90-100 clinical sites globally. PDS Biotech anticipates initiating the VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.
“Submission of the protocol and supportive CMC documents for this Phase 3 registrational trial is an important milestone for PDS Biotech and our VERSATILE-003 program investigating PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent or metastatic HPV16-positive HNSCC,” stated Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer. “Interim data from our ongoing VERSATILE-002 Phase 2 clinical trial have been very encouraging, with impressive interim OS and PFS results. With VERSATILE-003, we have an opportunity to confirm the Phase 2 results from VERSATILE-002 in a controlled, Phase 3 clinical trial comparing the combination of PDS0101 and KEYTRUDA® to KEYTRUDA® monotherapy.”
About PDS0101
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. In a Phase 1 study of PDS0101 in monotherapy, the treatment demonstrated the ability to generate multifunctional HPV16-targeted CD8 and CD4 T cells with minimal toxicity. Interim data suggest PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by reducing or shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.
About VERSATILE-002
VERSATILE-002 is a single-arm Phase 2 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.
Interim efficacy and safety data were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for ICI-naïve patients. Preliminary data from the first 34 patients demonstrated a 12-month overall survival rate of 87% and median progression free survival of 10.4 months. No Grade 4 or higher treatment related adverse events were observed, and Grade 3 treatment related adverse events were observed in 8% of patients.
About VERSATILE-003
VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® and Infectimune® are trademarks of PDS Biotechnology Corporation. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Two Product Acquisitions Plus Four Topline Clinical Trial Results Expected. Tonix reported a loss of $28.4 million or $(2.68) per share, and a cash balance of $25.6 million in cash on June 30, 2023. During the quarter, the company acquired two currently marketed products for migraine headache that turn it into an operating company with product sales. These products fit with its focus on CNS drugs and its four clinical trials that are expected to announce topline results before the end of 2023.
Two CNS Products Have Been Acquired. In June, Tonix acquired two migraine headache products containing sumatriptan with proprietary delivery technologies. Zembrace SymTouch is an injectable sumatriptan packaged with an autoinjector for ease of use. Tosymra is a sumatriptan nasal spray with a permeation enhancer. These products have sales estimated at about $30 million during the previous 12 months. In addition, they add a sales force and CNS customer base for Tonix’s future products.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Full Patient Enrollment Expected Within Six Months
ATLANTA, GA, August 10, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that vaccinations have begun in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355) of GEO-CM04S1 in patients with chronic lymphocytic leukemia (CLL), being conducted at City of Hope National Medical Center.
Despite a high vaccination rate, CLL patients may be at high risk for lethal COVID-19 infection due to poor immune response to currently available vaccines. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone to carry SARS-CoV-2 virus antigens that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. By targeting both the spike (S) and nucleocapsid (N) protein antigens, GEO-CM04S1 broadens the specificity of the immune responses and protects against the loss of efficacy associated with current vaccines due to the significant sequence variation observed with the spike antigen.
The study is examining the use of two injections of GEO-CM04S1, three months apart, to assess immune responses in these vulnerable patients, with an mRNA vaccine (currently, the Pfizer-BioNTech Bivalent vaccine) as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be assessed at 56 days following the first booster injection. Up to 40 participants in each arm will be vaccinated, with immune responses evaluated and compared at the interim and final analyses.
David Dodd, GeoVax President and CEO, stated, “We are very pleased with the rapid start for this third important study for GEO-CM04S1, which we expect will achieve full patient enrollment within six months. We believe the GEO-CM04S1 vaccine, containing the two antigens, S and N, along with the recognized antibody and cellular immune responses resulting from the MVA approach, has the potential to offer greater booster protection than that from the current vaccines in use, as well as provide a greater degree of protection within immunocompromised patients. We expect the CLL trial will add to the data coming from our other ongoing trials, confirming the potential benefit of GEO-CM04S1 in another population of immunocompromised individuals. We look forward to sharing progress reports as we advance.”
About GEO-CM04S1
GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.
A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of GEO-CM04S1 (ClinicalTrials.gov Identifier: NCT04977024) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment) indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. GEO-CM04S1 also continues to advance in another Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
GeoVax Continues To Make Clinical and Preclinical Progress. GeoVax Labs reported a 2Q23 loss of $5.9 million or $(0.22) per share and reviewed progress made during the quarter. The company continues to enroll patients in the Gedeptin Phase 1/2 trial in head and neck cancer, as well as its CM04S1 Phase 2 clinical trials in immunocompromised patients and as a second-generation booster against COVID-19.
Interim Gedeptin Data Was Presented. As discussed in our July 11 Research Note, GeoVax presented interim data from the Phase 1/2 trial testing Gedeptin in head and neck cancer. The presentation included the first 8 patients out of the planned enrollment of 10 patients. Gedeptin achieved Stable Disease in 5 out of 7 evaluable patients, according to RECIST 1.1 criteria. Laboratory measurements showed evidence of successful delivery of the gene, its activation, and immunological markers that were consistent with the expected tissue response.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Progress and Promising Outlook for Gedeptin® and GEO-CM04S1
Phase 2 GEO-CM04S1 Clinical Trial Initiated for Patients with Chronic Lymphocytic Leukemia
Company to Host Conference Call and Webcast Today at 4:30 p.m. ET
Atlanta, GA, August 9, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today announced its financial results for the quarter ended June 30, 2023, and recent corporate highlights.
David Dodd, GeoVax’s Chairman and CEO, commented, “The first half of 2023 has been highly productive for GeoVax, with continued enrollment in, and positive interim clinical data presented for, both of our lead programs, Gedeptin® and GEO-CM04S1. We are also excited to have recently announced the start of an important third Phase 2 clinical study for GEO-CM04S1, in patients with chronic lymphocytic leukemia. Our next-generation COVID-19 vaccine, which utilizes an MVA-vector containing the two antigens, S and N, induces broad and durable antibody and cellular immune responses that we believe has the potential to offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, particularly in highly vulnerable immunocompromised patients.”
Mr. Dodd continued, “In addition to clinical progress, there are other notable achievements that set the stage for our future success. We have made significant progress in developing a high-yield, high-capacity, continuous avian cell line system for manufacturing our MVA-based vaccines and immunotherapies, and we recently partnered with Advanced Bioscience Laboratories, Inc. to support current Good Manufacturing Practices production of our MVA-based products through late-stage development and eventual commercialization. Additionally, the recent expansion of our GEO-CM04S1 rights to include development for Mpox and smallpox adds to other rights we previously secured from the NIH covering preclinical, clinical, and commercial uses of the NIH-MVA. This provides a compelling opportunity to leverage our MVA-based vaccine expertise and help expand the global public health supply options available for the worldwide public health threats posed by SARS-CoV-2, Mpox and smallpox. We expect significant clinical developments and other important events during the remainder of 2023, and we look forward to continuing to share news of our progress.”
Recent Business Highlights:
New Clinical Trial Initiated for GEO-CM04S1. In July, GeoVax announced the start of a Phase 2 COVID-19 vaccine booster investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355) in patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. As a result of their medical status, CLL patients are largely unable to mount a sufficient antibody response to the mRNA vaccines. The trial is expected to enroll approximately 80 patients, comparing GEO-CM04S1 vs the Pfizer/BioNTech Bivalent vaccine. Completion of patient enrollment is expected within approximately six months. This investigator-initiated trial is being primarily funded by a private family foundation with GeoVax supporting the analysis of samples, so it is expected to have minimal impact on the Company’s balance sheet.
Gedeptin® Clinical Trial Data. Interim data from the Phase 1/2 clinical trial of Gedeptin® was presented at the American Association for Cancer Research (AACR) and the American Head and Neck Society (AHNS) joint Head and Neck Cancer Conference in July. The ongoing Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT03754933) is evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck cancers whose tumor(s) are accessible for injection, and who have no curable treatment options. The poster presentation, which can be viewed here, highlighted data from 8 patients enrolled in the study to date, noting no dose-limiting toxicities or serious adverse events definitively attributable to treatment, with impairment of tumor growth in targeted lesions observed in 5 of 7 patients (one patient remaining under study).
The study is being funded in part by the U.S. Food and Drug Administration (FDA) pursuant to its Orphan Products Clinical Trials Grants Program. The FDA has also granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of the mouth, salivary gland, and other oral cavities. GeoVax expects to complete the current trial by year-end 2023, after which expanded development of Gedeptin is anticipated, both as monotherapy and combination therapy in conjunction with other therapies to potentially include immune checkpoint inhibitors, angiogenesis inhibitors, radiation, chemotherapy, etc.
GEO-CM04S1 Clinical Trial Data. In April, unpublished data from the open-label portion of the Phase 2 trial of GEO-CM04S1 in patients with hematologic cancers receiving cell transplants or CAR-T therapy (gov Identifier: NCT04977024) was presented during the 23rd Annual World Vaccine Congress. This trial is investigating GEO-CM04S1 in a profoundly immunosuppressed patient population due to their pre-transplant induction regimens. The preliminary analysis indicates GEO-CM04S1 is highly immunogenic in these patients, inducing both neutralizing antibodies and T cell responses, which the Company believes are important to confer protection against severe COVID-19. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines and is anticipated to include multiple sites both within and outside the U.S.
Further underscoring the need for next-generation COVID-19 vaccines such as GEO-CM04S1, GeoVax scientists co-authored an article titled, “MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development”, published in the June 2023 issue of the online journal Vaccine Insights. The article, accessible here, provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. Regarding COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.
Mpox Vaccine Rights Added to GEO-CM04S1. In April, GeoVax expanded its rights under its license agreement with City of Hope (COH) for GEO-CM04S1, which now grants GeoVax development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2. Orthopoxviruses include Mpox, smallpox, and other viruses that cause disease in humans. GEO-CM04S1, which can induce strong antibody and T cell responses against the SARS-CoV-2 virus variants, also offers the possibility of protection against Mpox and smallpox diseases, further differentiating GEO-CM04S1 as compared to current mRNA-based COVID-19 vaccines. Such attributes may be especially important in vulnerable patient populations, such as the immune-compromised, and in geographic areas where both diseases are endemic. Such a vaccine may offer a simplified vaccine regimen for protection against diseases associated with SARS-CoV-2 and orthopoxviruses.
GEO-MVA (Mpox and smallpox vaccine). Following the recent announcement of GeoVax acquiring the rights from NIH to develop, manufacture and commercialize MVA as a vaccine against Mpox and smallpox, the Company has advanced to active regulatory discussions related to an expedited regulatory path for registration. GeoVax is focused on being the first U.S. supplier of the vaccine, providing expanded supply options for public health worldwide.
Manufacturing Development Progress. In May, GeoVax announced it had entered into an agreement with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of the company’s vaccine candidates, including GEO-CM04S1. ABL, a subsidiary of Institut Mérieux, is a pure-play contract development and manufacturing organization (CDMO) specialized in the development and manufacturing of gene therapies, oncolytic viruses, and vaccine candidates. With cGMP facilities in the U.S. and Europe, ABL is well-positioned to support GeoVax’s global development programs through late-stage development and eventual commercialization.
Earlier in 2023, GeoVax announced significant progress in developing a high-yield, high-capacity, continuous avian cell line system for manufacturing its MVA-based vaccines and immunotherapies. The Company is accelerating activities towards fully implementing a proprietary, continuous cell line manufacturing system that will provide lower-cost, scalable versatility for broad MVA vaccine and immunotherapy applications. GeoVax is on course to expand MVA applications from stockpile-based solutions for niche medical markets to have the capability to respond to large-scale worldwide requirements on a timely basis.
Preclinical Programs. Data from recent nonhuman primate studies of GEO-MM01 against Marburg virus were presented during the 23rd Annual World Vaccine Congress. Of particular interest, immunization with GEO-MM01 conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus. Vaccination protected nonhuman primates from viremia, weight loss, and death following challenge with a lethal Marburg virus dose. Evaluation of immune responses following vaccination demonstrated the presence of both neutralizing antibodies and functional T cells, indicating a breadth of response capable of offering significant protection.
Patent Portfolio Development. In July, GeoVax announced that the U.S. Patent and Trademark Office issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company’s patent application No. 15/543,139 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40).” The claims granted by the patent generally cover GeoVax’s vector platform for expressing ebolavirus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus. GeoVax previously demonstrated that a single intramuscular (IM) dose of its vaccine candidate, GEO-EM01, provided 100% protection in rhesus macaques challenged with a lethal dose of Zaire ebolavirus (EBOV). Additionally, the Company’s preclinical efficacy studies of its Sudan ebolavirus (SUDV) vaccine candidate demonstrated that a single dose of the vaccine protected 100% of small animals challenged with a lethal dose of SUDV.
Earlier in 2023, GeoVax announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, “Method for Generating a ZIKV Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein.” Preclinical studies demonstrated that a single dose of GEO-ZM02 provided 100% protection against a lethal dose of the Zika virus.
These patents add to the Company’s growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.
Financial Results
Net Loss: Net loss for the three months ended June 30, 2023, was $5,927,620, or $0.22 per share, as compared to $2,241,699, or $0.18 per share, for the comparable period in 2022. For the six months ended June 30, 2023, the Company’s net loss was $9,965,536 ($0.38 per share) as compared to a net loss of $4,669,214 ($0.47 per share) in 2022.
R&D Expenses: Research and development expenses were $4,719,728 and $7,538,917 for the three-month and six-month periods ended June 30, 2023, compared to $1,307,177 and $2,637,721 for the comparable periods in 2022, with the increases primarily due to the cost of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, additional personnel costs, technology license fees, costs of preclinical research activities and a generally higher level of activity.
G&A Expenses: General and administrative expenses were $1,459,093 and $2,910,518 for the three-month and six-month periods ended June 30, 2023, compared to $935,311 and $2,114,335 for the comparable periods in 2022, with the increases primarily due to higher personnel costs, investor relations consulting costs, patent costs and other expenses supportive of a higher level of activity.
Cash Position: GeoVax reported cash balances of $17,788,911 at June 30, 2023, as compared to $27,612,732 at December 31, 2022.
Summarized financial information is included. Further information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.
Conference Call Details
Management will host a conference call scheduled to begin at 4:30 p.m. ET today, August 9, 2023, to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.
A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
PRINCETON, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that the Company will release financial results for the second quarter of 2023 on Monday, August 14, 2023, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.
Monday, August 14, 2023, 8:00 AM ET Domestic: 877-407-3088 International: 201-389-0927 Conference ID: 13739270 Webcast: PDS Biotech Earnings Webcast
After the live webcast, the event will be archived on PDS Biotech’s website for six months.
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
PRINCETON, N.J., Aug. 02, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that Dr. Frank Bedu-Addo, Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2023 being held August 7-8, 2023. Details for the event are as follows:
BTIG Virtual Biotechnology Conference 2023 Presentation Date: Tuesday, August 8, 2023 Event: Fireside chat Time: 11:30 AM EDT
For more information about the conference or to schedule one-on-one meetings, please contact your BTIG representative directly.
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune® T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune® based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
GeoVax to Host Second Quarter 2023 Conference Call at 4:30 PM ET
ATLANTA, GA, July 26, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, announced today that it will report second quarter 2023 financial results on Wednesday, August 9, 2023, after the market closes.
Following the release, management will host a live conference call and webcast to provide a general business update and discuss financial results. Subsequent to management’s prepared remarks, there will be a Q&A period for analysts and others.
A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.
